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This is a new policy published on 1/28/2020. It will be effective on 2/29/2020 or later.
  
Horizon BCBSNJ
Uniform Medical Policy ManualSection:Treatment
Policy Number:163
Effective Date: 02/29/2020
Original Policy Date:01/28/2020
Last Review Date:
Date Published to Web: 01/28/2020
Subject:
Radiofrequency Coblation Tenotomy for Musculoskeletal Conditions

Description:
_______________________________________________________________________________________

IMPORTANT NOTE:

The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.

Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.

__________________________________________________________________________________________________________________________

Radiofrequency (RF) coblation is being evaluated for the treatment of plantar fasciitis, lateral epicondylitis, and various musculoskeletal tendinopathies. When utilized for tenotomy, bipolar RF energy is directed into the tendon to generate a controlled, low-temperature field of ionizing particles that break organic bonds, ablating or debriding target tissue with the goal of relieving pain and restoring function.

PopulationsInterventionsComparatorsOutcomes
Individuals:
    • With plantar fasciitis
Interventions of interest are:
    • Radiofrequency coblation tenotomy
Comparators of interest are:
    • Conservative therapy (eg, physical therapy, activity modification, splinting or bracing, orthotics)
    • Nonsteroidal anti-inflammatory therapy
    • Local corticosteroid injections
    • Standard surgery
Relevant outcomes include:
    • Symptoms
    • Functional outcomes
    • Quality of life
    • Medication use
    • Treatment-related morbidity
Individuals:
    • With lateral epicondylitis or wrist tendinopathy
Interventions of interest are:
    • Radiofrequency coblation tenotomy
Comparators of interest are:
    • Conservative therapy (eg, physical therapy, activity modification, splinting or bracing)
    • Nonsteroidal anti-inflammatory therapy
    • Standard surgery
Relevant outcomes include:
    • Symptoms
    • Functional outcomes
    • Quality of life
    • Medication use
    • Treatment-related morbidity
Individuals:
    • With shoulder or rotator cuff tendinopathy
Interventions of interest are:
    • Radiofrequency coblation tenotomy
Comparators of interest are:
    • Conservative therapy (eg, physical therapy, activity modification)
    • Nonsteroidal anti-inflammatory therapy
    • Local corticosteroid injection
    • Standard surgery
Relevant outcomes include:
    • Symptoms
    • Functional outcomes
    • Quality of life
    • Medication use
    • Treatment-related morbidity
Individuals:
    • With Achilles tendinopathy
Interventions of interest are:
    • Radiofrequency coblation tenotomy
Comparators of interest are:
    • Conservative therapy (eg, physical therapy, activity modification, splinting or bracing)
    • Nonsteroidal anti-inflammatory therapy
    • Standard surgery
Relevant outcomes include:
    • Symptoms
    • Functional outcomes
    • Quality of life
    • Medication use
    • Treatment-related morbidity
Individuals:
    • With patellar tendinopathy
Interventions of interest are:
    • Radiofrequency coblation tenotomy
Comparators of interest are:
    • Conservative therapy (eg, physical therapy, activity modification, splinting or bracing)
    • Nonsteroidal anti-inflammatory therapy
    • Standard surgery
Relevant outcomes include:
    • Symptoms
    • Functional outcomes
    • Quality of life
    • Medication use
    • Treatment-related morbidity

BACKGROUND

Radiofrequency Coblation

RF coblation uses bipolar low-frequency energy in an electrically conductive fluid (eg, saline) to generate a high-density plasma field around the energy source. This creates a low-temperature field of ionizing particles that break organic bonds within the target tissue. Coblation technology is used in a variety of surgical procedures, particularly related to otolaryngology and orthopedics. The proposed advantage of coblation is that the procedure provides for controlled and highly localized ablation, resulting in minimal damage to surrounding tissue. RF coblation was also found to exhibit several properties that may make it an attractive option for addressing the underlying pathophysiology of chronic tendinopathies, namely increased angiogenesis, reduction of inflammatory responses, and increased expression of growth factors. RF coblation surgical wands are utilized by orthopedic surgeons in minimally invasive arthroscopic procedures to facilitate soft tissue debridement, subacromial decompression, meniscal removal and sculpting, or tendon debridement.

The use of coblation technology for disc nucleoplasty and sacroiliac joint pain is addressed separately in 'Decompression of the Intervertebral Disc Using Laser Energy (Laser Discectomy) or Radiofrequency Coblation (Nucleoplasty)' (Policy #077 in the Treatment Section), and 'Radiofrequency Joint Ablation/Denervation' (Policy #158 in the Treatment Section).

Tendinopathy

Tendinopathy is a clinical pain syndrome characterized by tendon thickening due to proliferation and chronic irritation of neovascular repair tissue with a history of repetitive tendon loading. This condition commonly results from overuse and has a high incidence rate in athletes and laborers. Clinical history should clarify predisposing training or activity and assess the level of functioning. Biomechanical abnormalities during activity should be identified and corrected. Standard treatment may, therefore, consist of biomechanical modification, activity modification, physical therapy (eg, heavy load resistance training), and nonsteroidal anti-inflammatory medication. For chronic tendinopathies, glucocorticoids should only be used in select cases (eg, rotator cuff tendinopathy). Surgical consultation following six months of a well-designed physical therapy program with adjunct medical treatments can be considered if there is no improvement in pain or function. Validated and reliable functional assessment scores should be utilized by the clinician to grade symptoms and assess patient function. Examples of suitable scales include the Victoria Institute of Sport Assessment for Achilles tendinopathy. Surgical approaches may involve incisions to the paratendon and removal of adhesions and degenerate tissue. Longitudinal incisions may be made in the tendon to promote a repair response. This latter strategy has also been delivered via minimally invasive arthroscopic approaches. These approaches may also address the debridement of the neovascular supply to the tendon surface. Collectively, a prolonged recovery duration to accommodate tendon healing may be required with these interventions.

Plantar Fasciitis

Plantar fasciitis is a musculoskeletal condition characterized by pain in the plantar region of the foot that worsens upon initiation of walking and with local point tenderness elicited during a clinical examination. Radiographic and ultrasonographic studies are not typically indicated for primary diagnosis but may be useful in ruling out alternative causes and visualizing the thickening of the plantar fascia. Initial standard therapy may consist of stretching exercises, orthotics, activity and lifestyle modification, nonsteroidal anti-inflammatory drugs, splints or casts, and glucocorticoid injections. The vast majority of patients improve without surgery. Surgery is generally considered a last line of therapy and is reserved for individuals who do not respond to at least 6 to 12 months of initial, nonsurgical therapy. Surgical approaches include variations of open or endoscopic, partial or complete, plantar fascia release which may or may not include calcaneal spur resection, excision of abnormal tissue, and nerve decompression. The use of RF microtenotomy during open or percutaneous surgery has been explored alone or in combination with plantar fasciotomy.

Plantar fasciitis is one of the most common causes of foot and heel pain in adults. It is estimated to be responsible for approximately one million patient medical visits per year in the U. S. The peak incidence of the condition in the general population occurs between ages 40 and 60. There is a higher incidence rate among runners with a younger age of onset. The etiology of plantar fasciitis is poorly understood and may be multifactorial in nature. Contributing risk factors may include obesity, prolonged standing or activity, flat feet, and reduced ankle dorsiflexion. Plantar fasciitis has been reported in association with fluoride use for the treatment of osteoporosis. Differential sources of foot and heel pain may include Achilles tendinopathy, stress fractures due to osteoporosis, rheumatoid arthritis, peripheral neuropathies associated with diabetes, extrinsic factors (eg, inappropriate footwear), aging, and structural disorders.

Lateral Epicondylitis

Lateral epicondylitis, also known as tennis elbow, represents chronic tendinosis of the myotendinous group of the lateral epicondyle characterized by pain and disability. The incidence in the general population may approach 1 to 3 percent. Risk factors include smoking, obesity, forceful activity, and repetitive activity for at least two hours daily. Lateral epicondylitis is characterized by injury to the extensor carpi radialis brevis or extensor digitorum communis muscles. The condition is diagnosed through findings of localized tenderness and pain with clinical examination. Initial conservative management includes modification of activity and biomechanics, counterforce bracing or splinting, nonsteroidal anti-inflammatory drugs, and physical therapy. Surgical referral is typically reserved for patients with severe symptoms that do not improve despite compliance with an appropriately designed physical therapy program for at least six months.

Regulatory Status

In 2014,the TOPAZ® EZ Microdebrider Coblation® Wand with Integrated Finger Switch, an electrosurgical cutting and coagulation device (ArthroCare Corporation, K140521), was cleared for marketing by the U.S. Food and Drug Administration through the 510(k) process, on the basis of an earlier predicate device (ArthroCare Topaz Wand, K080282, 2008). The surgical wands are indicated for debridement, resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures, including fasciotomy, synovectomy, tenotomy, and capsulotomy of the foot and tenotomy of the knee, wrist, elbow, ankle, shoulder, and rotator cuff. Food and Drug Administration product code: GEI.

Related Policies

  • Radiofrequency Joint Ablation/Denervation (Policy #158 in the Treatment Section)
  • Decompression of the Intervertebral Disc Using Laser Energy (Laser Discectomy) or Radiofrequency Coblation (Nucleoplasty) (Policy #077 in the Treatment Section)

Policy:
(NOTE: For Medicare Advantage and Medicaid Products, please refer to the respective sections below for coverage guidance.)

Radiofrequency coblation tenotomy is considered investigational as a treatment for musculoskeletal conditions, including but not limited to the following conditions:
    • plantar fasciitis
    • lateral epicondylitis
    • shoulder or rotator cuff tendinopathy
    • Achilles tendinopathy
    • patellar tendinopathy
    • wrist tendinopathy


Medicare Coverage:
There is no National Coverage Determination (NCD). In the absence of an NCD, coverage decisions are left to the discretion of Local Medicare Carriers. Novitas Solutions, Inc, the Local Medicare Carrier for jurisdiction JL, has not issued a determination for this service. Therefore, Medicare Advantage Products will follow the Horizon BCBSNJ Medical Policy.


Medicaid Coverage:


[RATIONALE: This policy was created in 2020 with searches of the MEDLINE database through October 3, 2019.

Evidence reviews assess the clinical evidence to determine whether the use of technology improves the net health outcome. Broadly defined, health outcomes are the length of life, quality of life (QOL), and ability to function including benefits and harms. Every clinical condition has specific outcomes that are important to patients and managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.

To assess whether the evidence is sufficient to draw conclusions about the net health outcome of technology, two domains are examined: the relevance, and quality and credibility. To be relevant, studies must represent one or more intended clinical use of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial (RCT) is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. RCTs are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.

Plantar Fasciitis

Clinical Context and Therapy Purpose

The purpose of radiofrequency (RF) coblation tenotomy is to provide a treatment option that is an alternative to or an improvement on existing therapies for patients with musculoskeletal conditions.

The question addressed in this policy is: Does the use of RF coblation tenotomy improve the net health outcome in patients with plantar fasciitis?

The following PICOs were used to select literature to inform this review.

Patients

The relevant population of interest are individuals with plantar fasciitis.

Interventions

The therapy being considered is RF coblation tenotomy, also referred to as microtenotomy. Patients with plantar fasciitis are managed by orthopedic specialists and physical therapists in an outpatient setting.

Comparators

The following practice is currently being used to treat plantar fasciitis: conservative management, including orthotics, activity and lifestyle modification, splinting or casting, and physical therapy. Surgical referral may be appropriate for patients not responding to at least 6 to 12 months of initial, non-operative therapy. Surgical interventions include variations of open or endoscopic, partial or complete, plantar fasciotomy which may or may not include calcaneal spur resection, excision of abnormal tissue, and nerve decompression.

Outcomes

The general outcomes of interest are symptoms, functional outcomes,QOL, medication use, and treatment-related morbidity. Follow-up through at least one year is of interest to monitor outcomes.

Pain symptoms are typically reported via the visual analog scale (VAS) or numerical rating scale (NRS). A score reduction of at least two points is considered clinically meaningful.Functional outcomes for plantar fasciitis are typically assessed via the American Orthopaedic Foot & Ankle Society (AOFAS) hindfoot score, with a score of 100 reflecting an asymptomatic patient. Patient-reported functional and QOL outcomes are typically assessed by the Short-Form 36-Item Health Survey (SF-36), with subscores available for various physical or mental functional domains. A score of 100 indicates an asymptomatic patient.

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

    • To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;
    • In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
    • To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.
    • Studies with duplicative or overlapping populations were excluded.
    • Studies not identifying the marketed version of the technology were excluded.
Comparative Cohort Studies

Wang et al (2017) published the results of a retrospective, cohort study evaluating outcomes with endoscopic plantar fasciotomy (n=12) compared to RF microtenotomy (n=22) for recalcitrant plantar fasciitis at a single-center from 2007 to 2015. Prospectively collected data from 34/58 patients undergoing either procedure were included in this study as they had a complete data set with 1 year of follow-up. Patients were required to fail a conservative treatment program of at least six months in duration. The AOFAS hindfoot score scale (total score [HINDTOT], visual analog scale pain score [HINDVAS]) and the patient-reported SF-36 were administrated pre-operatively and at 3, 6, and 12 months post-operatively. There was no difference in baseline outcome measures. At 3 months, patients receiving endoscopic plantar fasciotomy had better results compared to patients receiving open RF microtenotomy, with statistically significant improvement in visual analog pain scores (HINDVAS; 0.9 vs 3.3; p=0.027) and patient-reported social-functioning (92.5 vs 71.3; p=0.030) and role-functioning-emotional (93.3 vs 80.4; p=0.030). At six months and one year post-treatment, no significant differences between treatment groups were noted. HINDVAS scores decreased from 7.2 to 1.3 and 7.3 to 0.9 over 1 year in fasciotomy and RF microtenotomy groups, respectively. Complications consisting of reports of persistent postoperative pain, recurrence of pain at 6 months, and recurrence of pain at 1 year were 0% vs 9.1%, 8.3% vs 13.6%, and 16.7% vs 13.6% in fasciotomy and RF microtenotomy groups, respectively.

Chou et al (2016) evaluated outcomes in patients undergoing plantar fasciotomy, RF microtenotomy, or both procedures between 2007 and 2014 at a single-institution. Patients were required to fail conservative therapy and contain a full data set with one year of follow-up to be included for analysis. Patients were evaluated preoperatively and at 6 months and 1-year post-treatment with the AOFAS Ankle-Hindfoot Scale and SF-36 Health Survey. A total of 27 feet (n=27 patients) underwent plantar fasciotomy, 55 feet (n=48 patients) underwent RF microtenotomy, and 9 feet (n=9 patients) underwent both procedures. The rate of complications consisting of consistent heel pain at 1 year in each group was 11%, 7.3%, and 33%, respectively. Differences in complications between groups were not found to be statistically significant (p=0.069). No significant differences were reported between groups for all outcomes measured at each time point. HINDVAS pain scores (standard deviation [SD]) at baseline and 1 year were 7.407 (1.185) vs 1.963 (2.653), 7.352 (1.580) vs 1.585 (2.389), and 7.667 (2.000) vs 0.556 (1.333) for fasciotomy, RF microtenotomy, and combination groups, respectively.

Tay et al (2012) conducted a prospective cohort study comparing percutaneous RF microtenotomy (n=27) and open RF microtenotomy (n=32) in patients with plantar fasciitis.Outcomes were measured with the AOFAS Ankle-Hindfoot scale scores and SF-36 Health Survey at baseline and 3, 6, and 12 months post-treatment. At three months, there was no significant difference in HINDVAS pain scores and AOFAS HINDTOT between groups. However, the SF-36 reported a statistically significant difference in bodily pain between the open (59.2) and percutaneous (44.2) groups (p=0.017). At six months, there were no significant differences in HINDVAS pain scores and AOFAS HINDTOT between groups. However, SF-36 component scores for vitality (72.0 vs 56.5; p=0.007), functioning (emotional) (100.0 vs 75.6; p=0.006), and mental health (84.4 vs 74.9; p=0.049) fared significantly better in the percutaneous vs open RF microtenotomy groups. While it is unclear to what extent these findings correlate with baseline differences in SF-36 mental health findings (84.0 vs 74.25; p=0.028), no significant differences in SF-36 outcome measures were detected at 12 months between groups. SF-36 score for role functioning (physical) were pooled for analysis. Scores increased from 25.0 at baseline to 68.8 at 12 months (p=0.009). At 12 months, the open group had a significantly lower pain score of 0.78 vs 3.00 in the percutaneous group (p=0.035) but the AOFAS hindfoot score was not significantly different (74.9 vs 87.0; p=0.159).

Study characteristics and results are summarized in Tables 1 and 2. Study relevance, design, and conduct limitations are summarized in Tables 3 and 4.

Table 1. Comparative Study Characteristics: Plantar Fasciitis

StudyStudy TypeCountryDatesParticipantsInterventionComparator(s)Follow-Up
Wang et al (2017)Cohort, retrospectiveSingapore2007-2015Patients with plantar fasciitis who failed a conservative therapy program of at least 6 months in duration. Patients with a BMI >35kg/m2 were excluded.Open RF coblation microtenotomy via TOPAZ microdebrider device (ArthroCare) (n=22)Endoscopic plantar fasciotomy or combination treatment (n=12)12 Months
Chou et al (2016)Cohort, prospectiveSingapore2007-2014Patients with plantar fasciitis who failed conservative therapy with a full set of clinical data.Open or percutaneous RF coblation microtenotomy via TOPAZ microdebrider device (ArthroCare) (n=48)Plantar fasciotomy with dissection or use of an endoscope (n=27) or combination of both treatments (n=9)12 Months
Tay et al (2012)Cohort, prospectiveSingapore2007-2009Patients with plantar fasciitis who failed a conservative therapy program of at least 6 months in duration. Patients with a BMI >35kg/m2 were excluded.Open RF coblation microtenotomy via TOPAZ microdebrider device (ArthroCare) (n=32)Percutaneous RF coblation microtenotomy via TOPAZ microdebrider device (ArthroCare) (n=27)12 Months
BMI: body mass index; RF: radiofrequency.

Table 2. Comparative Study Results: Plantar Fasciitis
StudyPain Outcomes1Functional Outcomes2Patient-Reported SF-36 Physical Outcomes3Persistent Postoperative Heel Pain (%)
Baseline3 Months12 MonthsBaseline3 Months12 MonthsRFP at BaselineRFP at 12 Months12 Months
Wang et al (2017)N=34N=34N=34N=34N=34N=34N=34N-34N=34
Endoscopic plantar fasciotomy (95% CI)7.2 (NR)0.9 (NR)1.3 (NR)49.8 (NR)92.1 (NR)88.3 (NR)8.383.30%
Open RF microtenotomy (95% CI)7.3 (NR)3.3 (NR)0.9 (NR)40.2 (NR)75.2 (NR)92.0 (NR)12.579.09.1%
p0.4210.0270.3240.0890.0840.4640.5950.992NR
Baseline6 Months12 MonthsBaseline6 Months12 MonthsPCS at BaselinePCS at 12 Months12 Months
Chou et al (2016)N=84N=84N=84N=84N=84N=84N=84N=84N=84
Plantar fasciotomy (SD)7.407 (1.185)3.037 (3.006)1.963 (2.653)41.148 (14.392)76.926 (23.362)83.741 (20.594)43.500 (17.238)66.861 (25.551)11%
RF microtenotomy (SD)7.352 (1.580)2.685 (2.821)1.585 (2.389)43.000 (14.907)80.245 (19.620)86.731 (18.238)41.355 (17.587)65.705 (20.314)7.3%
Combination (SD)7.667 (2.000)1.667 (2.646)0.556 (1.333)46.000 (15.804)94.25 (11.285)91.667 (10.571)47.167 (16.691)51.861 (24.197)33%
pNRNRNRNRNRNR>0.05>0.05NR
Baseline6 Months12 MonthsBaseline6 Months12 MonthsRFP at Baseline*RFP at 12 Months*12 Months
Tay et al (2012)N=59N=45N=21N=59N=45N=21N=59N=21N=21
Percutaneous RF microtenotomy (95% CI)7.48 (NR)3.05 (NR)3.00 (NR)42.2 (NR)76.60 (NR)74.92 (NR)25.0 (NR)68.8 (NR)NR
Open RF microtenotomy (95% CI)7.56 (NR)3.58 (NR)0.78 (NR)41.5 (NR)68.64 (NR)87.00 (NR)NR
p0.858NR0.0350.850NR0.1590.009NR
CI: confidence interval; NR: not reported; RF: radiofrequency; RFP: role-functioning, physical; SD: standard deviation; SF-36: Short Form 36 Health Survey.
* Outcome was pooled for all treatment groups.

