Medical Policy

Policy Num:       07.001.133
Policy Name:    Radiofrequency Coblation Tenotomy for Musculoskeletal Conditions
Policy ID:          [07.001.133]  [Ac / B / M- / P-]   [7.01.165]

Last Review:       January 17, 2025
Next Review:      January 20, 2026
 

Related Policies:

06.001.061 - Diagnosis and Treatment of Sacroiliac Joint Pain
07.001.005- Decompression of the Intervertebral Disc Using Laser Energy (Laser Discectomy) or Radiofrequency-Coblation (Nucleoplasty)

Radiofrequency Coblation Tenotomy for Musculoskeletal Conditions

Summary

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.

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 oneto 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.

Objective

The objective of this evidence review is to determine whether the use of tenotomy (ie, microtenotomy, microdebridement) with bipolar radiofrequency coblation devices improves the net health outcome in patients with various musculoskeletal conditions of the foot, ankle, elbow, shoulder, knee, and wrist.

Policy Statements

Radiofrequency coblation tenotomy is considered investigational as a treatment for musculoskeletal conditions, including but not limited to, the following conditions:

• plantar fasciitis;

• lateral epicondylitis;

• wrist tendinopathy;

• shoulder or rotator cuff tendinopathy;

• Achilles tendinopathy;

• patellar tendinopathy.

Policy Guidelines

See the Codes table for details.

Benefit Application

BlueCard/National Account Issues

State or federal mandates (eg, Federal Employee Program) may dictate that certain U.S. Food and Drug Administration-approved devices, drugs, or biologics may not be considered investigational, and thus these devices may be assessed only by their medical necessity.

Benefits are determined by the group contract, member benefit booklet, and/or individual subscriber certificate in effect at the time services were rendered. Benefit products or negotiated coverages may have all or some of the services discussed in this medical policy excluded from their coverage.

Background

Radiofrequency Coblation

Radiofrequency (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.^1, 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 evidence reviews 7.01.93 and 6.01.23.

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 6 months of a well-designed physical therapy program with adjunct medical treatments can be considered if there is no improvement in pain or function.^2, 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.^3, 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.^4,5, 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.^6,

Plantar fasciitis is one of the most common causes of foot and heel pain in adults. It is estimated to be responsible for approximately 1 million patient medical visits per year in the U.S.^7, 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.^8,9, Plantar fasciitis has been reported in association with fluoride use for the treatment of osteoporosis.^10, 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%.^11, Risk factors include smoking, obesity, forceful activity, and repetitive activity for at least 2 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.^12, 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 6 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 (FDA) 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. FDA product code: GEI.

Rationale

This evidence review was created in December 2019 and has been updated regularly with searches of the PubMed database. The most recent literature update was performed through November 7, 20243, 2023.

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, 2 domains are examined: the relevance, and quality and credibility. To be relevant, studies must represent 1 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. Randomized controlled trials 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.

Promotion of greater diversity and inclusion in clinical research of historically marginalized groups (e.g., People of Color [African-American, Asian, Black, Latino and Native American]; LGBTQIA (Lesbian, Gay, Bisexual, Transgender, Queer, Intersex, Asexual); Women; and People with Disabilities [Physical and Invisible]) allows policy populations to be more reflective of and findings more applicable to our diverse members. While we also strive to use inclusive language related to these groups in our policies, use of gender-specific nouns (e.g., women, men, sisters, etc.) will continue when reflective of language used in publications describing study populations.

Population Reference No. 1 Policy Statement

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 following PICO was used to select literature to inform this review.

Populations

The relevant population of interest is individuals with plantar fasciitis.

Interventions

The therapy being considered is RF coblation tenotomy, also referred to as microtenotomy.

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 1 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 2 points is considered clinically meaningful.^13, 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.^14,

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.

