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Completed

NCT Number: NCT01554670

Radio-frequency (RF)-Based Plasma Micro-tenotomy for the Treatment of 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.

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Key information

Conditions

Rotator Cuff Shoulder Syndrome and Allied Disorders

Age range

26 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

RF micro-tenotomy

Procedure

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

Primary outcomes

  1. VAS pain score

    Time frame: postoperative 3-week

Secondary outcomes

  1. Shoulder range of motion (ROM)

    Time frame: 3-month, 6-month, 1-year

  2. ASES score

    Time frame: 3-month, 6-month, 1-year

  3. UCLA score

    Time frame: UCLA score

  4. Constant-Murley score

    Time frame: 3-month, 6-month, 1-year

  5. SST score

    Time frame: 3-month, 6-month, 1-year

Sponsors and collaborators

Lead sponsor

Beijing Hospital

Other Gov

Registry information

Official study title

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

Acronym: RF

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Mar 15, 2012
Registry last updated
Mar 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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