Efficacy of a Criteria Based Clinical Pathway for Rehabilitation of Shoulder Injuries
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUnited States Naval Medical Center, San Diego
About 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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Active-duty Service members over the age of 18 who are seeking medical attention for shoulder pain or injury will be recruited to participate in this study.
Disqualifiers
The exclusion criteria include individuals who have sustained cervical or thoracic spine injury in the past year; an upper extremity or spine injury within the past year and have not been cleared to perform their previous duty requirements; a diagnosis of adhesive capsulitis; individuals referred to post-operative rehabilitation for the shoulder; individuals who are scheduled for shoulder surgery within the following 12 weeks; pain originating from a body region other than shoulder or is non-orthopaedic in nature; individuals who have sustained an upper extremity limb loss; individuals pending a medical evaluation board, discharge from the military, or pending litigation for an injury.
Trial design
Design model
Parallel
Treatments tested in this trial
CRISP: Criteria-Based Approach for the Rehabilitation for Non-Operative Shoulder Injuries
Other interventionThe 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 interventionThe 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.
Treatment groups
250 Participants
are divided into 2 treatment groupsGroup A: Criteria-based Rehabilitation for Injured Shoulders Paradigm (CRISP).Experimental treatment 1 intervention
Group B: Standard of CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Penn Shoulder Score
Patient-reported outcome with shoulder pain, satisfaction, and function subscales
Time frame
Initial and final clinical study assessments; 1-, 3-, 6- and 12-months post-randomizationSecondary outcomes
1
Referral to Surgical Intervention
Participant was referred to surgical invention for their shoulder injury.
Time frame
3-, 6-, 12- months2
Patient-Reported Outcomes Measurement Information System (PROMIS®)
Patient-reported outcome measuring physical, mental, and social health among individuals with various chronic conditions.
Time frame
Initial and final clinical study assessments; 1-, 3-, 6- and 12-months post-randomization3
Optimal Screening for Prediction of Referral and Outcome- Yellow Flag (OSPRO-YF)
The OSPRO-YF is a 10-item screening tool which incorporates several psychosocial domains, namely, mood, fear avoidance, and positive affect-coping.
Time frame
Initial and final clinical study assessments; 1-, 3-, 6- and 12-months post-randomization4
Military Orthopaedics Tracking Injuries and Outcomes Network (MOTION) Readiness Rehab Questionnaire
The Readiness Rehab Questionnaire assesses deployment readiness, containing questions including, "if called for a 6 month deployment today, my confidence to travel to/within a combat zone, carry/wear/use all required equipment and/or weapon, and perform required military duties for the duration of the 6 month deployment is:" and "my confidence to do my specific military duties with well managed pain is:\_\_", both scored on 0-100 scales.
Time frame
Initial and final clinical study assessments; 1-, 3-, 6- and 12-months post-randomizationSponsors and contacts
Click on the lead sponsor to view all of their trials.
United States Naval Medical Center, San Diego
Lead sponsor
Brooke Army Medical Center
Collaborator
Congressionally Directed Medical Research Programs
Collaborator
Henry M. Jackson Foundation for the Advancement of Military Medicine
Collaborator
The Geneva Foundation
Collaborator
Source ClinicalTrials.gov
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