Effectiveness of Pain Neuroscience Education (PNE) to Veterans With Post-Traumatic Stress and Low Back Pain

NCT05086159 | Completed

• 1 other identifier: GAM-16-024-HE
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

This trial compared traditional pain and stress education plus physical therapy to pain neuroscience education plus physical therapy in individuals with post-traumatic stress and chronic low back pain.

Conditions

Chronic Low Back Pain; Post-traumatic Stress

Keywords

chronic low back pain; post-traumatic stress; physical therapy; pain neuroscience education

Outcome Measures

Primary Outcomes (9)

• PTSD Check-list for Diagnostic and Statistical Manual of Mental Disorders (DSM 5) (PCL)

  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

• PTSD Check-list for Diagnostic and Statistical Manual of Mental Disorders (DSM 5) (PCL)

  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)

  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.

  8-weeks

• Roland-Morris Disability Questionnaire (RMDQ)

  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)

  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.

  4-weeks

• Roland-Morris Disability Questionnaire (RMDQ)

  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.

  8-weeks

• Numeric Pain Rating Scale (NPRS)

  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."

  Baseline

• Numeric Pain Rating Scale (NPRS)

  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."

  4-weeks

• Numeric Pain Rating Scale (NPRS)

  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."

  8-weeks

Secondary Outcomes (21)

• "Stressometer"

  Baseline

• "Stressometer"

  4-weeks

• "Stressometer"

  8-weeks

• Pain Catastrophizing Scale (PCS)

  Baseline

• Pain Catastrophizing Scale (PCS)

  4-weeks

Study Arms (2)

Traditional Education

ACTIVE COMPARATOR

Traditional biomedical education for back pain and standard stress education. Education was developed from "Back School", National PTSD Center, and PTSD Coach.

Behavioral: Exercise; Behavioral: Traditional Education

Pain Neuroscience Education

EXPERIMENTAL

Pain neuroscience education (PNE) was developed for this research comparing pain and stress symptoms to a radar that can become hypervigilant to threat.

Behavioral: Pain Neuroscience Education; Behavioral: Exercise

Interventions

Pain Neuroscience Education BEHAVIORAL

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.

Pain Neuroscience Education

Exercise BEHAVIORAL

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.

Pain Neuroscience Education; Traditional Education

Traditional Education BEHAVIORAL

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.

Traditional Education

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Keller Army Community Hospital: lead

Study Sites (1)

Lexington VA Medical Center

Lexington, Kentucky, 40502, United States

Location

Related Publications (16)

• 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.

  PMID: 15322439 BACKGROUND

• 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.

  PMID: 21586297 BACKGROUND

• 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.

  PMID: 22133255 BACKGROUND

• 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.

  PMID: 22893824 BACKGROUND

• 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.

  PMID: 24402979 BACKGROUND

• 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.

  PMID: 30067844 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 24887571 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 26221000 BACKGROUND

• 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.

  PMID: 2957704 BACKGROUND

• Moffett, J. K., & Frost, H. (2000). Back to fitness programme: The manual for physiotherapists to set up the classes. Physiotherapy, 86(6), 295-305.

  BACKGROUND

• 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.

  PMID: 22846347 BACKGROUND

• 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.

  PMID: 26076755 BACKGROUND

• Sullivan, M. J., Bishop, S. R., & Pivik, J. (1995). The pain catastrophizing scale: development and validation. Psychological assessment, 7(4), 524.

  BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 20, 2021
• First Posted: October 20, 2021
• Study Start: July 1, 2017
• Primary Completion: May 1, 2019
• Study Completion: August 1, 2021
• Last Updated: October 27, 2021

Record last verified: 2021-10

Locations

US (1)