Efficacy of a Criteria Based Clinical Pathway for Rehabilitation of Shoulder Injuries

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

Conditions

• Shoulder Pain
• Shoulder Injuries

Interventions

OTHER

CRISP: Criteria-Based Approach for the Rehabilitation for Non-Operative Shoulder Injuries

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. This approach has three phases: stabilization, to facilitate joint protection; strength and endurance, to optimize functional capacity; and power, to prepare the Service member for returning to previous level of duty.

OTHER

Standard of Care

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.

Sponsors & Collaborators

• Brooke Army Medical Center

  collaborator FED

• Congressionally Directed Medical Research Programs

  collaborator FED

• Henry M. Jackson Foundation for the Advancement of Military Medicine

  collaborator OTHER

• The Geneva Foundation

  collaborator OTHER

• United States Naval Medical Center, San Diego

  lead FED

Principal Investigators

• Marisunta Pontillo, PhD · Extremity Trauma and Amputation Center of Excellence, Defense Health Agency

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-03-01

Primary Completion

2027-08-30

Completion

2027-08-30

Countries

• United States

Study Locations