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The Influence of Eccentric Training on the Volume and Vascularisation of the Rotator Cuff in Patients With Rotator Cuff Tendinopathy and Healthy Subjects
Recruitment status was: Recruiting
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Purpose
Patients with rotator cuff tendinopathy make up a large part of the population in physiotherapy practice. The rotator cuff, a shoulder muscle group, plays an important role in causing pain. Tendons suffer large compression and friction, which can lead to degeneration of these tendons. Rehabilitation often leads to unsatisfying results.
In Achilles and patella tendinopathy, a new training program called eccentric training has shown very good results. Eccentric training contains exercises during which a force has to be resisted while the muscle lengthens instead of shortens. This would have a larger influence on tendon tissue. Some small studies also show promising results of eccentric training in patients with rotator cuff tendinopathy but the mechanisms behind these results remain unclear.
To investigate this, 30 patients with rotator cuff tendinopathy and 30 healthy subjects will be evaluated before and immediately after performing the exercise. Three measurements will be done: ultrasonographic measurement of tendon thickness, power Doppler imaging and measurement of microcirculation around the tendon with Oxygen to see. All measurements are non-invasive, pain free and without risks for the human body.
| Condition | Intervention |
|---|---|
| Rotator Cuff Tendinopathy | Behavioral: Eccentric exercise |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Single (Participant) Primary Purpose: Treatment |
| Official Title: | The Influence of Eccentric Training on the Volume and Vascularisation of the Rotator Cuff in Patients With Rotator Cuff Tendinopathy and Healthy Subjects |
- Tendon thickness measurement [ Time Frame: After 30 minutes rest, before performing the exercise. ]Grey scale ultrasound examination is used.
- Tendon vascularisation examination. [ Time Frame: After 30 minutes rest, before performing the exercise. ]Power Doppler ultrasound examination is used.
- Microcirculation around the tendon examination. [ Time Frame: After 30 minutes rest, before performing the exercise. ]Oxygen to see (spectrophotometry and laser Doppler) will be used.
- Tendon thickness measurements. [ Time Frame: 10 minutes after performing the exercise. ]Grey scale ultrasound examination is used.
- Tendon vascularisation examination. [ Time Frame: 10 minutes after performing the exercise. ]Power Doppler ultrasound examination is used.
- Microcirculation around the tendon examination. [ Time Frame: 10 minutes after performing the exercise. ]Oxygen to see (spectrophotometry and laser Doppler) will be used.
| Estimated Enrollment: | 60 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | June 2015 |
| Estimated Primary Completion Date: | April 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Healthy subjects |
Behavioral: Eccentric exercise
Patients and healthy subjects will perform an eccentric exercise during which a weight is lifted along the body and lowered with an extended arm at a slow speed. Weight is determined, based on pain in patients and based on force in healthy subjects.
|
| Active Comparator: Rotator cuff tendinopathy |
Behavioral: Eccentric exercise
Patients and healthy subjects will perform an eccentric exercise during which a weight is lifted along the body and lowered with an extended arm at a slow speed. Weight is determined, based on pain in patients and based on force in healthy subjects.
|
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria Patients:
- Male/ Female
- 18-40 years old
- Unilateral shoulder pain for at least 3 months
- Pain of at least 3/10 on a visual analogue scale
- Painful arc or pain at end range abduction
- 2/3 impingement tests positive
- 2/4 resistance tests positive
- Pain at insertion rotator cuff
Exclusion Criteria Patients:
- Spurling test positive
- Shoulder surgery in the past
- Osteoarthritis shoulder
- Full thickness ruptures
Inclusion Criteria Healthy subjects:
- Male/ Female
- 18-40 years old
Exclusion Criteria Healthy subjects:
- Shoulder pain during the last 3 months
- Shoulder surgery in the past
- Neck pain or disability
- Systemic disease (e.g. Marfan, Ehlers Danlos,…)
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01423682
| Contact: Annelies Maenhout | annelies.maenhout@ugent.be |
| Belgium | |
| University Hospital Ghent | Recruiting |
| Ghent, Belgium, 9000 | |
| Principal Investigator: Ann Cools, MD, PhD | |
| Sub-Investigator: Annelies Maenhout | |
| Principal Investigator: | Ann Cools, MD, PhD | University Ghent |
More Information
| Responsible Party: | University Ghent |
| ClinicalTrials.gov Identifier: | NCT01423682 History of Changes |
| Other Study ID Numbers: |
2011/482 |
| Study First Received: | August 23, 2011 |
| Last Updated: | December 4, 2014 |
Additional relevant MeSH terms:
|
Tendinopathy Neovascularization, Pathologic Muscular Diseases Musculoskeletal Diseases |
Tendon Injuries Wounds and Injuries Metaplasia Pathologic Processes |
ClinicalTrials.gov processed this record on September 21, 2017