Full Thickness Rotator Cuff TearNCT02740946
Enhanced Function and Quality of Life Following 5 Months of Exercise Therapy for Patients With Rotator Cuff Tears
A study testing Exercise therapy in people with Full Thickness Rotator Cuff Tear, run by Northern Orthopaedic Division, Denmark at 1 site in Denmark.
Trial summary
This study aims to evaluate the effect of 5 months of exercise therapy for patients with irreparable rotator cuff tears. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Full Thickness Rotator Cuff Tear
- What is being tested?
- Exercise therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2011to Jan 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- symptoms of rotator cuff rupture for at least three months with rupture of minimum musculus supraspinatus and musculus infraspinatus visualized by ultrasonography or arthroscopy
- no neurological conditions which could affect muscle strength or activity
- able to read and understand Danish
- both patients with and without a history of shoulder trauma were included
Who cannot join
- former rotator cuff surgery
- history of shoulder fracture or inflammatory conditions in the shoulder
- significant osteoarthritic changes on antero-posterior and/or lateral (outlet view) radiographs
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Northern Orthopaedic Division, Aalborg University Hospital
Aalborg, North Denmark, 9000
About this study
Official title: Enhanced Function and Quality of Life Following 5 Months of Exercise Therapy for Patients With Irreparable Rotator Cuff Tears - an Intervention Study
This study aims to evaluate the effect of 5 months of exercise therapy for patients with irreparable rotator cuff tears.
Read the detailed description
All included patients will receive exercise therapy consisting of two exercises focusing on strengthening m. deltoideus anterior and m. teres minor.
- Conditions
- Full Thickness Rotator Cuff Tear
- Being tested
- Exercise therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise therapyOther
5 months of exercise therapy with two strengthening exercises focusing on m. deltoideus anterior and m. teres minor. Furthermore, a warm up exercise was applied.
| Study group | Role | What they receive |
|---|---|---|
| Exercise therapy | Experimental | Exercise therapy 5 months Receives: Other: Exercise therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxford Shoulder Score
Change is measured from baseline to 3 and 5 months
Measured: Baseline, 3 months and 5 months
Secondary outcomes (6)
EuroQuol 5 Dimensions 5 Level EQ-5D-5L
Change is measured from baseline to 5 months
Measured: baseline and 5 months
Range of motion
Range of motion measured in flexion, abduction and external rotation using a goniometer. Change is measured from baseline to 5 months
Measured: Baseline and 5 months
Strength
Strength was measured in flexion, abduction, internal and external rotation using af dynamometer. Change is measured from baseline to 5 months
Measured: Baseline and 5 months
Dynamic flexion in degrees from 0 to 180
Change is measured from baseline to 5 months
Measured: Baseline and 5 months
Muscle activity using surface electromyography
Muscle activity was measured using surface electromyography of m. trapezius superior and m. deltoideus anterior Change is measured from baseline to5 months
Measured: Baseline and 5 months
Pain
Furthermore, patients were asked to evaluate their pain on a Visual Analogue Scale while performing flexion
Measured: Baseline and 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study startAug 2011
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Full Thickness Rotator Cuff TearStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern Orthopaedic Division, Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sten Rasmussen, MD, PhD, Principal investigator, Northern Orthopaedic Division, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02740946
- Sponsor's protocol ID
- N-20120040
- Status last verified
- Apr 2016
- First submitted
- 5 Apr 2016
- Last updated
- 15 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Christensen BH, Andersen KS, Rasmussen S, Andreasen EL, Nielsen LM, Jensen SL. Enhanced function and quality of life following 5 months of exercise therapy for patients with irreparable rotator cuff tears - an intervention study. BMC Musculoskelet Disord. 2016 Jun 8;17:252. doi: 10.1186/s12891-016-1116-6.
PubMed 27278468
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Function and Quality of Life Following 5 Months of Exercise Therapy for Patients With Irreparable Rotator Cuff Tears - an Intervention Study
- ClinicalTrials.gov ID
- NCT02740946
- Acronym / sponsor ID
- N-20120040
- Conditions
- Full Thickness Rotator Cuff Tear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Northern Orthopaedic Division, DenmarkUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 15 Apr 2016 (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 aims to evaluate the effect of 5 months of exercise therapy for patients with irreparable rotator cuff tears.
Detailed description
All included patients will receive exercise therapy consisting of two exercises focusing on strengthening m. deltoideus anterior and m. teres minor.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise therapy | Experimental | Other: Exercise therapyExercise therapy 5 months |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- symptoms of rotator cuff rupture for at least three months with rupture of minimum musculus supraspinatus and musculus infraspinatus visualized by ultrasonography or arthroscopy
- no neurological conditions which could affect muscle strength or activity
- able to read and understand Danish
- both patients with and without a history of shoulder trauma were included
Key exclusion criteria (3 listed)
- former rotator cuff surgery
- history of shoulder fracture or inflammatory conditions in the shoulder
- significant osteoarthritic changes on antero-posterior and/or lateral (outlet view) radiographs
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 |
|---|---|---|
| Exercise therapy5 months of exercise therapy with two strengthening exercises focusing on m. deltoideus anterior and m. teres minor. Furthermore, a warm up exercise was applied. | Other | Exercise therapy |
Primary outcome
Oxford Shoulder Score
Time frame: Baseline, 3 months and 5 months
Change is measured from baseline to 3 and 5 months
6 secondary outcomes
EuroQuol 5 Dimensions 5 Level EQ-5D-5L
Time frame: baseline and 5 months
Range of motion
Time frame: Baseline and 5 months
Strength
Time frame: Baseline and 5 months
Dynamic flexion in degrees from 0 to 180
Time frame: Baseline and 5 months
Muscle activity using surface electromyography
Time frame: Baseline and 5 months
Pain
Time frame: Baseline and 5 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 15 Apr 2016.
- Derived from this study: PubMed 27278468Christensen BH, Andersen KS, Rasmussen S, Andreasen EL, Nielsen LM, Jensen SL. Enhanced function and quality of life following 5 months of exercise therapy for patients with irreparable rotator cuff tears - an intervention study. BMC Musculoskelet Disord. 2016 Jun 8;17:252. doi: 10.1186/s12891-016-1116-6.
- Individual participant dataSharing planned: Yes
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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.
Sten Rasmussen, MD, PhD principal investigator
Northern Orthopaedic Division, Aalborg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise therapy in people with Full Thickness Rotator Cuff Tear, run by Northern Orthopaedic Division, Denmark at 1 site in Denmark.
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 15 Apr 2016. 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 Denmark. 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?
Oxford Shoulder Score (time frame: Baseline, 3 months and 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02740946, which also lists 1 linked publication.
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 15 Apr 2016.