Chronical Rotator Cuff TendinopathyNCT00782522
Effect Study of an Eccentric Training Program and Stretching for Patients With Chronical Rotator Cuff Tendinopathy
A study testing Eccentric training program and Traditional training program in people with Chronical Rotator Cuff Tendinopathy, run by University Ghent at 1 site in Belgium.
Trial summary
In the first part of the the study two new outcome measurements (force reproducibility and subacromial space) will be tested for reproducibility. Therefore 30 healthy people will be assessed. In a second part of the study 60 patients will be randomly allocated to two groups. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronical Rotator Cuff Tendinopathy
- What is being tested?
- Eccentric training program and Traditional training program
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteBelgium
- Study dates
- Apr 2009to Feb 2012
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- global tendon thinning
- inhomogeneous echo partitioning
- calcifications at the insertion
- symptoms present for at least 3 months: painful resisted isometric abduction, painful palpation of the supraspinatus tendon, impingement tests positive
Who cannot join
- documented full thickness rotator cuff rupture
- other lesions than CRCT at the moment of the study
- echographic criteria for ruptures (focal thinning, fluid-filled gap,compressibility)
Trial locations and contacts
1 site in 1 country.
About this study
In the first part of the the study two new outcome measurements (force reproducibility and subacromial space) will be tested for reproducibility. Therefore 30 healthy people will be assessed.
In a second part of the study 60 patients will be randomly allocated to two groups. Group A (n=30) will perform a traditional training program and group B (n=30) will perform an eccentric training program.
Read more
Before the onset of the training programs, pain, function, maximal force, range of motion, subacromial space and force reproducibility will be assessed. Both training programs will be accomplished at home. The first six weeks there will be an appointment with the therapist once a week to explain, correct and when necessary, aggravate the exercises. The next six weeks these appointments will be diminished to once every two weeks.
After 6 and after 12 weeks of training the patients will be reassessed for all the parameters.
- Conditions
- Chronical Rotator Cuff Tendinopathy
- Being tested
- Eccentric training program, Traditional training program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eccentric training programProcedure or surgery
Eccentric training program
Traditional training programProcedure or surgery
Traditional training program
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Eccentric training program Receives: Procedure: Eccentric training program |
| 2 | Active comparator | Traditional training program Receives: Procedure: Traditional training program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum force, pain and function,range of motion, force reproduction, subacromial space
Measured: After 6 and after 12 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 posted31 Oct 2008 (estimated)
- Study startApr 2009
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronical Rotator Cuff TendinopathyStudies 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
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Special Research Fund, Belgium
- Responsible party
- Sponsor
- Investigators
- Ann Cools, PhD, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00782522
- Sponsor's protocol ID
- 2008/380
- Status last verified
- Mar 2012
- First submitted
- 29 Oct 2008
- Last updated
- 27 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Study of an Eccentric Training Program and Stretching for Patients With Chronical Rotator Cuff Tendinopathy
- ClinicalTrials.gov ID
- NCT00782522
- Acronym / sponsor ID
- 2008/380
- Conditions
- Chronical Rotator Cuff Tendinopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- Special Research Fund, Belgium
- Study start
- Apr 2009
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 31 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.
In the first part of the the study two new outcome measurements (force reproducibility and subacromial space) will be tested for reproducibility. Therefore 30 healthy people will be assessed.
In a second part of the study 60 patients will be randomly allocated to two groups. Group A (n=30) will perform a traditional training program and group B (n=30) will perform an eccentric training program.
Before the onset of the training programs, pain, function, maximal force, range of motion, subacromial space and force reproducibility will be assessed. Both training programs will be accomplished at home. The first six weeks there will be an appointment with the therapist once a week to explain, correct and when necessary, aggravate the exercises. The next six weeks these appointments will be diminished to once every two weeks.
After 6 and after 12 weeks of training the patients will be reassessed for all the parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Eccentric training programEccentric training program |
| 2 | Active comparator | Procedure: Traditional training programTraditional training program |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- global tendon thinning
- inhomogeneous echo partitioning
- calcifications at the insertion
- symptoms present for at least 3 months: painful resisted isometric abduction, painful palpation of the supraspinatus tendon, impingement tests positive
Key exclusion criteria (3 listed)
- documented full thickness rotator cuff rupture
- other lesions than CRCT at the moment of the study
- echographic criteria for ruptures (focal thinning, fluid-filled gap,compressibility)
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 |
|---|---|---|
| Eccentric training programEccentric training program | Procedure or surgery | 1 |
| Traditional training programTraditional training program | Procedure or surgery | 2 |
Primary outcome
Maximum force, pain and function,range of motion, force reproduction, subacromial space
Time frame: After 6 and after 12 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 27 Mar 2012.
- Website of the University Hospital GhentLink provided by the sponsor.
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 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 Eccentric training program and Traditional training program in people with Chronical Rotator Cuff Tendinopathy, 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 27 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?
Maximum force, pain and function,range of motion, force reproduction, subacromial space (time frame: After 6 and after 12 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 27 Mar 2012; AzTrials last refreshed its copy on 26 Oct 2026.