1
Pain outcomes are based on visual analog scale component of the American Orthopaedic Foot & Ankle Society (AOFAS) hindfoot score.
2
Functional outcomes are based on the AOFAS hindfoot or ankle-hindfoot total score.
3
Patient-reported physical outcomes are based on the SF-36 Health Survey physical component score (PCS) or role functioning (physical) component (RFP) score, as specified.

Table 3. Relevance Limitations
StudyPopulationaInterventionbComparatorcOutcomesdFollow-Upe
Wang et al (2017)5. Clinical significant difference not prespecified.1. Not sufficient duration for long-term benefit.2. Not sufficient sample size for harms.
Chou et al (2016)3. Minimum duration of conservative treatment program prior to failure not specified.2. Outcomes not stratified by open vs percutaneous versions of procedure. 3. Unequal distribution of open and minimally invasive (percutaneous) procedures with comparator.1. Outcomes not stratified by open vs endoscopic versions of procedure.3. Unequal distribution of open and minimally invasive (endoscopic) procedures with intervention.5. Clinical significant difference not prespecified.1. Not sufficient duration for long-term benefit.2. Not sufficient sample size for harms.
Tay et al (2012)4. Study population is not representative of intended use. Mental health component scale scores statistically different at baseline between groups.2. Not a standard comparator.5. Clinical significant difference not prespecified.1. Not sufficient duration for long-term benefit.2. Not sufficient sample size for harms.
The study limitations stated in this table are those notable in the current review; this is not a comprehensive limitations assessment.
a
Population key: 1. Intended use population unclear; 2. Clinical context is unclear; 3. Study population is unclear; 4. Study population not representative of intended use.
b
Intervention key: 1. Not clearly defined; 2. Version used unclear; 3. Delivery not similar intensity as comparator; 4.Not the intervention of interest.
c
Comparator key: 1. Not clearly defined; 2. Not standard or optimal; 3. Delivery not similar intensity as intervention; 4. Not delivered effectively.
d
Outcomes key: 1. Key health outcomes not addressed; 2. Physiologic measures, not validated surrogates; 3. No CONSORT reporting of harms; 4. Not established and validated measurements; 5. Clinical significant difference not prespecified; 6. Clinical significant difference not supported.
e
Follow-Up key: 1. Not sufficient duration for benefit; 2. Not sufficient duration for harms.

Table 4. Study Design and Conduct Limitations
StudyAllocationaBlindingbSelective ReportingcData CompletenessdPowereStatisticalf
Wang et al (2017)1. Participants not randomly allocated. Intervention based on patient and surgeon choice.1. Not blinded to treatment assignment.1. Not registered.1. High loss to follow-up or missing data.5. Inappropriate exclusions. 14 patients with more than 1 foot and ankle pathology (unspecified) were deemed confounders whereas other studies have allowed this. 9 patients missed at least 1 follow-up appointment and were entirely excluded due to an incomplete dataset.1. Power calculation not reported.3. Confidence intervals and/or p values not reported.
Chou et al (2016)1. Participants not randomly allocated.1. Not blinded to treatment assignment. 3. Outcome not assessed by treating physician but unclear if blinded to treatment assignment.1. Not registered.1. Power calculations not reported.3. Confidence intervals and/or p values not reported.
Tay et al (2012)1. Participants not randomly allocated.1. Not blinded to treatment assignment. 3. Outcome not assessed by treating physician but unclear if blinded to treatment assignment.1. Not registered.1. High loss to follow-up or missing data.2. Inadequate handling of missing data..1. Power calculation not reported.3. Confidence intervals and/or p values not reported.
The study limitations stated in this table are those notable in the current review; this is not a comprehensive limitations assessment.
a
Allocation key: 1. Participants not randomly allocated; 2. Allocation not concealed; 3. Allocation concealment unclear; 4. Inadequate control for selection bias.
b
Blinding key: 1. Not blinded to treatment assignment; 2. Not blinded to outcome assessment; 3. Outcome assessed by treating physician.
c
Selective Reporting key: 1. Not registered; 2. Evidence of selective reporting; 3. Evidence of selective publication.
d
Data Completeness key: 1. High loss to follow-up or missing data; 2. Inadequate handling of missing data; 3. High number of crossovers; 4. Inadequate handling of crossovers; 5. Inappropriate exclusions; 6. No intent to treat analysis (per protocol for noninferiority trials).
e
Power key: 1. Power calculations not reported; 2. Power not calculated for primary outcome; 3. Power not based on clinically important difference.
f
Statistical key: 1. Intervention is not appropriate for outcome type: (a) continuous; (b) binary; (c) time to event; 2. Intervention is not appropriate for multiple observations per patient; 3. Confidence intervals and/or p values not reported; 4.Comparative treatment effects not calculated.

Case Series

Several small case series have addressed the use of RF microtenotomy for plantar fasciitis. Sean et al (2010) conducted a prospective, single-center pilot study in 14 patients with plantar fasciitis and failed conservative treatment of at least 6 months in duration. AOFAS ankle-hindfoot and SF-36 Health Survey scores were assessed at baseline and 3 and 6 months post-treatment. Mean AOFAS hindfoot scores improved from 34.47 to 69.27 and 71.33 at 3 and 6 months (p=0.00). There was a significant decrease in SF-36 bodily pain ratings (p=0.01), and significant increases in physical (p=0.01) and social function (p=0.04) scores. Twelve out of 14 (85.7%) of patients reported good to excellent satisfaction with their results at 6 months and 12 out of 14 (85.7%) had their expectations met at 6 months of follow-up. No peri- or postoperative complications were reported.

Section Summary: Plantar Fasciitis

Three nonrandomized, comparative cohort studies and case series demonstrate that the use of RF coblation microtenotomy for the treatment of plantar fasciitis improves pain and functional scores over 3-12 months, with better pain outcomes for open vs percutaneous approaches. No significant differences in these or patient-reported physical outcome measures were reported when compared to surgical fasciotomy. However, open RF coblation microtenotomy was associated with a higher incidence of postoperative persistent pain (9.1%) compared to endoscopic plantar fasciotomy (0%) in 1 study, with a separate study reporting a complication rate of 33% when both interventions were used in combination. A higher number of postoperative pain recurrences at 6 and 12 months were also reported with open RF coblation microtenotomy compared to endoscopic plantar fasciotomy. The durability of this intervention is unknown as no studies have reported long-term outcomes beyond 12 months. Studies are limited by small sample sizes, heterogeneity in surgical technique (open, percutaneous, endoscopic), missing data and/or inappropriate exclusions, lack of randomization, unclear blinding practices for patient outcome assessments, and poor statistical reporting. Due to these limitations and the increased complication rate, the efficacy of RF coblation microtenotomy for improving plantar fasciitis cannot be drawn from the current evidence.

Lateral Epicondylitis and Wrist Tendinopathy

Clinical Context and Therapy Purpose

The purpose of RF coblation tenotomy is to provide a treatment option that is an alternative to or an improvement on existing therapies for patients with musculoskeletal conditions.

The question addressed in this policy is: Does the use of RF coblation tenotomy improve the net health outcome in patients with lateral epicondylitis and wrist tendinopathy?

The following PICOs were used to select literature to inform this review.

Patients

The relevant population of interest are individuals with lateral epicondylitis or wrist tendinopathy.

Interventions

The therapy being considered is RF coblation tenotomy, also referred to as microtenotomy. Patients with lateral epicondylitis and wrist tendinopathy are managed by orthopedic specialists and physical therapists in an outpatient setting.

Comparators

The following practice is currently being used to treat lateral epicondylitis and wrist tendinopathy: conservative management, including activity and lifestyle modification, splinting or casting, and physical therapy. Surgical referral may be appropriate for patients not responding to at least 6 to 12 months of initial, non-operative therapy. Surgical interventions for lateral epicondylitis include the arthroscopic release of the extensor carpi radialis brevis (ECRB) tendon.

Outcomes

The general outcomes of interest are symptoms, functional outcomes, QOL, medication use, and treatment-related morbidity. Follow-up through at least one year is of interest to monitor outcomes.

Pain symptoms are typically reported via the VAS or NRS. A score reduction of at least two points is considered clinically meaningful. Functional and QOL outcomes relating to disability for lateral epicondylitis are typically assessed with the Disabilities of the Arm, Shoulder, and Hand questionnaire, with score reductions of at least 10.2 points meeting the threshold for a clinically meaningful difference and 12.2 points meeting the threshold for a minimal detectable change. Functional outcomes are frequently assessed with the Mayo Elbow Performance Score, with a score of 100 reflecting an asymptomatic patient.

Study Selection Criteria

Methodologically credible studies were selected using the criteria outlined in indication 1. No studies featuring the use of RF coblation technology for wrist tendinopathy were identified.

Randomized Clinical Trials

Lee et al (2018) conducted an RCT comparing the clinical effects of open RF microtenotomy (n=22) and arthroscopic release of the ECRB tendon (n=24) in patients with refractory lateral epicondylitis that had failed 2 or more corticosteroid injections, extracorporeal shock-wave therapy, and conventional treatment for least 6 consecutive months. Pre-operative MRI of the elbow was performed in all patients to assess for intra-articular or ligamentous lesions. The primary outcome was the Mayo Elbow Performance Score (MEPS) at 24 months post-procedure. Additional outcome measures included the VAS score for pain, flexion-extension arcs and grip strength, and the Disabilities of the Arm, Shoulder, and Hand questionnaire (DASH) at 3, 6, 12, and 24 months post-surgery. Fifty-five patients were randomized and 9 patients were lost to follow-up, leaving 46 patients for analysis. One complication consisting of persistent postoperative pain was reported in the arthroscopic release group and one complication consisting of postoperative ECRB rupture was reported in the RF microtenotomy group. Both patients recovered following revision surgery. Patients in both groups showed statistically significant functional improvement with regard to grip strength and DASH, VAS, and MEPS scores at two years (p<0.05). Differences between groups were not statistically significant. The mean operation time was significantly shorter for the RF microtenotomy group (mean (SD); 15.6 (3.6) vs 41.4 (5.2) min; p<0.001). Three patients (12.5%) in the arthroscopic release group and 2 patients (9.1%) in the RF microtenotomy group reported persistent pain or discomfort with a MEPS score <90 at 2 years.

