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Completed

NCT Number: NCT05086159

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lexington VA Medical Center

Lexington, Kentucky, 40502, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Roland-Morris Disability Questionnaire (RMDQ)

    Time frame: 4-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.

  6. 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.

  7. 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."

  8. 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."

  9. 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."

Secondary outcomes

  1. "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.

  2. "Stressometer"

    Time frame: 4-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.

  3. "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.

  4. Pain Catastrophizing Scale (PCS)

    Time frame: Baseline

    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.

  5. Pain Catastrophizing Scale (PCS)

    Time frame: 4-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.

  6. 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.

  7. Brief Survey of Pain Attitudes (SOPA-35)

    Time frame: Baseline

    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. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. Lumbar Spine 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 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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".

  20. 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.

  21. 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).

Sponsors and collaborators

Lead sponsor

Keller Army Community Hospital

Fed

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2021
First posted
Oct 20, 2021
Registry last updated
Oct 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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