Physical Therapy to Treat Chronic Pain in Survivors of Trauma

NCT03933189 | Completed

• 1 other identifier: 00000128
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; Disability Physical

Keywords

chronic pain; trauma; rehabilitiation; physical therapy; musculoskeletal pain

Outcome Measures

Primary Outcomes (1)

• Change in Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) Computer Adaptive Test (CAT)

  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.

  Baseline (pre-PT, week 0) and after completion of the 6th PT visit, at week 6

Secondary Outcomes (6)

• Change in Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference (PI) Computer Adaptive Test (CAT)

  Baseline (pre-PT, week 0) and after completion of the 6th PT visit, at week 6

• Change in Patient Reported Outcomes Measurement Information System (PROMIS) 29

  Baseline (pre-PT, week 0) and after completion of the 6th PT visit, at week 6.

• Change in Brief Pain Inventory

  Baseline (pre-PT, week 0) and after completion of the 6th PT visit, at week 6

• Change in Central Sensitization Inventory

  Baseline (pre-PT, week 0) and after completion of the 6th PT visit, at week 6.

• Change in Pain pressure threshold sensory testing

  Baseline (pre-PT, week 0) and after completion of the 6th PT visit, at week 6.

Study Arms (2)

Biomedical (BIOM) physical therapy

ACTIVE COMPARATOR

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

Biopsychosocial (BPS) physical therapy

ACTIVE COMPARATOR

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

Interventions

Physical Therapy OTHER

Physical therapy modalities to treat chronic pain

Biomedical (BIOM) physical therapy; Biopsychosocial (BPS) physical therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Vermont: lead

Study Sites (1)

Dee Physical Therapy

South Burlington, Vermont, 05403, United States

Location

Related Publications (13)

• Williams AC, Pena CR, Rice AS. Persistent pain in survivors of torture: a cohort study. J Pain Symptom Manage. 2010 Nov;40(5):715-22. doi: 10.1016/j.jpainsymman.2010.02.018. Epub 2010 Aug 3.

  PMID: 20678891 RESULT

• Baird E, Williams ACC, Hearn L, Amris K. Interventions for treating persistent pain in survivors of torture. Cochrane Database Syst Rev. 2017 Aug 18;8(8):CD012051. doi: 10.1002/14651858.CD012051.pub2.

  PMID: 28820231 RESULT

• Kim HJ, Yu SH. Effects of complex manual therapy on PTSD, pain, function, and balance of male torture survivors with chronic low back pain. J Phys Ther Sci. 2015 Sep;27(9):2763-6. doi: 10.1589/jpts.27.2763. Epub 2015 Sep 30.

  PMID: 26504288 RESULT

• Delitto A, George SZ, Van Dillen L, Whitman JM, Sowa G, Shekelle P, Denninger TR, Godges JJ; Orthopaedic Section of the American Physical Therapy Association. Low back pain. J Orthop Sports Phys Ther. 2012 Apr;42(4):A1-57. doi: 10.2519/jospt.2012.42.4.A1. Epub 2012 Mar 30.

  PMID: 22466247 RESULT

• Henry SM, Van Dillen LR, Ouellette-Morton RH, Hitt JR, Lomond KV, DeSarno MJ, Bunn JY. Outcomes are not different for patient-matched versus nonmatched treatment in subjects with chronic recurrent low back pain: a randomized clinical trial. Spine J. 2014 Dec 1;14(12):2799-810. doi: 10.1016/j.spinee.2014.03.024. Epub 2014 Mar 22.

  PMID: 24662210 RESULT

• Moseley GL, Flor H. Targeting cortical representations in the treatment of chronic pain: a review. Neurorehabil Neural Repair. 2012 Jul-Aug;26(6):646-52. doi: 10.1177/1545968311433209. Epub 2012 Feb 13.

  PMID: 22331213 RESULT

• Malfliet A, Kregel J, Meeus M, Danneels L, Cagnie B, Roussel N, Nijs J. Patients With Chronic Spinal Pain Benefit From Pain Neuroscience Education Regardless the Self-Reported Signs of Central Sensitization: Secondary Analysis of a Randomized Controlled Multicenter Trial. PM R. 2018 Dec;10(12):1330-1343.e1. doi: 10.1016/j.pmrj.2018.04.010. Epub 2018 May 9.

  PMID: 29753112 RESULT

• Simons LE, Elman I, Borsook D. Psychological processing in chronic pain: a neural systems approach. Neurosci Biobehav Rev. 2014 Feb;39:61-78. doi: 10.1016/j.neubiorev.2013.12.006. Epub 2013 Dec 27.

  PMID: 24374383 RESULT

• Bowering KJ, O'Connell NE, Tabor A, Catley MJ, Leake HB, Moseley GL, Stanton TR. The effects of graded motor imagery and its components on chronic pain: a systematic review and meta-analysis. J Pain. 2013 Jan;14(1):3-13. doi: 10.1016/j.jpain.2012.09.007. Epub 2012 Nov 15.

  PMID: 23158879 RESULT

• Daffada PJ, Walsh N, McCabe CS, Palmer S. The impact of cortical remapping interventions on pain and disability in chronic low back pain: a systematic review. Physiotherapy. 2015 Mar;101(1):25-33. doi: 10.1016/j.physio.2014.07.002. Epub 2014 Aug 1.

  PMID: 25442672 RESULT

• Flor H, Denke C, Schaefer M, Grusser S. Effect of sensory discrimination training on cortical reorganisation and phantom limb pain. Lancet. 2001 Jun 2;357(9270):1763-4. doi: 10.1016/S0140-6736(00)04890-X.

  PMID: 11403816 RESULT

• Wallman KE, Morton AR, Goodman C, Grove R, Guilfoyle AM. Randomised controlled trial of graded exercise in chronic fatigue syndrome. Med J Aust. 2004 May 3;180(9):444-8. doi: 10.5694/j.1326-5377.2004.tb06019.x.

  PMID: 15115421 RESULT

• Landmark T, Romundstad P, Borchgrevink PC, Kaasa S, Dale O. Associations between recreational exercise and chronic pain in the general population: evidence from the HUNT 3 study. Pain. 2011 Oct;152(10):2241-2247. doi: 10.1016/j.pain.2011.04.029. Epub 2011 May 23.

  PMID: 21601986 RESULT

MeSH Terms

Conditions

Chronic Pain; Wounds and Injuries; Musculoskeletal Pain

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Justine Dee, MS

  University of Vermont

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Model Details: Blinded randomized controlled study.

Study Record Dates

• First Submitted: April 24, 2019
• First Posted: May 1, 2019
• Study Start: June 18, 2019
• Primary Completion: July 30, 2021
• Study Completion: July 30, 2021
• Last Updated: September 29, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)