Psychologically-Based Physical Therapy Treatment for Deployed U.S. Sailors and Marines With Musculoskeletal Injuries

Study Overview
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Brief Summary
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The main objective of this pilot project is to demonstrate the effectiveness of a psychologically-based physical therapy (PBPT) intervention for the prevention of disability in Active Duty Service Members who sustained a musculoskeletal injury (MSI) during deployment in support of combat operations on a carrier. This intervention is intended to optimize recovery and restore function in injured Active Duty Service Members. The three aims necessary to accomplish the main objective are: Demonstrate the feasibility of implementing PBPT on board a carrier; Document and compare risk factors related to disability from MSI aboard two carriers; Demonstrate the effectiveness of the PBPT intervention in a comparative effectiveness trial

Detailed Description
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Musculoskeletal injuries pose a significant problem for Active Duty Service Members and are the main reason for separation and long-term disability. Little information exists on the determinants of disability and seeking care patterns in Sailors and Marines who experience MSI during deployment in support of combat operations, despite the fact that these branches of the armed services have the highest level of attrition from these disorders of all branches PBPT implemented in this setting has the potential to have a dramatic impact on the study outcomes. It is expected that an intervention of psychologically-based physical therapy targeting the common psychological risk factors (yellow flags) that include fear of activity including work, psychological distress, and perceived disability will be effective in reducing these risk factors and optimizing recovery and restoring function in the intervention group. Active Duty Service Members who seek care for a MSI on a carrier will benefit from early care by a trained physical therapist, which will reduce the likelihood of the formation or maintenance of maladaptive beliefs about injury previously found to be associated with disability. The proposed study design is a quasi-experimental, pre-post- test with a non-concurrent control group to test the effectiveness of psychologically-based physical therapy aboard a US Navy Aircraft Carrier. This approach will consist of one deployed carrier serving as the intervention and a second carrier serving as a control. The two carriers (intervention and equivalent control) will be chosen based on deployment schedules. Both carriers will have similar deployment characteristics to include; length of deployment, crew size and deployed health care team. For the purposes of this project, measurements will be done during deployment (pre physical therapy intervention and one month after enrollment) and after deployment. Thus, two different endpoints will be used, a post treatment endpoint (one month after enrollment), and a second which takes place after the carrier returns from deployment.

Official Title
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A Pilot Study to Test the Efficacy of Psychologically-Based Physical Therapy Training for Treating Deployed U.S. Sailors and Marines With Musculoskeletal Injuries

Conditions
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Musculoskeletal Injury

Intervention / Treatment
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* Behavioral: Psychologically - Based Physical Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects presenting to medical for a primary complaint of a new MSI. A new MSI is considered in this study when the subject has not sought treatment for a period of 30 days or more prior to presenting to medical. Exclusion Criteria: Subjects not eligible include those who require medical evacuation, or have a trauma/ comorbidities that may prevent them from receiving physical therapy treatment (i.e. amputations, fractures, contusions and other 'Red Flags' that required specialized medical care).
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Physical Therapy<br>Usual care of physical therapy and rehabilitation for a musculoskeletal injury. Patients complete self-rated standardized surveys before and following treatment. | |
| Experimental: Psychologically-Based Physical Therapy<br>Psychologically-Based Physical Therapy includes the early identification and management of psychological obstacles to recovery in order to modify maladaptive responses previously found to be associated with chronicity and disability. This is accomplished through patient education, an emphasis on functional goals and encouraging self-care techniques. Patients complete self-rated standardized surveys before and following treatment. | Behavioral: Psychologically - Based Physical Therapy<br>* Psychologically - Based Physical Therapy targeting risk factors for disability.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychological Distress (STarT Back Generic Screening Tool) | Measured using the STarT Back Generic Screening Tool. | Change from baseline to one month following treatment. | 
| Expectations of Recovery (single item question ) | Measured using a single item question constructed by the research team. | Change from baseline to one month following treatment. | 
| Self-Efficacy (COMI) | Measured using adapted questions from the Core Outcome Measurements Index (COMI). | Change from baseline to one month following treatment. | 
| Fear Of Work Activity (STarT Back Screening Tool) | Measured using questions adapted from the STarT Back Screening Tool. | Change from baseline to one month following treatment. | 
| Quality of Life (SF-12) | Measured using questions adapted from Short Form Health Survey(SF-12) | Measured one month following treatment. | 
| Perceived Disability (COMI) | Measured using adapted questions from the Core Outcome Measurements Index (COMI). | Change from baseline to one month following treatment. | 
| Pain Interference (DVPRS) | Measured using the Defense and Veterans Pain rating Scale (DVPRS). | Change from baseline to one month following treatment. | 
| Satisfaction with Process of Care (MRPS) | Measured using the MedRisk Instrument for Measuring Patient Satisfaction (MRPS) | Measured one month after treatment. | 
| Outcome Satisfaction (COMI) | Measured using adapted questions from the Core Outcome Measurements Index (COMI). | Measured one month after treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health Care Utilization (AHLTA) | Measured using the Armed Forces Health Longitudinal Technology Application (AHLTA). | Measured at six month follow-up | 
| Limited Duty (MEDBOLTT Database) | Measured using the MEDBOLTT Database. | Measured at six month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Musculoskeletal Injury, physical therapy, psychological intervention, risk factors