Review of Evidence

Systematic Reviews

Nayar et al (2023) completed a systematic review of surgical treatment options for plantar fasciitis including open plantar fasciotomy, endoscopic plantar fasciotomy, gastrocnemius release, RF microtenotomy, and dry needling.^15, A total of 17 studies (8 RCTs, 3 prospective cohort, and 6 retrospective cohort) with 865 patients were selected for inclusion. Radiofrequency microtenotomy was investigated in 4 studies (n=215), all of which were retrospective cohort studies (see Comparative Cohort Studies summaries below). Two studies compared RF microtenotomy to open plantar fasciotomy, 1 to edoscopic plantar fasciotomy, and 1 to proximal medial gastrocnemius release. The 2 studies comparing RF microtenetomy and plantar fasciotomy found no difference between groups in VAS and AOFAS outcomes. Similarly, the other studies found no difference in pain or function between groups. In network meta-analysis, RF microtenotomy significantly improved VAS compared with nonoperative management (weighted mean difference, -2.72; 95% CI, -4.84 to -0.060). No other significant difference between RF microtenotomy and other surgical interventions was found (mean differences not reported). The analysis is limited by the lack of high-quality studies. Studies included were largely observational, and at some risk of bias.

Comparative Cohort Studies

Yuan et al (2020) retrospectively compared open plantar fasciotomy to RF microtenotomy in 31 patients with plantar fasciitis.^16, Although operative time (19.93 minutes vs. 36.78 minutes) and recovery time (13.27 days vs. 25.94 days) were shorter with RF microtenotomy, there were no differences in VAS scores or AOFAS score between the treatments.

Huang et al (2018) reviewed all patients with plantar fasciitis (N=34) who underwent RF microtenotomy (TOPAZ device) with or without a gastrocnemius recession from 2007 to 2014 at a single institution.^17, The AOFAS hindfoot score scale (total score [HINDTOT], VAS pain score [HINDVAS]) and the patient-reported SF-36 were administrated pre-operatively and at 3, 6, and 12 months post-operatively. There were no significant differences in HINDTOT or HINDVAS between groups at any of the measured timepoints. Components of SF-36 scores were also similar between individual treatments, but some components were improved with combination treatment compared with either RF microtenotomy or gastrocnemius recession alone.

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.^14, 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 6 months in duration. The AOFAS hindfoot score scale (HINDTOT and 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=.027), patient-reported social-functioning (92.5 vs. 71.3; p=.030), and role-functioning-emotional (93.3 vs. 80.4; p=.030). At 6 months and 1 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.^6, Patients were required to fail conservative therapy and contain a full data set with 1 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=.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.^1, 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 3 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=.017). At 6 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=.007), functioning (emotional) (100.0 vs. 75.6; p=.006), and mental health (84.4 vs. 74.9; p=.049) fared significantly better in the percutaneous versus 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=.028), no significant differences in SF-36 outcome measures were detected at 12 months between groups. SF-36 scores for role functioning (physical) were pooled for analysis. Scores increased from 25.0 at baseline to 68.8 at 12 months (p=.009). At 12 months, the open group had a significantly lower pain score of 0.78 versus 3.00 in the percutaneous group (p=.035) but the AOFAS hindfoot score was not significantly different (74.9 vs. 87.0; p=.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

     BMI: body mass index; RF: radiofrequency.

Table 2. Comparative Study Results: Plantar Fasciitis

    CI: confidence interval; NR: not reported; PCS: physical component score; 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. 4 Outcomes reported at last follow-up.

Table 3. Study Relevance Limitations

    The study limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment. a Population key: 1. Intended use population unclear; 2. Study population is unclear; 3. Study population not representative of intended use; 4, Enrolled populations do not reflect relevant diversity; 5. Other. b Intervention key: 1. Not clearly defined; 2. Version used unclear; 3. Delivery not similar intensity as comparator; 4. Not the intervention of interest (e.g., proposed as an adjunct but not tested as such); 5: Other. c Comparator key: 1. Not clearly defined; 2. Not standard or optimal; 3. Delivery not similar intensity as intervention; 4. Not delivered effectively; 5. Other. d Outcomes key: 1. Key health outcomes not addressed; 2. Physiologic measures, not validated surrogates; 3. Incomplete reporting of harms; 4. Not establish and validated measurements; 5. Clinically significant difference not prespecified; 6. Clinically significant difference not supported; 7. Other. e Follow-Up key: 1. Not sufficient duration for benefit; 2. Not sufficient duration for harms; 3. Other.

