- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05086159
Effectiveness of Pain Neuroscience Education (PNE) to Veterans With Post-Traumatic Stress and Low Back Pain
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kentucky
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Lexington, Kentucky, United States, 40502
- Lexington VA Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Pain located between the 12th rib and buttocks that in the opinion of the screening examiner is originating from the lumbar region
- Current episode of back pain duration of 3 months or longer
- Active duty military or Veteran
- Read and speak English well enough to provide informed consent and follow study instructions
Exclusion Criteria:
- History of prior surgery to the lumbosacral spine within the previous 12 months
- Presence of neurogenic LBP defined by a positive contralateral straight leg raise (reproduction of symptoms below 45 degrees) or reflex, sensation, or strength deficits in a pattern consistent with nerve root compression
- Medical "red flags" of a potentially serious condition including cauda equina syndrome, major or rapidly progressing neurological deficit, fracture, cancer, infection, or systemic disease
- Discharged from physical therapy within the past 3 months for lower back pain
- Current diagnosis of psychotic conditions or medications (bi-polar, schizophrenia, personality disorder).
- Substance abuse or psychosis within 6 months of research.
- Unable to discontinue other active therapies until completion of clinical trial follow-up (8 weeks).
- Suicidal ideation
- Current pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Traditional Education
Traditional biomedical education for back pain and standard stress education.
Education was developed from "Back School", National PTSD Center, and PTSD Coach.
|
The exercise protocol for each group will be identical and modeled after the "Back to Fitness" program.
This program will consist of a 5-10-minute cardiovascular warm-up of walking in place or riding an exercise bike.
Next is a 15-minute circuit consisting of 10 different general exercises for 1-minute each.
Finally, a 5-minute cool down will consist of light stretching and trunk range of motion exercises.
Each exercise will be tailored as easy, medium, or hard depending on the individual patient's tolerance.
This program has been shown to be equally as effective as motor control exercises for long-term outcomes in patients with non-specific LBP.
Weekly education sessions lasting approximately 30 minutes each, once a week for four weeks. Session 1 will include a basic overview of the anatomy of the spine. Session 2 will discuss an overview of stress symptoms to include hypervigilance, avoidance, and re-experiencing. Session 3 will cover common recommendations delivered in stress education: the do's and don'ts of stress management. Session 4: review and mindfulness. |
Experimental: Pain Neuroscience Education
Pain neuroscience education (PNE) was developed for this research comparing pain and stress symptoms to a radar that can become hypervigilant to threat.
|
The exercise protocol for each group will be identical and modeled after the "Back to Fitness" program.
This program will consist of a 5-10-minute cardiovascular warm-up of walking in place or riding an exercise bike.
Next is a 15-minute circuit consisting of 10 different general exercises for 1-minute each.
Finally, a 5-minute cool down will consist of light stretching and trunk range of motion exercises.
Each exercise will be tailored as easy, medium, or hard depending on the individual patient's tolerance.
This program has been shown to be equally as effective as motor control exercises for long-term outcomes in patients with non-specific LBP.
Weekly education sessions lasting approximately 30 minutes each, once a week for four weeks. Session 1: the nervous system is like an alarm to protect. Session 2: common ways the nervous system becomes sensitive. Session 3: importance of gradual conditioning and neuroplasticity. Session 4: common ways to decrease nervous system sensitivity. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PTSD Check-list for Diagnostic and Statistical Manual of Mental Disorders (DSM 5) (PCL)
Time Frame: Baseline
|
The PCL is a 20-item checklist that measures the clusters of symptoms associated with PTSD according to the revised DSM.
Scores range from 0-80 with higher numbers indicating higher PTSD symptomology.
|
Baseline
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PTSD Check-list for Diagnostic and Statistical Manual of Mental Disorders (DSM 5) (PCL)
Time Frame: 4-weeks
|
The PCL is a 20-item checklist that measures the clusters of symptoms associated with PTSD according to the revised DSM.
Scores range from 0-80 with higher numbers indicating higher PTSD symptomology.
|
4-weeks
|
PTSD Check-list for Diagnostic and Statistical Manual of Mental Disorders (DSM 5) (PCL)
Time Frame: 8-weeks
|
The PCL is a 20-item checklist that measures the clusters of symptoms associated with PTSD according to the revised DSM.
Scores range from 0-80 with higher numbers indicating higher PTSD symptomology.
