Criteria-Based Rehabilitation for Shoulder Injuries
(CRISP Trial)

Recruiting in Palo Alto (17 mi)

Overseen byMarisunta Pontillo, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: United States Naval Medical Center, San Diego

No Placebo Group

Trial Summary

What is the purpose of 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

This trial is for individuals with non-operative shoulder injuries, including shoulder pain and SLAP tears. Participants must be able to attend physical therapy and multiple clinical assessments at a Military Treatment Facility. Specific eligibility criteria are not provided.

Inclusion Criteria

I am an active-duty Service member over 18 seeking care for shoulder pain or injury.

Exclusion Criteria

I had a neck or upper back injury in the last year.

Individuals pending a medical evaluation board, discharge from the military, or pending litigation for an injury

I am referred for shoulder rehab after surgery.

+5 more

Participant Groups

The study compares two approaches: the current standard of care versus CRISP, a novel criteria-based rehabilitation program for shoulder injuries. It will assess patient outcomes, strength differences, and factors influencing readiness to return to duty.

2Treatment groups

Experimental Treatment

Active Control

Group I: Criteria-based Rehabilitation for Injured Shoulders Paradigm (CRISP).Experimental Treatment1 Intervention

The CRISP group will undergo physical therapy treatment, directed by a research physical therapist, including both supervised physical therapy and a guided home exercise program.

Group II: Standard of CareActive Control1 Intervention

The standard of care group will serve as the control arm and complete a period of physical rehabilitation under the supervision of a Military Health System physical therapist without study-specific guidance or interventions.