Radio-frequency (RF)-Based Plasma Micro-tenotomy for the Treatment of Shoulder Impingement Syndrome
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| First Received Date ICMJE | March 1, 2012 | ||||
| Last Updated Date | March 18, 2012 | ||||
| Start Date ICMJE | January 2009 | ||||
| Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
VAS pain score [ Time Frame: postoperative 3-week ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01554670 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Radio-frequency (RF)-Based Plasma Micro-tenotomy for the Treatment of Shoulder Impingement Syndrome | ||||
| Official Title ICMJE | A Prospective Randomized Controlled Study of Radio-frequency Treatment for Shoulder Impingement Syndrome | ||||
| Brief 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Rotator Cuff Shoulder Syndrome and Allied Disorders | ||||
| Intervention ICMJE | 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 |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 65 | ||||
| Completion Date | February 2011 | ||||
| Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 26 Years to 74 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01554670 | ||||
| Other Study ID Numbers ICMJE | radio-frequency micro-tenotomy, shoulder impingement | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Yi Lu, Beijing Hospital | ||||
| Study Sponsor ICMJE | Beijing Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Beijing Hospital | ||||
| Verification Date | March 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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