PiPT in ADSM With MSD

NCT05132400 | Completed Results

• 1 other identifier: 21-01351
• Study Type: observational
• Target: 427
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; Musculoskeletal Diseases or Conditions

Keywords

Psychologically informed Physical Therapy (PiPT)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change in Pain Catastrophizing Scale (PCS) Score

  Baseline, Follow-up 4 weeks

• Change in Hospital Anxiety and Depression Scale (HADS) Score

  Baseline, Follow-up 4 weeks

• Change in Fear Avoidance Beliefs Questionnaire (FABQ) Score

  Baseline, Follow-up 4 weeks

• Change in Pain Self-Efficacy Questionnaire (PSEQ) Score

  Baseline, Follow-up 4 weeks

• MedRisk Instrument for Measuring Patient Satisfaction (MRPS) - Satisfaction With Process of Care Score

  Follow-up 4 weeks

Study Arms (2)

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

Interventions

Psychological-informed Physical Therapy (PiPT) Training BEHAVIORAL

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.

Post-Training Arm (Intervention)

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead
• United States Department of Defense: collaborator
• United States Naval Medical Center, Portsmouth: collaborator
• Henry M. Jackson Foundation for the Advancement of Military Medicine: collaborator

Study Sites (1)

Naval Medical Center Portsmouth

Portsmouth, Virginia, 23708, United States

Location

MeSH Terms

Conditions

Chronic Pain; Musculoskeletal Diseases

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Marco Campello, PT, PhD
• Organization: NYU Langone Health

Marco.campello@nyulangone.org

212-255-6690

Study Officials

• Marco Campello, PT, PhD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2021
• First Posted: November 24, 2021
• Study Start: December 28, 2021
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: May 11, 2025
• Results First Posted: May 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.

Locations

US (1)