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

Sponsor

University Ghent (Other)

Overall Status

Completed

CT.gov ID

NCT01423682

Collaborator

Fund for Scientific Research, Flanders, Belgium (Other)

Enrollment

Location

Arms

Actual Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Actual 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

Actual Study Start Date :

Apr 1, 2012

Actual Primary Completion Date :

Apr 1, 2015

Actual Study Completion Date :

Jun 1, 2015

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

Tendon thickness measurement [After 30 minutes rest, before performing the exercise.]
Grey scale ultrasound examination is used.
Tendon vascularisation examination. [After 30 minutes rest, before performing the exercise.]
Power Doppler ultrasound examination is used.
Microcirculation around the tendon examination. [After 30 minutes rest, before performing the exercise.]
Oxygen to see (spectrophotometry and laser Doppler) will be used.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

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 Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Ghent	Ghent		Belgium	9000

Sponsors and Collaborators

University Ghent
Fund for Scientific Research, Flanders, Belgium

Investigators

Principal Investigator: Ann Cools, MD, PhD, University Ghent

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Ghent

ClinicalTrials.gov Identifier:

NCT01423682

Other Study ID Numbers:

2011/482

First Posted:

Aug 26, 2011

Last Update Posted:

Nov 19, 2021

Last Verified:

Nov 1, 2021

Additional relevant MeSH terms:

Tendinopathy

Neovascularization, Pathologic

Study Results

No Results Posted as of Nov 19, 2021