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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by University Ghent.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Fund for Scientific Research, Flanders, Belgium
Information provided by (Responsible Party):
University Ghent
ClinicalTrials.gov Identifier:
NCT01423682
First received: August 23, 2011
Last updated: April 13, 2012
Last verified: April 2012
  Purpose

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 Intervention
Rotator Cuff Tendinopathy
Behavioral: Eccentric exercise

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by University Ghent:

Primary Outcome Measures:
  • Tendon thickness measurement [ Time Frame: After 30 minutes rest, before performing the exercise. ] [ Designated as safety issue: No ]
    Grey scale ultrasound examination is used.

  • Tendon vascularisation examination. [ Time Frame: After 30 minutes rest, before performing the exercise. ] [ Designated as safety issue: No ]
    Power Doppler ultrasound examination is used.

  • Microcirculation around the tendon examination. [ Time Frame: After 30 minutes rest, before performing the exercise. ] [ Designated as safety issue: No ]
    Oxygen to see (spectrophotometry and laser Doppler) will be used.


Secondary Outcome Measures:
  • Tendon thickness measurements. [ Time Frame: 10 minutes after performing the exercise. ] [ Designated as safety issue: No ]
    Grey scale ultrasound examination is used.

  • Tendon vascularisation examination. [ Time Frame: 10 minutes after performing the exercise. ] [ Designated as safety issue: No ]
    Power Doppler ultrasound examination is used.

  • Microcirculation around the tendon examination. [ Time Frame: 10 minutes after performing the exercise. ] [ Designated as safety issue: No ]
    Oxygen to see (spectrophotometry and laser Doppler) will be used.


Estimated Enrollment: 60
Study Start Date: April 2012
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01423682

Contacts
Contact: Annelies Maenhout annelies.maenhout@ugent.be

Locations
Belgium
University Hospital Ghent Not yet 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

No publications provided

Responsible Party: University Ghent
ClinicalTrials.gov Identifier: NCT01423682     History of Changes
Other Study ID Numbers: 2011/482
Study First Received: August 23, 2011
Last Updated: April 13, 2012
Health Authority: Belgium: Ethics Committee

Additional relevant MeSH terms:
Neovascularization, Pathologic
Tendinopathy
Metaplasia
Pathologic Processes
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on July 22, 2014