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

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

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.

Study Overview

• Status: Completed
• Conditions: Rotator Cuff Shoulder Syndrome and Allied Disorders
• Intervention / Treatment: Procedure: RF micro-tenotomy

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 26 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. a skeletally mature patient who agreed to participate in the study
2. 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
3. supraspinatous tendinosis was confirmed on preoperative MRI
4. the symptoms were not relieved by a standardized conservative treatment regime
5. patient underwent standard arthroscopic subacromial decompression surgery.

Exclusion Criteria:

1. any concomitant partial or full-thickness rotator cuff tear verified both on pre-operative MRI or intra-operative finding
2. concomitant biceps lesions or internal impingement
3. any history of surgical treatment on the same shoulder.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: arthroscopic subacromial decompression; 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; 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; 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; Other Names: RF-based plasma micro-tenotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
VAS pain score	postoperative 3-week

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Beijing Hospital
• Investigators: Study Director: Chunyan Jiang, MD, PhD, Beijing JST Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: March 1, 2012
• First Submitted That Met QC Criteria: March 13, 2012
• First Posted (Estimate): March 15, 2012

Study Record Updates

• Last Update Posted (Estimate): March 20, 2012
• Last Update Submitted That Met QC Criteria: March 18, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: Shoulder surgery; Arthroscopic subacromial decompression; Bipolar radiofrequency; Tendon debridement
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Disease; Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Syndrome; Shoulder Impingement Syndrome
• Other Study ID Numbers: radio-frequency micro-tenotomy; shoulder impingement (Project of Beijing Academic Star)