Efficacy of a Criteria Based Clinical Pathway for Rehabilitation of Shoulder Injuries
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUnited States Naval Medical Center, San Diego
About this trial
The goal of this clinical trial is to compare the current standard of care for rehabilitation of non-operative shoulder injuries to a novel, criteria-based approach (CRISP). Additionally, this study will identify factors which contribute to return to duty readiness. The main questions it aims to answer are:
* Are there differences in patient reported outcomes between participants who undergo the criteria-based rehabilitation program versus the standard of care for shoulder injuries? * Are there differences in clinical measures (strength, etc.) between participants who undergo the criteria-based rehabilitation program versus the standard of care for shoulder injuries? * Are there clinical or rehabilitation factors, or participant characteristics, that contribute to return to duty readiness?
Participants will be randomized to either complete their rehabilitation per the standard of care with a physical therapist in a Military Treatment Facility or complete the CRISP program with a research physical therapist. Participants will:
* Attend physical therapy for a non-operative shoulder injury * Attend initial and final clinical assessments at the clinic * Complete patient reported outcomes at 1-, 3-, 6- and 12-month timepoints
Eligibility criteria
Qualifiers
Active-duty Service members over the age of 18 who are seeking medical attention for shoulder pain or injury will be recruited to participate in this study.
Disqualifiers
The exclusion criteria include individuals who have sustained cervical or thoracic spine injury in the past year; an upper extremity or spine injury within the past year and have not been cleared to perform their previous duty requirements; a diagnosis of adhesive capsulitis; individuals referred to post-operative rehabilitation for the shoulder; individuals who are scheduled for shoulder surgery within the following 12 weeks; pain originating from a body region other than shoulder or is non-orthopaedic in nature; individuals who have sustained an upper extremity limb loss; individuals pending a medical evaluation board, discharge from the military, or pending litigation for an injury.
Trial design
Treatments tested in this trial
- CRISP: Criteria-Based Approach for the Rehabilitation for Non-Operative Shoulder Injuries
- Standard of Care
Treatment groups
250 Participants
are divided into 2 treatment groupsSponsors and collaborators
United States Naval Medical Center, San Diego
Lead sponsor
Brooke Army Medical Center
Collaborator
Congressionally Directed Medical Research Programs
Collaborator
Henry M. Jackson Foundation for the Advancement of Military Medicine
Collaborator
The Geneva Foundation
Collaborator
Source ClinicalTrials.gov