Radio-frequency (RF)-Based Plasma Micro-tenotomy for the Treatment of Shoulder Impingement Syndrome

Study Overview
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Brief Summary
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The purpose of this study is to determine whether radio-frequency (RF)-based plasma micro-tenotomy has a positive effective for the treatment of shoulder impingement syndrome with cuff tendinosis. Eighty patients with impingement syndrome and cuff tendinosis that treated arthroscopic were enrolled in the study. Patients were randomly assigned to receive either arthroscopic subacromial decompression alone (ASD group, n=40) or arthroscopic subacromial decompression combined with RF-based plasma micro-tenotomy (RF group, n=40). Clinical outcome data including VAS(Visual Analogue Scale) pain score, Shoulder range of motion (ROM), ASES(American Shoulder And Elbow Surgeons) score, UCLA(University of California, Los Angeles) score, Constant-Murley score and SST(Simple Shoulder Test) score were recorded preoperatively and at postoperative 3-week, 6-week, 3-month, 6-month and 1-year.

Official Title
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A Prospective Randomized Controlled Study of Radio-frequency Treatment for Shoulder Impingement Syndrome

Conditions
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Rotator Cuff Shoulder Syndrome and Allied Disorders

Intervention / Treatment
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* Procedure: RF micro-tenotomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: a skeletally mature patient who agreed to participate in the study shoulder impingement syndrome was diagnosed by one senior surgeon (CYJ) and without any sign of rotator cuff tear both on pre-operative MRI or intra-operative arthroscopic view supraspinatous tendinosis was confirmed on preoperative MRI the symptoms were not relieved by a standardized conservative treatment regime patient underwent standard arthroscopic subacromial decompression surgery. Exclusion Criteria: any concomitant partial or full-thickness rotator cuff tear verified both on pre-operative MRI or intra-operative finding concomitant biceps lesions or internal impingement any history of surgical treatment on the same shoulder.

Ages Eligible for Study
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Minimum Age: 26 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: arthroscopic subacromial decompression<br>A thorough subacromial decompression was performed as described by Neer (which include coracoacromial ligament resection, excision of the anterio-lateral tip of the acromion and thorough debridement of the bursa). | |
| Active Comparator: decompression+RF micro-tenotomy<br>A thorough subacromial decompression was performed as described by Neer (which include coracoacromial ligament resection, excision of the anterio-lateral tip of the acromion and thorough debridement of the bursa).an additional bipolar RF-based device (TOPAZ, Arthrocare, Austin, TX) connected to a System2000 generator (Arthrocare, Austin, TX) was used to perform the micro-tenotomy. The device functions using a controlled plasma-mediated RF-based process (Co-ablation).The device was placed on the tendon perpendicular to its surface, for 500 milliseconds, and micro-debridement was performed at 5-mm intervals by a 2-row fashion, which covered most of the foot-print region of the supraspinatous tendon and at a depth of 3 to 5 mm | Procedure: RF micro-tenotomy<br>* an additional bipolar RF-based device (TOPAZ, Arthrocare, Austin, TX) connected to a System2000 generator (Arthrocare, Austin, TX) was used to perform the micro-tenotomy. The device functions using a controlled plasma-mediated RF-based process (Co-ablation).The device was placed on the tendon perpendicular to its surface, for 500 milliseconds, and micro-debridement was performed at 5-mm intervals by a 2-row fashion, which covered most of the foot-print region of the supraspinatous tendon and at a depth of 3 to 5 mm<br>* Other names: RF-based plasma micro-tenotomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS pain score |  | postoperative 3-week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shoulder range of motion (ROM) |  | 3-month, 6-month, 1-year | 
| ASES score |  | 3-month, 6-month, 1-year | 
| UCLA score |  | UCLA score | 
| Constant-Murley score |  | 3-month, 6-month, 1-year | 
| SST score |  | 3-month, 6-month, 1-year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arthroscopic subacromial decompression, Bipolar radiofrequency, Tendon debridement, Shoulder surgery