NCT02092272

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

March 18, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 20, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

February 10, 2015

Status Verified

February 1, 2015

Enrollment Period

11 months

First QC Date

March 18, 2014

Last Update Submit

February 6, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • patient adherence to standard of care eccentric exercise regimens

    12 weeks

Study Arms (2)

instructional exercise video source

EXPERIMENTAL

instructional exercise video source

Behavioral: instructional exercise video source

Standard Therapy

NO INTERVENTION

Standard Therapy

Interventions

instructional exercise video source

instructional exercise video source

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mike O'Callaghan Federal Hospital

Nellis Air Force Base, Nevada, 89191, United States

Location

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Connor McKeown, MD

    Mike O'Callaghan Military Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2014

First Posted

March 20, 2014

Study Start

March 1, 2014

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

February 10, 2015

Record last verified: 2015-02

Locations