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

November 18, 2021 updated by: University Ghent

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

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Ghent, Belgium, 9000
        • University Hospital Ghent

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Active Comparator: Rotator cuff tendinopathy
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.

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.
Grey scale ultrasound examination is used.
After 30 minutes rest, before performing the exercise.
Tendon vascularisation examination.
Time Frame: After 30 minutes rest, before performing the exercise.
Power Doppler ultrasound examination is used.
After 30 minutes rest, before performing the exercise.
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.
After 30 minutes rest, before performing the exercise.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2012

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

August 23, 2011

First Submitted That Met QC Criteria

August 25, 2011

First Posted (Estimate)

August 26, 2011

Study Record Updates

Last Update Posted (Actual)

November 19, 2021

Last Update Submitted That Met QC Criteria

November 18, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

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.

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