PiPT in ADSM With MSD

Completed

Conditions: Musculoskeletal Diseases or Conditions
Chronic Pain

Interventions: Behavioral: Psychological-informed Physical Therapy (PiPT) Training

Registration Number: NCT05132400

Lead Sponsor: NYU Langone Health

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 427

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Post-Training Arm (Intervention)	Psychological-informed Physical Therapy (PiPT) Training	-

Primary Outcome Measures

Name	Time	Method
Change in Pain Disability Index (PDI) Score	Baseline, Follow-up 4 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Change in Pain Catastrophizing Scale (PCS) Score	Baseline, Follow-up 4 weeks	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.
Change in Hospital Anxiety and Depression Scale (HADS) Score	Baseline, Follow-up 4 weeks	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.
Change in Fear Avoidance Beliefs Questionnaire (FABQ) Score	Baseline, Follow-up 4 weeks	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.
Change in Pain Self-Efficacy Questionnaire (PSEQ) Score	Baseline, Follow-up 4 weeks	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.
MedRisk Instrument for Measuring Patient Satisfaction (MRPS) - Satisfaction With Process of Care Score	Follow-up 4 weeks	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.
Core Outcome Measures Index (COMI) - Satisfaction With the Outcome Score	Follow-up 4 weeks	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.