Hamlin et al (2018) published the results of an RCT comparing RF microtenotomy (n=21) with standard open release surgery (n=18) for refractory lateral epicondylitis. Themerical Rating Scale (NRS pain scores and DASH scores were evaluated at baseline, 6 weeks, 6 months, and 12 months. Grip strength was assessed at baseline and six weeks. The primary outcome measure was the NRS pain score at 12 months. NRS pain scores improved significantly in both groups at all time points. There was a significant difference between RF microtenotomy [mean (SD); -2.285 (0.5174)] and open release surgery [-4.689 (0.6012); p=0.0021] at 6 weeks only. Grip strength improved by 31% in the RF microtenotomy group compared to 38% in the open release surgery group, however, there were no significant differences between initial and 6-week scores nor between groups. Two patients (9.5%) that received RF microtenotomy opted to receive open release surgery after the final assessment of the study due to persistent symptoms. Two patients (11.1%) that received open release surgery also reported persistent symptoms at 1 year. The study investigators indicate that since RF microtenotomy provides no clear treatment or risk-benefit, surgical candidates should be offered open release surgery.

Meknas et al (2013) randomized patients to either open release surgery (n=11) or RF microtenotomy (n=13) for treatment of refractory lateral epicondylitis following the failure of 1 year of conservative treatment. Outcome measures included VAS pain scores, grip strength, and MEPS score functional assessment. Select patients were also evaluated via MRI and dynamic infrared thermography. One patient in the open release group died prior to mid-term follow-up. One patient in the RF microtenotomy group was excluded due to revision open release surgery. Mean follow-up for the open release group was 75.5 months (SD, 8.1 months) and 68.4 months (SD, 6.2 months) for the RF microtenotomy group (p=0.02). NRS scores decreased significantly for both groups with no statistically significant differences between groups at baseline or mid-term follow-up. Grip strength increased in both groups but was not found to be significant or significantly different between groups. Median MEPS scores improved significantly in both groups with no significant differences between treatments. Dynamic infrared thermography revealed seven hot spots in each group preoperatively. At medium-term follow-up, the number of detected hot spots was reduced to 1 in the open release group (p=0.041) and 4 in the microtenotomy group (p=0.092). Differences in the total number of hot spots between groups were not significant.

Study characteristics and results are summarized in Tables 5 and 6. Study relevance, design, and conduct limitations are summarized in Tables 7 and 8.

Table 5. Comparative Study Characteristics: Lateral Epicondylitis
StudyStudy TypeCountryDatesParticipantsInterventionComparator(s)Follow-Up
Lee et al (2018)RCTSouth Korea2010-2015Patients with refractory lateral epicondylitis who had failed a conservative therapy program of at least 6 months’ duration, including 2 or more corticosteroid injections and ESWTRF coblation microtenotomy via TOPAZ microdebrider electrode (Smith & Nephew)

(n=22)

Arthroscopic tendon release of the ECRB tendon

(n=24)

24 months
Hamlin et al (2018)RCTScotlandNRPatients with lateral epicondylitis who failed non-operative treatment with local steroid injections and physiotherapyRF coblation microtenotomy via TOPAZ microdebrider wand (ArthroCare)

(n=21)

Open release surgery

(n=18)

12 months
Meknas et al (2013)RCTNorway2006-2007Patients with refractory lateral epicondylitis who failed a conservative therapy program of at least 1 year in durationRF coblation microtenotomy via TOPAZ microdebrider electrode (ArthroCare)

(n=13)

Open release surgery

(n=11)

5-7 years
ECRB: extensor carpi radialis brevis; ESWT: extracorporeal shock-wave therapy; NR: not reported; RCT: randomized controlled trial; RF: radiofrequency.

Table 6. Comparative Study Results: Lateral Epicondylitis
StudyPain Outcomes1MEPS Functional OutcomesDASH Disability OutcomesMean Grip Strength (SD)
VAS at Baseline24 MonthsBaseline24 MonthsBaseline24 MonthsBaseline, kg24 Months, kg
Lee et al (2018)N=46N=46N=46N=46N=46N=46N=46N=46
RF microtenotomy (SD)7.27 (0.94)1.50 (1.29)53.9 (6.7)95.7 (6.8)60 (9)*21 (12)*19.97 (6.74)27.31 (6.90)
Arthroscopic tendon release (SD)7.33 (1.05)1.41 (1.14)55.2 (6.3)95.4 (8.7)57 (13)*20 (11)*20.20 (6.35)25.75 (6.56)
p0.8380.802NRNRNRNR0.4380.905
NRS at Baseline12 MonthsBaseline12 MonthsBaseline12 MonthsBaseline, lb6 Weeks, lb
Hamlin et al (2018)N=39N=39N=39N=39N=39N=39N=39N=39
RF microtenotomy (SD)7.0 (NR)-4.974 (0.626)NRNR45.8 (NR)-39.55 (4.956)41.2 (NR)60.0 (NR)
Open release (SD)7.9 (NR)-5.124 (0.702)NRNR50.0 (NR)-28.31 (6.252)35.7 (NR)49.3 (NR)
MD (SD)NRNRNRNRNR12.83 (7.927)NRNR
pNR0.8536NRNRNR0.1144NR0.8601
NRS at Baseline5-7 YearsBaseline5-7 YearsBaseline5-7 YearsBaseline, kg5-7 Years, kg
Meknas et al (2013)N=24N=22N=24N=22N=24N=22N=24N=22
RF microtenotomy (SD)7.1 (1.6)1.4 (2.3)55.4 (12.6)96.4 (9.9)NRNR28.3 (16.9)33.8 (13.1)
Open release (SD)6.4 (1.5)1.3 (1.7)61.9 (17.1)96.0 (9.4)NRNR29.1 (12.9)37.7 (6.1)
pNRNRNRNRNRNRNRNR
DASH: Disabilities of the Arm, Shoulder, and Hand questionnaire; MD: mean difference; MEPS: Mayo Elbow Performance Score; NR: not reported; NRS: numerical rating scale; RF: radiofrequency; SD: standard deviation; VAS: visual analog scale.

* Values estimated from graphs.

1 Pain outcomes are based on visual analog scale (VAS) or numerical rating scale (NRS) scores.


Table 7. Relevance Limitations
StudyPopulationaInterventionbComparatorcOutcomesdFollow-Upe
Lee et al (2018)4. Requirement to fail ESWT is not typical inclusion requirement for conservative therapy. Patients were heavily pre-treated.2. Not sufficient sample size for harms.
Hamlin et al (2018)1. Not sufficient duration for long-term benefit.

2. Not sufficient sample size for harms.

Meknas et al (2013)1. Not sufficient duration for long-term benefit.

2. Not sufficient sample size for harms.

The study limitations stated in this table are those notable in the current review; this is not a comprehensive limitations assessment.

ESWT: extracorporeal shock-wave therapy.
a Population key: 1. Intended use population unclear; 2. Clinical context is unclear; 3. Study population is unclear; 4. Study population not representative of intended use.

b Intervention key: 1. Not clearly defined; 2. Version used unclear; 3. Delivery not similar intensity as comparator; 4.Not the intervention of interest.

c Comparator key: 1. Not clearly defined; 2. Not standard or optimal; 3. Delivery not similar intensity as intervention; 4. Not delivered effectively.

d Outcomes key: 1. Key health outcomes not addressed; 2. Physiologic measures, not validated surrogates; 3. No CONSORT reporting of harms; 4. Not established and validated measurements; 5. Clinical significant difference not prespecified; 6. Clinical significant difference not supported.

e Follow-Up key: 1. Not sufficient duration for benefit; 2. Not sufficient duration for harms.

Table 8. Study Design and Conduct Limitations
StudyAllocationaBlindingbSelective ReportingcData CompletenessdPowereStatisticalf
Lee et al (2018)1. Not blinded to treatment assignment.1. Not registered.1. Underpowered due to loss to follow-up.3. Underpowered due to higher than anticipated dropout rate. Power based on interim analysis and not on clinically important differences.3. Confidence intervals and/or p values not reported for all outcome measures.
Hamlin et al (2018)1. Patients were blinded with regard to surgical treatment until the final review.

3. Blinding of outcome assessments unclear.

2. MEPS scores were collected but were not reported.1. Underpowered due to loss to follow-up.3. Confidence intervals and/or p values not reported for all outcome measures.
Meknas et al (2013)1. Not blinded to treatment assignment.

3. Blinding of outcome assessments unclear. Treating physician made the initial clinical assessment prior to randomization.

1. Not registered.1. High loss to follow-up or missing data.

2. Inadequate handling of missing data or varied delivery of clinical assessments.

4. Inadequate handling of crossovers.

6. Unclear ITT analysis.

1. Power calculation not reported.3. Confidence intervals and/or p values not reported for all outcome measures.
ITT: intent to treat; MEPS: Mayo Elbow Performance Score.

The study limitations stated in this table are those notable in the current review; this is not a comprehensive limitations assessment.

a
Allocation key: 1. Participants not randomly allocated; 2. Allocation not concealed; 3. Allocation concealment unclear; 4. Inadequate control for selection bias.
b
Blinding key: 1. Not blinded to treatment assignment; 2. Not blinded to outcome assessment; 3. Outcome assessed by treating physician.
c
Selective Reporting key: 1. Not registered; 2. Evidence of selective reporting; 3. Evidence of selective publication.
d
Data Completeness key: 1. High loss to follow-up or missing data; 2. Inadequate handling of missing data; 3. High number of crossovers; 4. Inadequate handling of crossovers; 5. Inappropriate exclusions; 6. No intent to treat analysis (per protocol for noninferiority trials).
e
Power key: 1. Power calculations not reported; 2. Power not calculated for primary outcome; 3. Power not based on clinically important difference.
f
Statistical key: 1. Intervention is not appropriate for outcome type: (a) continuous; (b) binary; (c) time to event; 2. Intervention is not appropriate for multiple observations per patient; 3. Confidence intervals and/or p values not reported; 4.Comparative treatment effects not calculated.

