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
  Purpose

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.


Condition Intervention Phase
Rotator Cuff Shoulder Syndrome and Allied Disorders
Procedure: RF micro-tenotomy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Controlled Study of Radio-frequency Treatment for Shoulder Impingement Syndrome

Resource links provided by NLM:


Further study details as provided by Beijing Hospital:

Primary Outcome Measures:
  • VAS pain score [ Time Frame: postoperative 3-week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 65
Study Start Date: January 2009
Study Completion Date: February 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: RF-based plasma micro-tenotomy

  Eligibility

Ages Eligible for Study:   26 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01554670

Sponsors and Collaborators
Beijing Hospital
Investigators
Study Director: Chunyan Jiang, MD, PhD Beijing JST Hospital
  More Information

No publications provided

Responsible Party: Yi Lu, Deputy director of the physician, Beijing Hospital
ClinicalTrials.gov Identifier: NCT01554670     History of Changes
Other Study ID Numbers: radio-frequency micro-tenotomy, shoulder impingement
Study First Received: March 1, 2012
Last Updated: March 18, 2012
Health Authority: China: Ministry of Health

Keywords provided by Beijing Hospital:
Arthroscopic subacromial decompression
Bipolar radiofrequency
Tendon debridement
Shoulder surgery

Additional relevant MeSH terms:
Syndrome
Shoulder Impingement Syndrome
Disease
Pathologic Processes
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on September 18, 2014