Effectiveness of Pain Neuroscience Education (PNE) to Veterans With Post-Traumatic Stress and Low Back Pain
NCT ID: NCT05086159
Last Updated: 2021-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
47 participants
INTERVENTIONAL
2017-07-01
2021-08-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Traditional Education
Traditional biomedical education for back pain and standard stress education. Education was developed from "Back School", National PTSD Center, and PTSD Coach.
Exercise
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.
Traditional Education
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.
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.
Pain Neuroscience Education
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.
Exercise
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.
Interventions
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Pain Neuroscience Education
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.
Exercise
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.
Traditional Education
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Keller Army Community Hospital
FED
Responsible Party
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Timothy Benedict
Associate Professor
Locations
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Lexington VA Medical Center
Lexington, Kentucky, United States
Countries
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References
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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.
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.
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
Other Identifiers
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GAM-16-024-HE
Identifier Type: -
Identifier Source: org_study_id