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Clinical Trials/NCT05132400
NCT05132400
Completed
Not Applicable

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

NYU Langone Health1 site in 1 country427 target enrollmentDecember 28, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Pain
Sponsor
NYU Langone Health
Enrollment
427
Locations
1
Primary Endpoint
Change in Pain Disability Index (PDI) Score
Status
Completed
Last Updated
11 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 28, 2021
End Date
June 1, 2024
Last Updated
11 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Change in Pain Disability Index (PDI) Score

Time Frame: 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 Outcomes

  • 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)
  • Core Outcome Measures Index (COMI) - Satisfaction With the Outcome Score(Follow-up 4 weeks)

Study Sites (1)

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