PiPT in ADSM With MSD

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05132400
• Other study ID #: 21-01351
• Status: Completed
• Start date: December 28, 2021
• Est. completion date: June 1, 2024

Study information

• Verified date: June 2024
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 427
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Musculoskeletal Diseases
• Musculoskeletal Diseases or Conditions

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.

Locations

Country	Name	City	State
United States	Naval Medical Center Portsmouth	Portsmouth	Virginia

Sponsors (4)

Lead Sponsor	Collaborator
NYU Langone Health	Henry M. Jackson Foundation for the Advancement of Military Medicine, United States Department of Defense, United States Naval Medical Center, Portsmouth

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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, Year 1
Secondary	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, Year 1
Secondary	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, Year 1
Secondary	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, Year 1
Secondary	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, Year 1
Secondary	Change in 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.	Baseline, Year 1
Secondary	Change in 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.	Baseline, Year 1