Section Summary: Lateral Epicondylitis

Three small RCTs comparing RF coblation microtenotomy to open or arthroscopic elbow release surgery demonstrate significant reductions in pain scores (>2) at post-operative time points of one to seven years for both approaches, with no significant differences between treatment groups. Similar results are noted for MEPS functional assessments. For DASH disability assessments, open release surgery met the threshold for a clinically meaningful improvement over RF microtenotomy at one year in one study, though this mean difference was not statistically significant. Studies were generally underpowered or demonstrated inconsistent delivery and unclear blinding of outcome assessments and inappropriate handling of missing or crossover data.

Achilles Tendinopathy

Clinical Context and Therapy Purpose

The purpose of RF coblation tenotomy is to provide a treatment option that is an alternative to or an improvement on existing therapies for patients with musculoskeletal conditions.

The question addressed in this policy is: Does the use of RF coblation tenotomy improve the net health outcome in patients with Achilles tendinopathy?

The following PICOs were used to select literature to inform this review.

Patients

The relevant population of interest are individuals with Achilles tendinopathy.

Interventions

The therapy being considered is RF coblation tenotomy, also referred to as microtenotomy or microdebridement. Patients with Achilles tendinopathy are managed by orthopedic specialists and physical therapists in an outpatient setting.

Comparators

The following practice is currently being used to treat Achilles tendinopathy: conservative management, including activity and lifestyle modification, splinting or casting, and physical therapy. Surgical referral may be appropriate for patients not responding to at least 6 to 12 months of initial, non-operative therapy. Surgical interventions for midportion Achilles tendinopathy may include open peri- or intratendinous debridement, flexor hallucis longus transfer, longitudinal tenotomy, gastrocnemius lengthening or recession, minimally invasive paratenon debridement, and surgical decompression.

Outcomes

The general outcomes of interest are symptoms, functional outcomes, QOL, medication use, and treatment-related morbidity. Follow-up through at least one year is of interest to monitor outcomes.

Pain symptoms are typically reported via the VAS or NRS. A score reduction of at least two points is considered clinically meaningful. The Victoria Institute of Sport Assessment (VISA) questionnaire for Achilles tendinopathy (VISA-A) is typically utilized to assess functional, pain, and activity domains of Achilles tendinopathy, where 100 represents a perfect score. Successful recovery is typically defined with scores >80.

Study Selection Criteria

Methodologically credible studies were selected using the criteria outlined in indication 1.

Randomized Clinical Trials

Morrison et al (2017) conducted a single-blinded RCT evaluating RF coblation microdebridement compared to surgical decompression for patients with noninsertional Achilles tendinopathy who had failed a conservative management program of at least 6 months in duration. The primary outcome measure was the difference in VAS pain score at six months. The secondary outcome measure was the VISA-A score. The control group had significantly less severe symptoms as indicated by higher VISA-A scores and lower VAS scores at baseline. Both groups demonstrated statistically significant improvements in scores at six months, with no significant differences noted between groups (p>0.05). The analysis of covariance was adjusted for age, sex, and BMI. Not all study subjects demonstrated improvement in their VAS scores. In the control group, 2 patients (12.5%) reported worsening of pain (12.5%) and 1 (6.25%) reported no change. In the RF microdebridement group, 2 patients (10%) reported worsening of pain and 4 (20%) reported no change. Two patients (12.5%) reported a decrease in VISA-A score following decompression surgery compared to 5 patients (25%) in the RF microdebridement group. Complications included two cases of superficial wound infection in the decompression group and one partial Achilles rupture in the RF microdebridement group. Study investigators concluded there was no added benefit for the use of RF microdebridement and have discontinued its use in their practice.

Study characteristics and results are summarized in Tables 9 and 10. Study relevance, design, and conduct limitations are summarized in Tables 11 and 12.

Table 9. Comparative Study Characteristics: Achilles Tendinopathy
StudyStudy TypeCountryDatesParticipantsInterventionComparatorFollow-Up
Morrison et al (2017)RCTUnited Kingdom2009-2014Patients with refractory noninsertional Achilles tendinopathy who had failed a conservative therapy program of at least 6 months’ duration, with diagnosis confirmed via MRI. Patients utilized a physical therapy program during weeks 2-12 post-treatment.RF coblation microdebridement via TOPAZ microdebrider wand (ArthroCare) (n=20)Surgical decompression (n=16)6 months
MRI: magnetic resonance imaging; RCT: randomized controlled trial; RF: radiofrequency.

Table 10. Comparative Study Results: Achilles Tendinopathy
StudyPain Outcomes1VISA-A Functional Outcomes
Mean VAS at Baseline6 MonthsMD (Range)pMean VISA-A at Baseline6 MonthsMD (Range)p
Morrison et al (2017)N=36N=36N=36N=36N=36N=36N=36N=36
RF microdebridement (Range)5.6 (2 to 9)2.6 (0 to 8)-3.1 (-9 to 2)<0.00131.4 (10 to 53)60 (15 to 99)28.7 (-15 to 66)<0.001
Surgical decompression (Range)3.8 (1 to 7)2.0 (0 to 7)-1.8 (-6 to 4)0.01242.4 (14 to 79)66.7 (19 to 100)24.3 (-10 to 61)<0.001
p0.00910.50410.1930.04710.3950.569
BMI: body mass index; MD: mean difference; RF: radiofrequency; VAS: visual analog scale: VISA-A: Victoria Institute of Sport Assessment (VISA) questionnaire for Achilles tendinopathy.
1 Statistical analysis of covariance was adjusted for age, sex, and BMI.

Table 11. Relevance Limitations
StudyPopulationaInterventionbComparatorcOutcomesdFollow-Upe
Morrison et al (2017)1. Criteria for MRI confirmation of diagnosis are not specified.

4. Comparator group exhibited significantly less severe pain and functional symptom scores at baseline.

5. Clinical significant difference for VISA-A scale not provided.

6. Clinical significant difference for comparator not fully established.

1-2. Not sufficient duration for benefit or harms.
MRI: magnetic resonance imaging; VISA-A: Victoria Institute of Sport Assessment (VISA) questionnaire for Achilles tendinopathy.
The study limitations stated in this table are those notable in the current review; this is not a comprehensive limitations assessment.

a
Population key: 1. Intended use population unclear; 2. Clinical context is unclear; 3. Study population is unclear; 4. Study population not representative of intended use.
b
Intervention key: 1. Not clearly defined; 2. Version used unclear; 3. Delivery not similar intensity as comparator; 4.Not the intervention of interest.
c
Comparator key: 1. Not clearly defined; 2. Not standard or optimal; 3. Delivery not similar intensity as intervention; 4. Not delivered effectively.
d
Outcomes key: 1. Key health outcomes not addressed; 2. Physiologic measures, not validated surrogates; 3. No CONSORT reporting of harms; 4. Not established and validated measurements; 5. Clinical significant difference not prespecified; 6. Clinical significant difference not supported.
e
Follow-Up key: 1. Not sufficient duration for benefit; 2. Not sufficient duration for harms.

Table 12. Study Design and Conduct Limitations
StudyAllocationaBlindingbSelective ReportingcData CompletenessdPowereStatisticalf
Morrison et al (2017)1. Single-blinded study.

2. Blinding of outcome assessment not clear.

1. Not registered.

2. Evidence of selective reporting. Planned 6-week outcome assessments were canceled due to postoperative restrictions.

3. Confidence intervals and/or p values not reported.
The study limitations stated in this table are those notable in the current review; this is not a comprehensive limitations assessment.
a
Allocation key: 1. Participants not randomly allocated; 2. Allocation not concealed; 3. Allocation concealment unclear; 4. Inadequate control for selection bias.
b
Blinding key: 1. Not blinded to treatment assignment; 2. Not blinded to outcome assessment; 3. Outcome assessed by treating physician.
c
Selective Reporting key: 1. Not registered; 2. Evidence of selective reporting; 3. Evidence of selective publication.
d
Data Completeness key: 1. High loss to follow-up or missing data; 2. Inadequate handling of missing data; 3. High number of crossovers; 4. Inadequate handling of crossovers; 5. Inappropriate exclusions; 6. No intent to treat analysis (per protocol for noninferiority trials).
e
Power key: 1. Power calculations not reported; 2. Power not calculated for primary outcome; 3. Power not based on clinically important differences.
f
Statistical key: 1. Intervention is not appropriate for outcome type: (a) continuous; (b) binary; (c) time to event; 2. Intervention is not appropriate for multiple observations per patient; 3. Confidence intervals and/or p values not reported; 4.Comparative treatment effects not calculated.
Retrospective Studies

Shibuya et al (2012) conducted a retrospective review of institutional patient cases to elucidate the safety and efficacy of percutaneous RF coblation for the treatment of insertional Achilles tendinopathy between 2005 and 2011. Forty-seven patients were identified ranging in age from 23 to 76. The mean BMI was 37.1 (SD, 6.96) with a mean follow-up duration of 8.6 months (range, 1 to 40). Revision surgery was performed in 15% of patients. Twenty-six patients (55%) had at least 3 months of follow-up data available, and revision surgery was performed in 23%. Study authors believe these higher than typical rates of reoperation indicate that a percutaneous approach may not be as effective as an open technique. Furthermore, patients in this study had a high mean BMI, whereas other studies addressing foot and ankle tendinopathies have typically excluded patients with a BMI >35 due to a known correlation with poorer outcomes.

Section Summary: Achilles Tendinopathy

A small, single-blinded RCT did not demonstrate an added benefit for RF microdebridement compared to surgical decompression. Pain and functional outcomes improved in both groups but were not statistically different at asix-month follow-up. The study was limited by a control group that showed significantly less severe symptom scores at baseline that did not fully meet the two point threshold for a clinically meaningful difference in pain score reduction. Larger, adequately controlled studies with longer follow-up durations are required to appropriately assess the technology.

Shoulder and Rotator Cuff Tendinopathy

Clinical Context and Therapy Purpose

The purpose of RF coblation tenotomy is to provide a treatment option that is an alternative to or an improvement on existing therapies for patients with musculoskeletal conditions.