Table 4. Study Design and Conduct Limitations

    The study limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment. a Allocation key: 1. Participants not randomly allocated; 2. Allocation not concealed; 3. Allocation concealment unclear; 4. Inadequate control for selection bias; 5. Other. b Blinding key: 1. Participants or study staff not blinded; 2. Outcome assessors not blinded; 3. Outcome assessed by treating physician; 4. Other. c Selective Reporting key: 1. Not registered; 2. Evidence of selective reporting; 3. Evidence of selective publication; 4. Other. 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. Not intent to treat analysis (per protocol for noninferiority trials); 7. Other. e Power key: 1. Power calculations not reported; 2. Power not calculated for primary outcome; 3. Power not based on clinically important difference; 4. Other. f Statistical key: 1. Analysis is not appropriate for outcome type: (a) continuous; (b) binary; (c) time to event; 2. Analysis is not appropriate for multiple observations per patient; 3. Confidence intervals and/or p values not reported; 4. Comparative treatment effects not calculated; 5. Other.

Case Series

Several small case series have addressed the use of RF microtenotomy for plantar fasciitis.^18,19,20, 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.^20, 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=.00). There was a significant decrease in SF-36 bodily pain ratings (p=.01), and significant increases in physical (p=.01) and social function (p=.04) scores. Twelve out of 14 (85.7%) 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

A systematic review of comparative cohort studies failed to find a difference in pain or function scores between RF coblation microtenotomy and other surgical intervention for plantar fasciitis.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 to 12 months, with better pain outcomes for open versus 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.

For individuals with plantar fasciitis who receive RF coblation tenotomy, the evidence includes nonrandomized, comparative cohort studies and case series. 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 to 12 months, with improved outcomes with open versus 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 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. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Population Reference No. 2

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 following PICO was used to select literature to inform this review.

Populations

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

Interventions

The therapy being considered is RF coblation tenotomy, also referred to as microtenotomy.

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 1 year is of interest to monitor outcomes.

Pain symptoms are typically reported via the VAS or NRS. A score reduction of at least 2 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 (DASH) 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.^13, Functional outcomes are frequently assessed with the Mayo Elbow Performance Score, with a score of 100 reflecting an asymptomatic patient.^18,

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.

Review of Evidence

Randomized Clinical Trials

Lee et al (2018) conducted a 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.^19, Pre-operative magnetic resonance imaging (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 DASH questionnaire 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 1 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 2 years (p<.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<.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 a RCT comparing RF microtenotomy (n=21) with standard open release surgery (n=18) for refractory lateral epicondylitis.^13, The NRS pain scores and DASH scores were evaluated at baseline, 6 weeks, 6 months, and 12 months. Grip strength was assessed at baseline and 6 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=.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.^18, 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=.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 7 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=.041) and 4 in the microtenotomy group (p=.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

     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

     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. a Values estimated from graphs.  1 Pain outcomes are based on visual analog scale (VAS) or numerical rating scale (NRS) scores.

Table 7. Study Relevance Limitations

    ESWT: extracorporeal shock-wave therapy. The study limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.  a Population key: 1. Intended use population unclear; 2. Study population is unclear; 3. Study population not representative of intended use; 4, Enrolled populations do not reflect relevant diversity; 5. Other. b Intervention key: 1. Not clearly defined; 2. Version used unclear; 3. Delivery not similar intensity as comparator; 4. Not the intervention of interest (e.g., proposed as an adjunct but not tested as such); 5: Other. c Comparator key: 1. Not clearly defined; 2. Not standard or optimal; 3. Delivery not similar intensity as intervention; 4. Not delivered effectively; 5. Other. d Outcomes key: 1. Key health outcomes not addressed; 2. Physiologic measures, not validated surrogates; 3. Incomplete reporting of harms; 4. Not establish and validated measurements; 5. Clinically significant difference not prespecified; 6. Clinically significant difference not supported; 7. Other. e Follow-Up key: 1. Not sufficient duration for benefit; 2. Not sufficient duration for harms; 3. Other.

