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

Chronic Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05086159
• Other study ID #: GAM-16-024-HE
• Status: Completed
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: August 1, 2021

Study information

• Verified date: October 2021
• Source: Keller Army Community Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Veterans and Service Members with low back pain (LBP) will be recruited for this research. Once Veterans consent to participate in this research, participants will undergo baseline testing. Next, participants will randomly be assigned to one of two types of education: pain neuroscience education or traditional biomedical education. Each Veteran will receive 30 minutes of interactive education once a week for 4 weeks, depending on their group assignment. Following each education session, Veterans will participate in an exercise class that will last approximately 30 minutes. After the 4 week intervention, Veterans will complete the same questionnaires and measures as at the beginning of the program. Veterans will also complete subjective questionnaires at 8 weeks. Finally, healthcare utilization will be measured for 12 months following the research intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: August 1, 2021
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain
• Post-traumatic Stress

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Lexington VA Medical Center	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Keller Army Community Hospital

Country where clinical trial is conducted

United States, 

References & Publications (16)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Linton SJ, Kamwendo K. Low back schools. A critical review. Phys Ther. 1987 Sep;67(9):1375-83. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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

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. — View Citation

Neziri AY, Curatolo M, Limacher A, Nüesch E, Radanov B, Andersen OK, Arendt-Nielsen L, Jüni 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. — View Citation

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. — View Citation

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. — View Citation

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

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	"Stressometer"	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.	Baseline
Secondary	"Stressometer"	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.	4-weeks
Secondary	"Stressometer"	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.	8-weeks
Secondary	Pain Catastrophizing Scale (PCS)	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.	Baseline
Secondary	Pain Catastrophizing Scale (PCS)	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.	4-weeks
Secondary	Pain Catastrophizing Scale (PCS)	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.	8-weeks
Secondary	Brief Survey of Pain Attitudes (SOPA-35)	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.	Baseline
Secondary	Brief Survey of Pain Attitudes (SOPA-35)	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
Secondary	Brief Survey of Pain Attitudes (SOPA-35)	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
Secondary	Pain Self-Efficacy Questionnaire (PSEQ)	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.	Baseline
Secondary	Pain Self-Efficacy Questionnaire (PSEQ)	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.	4-weeks
Secondary	Pain Self-Efficacy Questionnaire (PSEQ)	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.	8-weeks
Secondary	Lumbar Spine Pain Pressure Threshold (PPT)	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.	Baseline
Secondary	Lumbar Spine Pain Pressure Threshold (PPT)	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
Secondary	Suprascapular Pain Pressure Threshold (PPT)	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
Secondary	Suprascapular Pain Pressure Threshold (PPT)	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
Secondary	Spinal flexion	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.	Baseline
Secondary	Spinal flexion	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
Secondary	Post-program questionnaire	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
Secondary	Healthcare utilization, Cost	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.	12-months
Secondary	Healthcare utilization, Invasive Procedures	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).	12-months