Eccentric Exercises for Shoulder Pain (Eccentric)
Primary Purpose
Shoulder Pain
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
instructional exercise video source
Sponsored by
About this trial
This is an interventional supportive care trial for Shoulder Pain
Eligibility Criteria
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
Sites / Locations
- Mike O'Callaghan Federal Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
instructional exercise video source
Standard Therapy
Arm Description
instructional exercise video source
Standard Therapy
Outcomes
Primary Outcome Measures
patient adherence to standard of care eccentric exercise regimens
Secondary Outcome Measures
Full Information
NCT ID
NCT02092272
First Posted
March 18, 2014
Last Updated
February 6, 2015
Sponsor
Mike O'Callaghan Military Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02092272
Brief Title
Eccentric Exercises for Shoulder Pain
Acronym
Eccentric
Official Title
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?
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Terminated
Why Stopped
the PI left our facility and the new staff prefer alternate excersises
Study Start Date
March 2014 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mike O'Callaghan Military Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
instructional exercise video source
Arm Type
Experimental
Arm Description
instructional exercise video source
Arm Title
Standard Therapy
Arm Type
No Intervention
Arm Description
Standard Therapy
Intervention Type
Behavioral
Intervention Name(s)
instructional exercise video source
Intervention Description
instructional exercise video source
Primary Outcome Measure Information:
Title
patient adherence to standard of care eccentric exercise regimens
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Connor McKeown, MD
Organizational Affiliation
Mike O'Callaghan Military Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mike O'Callaghan Federal Hospital
City
Nellis AFB
State/Province
Nevada
ZIP/Postal Code
89191
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Eccentric Exercises for Shoulder Pain
We'll reach out to this number within 24 hrs