Table 8. Study Design and Conduct Limitations

    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 gaps assessment. a Allocation key: 1. Participants not randomly allocated; 2. Allocation not concealed; 3. Allocation concealment unclear; 4. Inadequate control for selection bias; 5. Other. b Blinding key: 1. Participants or study staff not blinded; 2. Outcome assessors not blinded; 3. Outcome assessed by treating physician; 4. Other. c Selective Reporting key: 1. Not registered; 2. Evidence of selective reporting; 3. Evidence of selective publication; 4. Other. 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. Not intent to treat analysis (per protocol for noninferiority trials); 7. Other. e Power key: 1. Power calculations not reported; 2. Power not calculated for primary outcome; 3. Power not based on clinically important difference; 4. Other. f Statistical key: 1. Analysis is not appropriate for outcome type: (a) continuous; (b) binary; (c) time to event; 2. Analysis is not appropriate for multiple observations per patient; 3. Confidence intervals and/or p values not reported; 4. Comparative treatment effects not calculated; 5. Other.

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 1 to 7 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 1 year in 1 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.

For individuals with lateral epicondylitis who receive RF coblation tenotomy, the evidence includes small randomized controlled trials (RCTs). 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 1 to 7 years of follow-up. For disability assessments in 1 study, open release surgery met the threshold for a clinically meaningful improvement over RF microtenotomy at 1 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 that the technology results in an improvement in the net health outcome.

Population Reference No. 4 Policy Statement

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 following PICO was used to select literature to inform this review.

Populations

The relevant population of interest is individuals with Achilles tendinopathy.

Interventions

The therapy being considered is RF coblation tenotomy, also referred to as microtenotomy or microdebridement.

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 paratendon debridement, and surgical decompression.^4,20,

Outcomes

The general outcomes of interest are symptoms, functional outcomes, QOL, medication use, and treatment-related morbidity. Follow-up through at least 1 year is of interest to monitor outcomes.

Pain symptoms are typically reported via the VAS or NRS. A score reduction of at least 2 points is considered clinically meaningful.^13, 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.^3, Successful recovery is typically defined with scores >80.^21,

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.

Review of Evidence

Randomized Clinical Trials

Morrison et al (2017) conducted a single-blind 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.^23, The primary outcome measure was the difference in VAS pain score at 6 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 6 months, with no significant differences noted between groups (p>.05). The analysis of covariance was adjusted for age, sex, and body mass index (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 2 cases of superficial wound infection in the decompression group and 1 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.

Al-Ani et al (2021) conducted a single-blind RCT evaluating RF microtenotomy compared to physical therapy for individuals with Achilles tendinopathy of at least 6 months in duration that was impairing daily and sports activities.^25, The primary outcome measure was VAS at 2 years, with a difference of 2 units considered a clinically important difference. The control group had significantly less severe symptoms as indicated by lower VAS scores at baseline. The RF microtenotomy group demonstrated significantly greater improvements in both the VAS and Foot and Ankle Outcome Score (FAOS) Quality of Life measures at 2 years. However, conclusions cannot be drawn based on these findings due to numerous and notable study relevance and design/conduct limitations as detailed below.

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

     MRI: magnetic resonance imaging; RCT: randomized controlled trial; RF: radiofrequency.

Table 10. Comparative Study Results: Achilles Tendinopathy

    FAOS: Foot and Ankle Outcome Score; MD: mean difference; NR: not reported; RF: radiofrequency; VAS: visual analog scale: VISA-A: Victoria Institute of Sport Assessment (VISA) questionnaire for Achilles tendinopathy. a Statistical analysis of covariance was adjusted for age, sex, and body mass index.

