PiPT in ADSM With MSD

Study Overview
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Brief Summary
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The study objective is to establish feasibility of implementing a psychologically informed rehabilitation strategy while concurrently assessing its' effectiveness in Active duty service members (ADSM) with musculoskeletal disorders (MSD) seeking care in a US Navy shore-based healthcare setting. This intervention is intended to improve the management of chronic pain in order to optimize ADSM function. The study team is proposing an observational prospective comparative cohort study. This study tests an implementation/strategy while observing/gathering information on the clinical intervention and related outcomes.

Official Title
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The Implementation of Psychologically Informed Physical Therapy to Prevent Chronification in Service Members With Musculoskeletal Disorders

Conditions
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Chronic Pain, Musculoskeletal Diseases or Conditions

Intervention / Treatment
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* Behavioral: Psychological-informed Physical Therapy (PiPT) Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ADSM (at baseline; separation from the military post-treatment will not be grounds for exclusion) Patients presenting to an NMCP or a branch clinic physical therapy department Patients who have only receive their evaluation appointment for their primary complaint Patients prescribing for a primary complaint of a MSD (the following ICD-10 codes will be included: M13, M14.8, M15-19, M21-25, M40-43, M46-48, M50-54, M60-71, M73, M75-77) Exclusion Criteria: Patients not eligible to receive outpatient physical therapy Patients receiving fewer than four treatment sessions of physical therapy Patients who are pregnant Patients receiving physical therapy for acute post-surgical recovery Patients scheduled for or subject to a Physical Evaluation Board (PEB) at baseline Coast Guard

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pre-Training Arm (Control)<br>To receive physical therapy treatment as usual, before PiPT occurs | |
| Post-Training Arm (Intervention)<br> | Behavioral: Psychological-informed Physical Therapy (PiPT) Training<br>* An approach designed to incorporate the concepts of cognitive behavioral therapy (CBT) for pain management into routine clinical PT practice in order to modify maladaptive responses associated with chronicity. The goal of PiPT is to promote a fast and optimal recovery by removing psychological obstacles, obviating the need for referral to a psychologist and facilitating triage to other health professionals in a timely manner when needed. PiPT training includes education about the neuropsychology of pain, patient communication skills, and identification of psychosocial risk factors for chronicity and treatment approaches that include reassurance, relaxation, and psycho-behavioral reactivation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain Disability Index (PDI) Score | PDI consists of 7 categories of life activity. The participant is asked to circle the number on the scale that describes the level of disability on typically experiences. A score of 0 means no disability at all, and a score of 10 signifies that all of the activities in which one would normally be involved have been totally disrupted or prevented by pain. The total range of score is 0-70; the higher the score, the greater the person's disability due to pain. | Baseline, Year 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain Catastrophizing Scale (PCS) Score | PCS is a 13-item self-report measure designed to assess catastrophic thinking related to pain among adults with or without chronic pain. Each item is rated on a 5-point Likert scale, from 0 (not at all) to 4 (all the time). The total range of score is 0-52; a higher score indicates a higher level of catastrophizing. A total score >30 indicates clinically relevant level of catastrophizing. | Baseline, Year 1 | 
| Change in Hospital Anxiety and Depression Scale (HADS) Score | HADS consists of two separate sub-sections: Anxiety and Depression. Each sub-section contains 7 items, where participants reply with responses that are closest to how he/she has been feeling in the past week with a score of 0-3. The total score range for both sub-sections is 0-21; a score of 0-7 indicates a normal range of anxiety, 8-10 = borderline abnormal, 11-21 = abnormal. The higher the score, the more abnormal the participant feels. | Baseline, Year 1 | 
| Change in Fear Avoidance Beliefs Questionnaire (FABQ) Score | FABQ is a self-reported questionnaire consisting of 16 questions scaled from 0-6. FABQ assesses the fear-avoidance beliefs of patients with chronic low back pain The total range of score is 0-96; a higher score indicates fear avoidance behaviors. For the purposes of this study, I have a claim for compensation for my pain will be excluded due to no relevance to the study. | Baseline, Year 1 | 
| Change in Pain Self-Efficacy Questionnaire (PSEQ) Score | PSEQ is a 10-item questionnaire developed to assess the confidence people with ongoing pain have in performing activities while in pain. The total range of score is 0-60; a higher score indicates greater levels of confidence in dealing with pain. High scores are strongly associated with clinically-significant functional levels. | Baseline, Year 1 | 
| Change in MedRisk Instrument for Measuring Patient Satisfaction (MRPS) - Satisfaction with Process of Care Score | Satisfaction with process of care is measured by the process of care subscale of the MRPS. There are 8 items in this subscale scored on a Likert scale of 1-5. The total score range is 8-40; the higher the score, the greater the satisfaction. | Baseline, Year 1 | 
| Change in Core Outcome Measures Index (COMI) - Satisfaction with the Outcome Score | Satisfaction with the outcome is measured by a single item derived from COMI: If you had to spend the rest of life with the symptoms you have right now, how would you feel about it?. The total range of score is 0-10; the higher the score, the worse one feels about the outcome. | Baseline, Year 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psychologically informed Physical Therapy (PiPT)