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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/18/2021.

Physical Therapy to Treat Chronic Pain in Survivors of Torture and Trauma

Clinicaltrials.gov identifier NCT03933189

Recruitment Status Recruiting

First Posted May 1, 2019

Last update posted July 12, 2019

Study Description

Brief summary:

This study will be assessing the effects of physical therapy (PT) for new Americans/refugees who are survivors of torture and/or trauma (STT) and have chronic pain. It is estimated that 78-83% of STT have chronic pain. With over 6000 refugees in Vermont, there are potentially high numbers of STT suffering from chronic pain and resultant disability. Physical therapists are well versed in treating pain and restoring function after an injury or illness. However, choice of PT intervention can vary based on the therapist's years of experience, type of PT practice specialization, or lack or specialization. Physical therapy has traditionally focused on a bio-medical (BIOM) approach. Some clinicians believe that the BIOM approach is ineffective in reducing chronic pain and loss of function, and that treatment requires a biopsychosocial (BPS) approach, targeting central and peripheral nervous system changes that occur with persistent pain. Pain education 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 pain education, however, have methodological issues. Exercise is another common PT treatment and is beneficial in promoting improved function and decreasing disability in many patient 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 now provided in routine clinical care: BIOM-based care versus BPS-based care. STT who are seen and screened at the Vermont Psychological Services Connecting Cultures program and who experience chronic pain and disability will be referred to PT. Upon referral, STT who meet the inclusion criteria will be invited to participate. STT who consent to the study will be randomized to either the BIOM-based group or the BPS-based group. All participants will undergo baseline assessment and complete the study questionnaires. Participants will complete 6 one-hour PT sessions once a week following their randomly assigned group plan. All baseline measures will be repeated by the blinded assessor after the 6th visit. This study aims to determine if there is a difference in the change in functional outcomes between the BIOM- and BPS-based intervention groups after completion of the 6 PT sessions.

  • Condition or Disease:Chronic Pain
    Disability Physical
  • Intervention/Treatment: Other: Physical Therapy
  • Phase: N/A
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 new Americans and refugees who are survivors of torture and trauma (STT). Numerous studies have assessed the mental health issues of STT 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 STT 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 STT 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 refugees and new Americans 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 STT living with chronic pain, the study findings will help therapists choose appropriate interventions to achieve optimal patient outcomes.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 100 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Intervention Model Description: Blinded randomized controlled study.
  • Masking: Single (Outcomes Assessor)
  • Primary Purpose: Treatment
  • Official Title: Physical Therapy for Individuals With Chronic Pain Due to Torture and/or Trauma: A Comparison of Physical Therapy Interventions
  • Actual Study Start Date: June 2019
  • Estimated Primary Completion Date: May 2020
  • Estimated Study Completion Date: May 2020
Arms and interventions
Arm Intervention/treatment
Active Comparator: Biomedical (BIOM) physical therapy
Six 60 minute PT sessions consisting of 15 minutes of education on topics such as ideal postural alignment (sitting, sleeping), maintenance of normal spinal curves, body mechanics, proper lifting techniques, home pain control via anti-inflammatory modalities such as ice; 15 minutes of manual therapy to region of pain (soft tissue and/or joint mobilization); 30 minutes of region specific exercises to address identified muscle imbalances -stretching and strengthening of the muscles local to the area of pain.
Other: Physical Therapy
Physical therapy modalities to treat chronic pain
Active Comparator: Biopsychosocial (BPS) physical therapy
Six 60 minute PT sessions consisting of 15 minutes of pain neuro-science education, 15 minutes of Graded Motor Imagery (GMI) techniques, (a progressive program of visual and mental exercises consisting of laterality exercises, motor imagery and mirror therapy); 30 minutes of a general conditioning exercise program individualized for each participant based on initial examination findings and participant presentation consisting of: A cardiovascular component which may include walking on a treadmill, stationary cycling, or a seated stepping machine. A muscle strengthening component for extremities and trunk. A flexibility component for upper and lower extremity musculature.
Other: Physical Therapy
Physical therapy modalities to treat chronic pain
Outcome Measures
  • Primary Outcome Measures: 1. Change in Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) Computer Adaptive Test (CAT) [ Time Frame: Baseline (pre-PT, week 0) and after completion of the 6th PT visit, at week 6 ]
    Self report tool assessing physical function using a 5 point scale ranging from "1 Unable to do" to "5 Without any difficulty". Values are summed into a raw score, which is converted into a T-score. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10.
  • Secondary Outcome Measures: 1. Change in Two-point discrimination sensory testing [ Time Frame: Baseline (pre-PT, week 0) and after completion of the 6th PT visit, at week 6. ]
    Quantitative sensory assessment of an individuals ability to discern one or two points of sensory input
  • 2. Change in Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference (PI) Computer Adaptive Test (CAT) [ Time Frame: Baseline (pre-PT, week 0) and after completion of the 6th PT visit, at week 6 ]
    Self report tool assessing how pain interferes and hinders engagement with social, cognitive, emotional, physical and recreational activities using a 5 point scale ranging from "1 Not at All", "2 A little bit", "3 Some what", "4 Quite a bit", "5 very much". Values are summed into a raw score, which is converted into a T-score. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10.
  • 3. Change in Patient Reported Outcomes Measurement Information System (PROMIS) 29 [ Time Frame: Baseline (pre-PT, week 0) and after completion of the 6th PT visit, at week 6. ]
    Self report tool assessing physical, mental, social health and wellbeing domains. Domains are scored on a 1-5 scale. Physical function scale ranges from "1 Unable to do" to "5 Without any difficulty"; anxiety, depression and ability to participate in social roles domain scales ranges from "1 Never" to "5 Always"; Fatigue, Sleep and Pain Interference domain scales range from "1 Not at all" to "5 Very Much" Values are summed into a raw score, which is converted into a T-score The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10.
  • 4. Change in Brief Pain Inventory [ Time Frame: Baseline (pre-PT, week 0) and after completion of the 6th PT visit, at week 6 ]
    Self report tool assessing pain intensity on an 11 point scale ranging from "0 No Pain" to "10 Pain as bad as you can imagine" and pain interference on an 11 point scale ranging from "0 Does not interfere" to "10 Completely Interferes". The 4 Pain intensity scores are used singly to represent pain severity. The Pain Interference is scored as the mean of the 7 items.
  • 5. Change in Central Sensitization Inventory [ Time Frame: Baseline (pre-PT, week 0) and after completion of the 6th PT visit, at week 6. ]
    Self report screening tool to identify central sensitization syndromes, measuring a participants self reported sensitivity to stimuli such as light, sounds, smells, muscle input and activity, on a 5 point scale ranging from "0 Never" to "4 Always". Values are summed into a total score, with higher score being worse sensitivity.
  • 6. Change in Pain pressure threshold sensory testing [ Time Frame: Baseline (pre-PT, week 0) and after completion of the 6th PT visit, at week 6. ]
    Quantitative sensory assessment of an individuals threshold to an applied pressure
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

- definition of torture as defined by the United Nations (UN) HUR 03051 determined by
referring clinical psychologist

- chronic spine and or extremity pain of greater than 6 months duration due to
torture/trauma,

- 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.

Contacts and Locations
Contacts

Contact: Justine Dee 8026562262 ext 8026562262 Justine.Dee@med.uvm.edu

Contact: Jason Fitzgerald 8028650010 jasonfitzgerald@deept.com

Locations

United States, Vermont
Dee Physical Therapy
South Burlington

Sponsors and Collaborators

University of Vermont

Investigators

Principal Investigator: Justine Dee, MS University of Vermont

More Information