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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yi Lu, Beijing Hospital
ClinicalTrials.gov Identifier:
NCT01554670
First received: March 1, 2012
Last updated: March 18, 2012
Last verified: March 2012

March 1, 2012
March 18, 2012
January 2009
December 2010   (final data collection date for primary outcome measure)
VAS pain score [ Time Frame: postoperative 3-week ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01554670 on ClinicalTrials.gov Archive Site
  • Shoulder range of motion (ROM) [ Time Frame: 3-month, 6-month, 1-year ] [ Designated as safety issue: No ]
  • ASES score [ Time Frame: 3-month, 6-month, 1-year ] [ Designated as safety issue: No ]
  • UCLA score [ Time Frame: UCLA score ] [ Designated as safety issue: No ]
  • Constant-Murley score [ Time Frame: 3-month, 6-month, 1-year ] [ Designated as safety issue: No ]
  • SST score [ Time Frame: 3-month, 6-month, 1-year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Radio-frequency (RF)-Based Plasma Micro-tenotomy for the Treatment of Shoulder Impingement Syndrome
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Rotator Cuff Shoulder Syndrome and Allied Disorders
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 Name: RF-based plasma micro-tenotomy
  • 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
    Intervention: Procedure: RF micro-tenotomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
65
February 2011
December 2010   (final data collection date for primary outcome measure)

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.
Both
26 Years to 74 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01554670
radio-frequency micro-tenotomy, shoulder impingement
No
Yi Lu, Beijing Hospital
Beijing Hospital
Not Provided
Study Director: Chunyan Jiang, MD, PhD Beijing JST Hospital
Beijing Hospital
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP