Clinical trial NCT05132400: PiPT in ADSM With MSD
Official title: The Implementation of Psychologically Informed Physical Therapy to Prevent Chronification in Service Members With Musculoskeletal Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Musculoskeletal Diseases or Conditions
Keywords: Psychologically informed Physical Therapy (PiPT)
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
name: United States Naval Medical Center, Portsmouth
name: Henry M. Jackson Foundation for the Advancement of Military Medicine
First posted: 2021-11-24
Enrollment: 427
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Pain Disability Index (PDI) Score
timeFrame: Baseline, Follow-up 4 weeks
Secondary outcomes:
measure: Change in Pain Catastrophizing Scale (PCS) Score
timeFrame: Baseline, Follow-up 4 weeks
measure: Change in Hospital Anxiety and Depression Scale (HADS) Score
timeFrame: Baseline, Follow-up 4 weeks
measure: Change in Fear Avoidance Beliefs Questionnaire (FABQ) Score
timeFrame: Baseline, Follow-up 4 weeks
measure: Change in Pain Self-Efficacy Questionnaire (PSEQ) Score
timeFrame: Baseline, Follow-up 4 weeks
measure: MedRisk Instrument for Measuring Patient Satisfaction (MRPS) - Satisfaction With Process of Care Score
timeFrame: Follow-up 4 weeks
measure: Core Outcome Measures Index (COMI) - Satisfaction With the Outcome Score
timeFrame: Follow-up 4 weeks
Other outcomes:
Locations:
city: Portsmouth
country: United States
facility: Naval Medical Center Portsmouth
state: Virginia
Study officials:
affiliation: NYU Langone Health
name: Marco Campello, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: