Criteria-Based Rehabilitation for Shoulder Injuries

(CRISP Trial)

Overseen By Sara Gorczynski

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: United States Naval Medical Center, San Diego

Disqualifiers: Cervical spine injury, Adhesive capsulitis, Upper extremity limb loss, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 12 months

250 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on rehabilitation for shoulder injuries, so it's best to discuss your medications with the trial coordinators or your doctor.

How does the CRISP treatment for shoulder injuries differ from other treatments?

The CRISP treatment for shoulder injuries is unique because it is criteria-based, meaning it is tailored to the specific needs and progress of each patient, unlike standard treatments that may follow a more generic approach. This personalized method focuses on correcting abnormal findings and balancing muscle forces, which can lead to more effective rehabilitation outcomes. ^{1 2 3 4 5}

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

Research Team

Marisunta Pontillo, PhD

Principal Investigator

Extremity Trauma and Amputation Center of Excellence, Defense Health Agency

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo physical therapy treatment, either standard of care or CRISP program, including supervised sessions and home exercises

12 months

Initial and final clinical assessments, virtual questionnaires at 1-, 3-, 6-, and 12-months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including patient-reported outcomes and clinical assessments

12 months

Virtual questionnaires at 1-, 3-, 6-, and 12-months

Treatment Details

Interventions

• CRISP

Trial Overview 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.

Participant Groups

Group I: Criteria-based Rehabilitation for Injured Shoulders Paradigm (CRISP). Experimental Treatment 1 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 Care Active Control 1 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.

Who Is Running the Clinical Trial?

United States Naval Medical Center, San Diego

Lead Sponsor

Trials

110

Recruited

24,200+

Congressionally Directed Medical Research Programs

Collaborator

Trials

59

Recruited

10,600+

Henry M. Jackson Foundation for the Advancement of Military Medicine

Collaborator

Trials

103

Recruited

94,300+

Brooke Army Medical Center

Collaborator

Trials

134

Recruited

28,100+

The Geneva Foundation

Collaborator

Trials

39

Recruited

13,700+

References

1. England pubmed.ncbi.nlm.nih.gov

Discriminating the precision of inertial sensors between healthy and damaged shoulders during scaption movement: A cross-sectional study. [2021]

2. Finland pubmed.ncbi.nlm.nih.gov

Rehabilitation of the shoulder. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Reliability and validity of shoulder function outcome measures in people with a proximal humeral fracture. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Rehabilitation of common shoulder injuries. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

A retrospective, descriptive study of shoulder outcomes in outpatient physical therapy. [2022]