Eccentric Exercises for Shoulder Pain

Shoulder Pain Clinical Trial

— 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?

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02092272
• Other study ID #: FWH20140038H
• Status: Terminated
• Phase: N/A
• First received: March 18, 2014
• Last updated: February 6, 2015
• Start date: March 2014
• Est. completion date: February 2015

Study information

• Verified date: February 2015
• Source: Mike O'Callaghan Federal Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Shoulder Pain

Intervention

Behavioral:
• instructional exercise video source
instructional exercise video source

Locations

Country	Name	City	State
United States	Mike O'Callaghan Federal Hospital	Nellis AFB	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
Mike O'Callaghan Federal Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	patient adherence to standard of care eccentric exercise regimens		12 weeks	No