The question addressed in this policy is: Does the use of RF coblation tenotomy improve the net health outcome in patients with shoulder and rotator cuff tendinopathy?

The following PICOs were used to select literature to inform this review.

Patients

The relevant population of interest are individuals with shoulder or rotator cuff tendinopathy.

Interventions

The therapy being considered is RF coblation tenotomy, also referred to as microtenotomy. Patients with shoulder or rotator cuff tendinopathy are managed by orthopedic specialists and physical therapists in an outpatient setting.

Comparators

The following practice is currently being used to treat shoulder or rotator cuff tendinopathy: conservative management, including activity and lifestyle modification, and physical therapy. Surgical referral may be appropriate for patients not responding to at least 6 to 12 months of initial, non-operative therapy. Surgical interventions may include subacromial decompression.

Outcomes

The general outcomes of interest are symptoms, functional outcomes, QOL, medication use, and treatment-related morbidity. Follow-up through at least one year is of interest to monitor outcomes.

Pain symptoms are typically reported via the VAS or NRS. A score reduction of at least two points is considered clinically meaningful. Functional outcomes may include Constant-Murley scores and range of motion.

Study Selection Criteria

Methodologically credible studies were selected using the criteria outlined in indication 1.

Randomized Clinical Trials

Al-Ani et al (2019) performed a small RCT evaluating arthroscopic subacromial acromioplasty (n=14) compared to RF microtenotomy (n=13) for the treatment of rotator cuff tendinopathy in patients with a minimum symptom duration of 6 months. About half of patients in each arm had previously received one to three corticosteroid injections at least six months prior to inclusion. The main outcome measures included VAS pain scores, functional Constant scores, and strength measures through two years. Significant pain reductions were reported at 12 weeks, 6 months, and 2 years, with no significant differences between groups. Treatment harms were not reported.

Lu et al (2013) randomized patients with shoulder impingement syndrome and rotator cuff tendinopathy to receive either arthroscopic subacromial decompression alone (n=40) or in combination with RF microtenotomy (n=40) using the TOPAZ microdebrider (ArthroCare) after failing a conservative management program of at least 5 months in duration. Outcome measures included VAS pain scores at three weeks, six weeks, three months, six months, and one year. Functional outcomes included a range of motion, American Shoulder & Elbow Surgeon’s score, Simple Shoulder Test questionnaire, UCLA score, and Constant-Murley score at three months, six months, and one year. Sixty-five out of 80 patients (81.3%) were available for final follow-up at 1 year. Pain scores decreased significantly at three weeks postoperatively for both treatment groups. While there was a significant difference between group pain scores at three weeks, the combination group did not meet the threshold for a clinically meaningful reduction in pain at this early time point compared to subacromial decompression only. Scores continued to improve over time with no significant difference between groups. For functional measures (American Shoulder & Elbow Surgeon’s score , UCLA, Simple Shoulder Test questionnaire, Constant-Murley, range of motion ), scores improved significantly for both groups with no significant differences between groups at any postoperative time point. The authors noted that they did not detect any added benefits for the addition of RF microtenotomy to the standard surgical procedure. The study is limited by a high loss to follow-up, the use of an independent observer that was not blinded to treatment assignment, and lack of reporting on harms.

Study characteristics and results are summarized in Tables 13 and 14. Study relevance, design, and conduct limitations are summarized in Tables 15 and 16.

Table 13. Comparative Study Characteristics: Rotator Cuff Tendinopathy
StudyStudy TypeCountryDatesParticipantsInterventionComparatorFollow-Up
Al-Ani et al (2019)RCTNorway2015-2016Patients with rotator cuff tendinopathy with an average symptom duration of 6 months. Half of patients failed 1-3 corticosteroid injections.RF coblation microtenotomy via TOPAZ microdebrider (ArthroCare) (n=13)Arthroscopic subacromial acromioplasty (n=14)2 years
Lu et al (2013)RCTChina2009-2010Patients with refractory shoulder impingement syndrome and rotator cuff tendinopathy who had failed a conservative management program of at least 5 months.RF coblation microtenotomy via TOPAZ microdebrider (ArthroCare) (n=40)Arthroscopic subacromial decompression (n=40)1 year
RCT: randomized controlled trial; RF: radiofrequency.

Table 14. Comparative Study Results: Rotator Cuff Tendinopathy
StudyPain Outcomes1Functional Outcomes2
Mean VAS at Baseline2 YearspMean at Baseline2 Yearsp
Al-Ani et al (2019)N=27N=27N=27N=27N=27N=27
RF microtenotomy (SD)7.0 (1.5)1.3 (2.1)<0.0137.7 (16.1)82.2 (13.2)<0.01
Arthroscopic acromioplasty (SD)6.9 (1.4)1.4 (2.1)<0.0141.2 (10.3)82.0 (13.0)<0.01
pNSNSNSNS
Lu et al (2013)Mean VAS at Baseline (N=65)1 Year

(N=65)

p

(N=65)

Mean at Baseline (N=65)1 Year (N=65)p (N=65)
RF microtenotomy (SD)5.5 (1.7)0.4 (1.1)0.03166.8 (20.5)96 (NR)*NR
Arthroscopic decompression (SD)5.3 (2.1)0.3 (0.9)0.01768.6 (15.6)99 (NR)*NR
p0.9210.6310.691NR
NR: not reported; NS: no significance; RF: radiofrequency; SD: standard deviation; VAS: visual analog scale.
* Scores estimated from graph.

1
Pain outcomes are based on visual analog scale (VAS) or numerical rating scale (NRS) scores.
2
Functional outcome measures are based on Constant-Murley scores.

Table 15. Relevance Limitations
StudyPopulationaInterventionbComparatorcOutcomesdFollow-Upe
Al-Ani et al (2019)3. Criteria for MRI grading of tendinosis are not specified.

4. Minimum conservative treatment program duration not standardized or specified.

2. MRI tendinosis score is not a validated outcome measure.

3. No reporting on harms.

5-6. Rationale for clinical significant difference not provided or supported.

2. No reporting on harms.
Lu et al (2013)4. Minimum conservative treatment duration was interrupted by other therapies at 8 weeks and shorter in total duration than most typical recommendations.3. No reporting on harms.

5. Clinical significant difference not prespecified.

2. Not sufficient duration for harms.
MRI: magnetic resonance imaging.
The study limitations stated in this table are those notable in the current review; this is not a comprehensive limitations assessment.

a
Population key: 1. Intended use population unclear; 2. Clinical context is unclear; 3. Study population is unclear; 4. Study population not representative of intended use.
b
Intervention key: 1. Not clearly defined; 2. Version used unclear; 3. Delivery not similar intensity as comparator; 4.Not the intervention of interest.
c
Comparator key: 1. Not clearly defined; 2. Not standard or optimal; 3. Delivery not similar intensity as intervention; 4. Not delivered effectively.
d
Outcomes key: 1. Key health outcomes not addressed; 2. Physiologic measures, not validated surrogates; 3. No CONSORT reporting of harms; 4. Not established and validated measurements; 5. Clinical significant difference not prespecified; 6. Clinical significant difference not supported.
e
Follow-Up key: 1. Not sufficient duration for benefit; 2. Not sufficient duration for harms.

Table 16. Study Design and Conduct Limitations
StudyAllocationaBlindingbSelective ReportingcData CompletenessdPowereStatisticalf
Al-Ani et al (2019)3. Allocation concealment unclear.1. Unclear blinding of treatment assignment.1. Not registered.3. Power not based on clinically important difference.3. Confidence intervals and/or p values not reported.
Lu et al (2013)1. Unclear blinding of treatment assignment.

2. Independent observer not blinded to treatment received.

1. Not registered.1. High loss to follow-up or missing data.3. Power not based on clinically important difference.3.Confidence intervals and/or p values not reported.
The study limitations stated in this table are those notable in the current review; this is not a comprehensive limitations assessment.
a
Allocation key: 1. Participants not randomly allocated; 2. Allocation not concealed; 3. Allocation concealment unclear; 4. Inadequate control for selection bias.
b
Blinding key: 1. Not blinded to treatment assignment; 2. Not blinded to outcome assessment; 3. Outcome assessed by treating physician.
c
Selective Reporting key: 1. Not registered; 2. Evidence of selective reporting; 3. Evidence of selective publication.
d
Data Completeness key: 1. High loss to follow-up or missing data; 2. Inadequate handling of missing data; 3. High number of crossovers; 4. Inadequate handling of crossovers; 5. Inappropriate exclusions; 6. No intent to treat analysis (per protocol for noninferiority trials).
e
Power key: 1. Power calculations not reported; 2. Power not calculated for primary outcome; 3. Power not based on clinically important difference.
f Statistical key: 1. Intervention is not appropriate for outcome type: (a) continuous; (b) binary; (c) time to event; 2. Intervention is not appropriate for multiple observations per patient; 3. Confidence intervals and/or p values not reported; 4.Comparative treatment effects not calculated.

Section Summary: Rotator Cuff Tendinopathy

Small RCTs did not demonstrate an added benefit for RF microdebridement compared to arthroscopic subacromial decompression surgery. Pain and functional outcomes improved in both groups but were not statistically different through one to two years follow-up. Neither study prespecified a clinically meaningful difference in outcome measures nor were harms assessed throughout their course. The loss to follow-up in one study was 18.7%. Larger studies with appropriate harms reporting are required to appropriately assess the technology.

Patellar Tendinopathy

Clinical Context and Therapy Purpose

The purpose of RF coblation tenotomy is to provide a treatment option that is an alternative to or an improvement on existing therapies for patients with musculoskeletal conditions.

The question addressed in this policy is: Does the use of RF coblation tenotomy improve the net health outcome in patients with patellar tendinopathy?

The following PICOs were used to select literature to inform this review.

Patients

The relevant population of interest are individuals with shoulder or patellar tendinopathy.

Interventions

The therapy being considered is RF coblation tenotomy, also referred to as microtenotomy. Patients with patellar tendinopathy are managed by orthopedic specialists and physical therapists in an outpatient setting.

Comparators

The following practice is currently being used to treat patellar tendinopathy: conservative management, including activity and lifestyle modification, and physical therapy. Surgical referral may be appropriate for patients not responding to at least 6 to 12 months of initial, non-operative therapy. Surgical interventions may include mechanical debridement.

