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Behavioural Intervention

Criteria-Based Rehabilitation for Shoulder Injuries (CRISP Trial)

N/A

Waitlist Available

Led By Marisunta Pontillo, PhD

Research Sponsored by United States Naval Medical Center, San Diego

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Individuals who have sustained cervical or thoracic spine injury in the past year

Individuals who are scheduled for shoulder surgery within the following 12 weeks

Timeline

Screening 3 weeks

Treatment Varies

Follow Up initial and final clinical study assessments; 1-, 3-, 6- and 12-months post-randomization

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to compare the current standard rehabilitation for non-operative shoulder injuries to a new criteria-based approach (CRISP). It will look at whether there are differences in patient outcomes and clinical measures between the

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves physical therapy interventions rather than medications, side effects may include discomfort or pain during exercises, potential muscle soreness post-therapy sessions, and risk of injury if exercises are performed improperly.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I am scheduled for shoulder surgery in the next 12 weeks.

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My pain comes from a part of my body that is not my shoulder and is not related to bones or joints.

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I have lost an arm or hand.

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I had an injury to my arm or spine within the last year and haven't been cleared to return to my usual duties.

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I have been diagnosed with frozen shoulder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ initial and final clinical study assessments; 1-, 3-, 6- and 12-months post-randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~initial and final clinical study assessments; 1-, 3-, 6- and 12-months post-randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and initial and final clinical study assessments; 1-, 3-, 6- and 12-months post-randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Penn Shoulder Score

Secondary study objectives

Military Orthopaedics Tracking Injuries and Outcomes Network (MOTION) Readiness Rehab Questionnaire

Optimal Screening for Prediction of Referral and Outcome- Yellow Flag (OSPRO-YF)

Patient-Reported Outcomes Measurement Information System (PROMIS®)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 6Eligibility criteria met