Table 11. Study Relevance Limitations

    FAOS: Foot and Ankle Outcome Score; 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 gaps assessment.  a Population key: 1. Intended use population unclear; 2. Study population is unclear; 3. Study population not representative of intended use; 4, Enrolled populations do not reflect relevant diversity; 5. Other. b Intervention key: 1. Not clearly defined; 2. Version used unclear; 3. Delivery not similar intensity as comparator; 4. Not the intervention of interest (e.g., proposed as an adjunct but not tested as such); 5: Other. c Comparator key: 1. Not clearly defined; 2. Not standard or optimal; 3. Delivery not similar intensity as intervention; 4. Not delivered effectively; 5. Other. d Outcomes key: 1. Key health outcomes not addressed; 2. Physiologic measures, not validated surrogates; 3. Incomplete reporting of harms; 4. Not establish and validated measurements; 5. Clinically significant difference not prespecified; 6. Clinically significant difference not supported; 7. Other. e Follow-Up key: 1. Not sufficient duration for benefit; 2. Not sufficient duration for harms; 3. Other.

Table 12. Study Design and Conduct Limitations

    The study limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment. a Allocation key: 1. Participants not randomly allocated; 2. Allocation not concealed; 3. Allocation concealment unclear; 4. Inadequate control for selection bias; 5. Other. b Blinding key: 1. Participants or study staff not blinded; 2. Outcome assessors not blinded; 3. Outcome assessed by treating physician; 4. Other. c Selective Reporting key: 1. Not registered; 2. Evidence of selective reporting; 3. Evidence of selective publication; 4. Other. 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. Not intent to treat analysis (per protocol for noninferiority trials); 7. Other. e Power key: 1. Power calculations not reported; 2. Power not calculated for primary outcome; 3. Power not based on clinically important difference; 4. Other. f Statistical key: 1. Analysis is not appropriate for outcome type: (a) continuous; (b) binary; (c) time to event; 2. Analysis is not appropriate for multiple observations per patient; 3. Confidence intervals and/or p values not reported; 4. Comparative treatment effects not calculated; 5. Other.

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.^22, 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-blind 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 a 6-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 2 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.

For individuals with Achilles tendinopathy who receive RF coblation tenotomy, the evidence includes a small, single-blind RCT. 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 6 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 2 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 that the technology results in an improvement in the net health outcome.

Population Reference No. 3 Policy Statement

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 following PICO was used to select literature to inform this review.

Populations

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

Interventions

The therapy being considered is RF coblation tenotomy, also referred to as microtenotomy.

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.^23,

Outcomes

The general outcomes of interest are symptoms, functional outcomes, QOL, medication use, and treatment-related morbidity. Follow-up through at least 1 year is of interest to monitor outcomes.

Pain symptoms are typically reported via the VAS or NRS. A score reduction of at least 2 points is considered clinically meaningful.^13, Functional outcomes may include Constant-Murley scores and range of motion.

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.

Review of Evidence

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.^24, About half of patients in each arm had previously received 1 to 3 corticosteroid injections at least 6 months prior to inclusion. The main outcome measures included VAS pain scores, functional Constant scores, and strength measures through 2 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.^23, Outcome measures included VAS pain scores at 3 weeks, 6 weeks, 3 months, 6 months, and 1 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 3 months, 6 months, and 1 year. Sixty-five out of 80 patients (81.3%) were available for final follow-up at 1 year. Pain scores decreased significantly at 3 weeks postoperatively for both treatment groups. While there was a significant difference between group pain scores at 3 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

     RCT: randomized controlled trial; RF: radiofrequency.

Table 14. Comparative Study Results: Rotator Cuff Tendinopathy

    NR: not reported; NS: no significance; RF: radiofrequency; SD: standard deviation; VAS: visual analog scale. a Pain outcomes are based on visual analog scale (VAS) or numerical rating scale (NRS) scores. b Functional outcome measures are based on Constant-Murley scores. c Scores estimated from graph. 

