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

Primary Purpose

Rotator Cuff Tendinopathy

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Eccentric exercise
Sponsored by
University Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Tendinopathy

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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,…)

Sites / Locations

  • University Hospital Ghent

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Healthy subjects

Rotator cuff tendinopathy

Arm Description

Outcomes

Primary Outcome Measures

Tendon thickness measurement
Grey scale ultrasound examination is used.
Tendon vascularisation examination.
Power Doppler ultrasound examination is used.
Microcirculation around the tendon examination.
Oxygen to see (spectrophotometry and laser Doppler) will be used.

Secondary Outcome Measures

Tendon thickness measurements.
Grey scale ultrasound examination is used.
Tendon vascularisation examination.
Power Doppler ultrasound examination is used.
Microcirculation around the tendon examination.
Oxygen to see (spectrophotometry and laser Doppler) will be used.

Full Information

First Posted
August 23, 2011
Last Updated
November 18, 2021
Sponsor
University Ghent
Collaborators
Fund for Scientific Research, Flanders, Belgium
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1. Study Identification

Unique Protocol Identification Number
NCT01423682
Brief Title
The Influence of Eccentric Training on the Volume and Vascularisation of the Rotator Cuff in Patients With Rotator Cuff Tendinopathy and Healthy Subjects
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 Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
April 2012 (Actual)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Ghent
Collaborators
Fund for Scientific Research, Flanders, Belgium

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tendinopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy subjects
Arm Type
Placebo Comparator
Arm Title
Rotator cuff tendinopathy
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Eccentric exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Tendon thickness measurement
Description
Grey scale ultrasound examination is used.
Time Frame
After 30 minutes rest, before performing the exercise.
Title
Tendon vascularisation examination.
Description
Power Doppler ultrasound examination is used.
Time Frame
After 30 minutes rest, before performing the exercise.
Title
Microcirculation around the tendon examination.
Description
Oxygen to see (spectrophotometry and laser Doppler) will be used.
Time Frame
After 30 minutes rest, before performing the exercise.
Secondary Outcome Measure Information:
Title
Tendon thickness measurements.
Description
Grey scale ultrasound examination is used.
Time Frame
10 minutes after performing the exercise.
Title
Tendon vascularisation examination.
Description
Power Doppler ultrasound examination is used.
Time Frame
10 minutes after performing the exercise.
Title
Microcirculation around the tendon examination.
Description
Oxygen to see (spectrophotometry and laser Doppler) will be used.
Time Frame
10 minutes after performing the exercise.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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,…)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann Cools, MD, PhD
Organizational Affiliation
University Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

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

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