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| Name | Class |
|---|---|
| Brooke Army Medical Center | FED |
| Congressionally Directed Medical Research Programs | FED |
| Henry M. Jackson Foundation for the Advancement of Military Medicine | OTHER |
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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:
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:
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. Therefore, we propose a study determining the optimal treatment progression to reduce unnecessary variability in management of non-operative of shoulder injuries for Service members through a phased, criteria-based clinical pathway: Criteria-based Rehabilitation for Injured Shoulders Paradigm (CRISP). Additionally, this study will identify factors which contribute to return to duty readiness.
To demonstrate the benefits of the CRISP program, we will determine the differences in physical, psychological, and quality of life patient-reported questionnaires, and clinical assessments of shoulder strength and function between the novel criteria-based rehabilitation program and the current standard of care for Service members with non-operative shoulder injuries within the Military Health System. To accomplish this, we will conduct a multi-site, single-blinded, randomized controlled trial in active duty Service members seeking care for a non-operative shoulder injury referred to physical therapy. We will recruit 250 Service members from the Naval Medical Forces (Pacific Region) and Brooke Army Medical Center/Center for the Intrepid. Participating Service members will complete clinical assessments and questionnaires at initial and final assessments; additionally, a link will be sent to participants to fill out questionnaires virtually at 1-, 3-, 6-, and 12-month time intervals. 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, for joint protection; strength and endurance, for functional capacity; and power, to prepare the Service member for returning to previous level of duty. 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. To our knowledge, this is the first study to compare a criteria-based exercise intervention approach to the usual standard of care for the conservative treatment of shoulder injuries as well as identifying factors which contribute to RTD readiness.
Without using a data-driven pathway to assess and rehabilitate shoulder injuries, Service members may experience a potential delay in returning to their previous military occupational specialty or deployability, and residual impairments may persist. In turn, this could lead to a higher incidence of re-injury or referral to surgical intervention. In the near-term, the findings from this study will enhance individual patient care within the MHS, accelerating return to duty for our Service members and with fewer physical limitations. We also anticipate our findings will help identify the predictors of shoulder function and return to duty readiness. This study's findings will directly influence patient care by elucidating which treatment paradigm optimizes shoulder function in Service members, ultimately leading to improvements in quality of life for Service members, reducing time lost from injuries, as well as maximizing Service members' readiness, unit cohesion, and mission accomplishment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Criteria-based Rehabilitation for Injured Shoulders Paradigm (CRISP). | Experimental | 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. |
|
| Standard of Care | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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®) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marisunta Pontillo, PhD | Contact | 215-266-1904 | marisunta.l.pontillo.civ@health.mil | |
| Sara Gorczynski | Contact | 619-532-9704 | sara.r.gorczynski.ctr@health.mil |
| Name | Affiliation | Role |
|---|---|---|
| Marisunta Pontillo, PhD | Extremity Trauma and Amputation Center of Excellence, Defense Health Agency | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Naval Medical Center San Diego | San Diego | California | 92134 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37300969 | Background | Barber P, Pontillo M, Bellm E, Davies G. Objective and subjective measures to guide upper extremity return to sport testing: A modified Delphi survey. Phys Ther Sport. 2023 Jul;62:17-24. doi: 10.1016/j.ptsp.2023.05.009. Epub 2023 May 27. | |
| 19339562 | Background | Owens BD, Dawson L, Burks R, Cameron KL. Incidence of shoulder dislocation in the United States military: demographic considerations from a high-risk population. J Bone Joint Surg Am. 2009 Apr;91(4):791-6. doi: 10.2106/JBJS.H.00514. |
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| The Geneva Foundation |
| OTHER |
multi-site, single-blinded, randomized controlled trial
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The outcomes assessor will not be a physical therapist and thus not involved with the participant's medical treatment.
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| 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. |
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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 |
| 33344031 | Background | Pontillo M, Sennett BJ, Bellm E. USE OF AN UPPER EXTREMITY FUNCTIONAL TESTING ALGORITHM TO DETERMINE RETURN TO PLAY READINESS IN COLLEGIATE FOOTBALL PLAYERS: A CASE SERIES. Int J Sports Phys Ther. 2020 Dec;15(6):1141-1150. doi: 10.26603/ijspt20201141. |
| 25364482 | Background | Pontillo M, Spinelli BA, Sennett BJ. Prediction of in-season shoulder injury from preseason testing in division I collegiate football players. Sports Health. 2014 Nov;6(6):497-503. doi: 10.1177/1941738114523239. |
| ID | Term |
|---|---|
| D020069 | Shoulder Pain |
| D000070599 | Shoulder Injuries |
| ID | Term |
|---|---|
| D018771 | Arthralgia |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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