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

Rotator Cuff Shoulder Syndrome and Allied Disorders Clinical Trial

— RF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01554670
• Other study ID #: radio-frequency micro-tenotomy
• Secondary ID: shoulder impinge
• Status: Completed
• Phase: Phase 4
• First received: March 1, 2012
• Last updated: March 18, 2012
• Start date: January 2009
• Est. completion date: February 2011

Study information

• Verified date: March 2012
• Source: Beijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: February 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 26 Years to 74 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rotator Cuff Shoulder Syndrome and Allied Disorders
• Shoulder Impingement Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS pain score		postoperative 3-week	No
Secondary	Shoulder range of motion (ROM)		3-month, 6-month, 1-year	No
Secondary	ASES score		3-month, 6-month, 1-year	No
Secondary	UCLA score		UCLA score	No
Secondary	Constant-Murley score		3-month, 6-month, 1-year	No
Secondary	SST score		3-month, 6-month, 1-year	No