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Clinical Trials/NCT02092272
NCT02092272TerminatedNot Applicable

Does Providing Instructional Exercise Videos Increase Patient Adherence Compared to In-office Instruction by Physician When Using Eccentric Exercises to Treat Shoulder Pain in Adults?

Mike O'Callaghan Military Hospital1 site in 1 country23 target enrollmentStarted: March 1, 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Sponsor
Enrollment
23
Locations
1
Primary Endpoint
patient adherence to standard of care eccentric exercise regimens

Study Overview

Brief Summary

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.

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:

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Investigator)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • •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

Arms & Interventions

Standard Therapy

No Intervention

Standard Therapy

instructional exercise video source

Experimental

instructional exercise video source

Intervention: instructional exercise video source (Behavioral)

Outcomes

Primary Outcomes

patient adherence to standard of care eccentric exercise regimens

Time Frame: 12 weeks

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Mike O'Callaghan Military Hospital
Sponsor Class
Fed
Responsible Party
Sponsor

Study Sites (1)

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