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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01423682
Other study ID # 2011/482
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 2012
Est. completion date June 2015

Study information

Verified date November 2021
Source University Ghent
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date June 2015
Est. primary completion date April 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
Belgium University Hospital Ghent Ghent

Sponsors (2)

Lead Sponsor Collaborator
University Ghent Fund for Scientific Research, Flanders, Belgium

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Tendon thickness measurement Grey scale ultrasound examination is used. After 30 minutes rest, before performing the exercise.
Primary Tendon vascularisation examination. Power Doppler ultrasound examination is used. After 30 minutes rest, before performing the exercise.
Primary Microcirculation around the tendon examination. Oxygen to see (spectrophotometry and laser Doppler) will be used. After 30 minutes rest, before performing the exercise.
Secondary Tendon thickness measurements. Grey scale ultrasound examination is used. 10 minutes after performing the exercise.
Secondary Tendon vascularisation examination. Power Doppler ultrasound examination is used. 10 minutes after performing the exercise.
Secondary Microcirculation around the tendon examination. Oxygen to see (spectrophotometry and laser Doppler) will be used. 10 minutes after performing the exercise.
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