- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01423682
The Influence of Eccentric Training on the Volume and Vascularisation of the Rotator Cuff in Patients With Rotator Cuff Tendinopathy and Healthy Subjects
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Ghent, Belgium, 9000
- University Hospital Ghent
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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,…)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Healthy subjects
|
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.
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Active Comparator: Rotator cuff tendinopathy
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tendon thickness measurement
Time Frame: After 30 minutes rest, before performing the exercise.
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Grey scale ultrasound examination is used.
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After 30 minutes rest, before performing the exercise.
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Tendon vascularisation examination.
Time Frame: After 30 minutes rest, before performing the exercise.
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Power Doppler ultrasound examination is used.
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After 30 minutes rest, before performing the exercise.
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Microcirculation around the tendon examination.
Time Frame: After 30 minutes rest, before performing the exercise.
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Oxygen to see (spectrophotometry and laser Doppler) will be used.
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After 30 minutes rest, before performing the exercise.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tendon thickness measurements.
Time Frame: 10 minutes after performing the exercise.
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Grey scale ultrasound examination is used.
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10 minutes after performing the exercise.
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Tendon vascularisation examination.
Time Frame: 10 minutes after performing the exercise.
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Power Doppler ultrasound examination is used.
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10 minutes after performing the exercise.
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Microcirculation around the tendon examination.
Time Frame: 10 minutes after performing the exercise.
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Oxygen to see (spectrophotometry and laser Doppler) will be used.
|
10 minutes after performing the exercise.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ann Cools, MD, PhD, University Ghent
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011/482
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Rotator Cuff Tendinopathy
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Shin Kong Wu Ho-Su Memorial HospitalCompletedRotator Cuff Tear | Ultrasonography | Rotator Cuff TendinopathyTaiwan
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University of Alabama at BirminghamTerminatedPartial Tear of Rotator Cuff | Tendinopathy of Rotator CuffUnited States
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InGeneron, Inc.Active, not recruitingRotator Cuff Tear | Rotator Cuff TendinitisUnited States
-
Sutherland Medical CenterActive, not recruitingRotator Cuff Tears | Rotator Cuff TendinosisPoland
-
National Taiwan University HospitalUnknownRotator Cuff Tears | Rotator Cuff TendinosisTaiwan
-
University of California, DavisCompletedRotator Cuff TendonitisUnited States
-
Michael KhazzamTerminatedRotator Cuff Tendinitis | Full Thickness Rotator Cuff TearUnited States
-
Guna S.p.aRecruitingRotator Cuff Injuries | Tendinopathy | Rotator Cuff Tendinitis | Syndrome Rotator Cuff | Tendinoses, Rotator CuffItaly
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GCS Ramsay Santé pour l'Enseignement et la RechercheRecruitingShoulder Rotator Cuff TendinitisFrance
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Afyonkarahisar Health Sciences UniversityCompletedMusculoskeletal Diseases | Shoulder Pain | Rotator Cuff Tendinopathy | Rotator Cuff SyndromeTurkey
Clinical Trials on Eccentric exercise
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University of MalagaUnknownRotator Cuff Tendinopathy
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Oslo University HospitalUniversity of OsloCompleted
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Universidad Europea de MadridCompletedAchilles Tendinopathy | Diastasis RectiSpain
-
Queen Margaret UniversityUnknownTendinopathy | Achilles TendonUnited Kingdom
-
Utah State UniversityNot yet recruitingBlood Flow Restriction
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Universidad Europea de MadridCompletedTendinopathy | Achilles TendonSpain
-
New York Institute of TechnologyRecruitingHypermobility SyndromeUnited States
-
Centre Hospitalier Universitaire de BesanconUnknownVentilatory Adaptation to Concentric Versus Eccentric Exercise in Patients With Severe COPD (CONvEX)Chronic Obstructive Pulmonary Disease SevereFrance
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University Hospital, Clermont-FerrandUnknown
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Uppsala UniversityThe Swedish Research Council; Uppsala County Council, Sweden; Amersham FoundationCompleted