Table 15. Study Relevance Limitations

    MRI: magnetic resonance imaging. The study limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.  a Population key: 1. Intended use population unclear; 2. Study population is unclear; 3. Study population not representative of intended use; 4, Enrolled populations do not reflect relevant diversity; 5. Other. b Intervention key: 1. Not clearly defined; 2. Version used unclear; 3. Delivery not similar intensity as comparator; 4. Not the intervention of interest (e.g., proposed as an adjunct but not tested as such); 5: Other. c Comparator key: 1. Not clearly defined; 2. Not standard or optimal; 3. Delivery not similar intensity as intervention; 4. Not delivered effectively; 5. Other. d Outcomes key: 1. Key health outcomes not addressed; 2. Physiologic measures, not validated surrogates; 3. Incomplete reporting of harms; 4. Not establish and validated measurements; 5. Clinically significant difference not prespecified; 6. Clinically significant difference not supported; 7. Other. e Follow-Up key: 1. Not sufficient duration for benefit; 2. Not sufficient duration for harms; 3. Other.

Table 16. Study Design and Conduct Limitations

    The study limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment. a Allocation key: 1. Participants not randomly allocated; 2. Allocation not concealed; 3. Allocation concealment unclear; 4. Inadequate control for selection bias; 5. Other. b Blinding key: 1. Participants or study staff not blinded; 2. Outcome assessors not blinded; 3. Outcome assessed by treating physician; 4. Other. c Selective Reporting key: 1. Not registered; 2. Evidence of selective reporting; 3. Evidence of selective publication; 4. Other. 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. Not intent to treat analysis (per protocol for noninferiority trials); 7. Other. e Power key: 1. Power calculations not reported; 2. Power not calculated for primary outcome; 3. Power not based on clinically important difference; 4. Other. f Statistical key: 1. Analysis is not appropriate for outcome type: (a) continuous; (b) binary; (c) time to event; 2. Analysis is not appropriate for multiple observations per patient; 3. Confidence intervals and/or p values not reported; 4. Comparative treatment effects not calculated; 5. Other.

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 1 to 2 years of 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%. Larger studies with appropriate harms reporting are required to appropriately assess the technology.

For individuals with shoulder or rotator cuff tendinopathy who receive RF coblation tenotomy, the evidence includes small RCTs. 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 1 to 2 years of 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 that the technology results in an improvement in the net health outcome.

Population Reference No. 5 Policy Statement

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 following PICO was used to select literature to inform this review.

Populations

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

Interventions

The therapy being considered is RF coblation tenotomy, also referred to as microtenotomy.

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 1 year is of interest to monitor outcomes.

Pain symptoms are typically reported via the VAS or NRS. A score reduction of at least 2 points is considered clinically meaningful.^13, Functional outcomes may include the Fulkerson-Shea Patellofemoral Joint Evaluation Score.^25,

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.

Review of Evidence

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).^25, All patients had failed a 6 month course of conservative treatment. The primary outcome measure was the Fulkerson-Shea Patellofemoral Joint Evaluation Score, which combines pain, functional, and clinical outcomes into an overall performance score. A score of 100 indicates a perfect score. While RF microdebridement achieved statistically higher scores at 1 and 2 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 microdebridement 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

     NR: not reported; RCT: randomized controlled trial; RF: radiofrequency.

Table 18. Comparative Study Results: Patellar Tendinopathy

     CI: confidence interval; NR: not reported; RF: radiofrequency. a Functional outcomes are based on the Fulkerson-Shea Patellofemoral Joint Evaluation Score.

Table 19. Study Relevance Limitations

    The study limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment. a Population key: 1. Intended use population unclear; 2. Study population is unclear; 3. Study population not representative of intended use; 4, Enrolled populations do not reflect relevant diversity; 5. Other. b Intervention key: 1. Not clearly defined; 2. Version used unclear; 3. Delivery not similar intensity as comparator; 4. Not the intervention of interest (e.g., proposed as an adjunct but not tested as such); 5: Other. c Comparator key: 1. Not clearly defined; 2. Not standard or optimal; 3. Delivery not similar intensity as intervention; 4. Not delivered effectively; 5. Other. d Outcomes key: 1. Key health outcomes not addressed; 2. Physiologic measures, not validated surrogates; 3. Incomplete reporting of harms; 4. Not establish and validated measurements; 5. Clinically significant difference not prespecified; 6. Clinically significant difference not supported; 7. Other. e Follow-Up key: 1. Not sufficient duration for benefit; 2. Not sufficient duration for harms; 3. Other.

