Effect Study of an Eccentric Training Program and Stretching for Patients With Chronical Rotator Cuff Tendinopathy

This study has been completed.
Sponsor:
Collaborator:
Special Research Fund, Belgium
Information provided by (Responsible Party):
University Ghent
ClinicalTrials.gov Identifier:
NCT00782522
First received: October 29, 2008
Last updated: March 26, 2012
Last verified: March 2012
  Purpose

In the first part of the the study two new outcome measurements (force reproducibility and subacromial space) will be tested for reproducibility. Therefore 30 healthy people will be assessed.

In a second part of the study 60 patients will be randomly allocated to two groups. Group A (n=30) will perform a traditional training program and group B (n=30) will perform an eccentric training program.

Before the onset of the training programs, pain, function, maximal force, range of motion, subacromial space and force reproducibility will be assessed. Both training programs will be accomplished at home. The first six weeks there will be an appointment with the therapist once a week to explain, correct and when necessary, aggravate the exercises. The next six weeks these appointments will be diminished to once every two weeks.

After 6 and after 12 weeks of training the patients will be reassessed for all the parameters.


Condition Intervention
Chronical Rotator Cuff Tendinopathy
Procedure: Eccentric training program
Procedure: Traditional training program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect Study of an Eccentric Training Program and Stretching for Patients With Chronical Rotator Cuff Tendinopathy

Resource links provided by NLM:


Further study details as provided by University Ghent:

Primary Outcome Measures:
  • Maximum force, pain and function,range of motion, force reproduction, subacromial space [ Time Frame: After 6 and after 12 weeks of training ] [ Designated as safety issue: No ]

Enrollment: 69
Study Start Date: April 2009
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Eccentric training program
Procedure: Eccentric training program
Eccentric training program
Active Comparator: 2
Traditional training program
Procedure: Traditional training program
Traditional training program

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • global tendon thinning
  • inhomogeneous echo partitioning
  • calcifications at the insertion
  • symptoms present for at least 3 months: painful resisted isometric abduction, painful palpation of the supraspinatus tendon, impingement tests positive

Exclusion Criteria:

  • documented full thickness rotator cuff rupture
  • other lesions than CRCT at the moment of the study
  • echographic criteria for ruptures (focal thinning, fluid-filled gap,compressibility)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00782522

Locations
Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Ghent
Special Research Fund, Belgium
Investigators
Principal Investigator: Ann Cools, PhD University Ghent
  More Information

Additional Information:
No publications provided

Responsible Party: University Ghent
ClinicalTrials.gov Identifier: NCT00782522     History of Changes
Other Study ID Numbers: 2008/380
Study First Received: October 29, 2008
Last Updated: March 26, 2012
Health Authority: Belgium: Institutional Review Board

Additional relevant MeSH terms:
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on April 15, 2014