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8-weeks
|
Roland-Morris Disability Questionnaire (RMDQ)
Time Frame: Baseline
|
The RMDQ is a subjective measure of disability recommended for LBP.
Users are asked to identify among 24 activities or statements that are influenced by their back pain.
The answers provide a score between 0 and 24, with higher scores representing more disability.
|
Baseline
|
Roland-Morris Disability Questionnaire (RMDQ)
Time Frame: 4-weeks
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The RMDQ is a subjective measure of disability recommended for LBP.
Users are asked to identify among 24 activities or statements that are influenced by their back pain.
The answers provide a score between 0 and 24, with higher scores representing more disability.
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4-weeks
|
Roland-Morris Disability Questionnaire (RMDQ)
Time Frame: 8-weeks
|
The RMDQ is a subjective measure of disability recommended for LBP.
Users are asked to identify among 24 activities or statements that are influenced by their back pain.
The answers provide a score between 0 and 24, with higher scores representing more disability.
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8-weeks
|
Numeric Pain Rating Scale (NPRS)
Time Frame: Baseline
|
The NPRS is an 11-point scale used to rate subjective pain intensity.
The NPRS has been shown to have good validity and reliability.
The scale ranges from 0 to 10 and has been shown to have acceptable responsiveness in patients with LBP.
This study's scale was anchored at 0, "no pain at all", to 10, "the worst pain you could imagine."
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Baseline
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Numeric Pain Rating Scale (NPRS)
Time Frame: 4-weeks
|
The NPRS is an 11-point scale used to rate subjective pain intensity.
The NPRS has been shown to have good validity and reliability.
The scale ranges from 0 to 10 and has been shown to have acceptable responsiveness in patients with LBP.
This study's scale was anchored at 0, "no pain at all", to 10, "the worst pain you could imagine."
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4-weeks
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Numeric Pain Rating Scale (NPRS)
Time Frame: 8-weeks
|
The NPRS is an 11-point scale used to rate subjective pain intensity.
The NPRS has been shown to have good validity and reliability.
The scale ranges from 0 to 10 and has been shown to have acceptable responsiveness in patients with LBP.
This study's scale was anchored at 0, "no pain at all", to 10, "the worst pain you could imagine."
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8-weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
"Stressometer"
Time Frame: Baseline
|
The stressometer is a short, one-item scale that measures patient distress on a scale from 0-10.
The stressometer is valid and responsive and correlates with more in-depth assessments of psychological stress.
A score of 4 or higher is considered positive for moderate distress.
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Baseline
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"Stressometer"
Time Frame: 4-weeks
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The stressometer is a short, one-item scale that measures patient distress on a scale from 0-10.
The stressometer is valid and responsive and correlates with more in-depth assessments of psychological stress.
A score of 4 or higher is considered positive for moderate distress.
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4-weeks
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"Stressometer"
Time Frame: 8-weeks
|
The stressometer is a short, one-item scale that measures patient distress on a scale from 0-10.
The stressometer is valid and responsive and correlates with more in-depth assessments of psychological stress.
A score of 4 or higher is considered positive for moderate distress.
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8-weeks
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Pain Catastrophizing Scale (PCS)
Time Frame: Baseline
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The Pain Catastrophizing Scale (PCS) measures pain catastrophizing which is defined as an exaggerated negative appraisal of noxious stimuli.
The PCS has good validity and excellent reliability in a LBP population.
Higher scores indicate more distressing beliefs about pain.
Scores range from 0-52.
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Baseline
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Pain Catastrophizing Scale (PCS)
Time Frame: 4-weeks
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The Pain Catastrophizing Scale (PCS) measures pain catastrophizing which is defined as an exaggerated negative appraisal of noxious stimuli.
The PCS has good validity and excellent reliability in a LBP population.
Higher scores indicate more distressing beliefs about pain.
Scores range from 0-52.
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4-weeks
|
Pain Catastrophizing Scale (PCS)
Time Frame: 8-weeks
|
The Pain Catastrophizing Scale (PCS) measures pain catastrophizing which is defined as an exaggerated negative appraisal of noxious stimuli.
The PCS has good validity and excellent reliability in a LBP population.
Higher scores indicate more distressing beliefs about pain.
Scores range from 0-52.
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8-weeks
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Brief Survey of Pain Attitudes (SOPA-35)
Time Frame: Baseline
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The Brief Survey of Pain Attitudes (SOPA-35) is a valid, reliable, and sensitive questionnaire that measures beliefs about pain across 7 domains.
