Eccentric Exercises for Rotator Cuff Tendinopathy

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Mike O'Callaghan Federal Hospital
Sponsor:
Information provided by (Responsible Party):
Mike O'Callaghan Federal Hospital
ClinicalTrials.gov Identifier:
NCT02092272
First received: March 18, 2014
Last updated: March 19, 2014
Last verified: March 2014
  Purpose

Patients will be randomly assigned to one of two groups using a random number generator. Group 1 will be provided with in-office instruction of standard of care eccentric exercises for rotator cuff tendinopathy. Group 2 will be provided with in-office instruction as well as a instructional exercise video source (DVD) to take home as a reminder on how to perform two specific standard of care eccentric exercises for rotator cuff tendinopathy. Each group will be given a card to track adherence to the standard of care eccentric exercise routine as measured only by the days that they accomplish their exercises. Study exercise diary will be collected after 12 weeks of treatment. Eccentric exercises are taught as part of standard of care for rotator cuff tendinopathy.


Condition Intervention
Rotator Cuff Tendinopathy
Behavioral: instructional exercise video source

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
Official Title: Does Providing Instructional Exercise Videos Increase Patient Adherence Compared to In-office Instruction by Physician When Using Eccentric Exercises to Treat Rotator Cuff Tendinopathy in Adults?

Resource links provided by NLM:


Further study details as provided by Mike O'Callaghan Federal Hospital:

Primary Outcome Measures:
  • patient adherence to standard of care eccentric exercise regimens [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 142
Study Start Date: March 2014
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: instructional exercise video source
instructional exercise video source
Behavioral: instructional exercise video source
instructional exercise video source
No Intervention: Standard Therapy
Standard Therapy

Detailed Description:

DoD beneficiaries age 18 or older will be recruited from the clinics at the Mike O'Callaghan Federal Medical Center (MOFMC). Subjects meeting the inclusion/exclusion criteria will be offered an opportunity to participate:

Screening Visit:

  • Obtain signed Informed Consent Document and HIPAA Authorization.
  • Verify inclusion/exclusion criteria

Visit 1 (may occur same day as Screening Visit):

  • Subjects will be randomly assigned to one of two groups by the Research Coordinator using a random number generator, thus the Investigators will be blinded to the group assignments:

    • Group 1: in-office instruction of the standard of care eccentric exercise regimen for rotator cuff tendinopathy.
    • Group 2: in-office instruction of the standard of care eccentric exercise regimen for rotator cuff tendinopathy and an instructional exercise video source (DVD).
  • Subjects will be given a study exercise diary to track adherence to the standard of care eccentric exercise routine.

Visit 2 (12 weeks post Visit 1):

• Study exercise diary will be collected to assess adherence. If the subject is unable to come in, they can return the study exercise diary via mail, or electronic mail.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion:

  • DoD beneficiary patient 18 years or older
  • Diagnosis of chronic (>30 days) rotator cuff tendinopathy of any etiology (traumatic vs over-use injury)

Exclusion:

  • Patients < 18 years of age
  • Patients with acute injury (fracture or injury within 30 days)
  • Patients unable to accomplish eccentric exercise regimen without assistance
  • Patients unable to view DVD
  • Pregnant women
  • Patients unable to read and/or understand English
  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: NCT02092272

Contacts
Contact: Jill M Clark, MBA/HCM 702-653-3298 jill.clark.3.ctr@us.af.mil

Locations
United States, Nevada
Mike O'Callaghan Federal Hospital Recruiting
Nellis AFB, Nevada, United States, 89191
Contact: Jill M Clark, MBA/HCM    702-653-3298    jill.clark.3.ctr@us.af.mil   
Principal Investigator: Kirk Middleton, DO         
Sponsors and Collaborators
Mike O'Callaghan Federal Hospital
Investigators
Principal Investigator: Kirk Middleton, DO Mike O'Callaghan Federal Hospital
  More Information

No publications provided

Responsible Party: Mike O'Callaghan Federal Hospital
ClinicalTrials.gov Identifier: NCT02092272     History of Changes
Other Study ID Numbers: FWH20140038H
Study First Received: March 18, 2014
Last Updated: March 19, 2014
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on September 18, 2014