The Influence of Eccentric Training on the Volume and Vascularisation of the Rotator Cuff in Patients With Rotator Cuff Tendinopathy and Healthy Subjects

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief 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.

Condition or disease	Intervention/treatment	Phase
Rotator Cuff Tendinopathy	Behavioral: Eccentric exercise	Not Applicable

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	60 participants
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
Study Start Date :	April 2012
Estimated Primary Completion Date :	April 2015
Estimated Study Completion Date :	June 2015

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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.

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Tendon thickness measurement [ Time Frame: After 30 minutes rest, before performing the exercise. ]
   Grey scale ultrasound examination is used.
2. Tendon vascularisation examination. [ Time Frame: After 30 minutes rest, before performing the exercise. ]
   Power Doppler ultrasound examination is used.
3. 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.

Secondary Outcome Measures :

1. Tendon thickness measurements. [ Time Frame: 10 minutes after performing the exercise. ]
   Grey scale ultrasound examination is used.
2. Tendon vascularisation examination. [ Time Frame: 10 minutes after performing the exercise. ]
   Power Doppler ultrasound examination is used.
3. Microcirculation around the tendon examination. [ Time Frame: 10 minutes after performing the exercise. ]
   Oxygen to see (spectrophotometry and laser Doppler) will be used.

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 40 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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 Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Annelies Maenhout		annelies.maenhout@ugent.be

Locations

Belgium
University Hospital Ghent	Recruiting
Ghent, Belgium, 9000
Principal Investigator: Ann Cools, MD, PhD
Sub-Investigator: Annelies Maenhout

Sponsors and Collaborators

University Ghent

Fund for Scientific Research, Flanders, Belgium

Investigators

Principal Investigator:	Ann Cools, MD, PhD	University Ghent

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	University Ghent
ClinicalTrials.gov Identifier:	NCT01423682 History of Changes
Other Study ID Numbers:	2011/482
First Posted:	August 26, 2011
Last Update Posted:	December 5, 2014
Last Verified:	December 2014

Additional relevant MeSH terms:

Tendinopathy; Neovascularization, Pathologic; Muscular Diseases; Musculoskeletal Diseases	Tendon Injuries; Wounds and Injuries; Metaplasia; Pathologic Processes