Clinical trial NCT03933189: Physical Therapy to Treat Chronic Pain in Survivors of Trauma
Official title: Physical Therapy for Individuals With Chronic Pain Due to Physical and/or Emotional Trauma: A Comparison of Physical Therapy Interventions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Disability Physical
Keywords: chronic pain
trauma
rehabilitiation
physical therapy
musculoskeletal pain
Lead sponsor: University of Vermont
Sponsor class: OTHER
First posted: 2019-05-01
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Blinded randomized controlled study.
Primary purpose: TREATMENT

Brief 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.

Detailed description: The purpose of this study is to compare two usual PT programs to determine if one is more effective than the other in reducing disability and pain in individuals who are survivors of physical and or emotional trauma. Numerous studies have assessed the mental health issues of SOT and the psychological interventions used to address these issues, but there has been little research on interventions that address the somatic pain and disability complaints in SOT in spite of the fact that 78-83% of survivors report chronic pain.

There is large variability in physical therapy management of painful conditions, representing an opportunity to improve patient care and outcomes. Choice of physical therapy intervention can vary based on the individual therapist's years of experience or type of PT practice specialization, or lack of specialization. The biomedical model (BIOM) of physical therapy (PT) management addresses pain problems by targeting treatment towards the physiologic structures or tissues in the region where the patient is reporting the pain sensations. This model follows the premise that pain is due to tissue damage and localized inflammation due to faulty biomechanics and movement patterns, injury, disease or disuse. The Academy of Orthopedic Physical Therapists Low Back Pain Clinical Practice Guidelines recommend manual therapy, targeted spine strengthening, endurance and flexibility exercises to treat patients with acute, sub-acute, and chronic back pain, and follows this BIOM approach. Additionally, there are a variety of exercise methods and manual therapies touted by practitioners leading to heterogeneous interventions given for similar patient conditions. A 2014 study compared the outcomes of two different types of targeted spine interventions for the treatment of low back pain, and found the results to be equivocal, with approximately half the subjects in each treatment group demonstrating significant improvement. A biopsychosocial (BPS) PT approach of pain neuroscience education, Graded Motor Imagery and general conditioning exercises encompassing the health and skill related components of fitness has also been found to reduce pain and improve function in patients with chronic low back pain, in patients with complex regional pain syndrome and in patients with phantom limb pain. These conditions involve central brain changes due to the experience of chronic pain; pain neuroscience education and Graded Motor Imagery are purported to address these central changes. These studies, however, had methodologic issues, such as lack of a control group or small sample sizes. Exercise helps address the fear avoidance component of chronic low back pain, and helps to improve strength, endurance and tolerance for daily functional activities. Furthermore, pain education was found to decrease pain and improve function in SOT in a small pilot study. Patient education is a major component of any PT intervention.

There are a few small studies that have examined the effects of a BPS approach with promising results for specific chronic pain conditions, and there are studies that support the BIOM approach in treating musculoskeletal pain conditions but BPS- and BIOM-based treatments have not previously been compared in a large randomized controlled trial, nor described in the treatment of chronic pain in STT.

Researchers have sought to determine PT methods that are most beneficial in reducing chronic pain and disability, but studies to date have been inconclusive. The investigators objective is to compare the BIOM and BSP methods of PT to identify best treatment for individuals who have experienced physical and/or emotional trauma and have resultant disabling chronic pain due to this trauma. Findings from this work could help physical therapists provide targeted, effective treatment to help ameliorate the effects of chronic pain and disability in this population. With 78-83% of SOT living with chronic pain, the study findings will help therapists choose appropriate interventions to achieve optimal patient outcomes.

Eligibility criteria: Inclusion Criteria:

* definition of trauma/torture as defined by the United Nations (UN) HUR 03051 determined by referring clinical psychologist
* definition of trauma as identified through screening via the Life Events Check List by the PI
* chronic spine and or extremity pain of greater than 6 months duration
* able to attend and participate in six, 60-minute intervention sessions
* ambulatory, with or without assistive devices for a minimum of 20 feet

Exclusion Criteria:

* Inability to walk a minimum of 20 feet
* inability to afford any insurance fee for the 6 visits needed for the research study.

Primary outcomes:
measure: Change in Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) Computer Adaptive Test (CAT)
timeFrame: Baseline (pre-PT, week 0) and after completion of the 6th PT visit, at week 6
Secondary outcomes:
measure: Change in Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference (PI) Computer Adaptive Test (CAT)
timeFrame: Baseline (pre-PT, week 0) and after completion of the 6th PT visit, at week 6
measure: Change in Patient Reported Outcomes Measurement Information System (PROMIS) 29
timeFrame: Baseline (pre-PT, week 0) and after completion of the 6th PT visit, at week 6.
measure: Change in Brief Pain Inventory
timeFrame: Baseline (pre-PT, week 0) and after completion of the 6th PT visit, at week 6
measure: Change in Central Sensitization Inventory
timeFrame: Baseline (pre-PT, week 0) and after completion of the 6th PT visit, at week 6.
measure: Change in Pain pressure threshold sensory testing
timeFrame: Baseline (pre-PT, week 0) and after completion of the 6th PT visit, at week 6.
measure: Change in Two-point discrimination sensory testing
timeFrame: Baseline (pre-PT, week 0) and after completion of the 6th PT visit, at week 6.
Other outcomes:
Locations:
city: South Burlington
country: United States
facility: Dee Physical Therapy
state: Vermont
Study officials:
affiliation: University of Vermont
name: Justine Dee, MS
role: PRINCIPAL_INVESTIGATOR
References:
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