Table 20. Study Design and Conduct Limitations

    The study limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment. a Allocation key: 1. Participants not randomly allocated; 2. Allocation not concealed; 3. Allocation concealment unclear; 4. Inadequate control for selection bias; 5. Other. b Blinding key: 1. Participants or study staff not blinded; 2. Outcome assessors not blinded; 3. Outcome assessed by treating physician; 4. Other. c Selective Reporting key: 1. Not registered; 2. Evidence of selective reporting; 3. Evidence of selective publication; 4. Other. 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. Not intent to treat analysis (per protocol for noninferiority trials); 7. Other. e Power key: 1. Power calculations not reported; 2. Power not calculated for primary outcome; 3. Power not based on clinically important difference; 4. Other. f Statistical key: 1. Analysis is not appropriate for outcome type: (a) continuous; (b) binary; (c) time to event; 2. Analysis is not appropriate for multiple observations per patient; 3. Confidence intervals and/or p values not reported; 4. Comparative treatment effects not calculated; 5. Other.

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.

For individuals with patellar tendinopathy who receive RF coblation tenotomy, the evidence includes 1 small RCT. 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 that the technology results in an improvement in the net health outcome.

Summary of Evidence

For individuals with plantar fasciitis who receive RF coblation tenotomy, the evidence includes nonrandomized, comparative cohort studies and case series. Relevant outcomes are symptoms, functional outcomes, QOL, medication use, and treatment-related morbidity. The trials reported improved pain and functional scores over 3 to 12 months, with improved outcomes with open versus 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 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. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with lateral epicondylitis who receive RF coblation tenotomy, the evidence includes small RCTs. 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 1 to 7 years of follow-up. For disability assessments in 1 study, open release surgery met the threshold for a clinically meaningful improvement over RF microtenotomy at 1 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 that the technology results in an improvement in the net health outcome.

For individuals with Achilles tendinopathy who receive RF coblation tenotomy, the evidence includes a small, single-blind RCT. 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 6 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 2 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 that the technology results in an improvement in the net health outcome.

For individuals with shoulder or rotator cuff tendinopathy who receive RF coblation tenotomy, the evidence includes small RCTs. 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 1 to 2 years of 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 that the technology results in an improvement in the net health outcome.

For individuals with patellar tendinopathy who receive RF coblation tenotomy, the evidence includes 1 small RCT. 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 that the technology results in an improvement in the net health outcome.

Supplemental Information

The purpose of the following information is to provide reference material. Inclusion does not imply endorsement or alignment with the evidence review conclusions.

Practice Guidelines and Position Statements

Guidelines or position statements will be considered for inclusion in ‘Supplemental Information’ if they were issued by, or jointly by, a US professional society, an international society with US representation, or National Institute for Health and Care Excellence (NICE). Priority will be given to guidelines that are informed by a systematic review, include strength of evidence ratings, and include a description of management of conflict of interest.

American College of Foot and Ankle Surgeons

In 2017, the American College of Foot and Ankle Surgeons 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.^26, 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

In 2013, the American College of Occupational and Environmental Medicine updated their treatment guidelines for lateral epicondylitis as a result of a systematic review of the literature.^27, 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.

Medicare National Coverage

The Centers for Medicare & Medicaid Services have determined that thermal intradiscal procedures, including percutaneous (or plasma) disc decompression or coblation, are not reasonable and necessary for the treatment of low back pain. Therefore, thermal intradiscal procedures, which include procedures that “employ the use of a radiofrequency energy source or electrothermal energy to apply or create heat and/or disruption within the disc for the treatment of low back pain, are noncovered.”^28,

However, the Centers for Medicare & Medicaid Services have not published a national coverage decision on radiofrequency coblation tenotomy for the musculoskeletal conditions addressed in this evidence review. In the absence of a national coverage determination, coverage determinations are left to the discretion of local Medicare carriers.

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: national clinical trial. a Denotes industry-sponsored or cosponsored trial.     

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CODES

Applicable Modifiers

N/A

Policy History