Rotator Cuff Shoulder Syndrome and Allied DisordersPhase 4RFNCT01554670
Radio-frequency (RF)-Based Plasma Micro-tenotomy for the Treatment of Shoulder Impingement Syndrome
A Phase 4 study testing RF micro-tenotomy in people with Rotator Cuff Shoulder Syndrome and Allied Disorders, run by Beijing Hospital.
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. Read more about this study
- Who is it for?
- Ages 26 to 74 years
- Conditions the study is for
- Rotator Cuff Shoulder Syndrome and Allied Disorders
- What is being tested?
- RF micro-tenotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to Feb 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 26 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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.
- Being tested
- RF micro-tenotomy
- Keywords
- Arthroscopic subacromial decompression, Bipolar radiofrequency, Tendon debridement, Shoulder surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RF micro-tenotomyProcedure or surgery
Also called RF-based plasma 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
| Study group | Role | What they receive |
|---|---|---|
| arthroscopic subacromial decompression | No intervention | 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). |
| decompression+RF micro-tenotomy | Active comparator | 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 Receives: Procedure: RF micro-tenotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS pain score
Measured: postoperative 3-week
Secondary outcomes (5)
Shoulder range of motion (ROM)
Measured: 3-month, 6-month, 1-year
ASES score
Measured: 3-month, 6-month, 1-year
UCLA score
Measured: UCLA score
Constant-Murley score
Measured: 3-month, 6-month, 1-year
SST score
Measured: 3-month, 6-month, 1-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2012 (estimated)
- Study startJan 2009
- Primary completionDec 2010
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff Shoulder Syndrome and Allied DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yi Lu, Beijing Hospital
- Investigators
- Chunyan Jiang, MD, PhD, Study director, Beijing JST Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01554670
- Sponsor's protocol ID
- radio-frequency micro-tenotomy
- Other IDs
- shoulder impingement
- Acronym
- RF
- Status last verified
- Mar 2012
- First submitted
- 1 Mar 2012
- Last updated
- 20 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Study of Radio-frequency Treatment for Shoulder Impingement Syndrome
- ClinicalTrials.gov ID
- NCT01554670
- Acronym / sponsor ID
- RF / radio-frequency micro-tenotomy
- Keywords
- Arthroscopic subacromial decompression, Bipolar radiofrequency, Tendon debridement, Shoulder surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Beijing HospitalOther government
- Study start
- Jan 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 15 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| arthroscopic subacromial decompression | No intervention | –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). |
| decompression+RF micro-tenotomy | Active comparator | Procedure: RF micro-tenotomyA 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 |
Who may qualify
- Ages
- 26 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RF micro-tenotomyAlso: RF-based plasma micro-tenotomyan 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 or surgery | decompression+RF micro-tenotomy |
Primary outcome
VAS pain score
Time frame: postoperative 3-week
5 secondary outcomes
Shoulder range of motion (ROM)
Time frame: 3-month, 6-month, 1-year
ASES score
Time frame: 3-month, 6-month, 1-year
UCLA score
Time frame: UCLA score
Constant-Murley score
Time frame: 3-month, 6-month, 1-year
SST score
Time frame: 3-month, 6-month, 1-year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chunyan Jiang, MD, PhD study director
Beijing JST Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing RF micro-tenotomy in people with Rotator Cuff Shoulder Syndrome and Allied Disorders, run by Beijing Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS pain score (time frame: postoperative 3-week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2012.