Eccentric Exercises for Shoulder Pain

NCT ID: NCT02092272

Last Updated: 2015-02-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2015-02-28

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.

Conditions

Shoulder Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

instructional exercise video source

instructional exercise video source

Group Type: EXPERIMENTAL

instructional exercise video source

Intervention Type: BEHAVIORAL

instructional exercise video source

Standard Therapy

Standard Therapy

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

instructional exercise video source

instructional exercise video source

Intervention Type: BEHAVIORAL

Eligibility Criteria

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:

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mike O'Callaghan Military Hospital

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Connor McKeown, MD

Role: PRINCIPAL_INVESTIGATOR

Mike O'Callaghan Military Hospital

Locations

Mike O'Callaghan Federal Hospital

Nellis Air Force Base, Nevada, United States

Countries

United States

Other Identifiers

FWH20140038H

Identifier Type: -

Identifier Source: org_study_id