This study was particularly interested in the harm sub-scale to assess whether patient's beliefs that pain means harm changes after the intervention.
Each domain is scored from 0-4 with 0 representing "very untrue" and 4 representing "very true."
A higher score for the SOPA-Harm subscale indicates that participants believe that pain is a sign of harm and damage to a greater degree than participants with a lower score on the scale.
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Baseline
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Brief Survey of Pain Attitudes (SOPA-35)
Time Frame: 4-weeks
|
The Brief Survey of Pain Attitudes (SOPA-35) is a valid, reliable, and sensitive questionnaire that measures beliefs about pain across 7 domains.
This study was particularly interested in the harm sub-scale to assess whether patient's beliefs that pain means harm changes after the intervention.
Each domain is scored from 0-4 with 0 representing "very untrue" and 4 representing "very true."
A higher score for the SOPA-Harm subscale indicates that participants believe that pain is a sign of harm and damage to a greater degree than participants with a lower score on the scale.
|
4-weeks
|
Brief Survey of Pain Attitudes (SOPA-35)
Time Frame: 8-weeks
|
The Brief Survey of Pain Attitudes (SOPA-35) is a valid, reliable, and sensitive questionnaire that measures beliefs about pain across 7 domains.
This study was particularly interested in the harm sub-scale to assess whether patient's beliefs that pain means harm changes after the intervention.
Each domain is scored from 0-4 with 0 representing "very untrue" and 4 representing "very true."
A higher score for the SOPA-Harm subscale indicates that participants believe that pain is a sign of harm and damage to a greater degree than participants with a lower score on the scale.
|
8-weeks
|
Pain Self-Efficacy Questionnaire (PSEQ)
Time Frame: Baseline
|
The Pain Self-Efficacy Questionnaire (PSEQ) is a questionnaire that measures an individual's self-perceived confidence to cope with physical activities "despite the pain".
Studies demonstrate that individuals who have low self-efficacy have higher disability.
Higher scores indicate a greater degree of confidence to function in life, "despite pain."
Scores range from 0-60.
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Baseline
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Pain Self-Efficacy Questionnaire (PSEQ)
Time Frame: 4-weeks
|
The Pain Self-Efficacy Questionnaire (PSEQ) is a questionnaire that measures an individual's self-perceived confidence to cope with physical activities "despite the pain".
Studies demonstrate that individuals who have low self-efficacy have higher disability.
Higher scores indicate a greater degree of confidence to function in life, "despite pain."
Scores range from 0-60.
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4-weeks
|
Pain Self-Efficacy Questionnaire (PSEQ)
Time Frame: 8-weeks
|
The Pain Self-Efficacy Questionnaire (PSEQ) is a questionnaire that measures an individual's self-perceived confidence to cope with physical activities "despite the pain".
Studies demonstrate that individuals who have low self-efficacy have higher disability.
Higher scores indicate a greater degree of confidence to function in life, "despite pain."
Scores range from 0-60.
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8-weeks
|
Lumbar Spine Pain Pressure Threshold (PPT)
Time Frame: Baseline
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Patients were tested in the prone position with a pillow under their shins to achieve approximately 15 degrees of knee flexion.
A research physical therapist applies a digital algometer probe (SBMEDIC Electronics, Sweden) with a gradual increase in force 5 cm lateral to the spinous process of L3 of the most symptomatic side until the participant reported the pressure as painful and pressed a button attached to the algometer.
This procedure was performed three times at the low back and averaged to determine the patient's Pain Pressure Threshold with approximately 30 seconds rest between repetitions.
Forces are measured in kPA with higher numbers indicating a greater tolerance for pressure and potentially less pain sensitivity.
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Baseline
|
Lumbar Spine Pain Pressure Threshold (PPT)
Time Frame: 4-weeks
|
Patients were tested in the prone position with a pillow under their shins to achieve approximately 15 degrees of knee flexion.
A research physical therapist applies a digital algometer probe (SBMEDIC Electronics, Sweden) with a gradual increase in force 5 cm lateral to the spinous process of L3 of the most symptomatic side until the participant reported the pressure as painful and pressed a button attached to the algometer.
This procedure was performed three times at the low back and averaged to determine the patient's Pain Pressure Threshold with approximately 30 seconds rest between repetitions.
Forces are measured in kPA with higher numbers indicating a greater tolerance for pressure and potentially less pain sensitivity.
|
4-weeks
|
Suprascapular Pain Pressure Threshold (PPT)
Time Frame: Baseline
|
Patients were tested in the prone position with a pillow under their shins to achieve approximately 15 degrees of knee flexion.
A research physical therapist applies a digital algometer probe (SBMEDIC Electronics, Sweden) with a gradual increase in force at the suprascapular region contralateral to the side tested in the low back, mid-way between the posterior border of the acromion and the 7th spinous process of the cervical spine.
This procedure was performed three times and averaged to determine the patient's Pain Pressure Threshold with approximately 30 seconds rest between repetitions.
Forces are measured in kPA with higher numbers indicating a greater tolerance for pressure and potentially less pain sensitivity.
|
Baseline
|
Suprascapular Pain Pressure Threshold (PPT)
Time Frame: 4-weeks
|
Patients were tested in the prone position with a pillow under their shins to achieve approximately 15 degrees of knee flexion.
A research physical therapist applies a digital algometer probe (SBMEDIC Electronics, Sweden) with a gradual increase in force at the suprascapular region contralateral to the side tested in the low back, mid-way between the posterior border of the acromion and the 7th spinous process of the cervical spine.
This procedure was performed three times and averaged to determine the patient's Pain Pressure Threshold with approximately 30 seconds rest between repetitions.
Forces are measured in kPA with higher numbers indicating a greater tolerance for pressure and potentially less pain sensitivity.
|
4-weeks
|
Spinal flexion
Time Frame: Baseline
|
Participants were asked to bend forward at the waist while keeping their knees straight and attempting to touch the floor.
The distance from the floor to the patient's most distal finger-tip was measured to the nearest tenth of a centimeter (cm).
Participants were instructed to stop "whenever you feel you need to stop."
Participants completed this procedure two times and the measures were averaged.
Lower numbers indicate greater range of motion with the lowest score possible 0cm.
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Baseline
|
Spinal flexion
Time Frame: 4-weeks
|
Participants were asked to bend forward at the waist while keeping their knees straight and attempting to touch the floor.
The distance from the floor to the patient's most distal finger-tip was measured to the nearest tenth of a centimeter (cm).
Participants were instructed to stop "whenever you feel you need to stop."
Participants completed this procedure two times and the measures were averaged.
Lower numbers indicate greater range of motion with the lowest score possible 0cm.
|
4-weeks
|
Post-program questionnaire
Time Frame: 8-weeks
|
This study adapted a questionnaire to assess the satisfaction and acceptability of the intervention on a numerical scale from 0-10 with 10 indicating "strongly agree" and 0 "strongly disagree".
|
8-weeks
|
Healthcare utilization, Cost
Time Frame: 12-months
|
Any medical appointment in the Veterans Affairs or Department of Defense health system in which a patient sought care or was evaluated for complaints of LBP for 12-months following study enrollment according to a medical provider's electronic documentation of the visit.
Subsequently, a physical therapist who was blinded to participant group allocation verified each medical encounter and then extracted all current procedural terminology (CPT) codes that were charged for each visit related to LBP.
In the Military and Veterans Health Affairs, costs are estimated based on the American Medical Association and Medicare equivalents for CPT codes.
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12-months
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Healthcare utilization, Invasive Procedures
Time Frame: 12-months
|
Any medical appointment in the Veterans Affairs or Department of Defense health system in which a patient sought care or was evaluated for complaints of LBP for 12-months following study enrollment according to a medical provider's electronic documentation of the visit.
Subsequently, a physical therapist who was blinded to participant group allocation verified each medical encounter and then extracted all current procedural terminology (CPT) codes that were charged for each visit related to LBP.
In the Military and Veterans Health Affairs, costs are estimated based on the American Medical Association and Medicare equivalents for CPT codes.
CPT codes were then classified as non-invasive or invasive (surgery, imaging, or injections).
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12-months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Louw A, Diener I, Butler DS, Puentedura EJ. The effect of neuroscience education on pain, disability, anxiety, and stress in chronic musculoskeletal pain. Arch Phys Med Rehabil. 2011 Dec;92(12):2041-56. doi: 10.1016/j.apmr.2011.07.198.
- Moseley GL, Nicholas MK, Hodges PW. A randomized controlled trial of intensive neurophysiology education in chronic low back pain. Clin J Pain. 2004 Sep-Oct;20(5):324-30. doi: 10.1097/00002508-200409000-00007.
