Chronic PainNCT03933189
Physical Therapy to Treat Chronic Pain in Survivors of Trauma
A study testing Physical Therapy in people with Chronic Pain and Disability Physical, run by University of Vermont at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Disability Physical
- What is being tested?
- Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2019to 30 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Inability to walk a minimum of 20 feet
- inability to afford any insurance fee for the 6 visits needed for the research study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dee Physical Therapy
South Burlington, Vermont, 05403
About this study
Official title: Physical Therapy for Individuals With Chronic Pain Due to Physical and/or Emotional Trauma: A Comparison of Physical Therapy Interventions
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.
Read the 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.
- Conditions
- Chronic Pain, Disability Physical
- Being tested
- Physical Therapy
- Keywords
- chronic pain, trauma, rehabilitiation, physical therapy, musculoskeletal pain
- Medical subject headings
- Chronic Pain, Wounds and Injuries, Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical TherapyOther
Physical therapy modalities to treat chronic pain
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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
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.
Measured: Baseline (pre-PT, week 0) and after completion of the 6th PT visit, at week 6.
Change in Brief Pain Inventory
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.
Measured: Baseline (pre-PT, week 0) and after completion of the 6th PT visit, at week 6
Change in Central Sensitization Inventory
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.
Measured: Baseline (pre-PT, week 0) and after completion of the 6th PT visit, at week 6.
Change in Pain pressure threshold sensory testing
Quantitative sensory assessment of an individuals threshold to an applied pressure
Measured: Baseline (pre-PT, week 0) and after completion of the 6th PT visit, at week 6.
Change in Two-point discrimination sensory testing
Quantitative sensory assessment of an individuals ability to discern one or two points of sensory input
Measured: Baseline (pre-PT, week 0) and after completion of the 6th PT visit, at week 6.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2019
- Study start18 Jun 2019
- Primary completion30 Jul 2021
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Blinded randomized controlled study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Justine Dee, University of Vermont
- Investigators
- Justine Dee, MS, Principal investigator, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03933189
- Sponsor's protocol ID
- 00000128
- Status last verified
- Sep 2021
- First submitted
- 24 Apr 2019
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20678891Baird 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.
PubMed 28820231Kim 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.
PubMed 26504288Delitto 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.
PubMed 22466247Henry 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.
PubMed 24662210Moseley 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.
PubMed 22331213Malfliet 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.
PubMed 29753112Simons 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.
PubMed 24374383Bowering 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.
PubMed 23158879Daffada 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.
PubMed 25442672Flor 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.
PubMed 11403816Wallman 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.
PubMed 15115421Landmark 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.
PubMed 21601986
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Therapy for Individuals With Chronic Pain Due to Physical and/or Emotional Trauma: A Comparison of Physical Therapy Interventions
- ClinicalTrials.gov ID
- NCT03933189
- Acronym / sponsor ID
- 00000128
- Conditions
- Chronic Pain, Disability Physical
- Keywords
- chronic pain, trauma, rehabilitiation, physical therapy, musculoskeletal pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Study start
- 18 Jun 2019 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 1 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Blinded randomized controlled study.
| Arm | Type | Receives |
|---|---|---|
| Biomedical (BIOM) physical therapy | Active comparator | Other: Physical TherapySix 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. |
| Biopsychosocial (BPS) physical therapy | Active comparator | Other: Physical TherapySix 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Inability to walk a minimum of 20 feet
- inability to afford any insurance fee for the 6 visits needed for the research study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical TherapyPhysical therapy modalities to treat chronic pain | Other | Biomedical (BIOM) physical therapy, Biopsychosocial (BPS) physical therapy |
Primary outcome
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.
6 secondary outcomes
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
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.
Change in Brief Pain Inventory
Time frame: Baseline (pre-PT, week 0) and after completion of the 6th PT visit, at week 6
Change in Central Sensitization Inventory
Time frame: Baseline (pre-PT, week 0) and after completion of the 6th PT visit, at week 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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- Results publication: PubMed 20678891Williams 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.
- Results publication: PubMed 28820231Baird 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.
- Results publication: PubMed 26504288Kim 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.
- Results publication: PubMed 22466247Delitto 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.
- Results publication: PubMed 24662210Henry 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.
- Results publication: PubMed 22331213Moseley 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.
- Results publication: PubMed 29753112Malfliet 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.
- Results publication: PubMed 24374383Simons 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.
- Results publication: PubMed 23158879Bowering 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.
- Results publication: PubMed 25442672Daffada 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.
- Results publication: PubMed 11403816Flor 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.
- Results publication: PubMed 15115421Wallman 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Justine Dee, MS principal investigator
University of Vermont
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Therapy in people with Chronic Pain and Disability Physical, run by University of Vermont at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03933189, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2021.