Rotator Cuff InjuryNCT02261701
Rehabilitation After Rotator Cuff Repair
A study testing Early mobilization and Post surgery shoulder lock in people with Rotator Cuff Injury, run by Uppsala University at 1 site in Sweden.
Trial summary
A new postoperative regimen with a new bandage technique after surgery results in a better shoulder function and quality of life after surgery - than traditional postoperative regimen with shoulder lock and abductor cushion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Injury
- What is being tested?
- Early mobilization and Post surgery shoulder lock
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2014to 30 Oct 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- planned shoulder surgery, rotator cuff repair
Who cannot join
- not swedish speaking
- reoperation
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Orthopaedic surgery, Physiotherapy
Västerås, Västmanland County, 721 89
About this study
Official title: Rehabilitation After Rotator Cuff Repair a Randomised Controlled Study
A new postoperative regimen with a new bandage technique after surgery results in a better shoulder function and quality of life after surgery - than traditional postoperative regimen with shoulder lock and abductor cushion.
Read the detailed description
A new postoperative regimen , with a new bandage technique with shorter immobilization time and without shoulder lock, is supposed to results in a better shoulder function 6 and 12 months after surgery. Function is measured by Constant score, pain with VAS and quality of life with EQ5D, 3 and 12 months after surgery. The two treatment groups are compared.
- Conditions
- Rotator Cuff Injury
- Being tested
- Early mobilization, Post surgery shoulder lock
- Keywords
- shoulder surgery, rotator cuff injury, rehabilitation, function, pain, quality of life
- Medical subject headings
- Rotator Cuff Injuries, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early mobilizationOther
Also called Collar´n cuff 4 weeks post surgery and early mobilization
Early mobilization, collar´n cuff 4 weeks post surgery and after this light exercises start and no further bandage.
Post surgery shoulder lockOther
Also called Shoulder lock three weeks post surgery
Post surgery: Shoulder lock with abduction cushion, additionally 3 weeks with collar´n cuff, and after this period light exercises are allowed and nu further bandage.
| Study group | Role | What they receive |
|---|---|---|
| Early mobilization | Experimental | Intervention is early mobilization, four weeks immobilization postsurgery with collar´n cuff only. Receives: Other: Early mobilization |
| Post surgery shoulder lock | Other | Post surgery shoulder lock with abduction cushion 3 weeks and after this period collar´n cuff 3 weeks Receives: Other: Post surgery shoulder lock |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder function
Shoulder function is assessed by Constant score
Measured: 6 months after surgery
Secondary outcomes (1)
Pain
Visual analogue scale
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionAug 2017
- Study completion30 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff InjuryStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ann Christin Johansson, PhD, Study chair, Center for Clinical Research County Västmanland, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02261701
- Sponsor's protocol ID
- LTV-426521
- Other IDs
- ACJCKFVästerås
- Status last verified
- May 2018
- First submitted
- 3 Sep 2014
- Last updated
- 9 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation After Rotator Cuff Repair a Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT02261701
- Acronym / sponsor ID
- LTV-426521
- Conditions
- Rotator Cuff Injury
- Keywords
- shoulder surgery, rotator cuff injury, rehabilitation, function, pain, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- Sep 2014 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- 30 Oct 2017 (actual)
- First posted
- 10 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.
A new postoperative regimen with a new bandage technique after surgery results in a better shoulder function and quality of life after surgery - than traditional postoperative regimen with shoulder lock and abductor cushion.
Detailed description
A new postoperative regimen , with a new bandage technique with shorter immobilization time and without shoulder lock, is supposed to results in a better shoulder function 6 and 12 months after surgery. Function is measured by Constant score, pain with VAS and quality of life with EQ5D, 3 and 12 months after surgery. The two treatment groups are compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early mobilization | Experimental | Other: Early mobilizationIntervention is early mobilization, four weeks immobilization postsurgery with collar´n cuff only. |
| Post surgery shoulder lock | Other | Other: Post surgery shoulder lockPost surgery shoulder lock with abduction cushion 3 weeks and after this period collar´n cuff 3 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- planned shoulder surgery, rotator cuff repair
Key exclusion criteria (2 listed)
- not swedish speaking
- reoperation
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 |
|---|---|---|
| Early mobilizationAlso: Collar´n cuff 4 weeks post surgery and early mobilizationEarly mobilization, collar´n cuff 4 weeks post surgery and after this light exercises start and no further bandage. | Other | Early mobilization |
| Post surgery shoulder lockAlso: Shoulder lock three weeks post surgeryPost surgery: Shoulder lock with abduction cushion, additionally 3 weeks with collar´n cuff, and after this period light exercises are allowed and nu further bandage. | Other | Post surgery shoulder lock |
Primary outcome
Shoulder function
Time frame: 6 months after surgery
Shoulder function is assessed by Constant score
1 secondary outcome
Pain
Time frame: 6 months after surgery
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 9 May 2018.
- Individual participant dataSharing planned: No
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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.
Ann Christin Johansson, PhD study chair
Center for Clinical Research County Västmanland, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early mobilization and Post surgery shoulder lock in people with Rotator Cuff Injury, run by Uppsala University at 1 site in Sweden.
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 1 inclusion and 2 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 9 May 2018. 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 Sweden. 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?
Shoulder function (time frame: 6 months after surgery). 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 9 May 2018.