Eccentric Exercises for Shoulder Pain (Eccentric)

February 6, 2015 updated by: Mike O'Callaghan Military Hospital

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?

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nevada
      • Nellis AFB, Nevada, United States, 89191
        • Mike O'Callaghan Federal Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion:

  • DoD beneficiary patient 18 years or older
  • Diagnosis of chronic (>30 days) shoulder pain 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: instructional exercise video source
Behavioral: instructional exercise video source
instructional exercise video source
No Intervention: Standard Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
patient adherence to standard of care eccentric exercise regimens
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mike O'Callaghan Military Hospital

Investigators

  • Principal Investigator: Connor McKeown, MD, Mike O'Callaghan Military Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

March 18, 2014

First Submitted That Met QC Criteria

March 18, 2014

First Posted (Estimate)

March 20, 2014

Study Record Updates

Last Update Posted (Estimate)

February 10, 2015

Last Update Submitted That Met QC Criteria

February 6, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FWH20140038H

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Shoulder Pain

Clinical Trials on instructional exercise video source

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahrain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe