Efficacy of a Criteria Based Clinical Pathway for Rehabilitation of Shoulder Injuries
NCT Number: NCT06536114
Acronym: CRISP
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Shoulder Pain|Shoulder Injuries
Interventions: OTHER: CRISP: Criteria-Based Approach for the Rehabilitation for Non-Operative Shoulder Injuries|OTHER: Standard of Care
Sponsor: United States Naval Medical Center, San Diego
Collaborators: Brooke Army Medical Center|Congressionally Directed Medical Research Programs|Henry M. Jackson Foundation for the Advancement of Military Medicine|The Geneva Foundation
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 250
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2025-03-01
Completion Date: 2027-08-30
Locations: Naval Medical Center San Diego, San Diego, California, 92134, United States

Summary:
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

Primary Outcome Measures: Penn Shoulder Score, Patient-reported outcome with shoulder pain, satisfaction, and function subscales, Initial and final clinical study assessments; 1-, 3-, 6- and 12-months post-randomization
Secondary Outcome Measures: Referral to Surgical Intervention, Participant was referred to surgical invention for their shoulder injury., 3-, 6-, 12- months|Patient-Reported Outcomes Measurement Information System (PROMIS®), Patient-reported outcome measuring physical, mental, and social health among individuals with various chronic conditions., Initial and final clinical study assessments; 1-, 3-, 6- and 12-months post-randomization|Optimal Screening for Prediction of Referral and Outcome- Yellow Flag (OSPRO-YF), The OSPRO-YF is a 10-item screening tool which incorporates several psychosocial domains, namely, mood, fear avoidance, and positive affect-coping., Initial and final clinical study assessments; 1-, 3-, 6- and 12-months post-randomization|Military Orthopaedics Tracking Injuries and Outcomes Network (MOTION) Readiness Rehab Questionnaire, The Readiness Rehab Questionnaire assesses deployment readiness, containing questions including, "if called for a 6 month deployment today, my confidence to travel to/within a combat zone, carry/wear/use all required equipment and/or weapon, and perform required military duties for the duration of the 6 month deployment is:" and "my confidence to do my specific military duties with well managed pain is:__", both scored on 0-100 scales., Initial and final clinical study assessments; 1-, 3-, 6- and 12-months post-randomization