Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06536114
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-31
Brief Title:
Efficacy of a Criteria Based Clinical Pathway for Rehabilitation of Shoulder Injuries
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy of a Criteria Based Clinical Pathway for Rehabilitation of Shoulder Injuries
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CRISP
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 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
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
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 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 CenterCenter 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 studys 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
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 CenterCenter 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 studys 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None