Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Physical Therapy to Treat Chronic Pain in Survivors of Trauma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03933189
Recruitment Status : Recruiting
First Posted : May 1, 2019
Last Update Posted : November 4, 2020
Sponsor:
Information provided by (Responsible Party):
Justine Dee, University of Vermont

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.

Condition or disease Intervention/treatment Phase
Chronic Pain Disability Physical Other: Physical Therapy Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Blinded randomized controlled study.
Masking: Single (Outcomes Assessor)
Masking Description: Participants will complete all the research outcome measures with a blinded independent examiner who will not be treating the participants and who will not know which treatment group participants are randomized to.
Primary Purpose: Treatment
Official Title: Physical Therapy for Individuals With Chronic Pain Due to Physical and/or Emotional Trauma: A Comparison of Physical Therapy Interventions
Actual Study Start Date : June 18, 2019
Estimated Primary Completion Date : May 15, 2021
Estimated Study Completion Date : May 15, 2021

Resource links provided by the National Library of Medicine


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




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 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03933189


Contacts
Layout table for location contacts
Contact: Justine Dee 8026562262 ext 8026562262 Justine.Dee@med.uvm.edu
Contact: Jason Fitzgerald 8028650010 jasonfitzgerald@deept.com

Locations
Layout table for location information
United States, Vermont
Dee Physical Therapy Recruiting
South Burlington, Vermont, United States, 05403
Contact: Justine Dee    802-656-2262 ext 8026562262    Justine.Dee@med.uvm.edu   
Contact: Justine Dee    8026562262 ext 8026562262    Justine.Dee@med.uvm.edu   
Sponsors and Collaborators
University of Vermont
Investigators
Layout table for investigator information
Principal Investigator: Justine Dee, MS University of Vermont
Publications of Results:

Layout table for additonal information
Responsible Party: Justine Dee, Clinical Associate Professor, University of Vermont
ClinicalTrials.gov Identifier: NCT03933189    
Other Study ID Numbers: 00000128
First Posted: May 1, 2019    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Justine Dee, University of Vermont:
chronic pain
trauma
rehabilitiation
physical therapy
musculoskeletal pain
Additional relevant MeSH terms:
Layout table for MeSH terms
Chronic Pain
Pain
Neurologic Manifestations