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Effect Study of an Eccentric Training Program and Stretching for Patients With Chronical Rotator Cuff Tendinopathy
This study is not yet open for participant recruitment.
Verified by University Ghent, October 2008
Sponsors and Collaborators: University Ghent
BOF
Information provided by: University Ghent
ClinicalTrials.gov Identifier: NCT00782522
  Purpose

In the first part of the the study two new outcome measurements (force reproducibility and tendon stiffness) 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, tendon stiffness and force reproducibility will be assessed. Both training programs will be accomplished at home. The first four weeks there will be an appointment with the therapist once a week to explain, correct and when necessary, aggravate the exercises. The next eight weeks these appointments will be diminished to once every two weeks.

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

For detection of long term effects of the eccentric training program, the patients will be assessed a third time at three months after the end of the training program.


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

MedlinePlus related topics: Tendinitis
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Effect Study of an Eccentric Training Program and Stretching for Patients With Chronical Rotator Cuff Tendinopathy

Further study details as provided by University Ghent:

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

Secondary Outcome Measures:
  • Maximum force, range of motion, pain and function, force reproduction, tendon stiffness [ Time Frame: At three months after the end of the training program ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: September 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Eccentric training program
Procedure: Eccentric training program
Eccentric training program
2: Active Comparator
Traditional training program
Procedure: Traditional training program
Traditional training program

  Eligibility

Ages Eligible for Study:   20 Years to 50 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

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

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

Website of the University Hospital Ghent  This link exits the ClinicalTrials.gov site

Responsible Party: University Ghent ( Ann Cools )
Study ID Numbers: 2008/380
Study First Received: October 29, 2008
Last Updated: October 30, 2008
ClinicalTrials.gov Identifier: NCT00782522  
Health Authority: Belgium: Institutional Review Board

Study placed in the following topic categories:
Tendinopathy
Tendon Injuries
Muscular Diseases
Musculoskeletal Diseases
Wounds and Injuries
Disorders of Environmental Origin

ClinicalTrials.gov processed this record on January 16, 2009