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NCT05132400

PiPT in ADSM With MSD

Completed Results posted Last updated 11 May 2025
What this trial tests

trial testing Psychological-informed Physical Therapy (PiPT) Training in Chronic Pain in 427 participants. Completed in 1 June 2024.

Timeline
28 December 2021
Primary endpoint
1 June 2024
1 June 2024

Quick facts

Lead sponsorNYU Langone Health
StatusCompleted
Study typeOBSERVATIONAL
Enrollment427
Start date28 December 2021
Primary completion1 June 2024
Estimated completion1 June 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

NYU Langone Health — full company profile →

Who can join

Adults 18 to 64, any sex, with Chronic Pain or Musculoskeletal Diseases or Conditions. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Pain Disability Index (PDI) Score Primary · 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.

GroupValue95% CI
Pre-Training Arm (Control)0± 11
Post-Training Arm (Intervention)33± 10
Change in Pain Catastrophizing Scale (PCS) Score Secondary · Baseline, Follow-up 4 weeks

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.

GroupValue95% CI
Pre-Training Arm (Control)0± 8
Post-Training Arm (Intervention)1± 7
Change in Hospital Anxiety and Depression Scale (HADS) Score Secondary · Baseline, Follow-up 4 weeks

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.

GroupValue95% CI
Pre-Training Arm (Control)-1± 5
Post-Training Arm (Intervention)0± 5
Change in Fear Avoidance Beliefs Questionnaire (FABQ) Score Secondary · Baseline, Follow-up 4 weeks

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.

GroupValue95% CI
Pre-Training Arm (Control)-3± 11
Post-Training Arm (Intervention)1± 12
Change in Pain Self-Efficacy Questionnaire (PSEQ) Score Secondary · Baseline, Follow-up 4 weeks

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.

GroupValue95% CI
Pre-Training Arm (Control)0± 9
Post-Training Arm (Intervention)0± 13
MedRisk Instrument for Measuring Patient Satisfaction (MRPS) - Satisfaction With Process of Care Score Secondary · Follow-up 4 weeks

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.

GroupValue95% CI
Pre-Training Arm (Control)32± 6
Post-Training Arm (Intervention)32± 6
Core Outcome Measures Index (COMI) - Satisfaction With the Outcome Score Secondary · Follow-up 4 weeks

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.

GroupValue95% CI
Pre-Training Arm (Control)11 – 2
Post-Training Arm (Intervention)21 – 3

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Chronic Pain

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05132400.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing