Shoulder Impingement SyndromeNCT02275689
Radiofrequency Microtenotomy for Treatment of Rotator Cuff Tendinopathy
A study testing Arthroscopic acromioplasty and Microtenotomy in people with Shoulder Impingement Syndrome, run by University Hospital of North Norway at 1 site in Norway.
Trial summary
This study compare the outcome (pain, function) after Radiofrequency microtenotomy (group I) and acromioplasty (group II) for treatment of rotator cuff tendinosis in the shoulder. The outcome of both methods will be compared to the physical therapy treatment (groupIII) Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Shoulder Impingement Syndrome
- What is being tested?
- Arthroscopic acromioplasty and Microtenotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2015to Dec 2016
- Phase
- Interventional
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Impingement pain in the shoulder at least 3 months
- MRI of shoulder reveal tendinosis
- Classification of Acromion morphology by RTG and or MRI
- daily pain
Who cannot join
- inflammatory joint disease
- Other comorbidity in the shoulder as instability, osteoarthritis or rotator cuff tear
- serious illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Alternative Treatment of Rotator Cuff Tendinopathy
This study compare the outcome (pain, function) after Radiofrequency microtenotomy (group I) and acromioplasty (group II) for treatment of rotator cuff tendinosis in the shoulder.
The outcome of both methods will be compared to the physical therapy treatment (groupIII)
Read the detailed description
Rotator cuff tendinosis cause pain and disability of the shoulder. Tendinosis, sometimes complicated by partial rupture, appears to be the major lesion in chronic rotator cuff tendinopathy. Important features is a poor intrinsic ability to heal.
Several patients receive treatment for shoulder tendinosis each year. Conservative treatments options include rest, stretching, strengthening, ice and/or physical therapy are used with difference results. A traditional surgical treatments (acromioplasty) have been reported with variable results..
The aim of this study is to evaluate improvement of VAS and functionality using Constant score before and after treatment of rotator cuff tendinosis using radiofrequency-plasma based microtenotomy in comparison to traditional acromioplasty and physical therapy.
- Conditions
- Shoulder Impingement Syndrome
- Being tested
- Arthroscopic acromioplasty, Microtenotomy
- Keywords
- Rotator cuff, Tendinosis, Impingement, radiofrequency
- Medical subject headings
- Shoulder Impingement Syndrome, Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopic acromioplastyProcedure or surgery
Surgical intervention With arthroscopic acromion resection
MicrotenotomyProcedure or surgery
Arthroscopic radiofrequency microtenotomy of rotator cuff tendon
| Study group | Role | What they receive |
|---|---|---|
| Arthrocopic acromioplasty | Active comparator | Surgical intervention with arthroscopic acromioplasty, bursectomy and subacromial decompression Receives: Procedure: Arthroscopic acromioplasty |
| Radiofrequency microtenotomy | Active comparator | Surgical intervention With arthroscopic radiofrequency microtenotomy Receives: Procedure: Microtenotomy |
| Physical therapy | No intervention | Muscle strength training, home trainings programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in VAS for pain
The patients will have a clinical control 6,12 weeks and 6 months postoperatively. The VAS will be registered every 2 weeks via SMS during 6 months
Measured: every 2 weeks. during 6 months
Change from baseline in VAS for pain,
Measured: 6 weeks, 6 months, and 12 months
Secondary outcomes (1)
Change from baseline in functionality measured by constant score
Measured: 6 weeks, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2014 (estimated)
- Study startMar 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder Impingement SyndromeStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Khaled Meknas, MD, PhD, Principal investigator, University Hospital of North Norway. 9038-Tromsø. Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02275689
- Sponsor's protocol ID
- 2011/1133
- Status last verified
- Dec 2016
- First submitted
- 22 Oct 2014
- Last updated
- 6 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alternative Treatment of Rotator Cuff Tendinopathy
- ClinicalTrials.gov ID
- NCT02275689
- Acronym / sponsor ID
- 2011/1133
- Conditions
- Shoulder Impingement Syndrome
- Keywords
- Rotator cuff, Tendinosis, Impingement, radiofrequency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 27 Oct 2014 (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.
This study compare the outcome (pain, function) after Radiofrequency microtenotomy (group I) and acromioplasty (group II) for treatment of rotator cuff tendinosis in the shoulder.
The outcome of both methods will be compared to the physical therapy treatment (groupIII)
Detailed description
Rotator cuff tendinosis cause pain and disability of the shoulder. Tendinosis, sometimes complicated by partial rupture, appears to be the major lesion in chronic rotator cuff tendinopathy. Important features is a poor intrinsic ability to heal.
Several patients receive treatment for shoulder tendinosis each year. Conservative treatments options include rest, stretching, strengthening, ice and/or physical therapy are used with difference results. A traditional surgical treatments (acromioplasty) have been reported with variable results..
The aim of this study is to evaluate improvement of VAS and functionality using Constant score before and after treatment of rotator cuff tendinosis using radiofrequency-plasma based microtenotomy in comparison to traditional acromioplasty and physical therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arthrocopic acromioplasty | Active comparator | Procedure: Arthroscopic acromioplastySurgical intervention with arthroscopic acromioplasty, bursectomy and subacromial decompression |
| Radiofrequency microtenotomy | Active comparator | Procedure: MicrotenotomySurgical intervention With arthroscopic radiofrequency microtenotomy |
| Physical therapy | No intervention | –Muscle strength training, home trainings programme |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Impingement pain in the shoulder at least 3 months
- MRI of shoulder reveal tendinosis
- Classification of Acromion morphology by RTG and or MRI
- daily pain
Key exclusion criteria (3 listed)
- inflammatory joint disease
- Other comorbidity in the shoulder as instability, osteoarthritis or rotator cuff tear
- serious illness
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 |
|---|---|---|
| Arthroscopic acromioplastySurgical intervention With arthroscopic acromion resection | Procedure or surgery | Arthrocopic acromioplasty |
| MicrotenotomyArthroscopic radiofrequency microtenotomy of rotator cuff tendon | Procedure or surgery | Radiofrequency microtenotomy |
Primary outcome
Change from baseline in VAS for pain
Time frame: every 2 weeks. during 6 months
The patients will have a clinical control 6,12 weeks and 6 months postoperatively. The VAS will be registered every 2 weeks via SMS during 6 months
Change from baseline in VAS for pain,
Time frame: 6 weeks, 6 months, and 12 months
1 secondary outcome
Change from baseline in functionality measured by constant score
Time frame: 6 weeks, 6 months and 12 months
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 6 Sep 2017.
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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.
Khaled Meknas, MD, PhD principal investigator
University Hospital of North Norway. 9038-Tromsø. Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthroscopic acromioplasty and Microtenotomy in people with Shoulder Impingement Syndrome, run by University Hospital of North Norway at 1 site in Norway.
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 4 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 6 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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?
Change from baseline in VAS for pain (time frame: every 2 weeks. during 6 months). The study lists 2 primary outcomes in all. 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 6 Sep 2017.