- Moeller-Bertram T, Keltner J, Strigo IA. Pain and post traumatic stress disorder - review of clinical and experimental evidence. Neuropharmacology. 2012 Feb;62(2):586-97. doi: 10.1016/j.neuropharm.2011.04.028. Epub 2011 May 10.
- Ruzek JI, Hoffman J, Ciulla R, Prins A, Kuhn E, Gahm G. Bringing Internet-based education and intervention into mental health practice: afterdeployment.org. Eur J Psychotraumatol. 2011;2. doi: 10.3402/ejpt.v2i0.7278. Epub 2011 Nov 17.
- Kuhn E, Greene C, Hoffman J, Nguyen T, Wald L, Schmidt J, Ramsey KM, Ruzek J. Preliminary evaluation of PTSD Coach, a smartphone app for post-traumatic stress symptoms. Mil Med. 2014 Jan;179(1):12-8. doi: 10.7205/MILMED-D-13-00271.
- Clewley D, Rhon D, Flynn T, Koppenhaver S, Cook C. Health seeking behavior as a predictor of healthcare utilization in a population of patients with spinal pain. PLoS One. 2018 Aug 1;13(8):e0201348. doi: 10.1371/journal.pone.0201348. eCollection 2018.
- Davies, C. C., & Nitz, A. J. (2009). Psychometric properties of the Roland-Morris Disability Questionnaire compared to the Oswestry Disability Index: a systematic review. Physical Therapy Reviews, 14(6), 399-408.
- Deyo RA, Dworkin SF, Amtmann D, Andersson G, Borenstein D, Carragee E, Carrino J, Chou R, Cook K, DeLitto A, Goertz C, Khalsa P, Loeser J, Mackey S, Panagis J, Rainville J, Tosteson T, Turk D, Von Korff M, Weiner DK. Report of the NIH task force on research standards for chronic low back pain. Spine (Phila Pa 1976). 2014 Jun 15;39(14):1128-43. doi: 10.1097/BRS.0000000000000434.
- Jensen, M. P., Turner, J. A., & Romano, J. M. (2000). Pain belief assessment: A comparison of the short and long versions of the surgery of pain attitudes. The Journal of Pain, 1(2), 138-150.
- Keegan D, Byrne K, Cullen G, Doherty GA, Dooley B, Mulcahy HE. The Stressometer: A Simple, Valid, and Responsive Measure of Psychological Stress in Inflammatory Bowel Disease Patients. J Crohns Colitis. 2015 Oct;9(10):881-5. doi: 10.1093/ecco-jcc/jjv120. Epub 2015 Jul 27.
- Linton SJ, Kamwendo K. Low back schools. A critical review. Phys Ther. 1987 Sep;67(9):1375-83. doi: 10.1093/ptj/67.9.1375.
- Moffett, J. K., & Frost, H. (2000). Back to fitness programme: The manual for physiotherapists to set up the classes. Physiotherapy, 86(6), 295-305.
- Neziri AY, Curatolo M, Limacher A, Nuesch E, Radanov B, Andersen OK, Arendt-Nielsen L, Juni P. Ranking of parameters of pain hypersensitivity according to their discriminative ability in chronic low back pain. Pain. 2012 Oct;153(10):2083-2091. doi: 10.1016/j.pain.2012.06.025. Epub 2012 Jul 28.
- Pincus T, Anwar S, McCracken LM, McGregor A, Graham L, Collinson M, McBeth J, Watson P, Morley S, Henderson J, Farrin AJ; OBI Trial Management Team. Delivering an Optimised Behavioural Intervention (OBI) to people with low back pain with high psychological risk; results and lessons learnt from a feasibility randomised controlled trial of Contextual Cognitive Behavioural Therapy (CCBT) vs. Physiotherapy. BMC Musculoskelet Disord. 2015 Jun 16;16:147. doi: 10.1186/s12891-015-0594-2.
- Sullivan, M. J., Bishop, S. R., & Pivik, J. (1995). The pain catastrophizing scale: development and validation. Psychological assessment, 7(4), 524.
- Weathers, F. W., Litz, B. T., Keane, T. M., Palmieri, P. A., Marx, B. P., & Schnurr, P. P. (2013). The PTSD Checklist for DSM-5 (PCL-5). Retrieved from www.ptsd.va.gov
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GAM-16-024-HE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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