PiPT in ADSM With MSD

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain; Musculoskeletal Diseases or Conditions
• Intervention / Treatment: Behavioral: Psychological-informed Physical Therapy (PiPT) Training

• Study Type: Observational
• Enrollment (Actual): 427

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Portsmouth, Virginia, United States, 23708
      • Naval Medical Center Portsmouth

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

US active duty service members (ADSM) receiving physical therapy for musculoskeletal disorders at Naval Medical Center Portsmouth (NMCP) and its branch health clinics.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pre-Training Arm (Control); To receive physical therapy treatment as usual, before PiPT occurs
Post-Training Arm (Intervention)	Behavioral: Psychological-informed Physical Therapy (PiPT) Training; 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.

What is the study measuring?

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, Follow-up 4 weeks

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, Follow-up 4 weeks
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, Follow-up 4 weeks
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, Follow-up 4 weeks
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, Follow-up 4 weeks
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.	Follow-up 4 weeks
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.	Follow-up 4 weeks

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: United States Department of Defense; Henry M. Jackson Foundation for the Advancement of Military Medicine; United States Naval Medical Center, Portsmouth
• Investigators: Principal Investigator: Marco Campello, PT, PhD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): December 28, 2021
• Primary Completion (Actual): June 1, 2024
• Study Completion (Actual): June 1, 2024

Study Registration Dates

• First Submitted: November 12, 2021
• First Submitted That Met QC Criteria: November 12, 2021
• First Posted (Actual): November 24, 2021

Study Record Updates

• Last Update Posted (Actual): May 11, 2025
• Last Update Submitted That Met QC Criteria: April 25, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Psychologically informed Physical Therapy (PiPT)
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain; Musculoskeletal Diseases
• Other Study ID Numbers: 21-01351

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to marco.campello@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No