Chronical Rotator Cuff Tendinopathy Clinical Trial
Official title:
Effect Study of an Eccentric Training Program and Stretching for Patients With Chronical Rotator Cuff Tendinopathy
| Verified date | March 2012 |
| Source | University Ghent |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Belgium: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 69 |
| Est. completion date | February 2012 |
| Est. primary completion date | February 2012 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Belgium | University Hospital Ghent | Ghent |
| Lead Sponsor | Collaborator |
|---|---|
| University Ghent | Special Research Fund, Belgium |
Belgium,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Maximum force, pain and function,range of motion, force reproduction, subacromial space | After 6 and after 12 weeks of training | No |