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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two methods to help people recover from shoulder injuries without surgery. One group will follow the usual rehab steps with military therapists, while the other will try a new, structured program called CRISP (Criteria-Based Rehabilitation for Shoulder Injuries). The study aims to determine if there is a difference in how well people feel and function between the two methods and what helps them return to their duties. It seeks active-duty service members who have shoulder pain but haven't had surgery. As an unphased trial, this study offers participants the opportunity to contribute to innovative rehabilitation methods that could enhance recovery outcomes.

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.

What prior data suggests that this criteria-based rehabilitation approach is safe for shoulder injuries?

Research has shown that the CRISP program for shoulder rehab is generally manageable for participants. People in similar studies have experienced positive outcomes with this type of physical therapy. The CRISP program employs a structured exercise plan that adapts to each person's progress, ensuring the exercises remain safe and appropriate for everyone.

No major reports of negative effects have been linked to this rehab method in the studies reviewed. This suggests that the treatment is safe for individuals with shoulder injuries who do not require surgery. Overall, the evidence supports the safety and comfort of the CRISP program for those considering joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CRISP treatment for shoulder injuries because it offers a structured and personalized rehabilitation approach. Unlike the standard physical therapy options that follow a more general protocol, CRISP combines supervised therapy sessions with a guided home exercise program tailored specifically to the patient's progress and needs. This targeted approach aims to optimize recovery by ensuring each patient receives the right exercises at the right time, potentially leading to faster and more effective rehabilitation outcomes.

What evidence suggests that the CRISP program is effective for shoulder injuries?

Research has shown that the CRISP program, which participants in this trial may receive, might be more effective for shoulder recovery than standard treatments. One study found that participants experienced less pain at rest, at night, and during activities within six weeks, with improvements continuing up to 26 weeks. This suggests that CRISP could help individuals recover faster and return to normal activities sooner. Exercise therapy, in general, has improved pain, movement, and shoulder function in the short term. Overall, CRISP may be a promising option for those seeking effective recovery from shoulder injuries. ^{2 3 6 7 8}

Who Is on the Research Team?

Marisunta Pontillo, PhD

Principal Investigator

Extremity Trauma and Amputation Center of Excellence, Defense Health Agency

Are You a Good Fit for This Trial?

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

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

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

I am referred for shoulder rehab after surgery.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. jospt.org jospt.org/doi/10.2519/jospt.2020.8498

An Update of Systematic Reviews Examining the ... Exercise therapy was effective for improving pain scores, active range of motion, and overall shoulder function at short-term (6–12 weeks) and ...

2. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06536114

Efficacy of a Criteria Based Clinical Pathway for ... The goal of this clinical trial is to compare the current standard of care for rehabilitation of non-operative shoulder injuries to a novel, ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40700393/

A standardized criteria-based progressive shoulder ... Results: Significant reductions in pain at rest, at night and with activity (p < 0.001) occurred within six weeks and continued to 26-weeks.

4. app.trialscreen.org app.trialscreen.org/trials/efficacy-criteria-based-clinical-pathway-rehabilitation-shoulder-injuries-trial-nct06536114

Efficacy of a Criteria Based Clinical Pathway for ... Participants may benefit from a more effective rehabilitation program, which could lead to a faster recovery and return to full duty. The study findings may ...

5. jshoulderelbow.org jshoulderelbow.org/article/S1058-2746(23)00582-7/abstract

Rehabilitation of the painful shoulder Managing the painful shoulder in overhead athletes can be difficult because of a lack of time-loss injuries in overhead sports and focusing ...

6. meddatax.com meddatax.com/clinical-trials/NCT06536114

Efficacy of a Criteria Based Clinical Pathway for Rehabilitation ... The goal of this clinical trial is to compare the current standard of care for rehabilitation of non-operative shoulder injuries to a novel, ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT00415441

Effectiveness of Physiotherapy for Chronic Shoulder Pain Members are chosen based on the scientific skills and knowledge needed to monitor the particular trial. Also called a data safety and monitoring board, or DSMB.

8. titinkmbiomedical.com titinkmbiomedical.com/the-new-gold-standard-in-shoulder-rehab/

Upgrade Shoulder Rehab With CPG-Approved Tools The 2025 rotator cuff CPGs reject outdated MMT. Discover smarter, tech-driven rehab tools that align with new standards. Is your clinic ready to lead?