Outcomes

The general outcomes of interest are symptoms, functional outcomes, QOL, medication use, and treatment-related morbidity. Follow-up through at least one year is of interest to monitor outcomes.

Pain symptoms are typically reported via the VAS or NRS. A score reduction of at least two points is considered clinically meaningful. Functional outcomes may include the Fulkerson-Shea Patellofemoral Joint Evaluation Score.

Study Selection Criteria

Methodologically credible studies were selected using the criteria outlined in indication 1.

Randomized Clinical Trials

Owens et al (2002) randomized patients with symptomatic patellar chondral lesions to RF coblation microdebridement (n=19) or mechanical debridement (n=20). All patients had failed a six-month course of conservative treatment. The primary outcome measure was the Fulkerson-Shea Patellofemoral Joint Evaluation Score, which pain, functional, and clinical outcomes into an overall performance score. A score of 100 indicates a perfect score. While RF microdebridment achieved statistically higher scores at one and two years of follow-up, a clinically meaningful difference was not prespecified and pain outcomes were not directly assessed. Furthermore, the incidence of crepitus in the afflicted knee was 55% for RF microdebridment compared to 32% for mechanical debridement after 2 years. This study was further limited by restricting enrollment to female patients only and not blinding the independent observer to treatment assignments.

Study characteristics and results are summarized in Tables 17 and 18. Study relevance, design, and conduct limitations are summarized in Tables 19 and 20.

Table 17. Comparative Study Characteristics: Patellar Tendinopathy
StudyStudy TypeCountryDatesParticipantsInterventionComparatorFollow-Up
Owens et al (2002)RCTU.S.NRFemale patients with chondral lesions symptomatic of patellar tendinoapathy who had failed a 6-month course of conservative treatment.RF coblation microdebridement via TOPAZ microdebrider (ArthroCare) (n=19)Mechanical debridement (n=20)2 years
NR: not reported; RCT: randomized controlled trial; RF: radiofrequency.

Table 18. Comparative Study Results: Patellar Tendinopathy
StudyCrepitusFunctional Outcomes1
Crepitus at Baseline1 Year2 YearsMean at Baseline1 Year2 Years
Owens et al (2002)N=39N=39N=39N=39N=39N=39
RF microtenotomy (95% CI)100% (NR)NR55% (NR)59.6 (53.5 to 64.8)87.9 (83.3 92.5)86.6 (81.4 to 91.8)
Mechanical debridement (95% CI)100% (NR)NR32% (NR)59.2 (53.4 to 64.9)80.0 (74.6 to 85.4)77.5 (72.2 to 82.8)
pNRNRNRNR0.0230.014
CI: confidence interval; NR: not reported; RF: radiofrequency.
1 Functional outcomes are based on the Fulkerson-Shea Patellofemoral Joint Evaluation Score.

Table 19. Relevance Limitations
StudyPopulationaInterventionbComparatorcOutcomesdFollow-Upe
Owens et al (2002)4. Enrollment restricted to female patients only. Not representative of intended use.2. Key pain outcomes not directly assessed.

3. No reporting on harms.

4. Not established and validated measurements.

5-6. Rational for clinical significant difference not provided or prespecified.

2. No reporting collected for harms.
The study limitations stated in this table are those notable in the current review; this is not a comprehensive limitations assessment.
a
Population key: 1. Intended use population unclear; 2. Clinical context is unclear; 3. Study population is unclear; 4. Study population not representative of intended use.
b
Intervention key: 1. Not clearly defined; 2. Version used unclear; 3. Delivery not similar intensity as comparator; 4.Not the intervention of interest.
c
Comparator key: 1. Not clearly defined; 2. Not standard or optimal; 3. Delivery not similar intensity as intervention; 4. Not delivered effectively.
d
Outcomes key: 1. Key health outcomes not addressed; 2. Physiologic measures, not validated surrogates; 3. No CONSORT reporting of harms; 4. Not established and validated measurements; 5. Clinical significant difference not prespecified; 6. Clinical significant difference not supported.
e
Follow-Up key: 1. Not sufficient duration for benefit; 2. Not sufficient duration for harms.

Table 20. Study Design and Conduct Limitations
StudyAllocationaBlindingbSelective ReportingcData CompletenessdPowereStatisticalf
Owens et al (2002)2. Outcome assessment not performed by blinded independent observer.1. Not registered.1. High loss to follow-up or missing data.

2. No intent to treat analysis to support superiority claims.

1. Power calculation not reported.3. Confidence intervals and/or p values not reported. Inconsistent p values reported for same outcome. Overlapping confidence intervals.
The study limitations stated in this table are those notable in the current review; this is not a comprehensive limitations assessment.
a
Allocation key: 1. Participants not randomly allocated; 2. Allocation not concealed; 3. Allocation concealment unclear; 4. Inadequate control for selection bias.
b
Blinding key: 1. Not blinded to treatment assignment; 2. Not blinded to outcome assessment; 3. Outcome assessed by treating physician.
c
Selective Reporting key: 1. Not registered; 2. Evidence of selective reporting; 3. Evidence of selective publication.
d
Data Completeness key: 1. High loss to follow-up or missing data; 2. Inadequate handling of missing data; 3. High number of crossovers; 4. Inadequate handling of crossovers; 5. Inappropriate exclusions; 6. No intent to treat analysis (per protocol for noninferiority trials).
e
Power key: 1. Power calculations not reported; 2. Power not calculated for primary outcome; 3. Power not based on clinically important difference.
f
Statistical key: 1. Intervention is not appropriate for outcome type: (a) continuous; (b) binary; (c) time to event; 2. Intervention is not appropriate for multiple observations per patient; 3. Confidence intervals and/or p values not reported; 4.Comparative treatment effects not calculated.

Section Summary: Patellar Tendinopathy

A small RCT did not demonstrate an added benefit for RF microdebridement compared to the mechanical debridement of chondral lesions in patients with patellar tendinopathy. The study lacked reporting with validated pain measures over time and reported a higher incidence of crepitus in patients undergoing RF microdebridement. Furthermore, the study only enrolled female participants, limiting the broader applicability of these findings. Larger studies with validated pain and functional outcome measures are required to adequately assess the technology.

Summary of Evidence

For individuals with plantar fasciitis who receive RF coblation tenotomy, the evidence includes nonrandomized, comparative cohort studies and case series. The relevant outcomes are symptoms, functional outcomes, quality of life (QOL), medication use, and treatment-related morbidity. The trials reported improved pain and functional scores over 3-12 months, with improved outcomes with open vs percutaneous approaches. However, open RF coblation microtenotomy was associated with a higher incidence of postoperative persistent pain (9.1%) compared to endoscopic plantar fasciotomy (0%) in one study, with a separate study reporting a complication rate of 33% when both interventions were used in combination. A higher number of postoperative pain recurrences at 6 and 12 months were also reported with open RF coblation microtenotomy compared to endoscopic plantar fasciotomy. The durability of this intervention is unknown as no studies have reported long-term outcomes beyond 12 months. Studies are limited by small sample sizes, heterogeneity in surgical technique (open, percutaneous, endoscopic), missing data and/or inappropriate exclusions, lack of randomization, unclear blinding practices for patient outcome assessments, and poor statistical reporting. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals with lateral epicondylitis who receive RF coblation tenotomy, the evidence includes small randomized controlled trials (RCTs). The relevant outcomes are symptoms, functional outcomes, QOL, medication use, and treatment-related morbidity. The trials compared RF microtenotomy to open or arthroscopic elbow release surgery. Clinically meaningful improvements in pain and functional scores were noted for all treatment arms, with no significant differences between groups through one to seven years of follow-up. For disability assessments in one study, open release surgery met the threshold for a clinically meaningful improvement over RF microtenotomy at one year, though this mean difference was not statistically significant. Studies were generally underpowered or demonstrated inconsistent delivery and unclear blinding of outcome assessments and inappropriate handling of missing or crossover data. No studies featuring RF coblation tenotomy for the treatment of wrist tendinopathy were identified. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals with Achilles tendinopathy who receive RF coblation tenotomy, the evidence includes a small, single-blinded RCT. The relevant outcomes are symptoms, functional outcomes, QOL, medication use, and treatment-related morbidity. The trial did not demonstrate an added benefit for RF microdebridement compared to surgical decompression. Pain and functional outcomes improved in both groups but were not statistically different at a six month follow-up. The study was limited by a control group that showed significantly less severe symptom scores at baseline that did not fully meet the two point threshold for a clinically meaningful difference in pain score reduction. Larger, adequately controlled studies with longer follow-up durations are lacking. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals with shoulder or rotator cuff tendinopathy who receive RF coblation tenotomy, the evidence includes small RCTs. The relevant outcomes are symptoms, functional outcomes, QOL, medication use, and treatment-related morbidity. Trials did not demonstrate an added benefit for RF microdebridement compared to arthroscopic subacromial decompression surgery. Pain and functional outcomes improved in both groups but were not statistically different through one to two years follow-up. Neither study prespecified a clinically meaningful difference in outcome measures nor were harms assessed throughout their course. The loss to follow-up in 1 study was 18.7%. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals with patellar tendinopathy who receive radiofrequency coblation tenotomy, the evidence includes one small RCT. The relevant outcomes are symptoms, functional outcomes, QOL, medication use, and treatment-related morbidity. The trial did not demonstrate an added benefit for RF microdebridement compared to mechanical debridement in patients with chondral lesions and patellar tendinopathy. The study lacked reporting with validated pain measures over time and reported a higher incidence of crepitus in patients undergoing RF microdebridement. Furthermore, the study only enrolled female participants, limiting the broader applicability of these findings. Larger studies with validated pain and functional outcome measures are required to adequately assess the technology. The evidence is insufficient to determine the effects of the technology on health outcomes.

