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

Part of paid clinical trials in San Diego, California.

Sponsor
United States Naval Medical Center, San Diego
Study ID
NCT06536114
Status
Not Yet Recruiting

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Conditions

  • Shoulder Injuries
  • Shoulder Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • CRISP: Criteria-Based Approach for the Rehabilitation for Non-Operative Shoulder Injuries — OTHER
    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.
  • Standard of Care — OTHER
    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.

Study Details

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

Key Dates

Start date
Mar 1, 2025
Status verified
Jul 2024
Primary completion
Aug 30, 2027
Completion
Aug 30, 2027

Study Design

Enrollment
250 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Criteria-based Rehabilitation for Injured Shoulders Paradigm (CRISP).
    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.
  • Active Comparator: 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.

Primary Outcome Measure

Penn Shoulder Score [ Time Frame: Initial and final clinical study assessments; 1-, 3-, 6- and 12-months post-randomization ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Naval Medical Center San DiegoSan DiegoCalifornia92134-

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Naval Medical Center San Diego· San Diego, CA

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