Shoulder ImpingementNCT00774956
Shoulder Training: Muscle Recruitment Patterns and the Effect of an Exercise Program
A study testing Exercise training program in people with Shoulder Impingement, run by University Ghent at 1 site in Belgium.
Trial summary
The purpose of this study is to investigate the muscle recruitment pattern and the effect of a 6 week shoulder exercise training program in healthy persons and subjects with shoulder impingement Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Shoulder Impingement
- What is being tested?
- Exercise training program
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2008to Jun 2011
- 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 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- current reported history of shoulder pain localised at the glenohumeral joint diagnosed as impingement
- two positive shoulder impingement tests
- pain reproduction during two of three additional categories of clinical tests
- the subject is able to perform pain-free arm elevations with a resistance of 0.5 kg
Who cannot join
- cervical and periscapular pain
- positive labral injury tests
- history of shoulder surgery
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate the muscle recruitment pattern and the effect of a 6 week shoulder exercise training program in healthy persons and subjects with shoulder impingement
- Conditions
- Shoulder Impingement
- Being tested
- Exercise training program
- Medical subject headings
- Shoulder Impingement Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise training programProcedure or surgery
A 6 week shoulder exercise training program
Exercise training programProcedure or surgery
A 6 week shoulder exercise training program
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Subject with shoulder impingement Receives: Procedure: Exercise training program |
| 2 | Active comparator | Healthy persons Receives: Procedure: Exercise training program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle recruitment pattern
Measured: After 6 weeks of training
Secondary outcomes (1)
Shoulder pain and functional ability in the patient group
Measured: After 6 weeks of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2008 (estimated)
- Study startSep 2008
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder ImpingementStudies of the same condition, open and under way.
- More trials run by University GhentThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guy Vanderstraeten, MD, PhD, Principal investigator, University GhentAnn Cools, PhD, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00774956
- Sponsor's protocol ID
- 2008/432
- Status last verified
- Mar 2012
- First submitted
- 25 Sep 2008
- 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
- Shoulder Training: Muscle Recruitment Patterns and the Effect of an Exercise Program
- ClinicalTrials.gov ID
- NCT00774956
- Acronym / sponsor ID
- 2008/432
- Conditions
- Shoulder Impingement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 17 Oct 2008 (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 investigate the muscle recruitment pattern and the effect of a 6 week shoulder exercise training program in healthy persons and subjects with shoulder impingement
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Exercise training programSubject with shoulder impingement |
| 2 | Active comparator | Procedure: Exercise training programHealthy persons |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- current reported history of shoulder pain localised at the glenohumeral joint diagnosed as impingement
- two positive shoulder impingement tests
- pain reproduction during two of three additional categories of clinical tests
- the subject is able to perform pain-free arm elevations with a resistance of 0.5 kg
Key exclusion criteria (3 listed)
- cervical and periscapular pain
- positive labral injury tests
- history of shoulder surgery
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 training programA 6 week shoulder exercise training program | Procedure or surgery | 1 |
| Exercise training programA 6 week shoulder exercise training program | Procedure or surgery | 2 |
Primary outcome
Muscle recruitment pattern
Time frame: After 6 weeks of training
1 secondary outcome
Shoulder pain and functional ability in the patient group
Time frame: After 6 weeks of training
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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Natural History of Shoulder Pathology in Manual Wheelchair Users
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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.
Guy Vanderstraeten, MD, PhD principal investigator
University Ghent
Ann Cools, PhD principal investigator
University Ghent
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 training program in people with Shoulder Impingement, run by University Ghent at 1 site in Belgium.
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 20 Mar 2012. 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 Belgium. 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?
Muscle recruitment pattern (time frame: After 6 weeks of training). 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.