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Clinical Trial NCT06536114 (CRISP) for Shoulder Pain, Shoulder Injuries is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Efficacy of a Criteria Based Clinical Pathway for Rehabilitation of Shoulder Injuries (CRISP) 250 Randomized Novel Treatment
Clinical Trial NCT06536114 (CRISP) is an interventional study for Shoulder Pain, Shoulder Injuries and is currently not yet recruiting. Enrollment is planned to begin on March 1, 2025 and continue until the study accrues 250 participants. Led by United States Naval Medical Center, San Diego, this study is expected to complete by August 30, 2027. The latest data from ClinicalTrials.gov was last updated on August 2, 2024.
Brief 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 rehab...
Detailed Description
Without a data-driven pathway to assess and rehabilitate shoulder injuries, clinicians may be using time rather than criteria to guide rehabilitation and clearance for return to duty. Delayed return to duty and subsequent injury or surgery contribute to time lost from duty, negative financial implications for the Military Health System, and adversely affect Service members' mental health and quality of life. Therefor...Show More
Official Title
Efficacy of a Criteria Based Clinical Pathway for Rehabilitation of Shoulder Injuries
Conditions
Shoulder PainShoulder InjuriesPublications
Scientific articles and research papers published about this clinical trial:Other Study IDs
- CRISP
- NMCSD.0024.0048
NCT ID Number
Start Date (Actual)
2025-03-01
Last Update Posted
2024-08-02
Completion Date (Estimated)
2027-08-30
Enrollment (Estimated)
250
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
shoulder
return-to-duty
physical therapy
rehabilitation
return-to-duty
physical therapy
rehabilitation
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalCriteria-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. | 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. |
Active ComparatorStandard 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. | 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 Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Penn Shoulder Score | Patient-reported outcome with shoulder pain, satisfaction, and function subscales | Initial and final clinical study assessments; 1-, 3-, 6- and 12-months post-randomization |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Referral to Surgical Intervention | Participant was referred to surgical invention for their shoulder injury. | 3-, 6-, 12- months |
Patient-Reported Outcomes Measurement Information System (PROMIS®) | Patient-reported outcome measuring physical, mental, and social health among individuals with various chronic conditions. | Initial and final clinical study assessments; 1-, 3-, 6- and 12-months post-randomization |
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. | Initial and final clinical study assessments; 1-, 3-, 6- and 12-months post-randomization |
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. | Initial and final clinical study assessments; 1-, 3-, 6- and 12-months post-randomization |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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.
- 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.
United States Naval Medical Center, San Diego- ⚕️Br...
Study Central Contact
Contact: Marisunta Pontillo, PhD, 215-266-1904, [email protected]
Contact: Sara Gorczynski, 619-532-9704, [email protected]
1 Study Locations in 1 Countries
California
Naval Medical Center San Diego, San Diego, California, 92134, United States