SUPPLEMENTAL INFORMATION

Practice Guidelines and Position Statements

American College of Foot and Ankle Surgeons

The American College of Foot and Ankle Surgeons (2017) published a clinical consensus statement on the diagnosis and treatment of adult acquired infracalcaneal heel pain based upon the best available evidence in the literature. The panel determined that the following statement was uncertain – that is – neither appropriate nor inappropriate:

    • “Other surgical techniques (eg, ultrasonic debridement using a microtip device, cryosurgery, and bipolar radiofrequency ablation) are safe and effective options for chronic, refractory plantar fasciitis.”
American College of Occupational and Environmental Medicine

The American College of Occupational and Environmental Medicine (2006) updated their treatment guidelines for lateral epicondylitis as a result of a systematic review of the literature. Surgery is recommended for cases inadequately responsive to multiple evidence-based treatments (Level of Evidence: I, insufficient evidence). Microtenotomy is also recommended (Level of Evidence: C, limited evidence base).

U.S. Preventive Services Task Force Recommendations

No U.S. Preventive Services Task Force recommendations for the use of radiofrequency coblation tenotomy have been identified.

Ongoing and Unpublished Clinical Trials

Some currently ongoing and unpublished trials that might influence this review are listed in Table 21.

Table 21. Summary of Key Trials
NCT No.Trial Name
Planned Enrollment
Completion Date
Ongoing
NCT03678948aEvaluation of the Efficacy of Radiofrequency-Based Debridement vs. Mechanical Debridement for the Treatment of Articular Cartilage Lesions
82
Jun 2021

(recruiting)

NCT03854682Surgical or Non-surgical Treatment of Plantar Fasciitis - A Randomized Clinical Trial
70
Jun 2023

(not yet recruiting)

Unpublished
NCT03274557Treatment of Achilles Tendinose
40
Dec 2018

(complete)

NCT02304952Eccentric Exercise or Radiofrequent Microtenotomy as Treatment of Chronic Lateral Epicondylalgia - a Randomized Controlled Trial
100
Sep 2018

(unknown)

NCT01803880aA Prospective, Double-Blinded, Multicenter, Randomized, Controlled Trial to Evaluate Mechanical Debridement vs. Radiofrequency-Based Debridement in the Treatment of Articular Cartilage Lesions
148
Jul 2017

(terminated)

NCT02275689Alternative Treatment of Rotator Cuff Tendinopathy
34
Dec 2016

(completed)

NCT00534781aRadiofrequency-based Plasma Microdebridement Compared to Surgical Microdebridement for Treating Achilles Tendinosis: A Prospective, Randomized, Controlled Multi-Center Study
60
Sep 2010

(completed)

NCT00189592aPlantar Fasciosis Treatment Using Coblation® Prospective, Double-Blind, Randomized Controlled Study
45
Jun 2008

(completed)

NCT00420875aClinical Evaluation of Placement of Radiofrequency-based Plasma Microdebridement in the Treatment Algorithm for Foot and Ankle Tendinosis and Plantar Fasciosis
0
Jun 2007

(withdrawn)

NCT: national clinical trial.
a
Denotes industry-sponsored or cosponsored trial.]
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Horizon BCBSNJ Medical Policy Development Process:

This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.

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Index:
Radiofrequency Coblation Tenotomy for Musculoskeletal Conditions
Coblation Tenotomy for Musculoskeletal Conditions
RF Coblation Tenotomy for Musculoskeletal Conditions
Plantar Fasciitis, RF Coblation Tenotomy
Lateral Epicondylitis, RF Coblation Tenotomy
Shoulder Tendinopathy, RF Coblation Tenotomy
Rotator Cuff, RF Coblation Tenotomy
Achilles Tendinopathy, RF Coblation Tenotomy
Patellar Tendinopathy, RF Coblation Tenotomy
Wrist Tendinopathy, RF Coblation Tenotomy
TOPAZ® EZ Microdebrider Coblation® Wand

References:
1. Tay KS, Ng YC, Singh IR et al. Open technique is more effective than percutaneous technique for TOPAZ radiofrequency coblation for plantar fasciitis.. Foot Ankle Surg, 2012 Oct 25;18(4). PMID 23093126

2. Davenport TE, Kulig K, Matharu Y et al. The EdUReP model for nonsurgical management of tendinopathy.. Phys Ther, 2005 Sep 27;85(10). PMID 16180958

3. Robinson JM, Cook JL, Purdam C et al. The VISA-A questionnaire: a valid and reliable index of the clinical severity of Achilles tendinopathy.. Br J Sports Med, 2001 Oct 2;35(5). PMID 11579069

4. Lohrer H, David S, Nauck T. Surgical treatment for achilles tendinopathy - a systematic review.. BMC Musculoskelet Disord, 2016 May 12;17:207. PMID 27165287

5. Nirschl RP, Pettrone FA. Tennis elbow. The surgical treatment of lateral epicondylitis.. J Bone Joint Surg Am, 1979 Sep 1;61(6A). PMID 479229

6. Chou AC, Ng SY, Su DH et al. Radiofrequency microtenotomy is as effective as plantar fasciotomy in the treatment of recalcitrant plantar fasciitis.. Foot Ankle Surg, 2016 Nov 5;22(4). PMID 27810027

7. Riddle DL, Schappert SM. Volume of ambulatory care visits and patterns of care for patients diagnosed with plantar fasciitis: a national study of medical doctors.. Foot Ankle Int, 2004 May 12;25(5). PMID 15134610

8. Riddle DL, Pulisic M, Pidcoe P et al. Risk factors for Plantar fasciitis: a matched case-control study.. J Bone Joint Surg Am, 2003 May 3;85(5). PMID 12728038

9. Rano JA, Fallat LM, Savoy-Moore RT. Correlation of heel pain with body mass index and other characteristics of heel pain.. J Foot Ankle Surg, 2002 Jan 5;40(6). PMID 11777230

10. Riggs BL, Hodgson SF, Hoffman DL et al. Treatment of primary osteoporosis with fluoride and calcium. Clinical tolerance and fracture occurrence.. JAMA, 1980 Feb 1;243(5). PMID 7351765

11. Shiri R, Viikari-Juntura E, Varonen H et al. Prevalence and determinants of lateral and medial epicondylitis: a population study.. Am. J. Epidemiol., 2006 Sep 14;164(11). PMID 16968862

12. Struijs PA, Kerkhoffs GM, Assendelft WJ et al. Conservative treatment of lateral epicondylitis: brace versus physical therapy or a combination of both-a randomized clinical trial.. Am J Sports Med, 2004 Feb 24;32(2). PMID 14977675

13. Hamlin K, Munro C, Barker SL et al. Open release versus radiofrequency microtenotomy in the treatment of lateral epicondylitis: a prospective randomized controlled trial.. Shoulder Elbow, 2017 Dec 26;10(1). PMID 29276537

14. Wang W, Rikhraj IS, Chou ACC et al. Endoscopic Plantar Fasciotomy vs Open Radiofrequency Microtenotomy for Recalcitrant Plantar Fasciitis.. Foot Ankle Int, 2017 Nov 29;39(1). PMID 29182482

15. Weil L, Glover JP, Weil LS. A new minimally invasive technique for treating plantar fasciosis using bipolar radiofrequency: a prospective analysis.. Foot Ankle Spec, 2008 Feb 1;1(1). PMID 19825686

16. Yeap EJ, Chong KW, Yeo W et al. Radiofrequency coblation for chronic foot and ankle tendinosis.. J Orthop Surg (Hong Kong), 2010 Jan 13;17(3). PMID 20065374

17. Sean NY, Singh I, Wai CK. Radiofrequency microtenotomy for the treatment of plantar fasciitis shows good early results.. Foot Ankle Surg, 2010 Nov 5;16(4). PMID 21047605

18. Meknas K, Al Hassoni TN, Odden-Miland NA et al. Medium-Term Results After Treatment of Recalcitrant Lateral Epicondylitis: A Prospective, Randomized Study Comparing Open Release and Radiofrequency Microtenotomy.. Orthop J Sports Med, 2013 Sep 1;1(4). PMID 26535247

19. Lee JH, Park I, Hyun HS et al. A Comparison of Radiofrequency-Based Microtenotomy and Arthroscopic Release of the Extensor Carpi Radialis Brevis Tendon in Recalcitrant Lateral Epicondylitis: A Prospective Randomized Controlled Study.. Arthroscopy, 2018 Jan 26;34(5). PMID 29366739

20. Morrison RJM, Brock TM, Reed MR et al. Radiofrequency Microdebridement Versus Surgical Decompression for Achilles Tendinosis: A Randomized Controlled Trial.. J Foot Ankle Surg, 2017 May 13;56(4). PMID 28495412

21. Martin RL, Chimenti R, Cuddeford T et al. Achilles Pain, Stiffness, and Muscle Power Deficits: Midportion Achilles Tendinopathy Revision 2018.. J Orthop Sports Phys Ther, 2018 May 2;48(5). PMID 29712543

22. Shibuya N, Thorud JC, Humphers JM et al. Is percutaneous radiofrequency coblation for treatment of Achilles tendinosis safe and effective?. J Foot Ankle Surg, 2012 Sep 15;51(6). PMID 22974813

23. Lu Y, Zhang Q, Zhu Y et al. Is radiofrequency treatment effective for shoulder impingement syndrome? A prospective randomized controlled study.. J Shoulder Elbow Surg, 2013 Sep 3;22(11). PMID 23994459

24. Al-Ani Z, Jacobsen EW, Kartus JT et al. Radiofrequency microtenotomy: a promising method for treatment of rotator cuff tendinopathy.. Knee Surg Sports Traumatol Arthrosc, 2019 Sep 2. PMID 31473769

25. Owens BD, Stickles BJ, Balikian P et al. Prospective analysis of radiofrequency versus mechanical debridement of isolated patellar chondral lesions.. Arthroscopy, 2002 Feb 7;18(2). PMID 11830808

26. Schneider HP, Baca JM, Carpenter BB et al. American College of Foot and Ankle Surgeons Clinical Consensus Statement: Diagnosis and Treatment of Adult Acquired Infracalcaneal Heel Pain.. J Foot Ankle Surg, 2017 Dec 30;57(2). PMID 29284574

27. Hegmann KT, Hoffman HE, Belcourt RM et al. ACOEM practice guidelines: elbow disorders.. J. Occup. Environ. Med., 2013 Aug 22;55(11). PMID 23963225

28. Centers for Medicare & Medicaid Services (CMS). National Coverage Determination for Thermal Intradiscal Procedures (TIPs) (150.11). 2009; https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=324. Accessed November 12, 2019.

Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)

CPT*

    HCPCS

    * CPT only copyright 2020 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.

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