PiPT in ADSM With MSD

NCT ID: NCT05132400

Last Updated: 2025-05-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

427 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-28

Study Completion Date

2024-06-01

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.

Detailed Description

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Conditions

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Chronic Pain Musculoskeletal Diseases or Conditions

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pre-Training Arm (Control)

To receive physical therapy treatment as usual, before PiPT occurs

No interventions assigned to this group

Post-Training Arm (Intervention)

Psychological-informed Physical Therapy (PiPT) Training

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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United States Department of Defense

FED

Sponsor Role collaborator

United States Naval Medical Center, Portsmouth

FED

Sponsor Role collaborator

Henry M. Jackson Foundation for the Advancement of Military Medicine

OTHER

Sponsor Role collaborator

NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marco Campello, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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Naval Medical Center Portsmouth

Portsmouth, Virginia, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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21-01351

Identifier Type: -

Identifier Source: org_study_id

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