Physical Therapy to Treat Chronic Pain in Survivors of Trauma

NCT03933189 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2021-09-29

No results posted yet for this study

Summary

This study will assess the effects of physical therapy (PT) for individuals who are survivors of trauma (SOT) and have chronic pain. While much has been studied about the psychological effects and treatment of trauma, little is known about the PT management of chronic pain and loss of function SOT experience. With over 24 million people in the U.S. suffering from chronic pain there are potentially high numbers of individuals living with resultant disability associated with that pain. Physical therapists are well versed in treating pain and restoring function. However, choice of PT can vary based on therapist years of experience and type or lack of PT specialization. Physical therapy has traditionally focused on a bio-medical (BIOM) approach. Some believe that the BIOM approach is ineffective in reducing chronic pain and functional loss, and that PT requires a biopsychosocial (BPS) approach, targeting central nervous system changes that occur with chronic pain. Pain education (PE) and Graded Motor Imagery (GMI) are PT interventions thought to address these brain changes, and are used by physical therapists to treat patients with phantom limb pain and Complex Regional Pain Syndrome. Most of the studies examining the effects of GMI and PE have methodological issues. Exercise is another common PT treatment and is beneficial in promoting improved function and decreasing disability for many conditions. Although PTs in clinical practice can offer all of these modalities, there is little high quality evidence to support the choice among them. This study will compare two varieties of PT: BIOM-based versus BPS-based care. Individuals with chronic pain who are referred to PT by their primary care provider or self-referred will be screened for trauma history by the PI. SOT who are seen at a community psychology center who experience chronic pain and disability will be referred to PT. Upon referral, SOT who meet the inclusion criteria will be invited to participate. SOT who consent to the study will be randomized to either the BIOM-based or the BPS-based group. All participants will undergo baseline assessment. Participants will complete 6 one-hour PT sessions once a week following their randomly assigned plan. All baseline measures will be repeated by the blinded assessor after the 6th visit; scores will be assessed to determine if there is a difference in the change in functional outcomes between the BIOM- and BPS-based groups after completion of the 6 PT sessions.

Conditions

Interventions

OTHER

Physical Therapy

Physical therapy modalities to treat chronic pain

Sponsors & Collaborators

  • University of Vermont

    lead OTHER

Principal Investigators

  • Justine Dee, MS · University of Vermont

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-18
Primary Completion
2021-07-30
Completion
2021-07-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03933189 on ClinicalTrials.gov