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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Chronic Low Back Pain, Post-traumatic Stress

Intervention / Treatment
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* Behavioral: Pain Neuroscience Education
* Behavioral: Exercise
* Behavioral: Traditional Education


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Traditional Education<br>Traditional biomedical education for back pain and standard stress education. Education was developed from Back School, National PTSD Center, and PTSD Coach. | Behavioral: Exercise<br>* 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.<br>Behavioral: Traditional Education<br>* 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.<br>|
| Experimental: Pain Neuroscience Education<br>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<br>* 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.<br>Behavioral: Exercise<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic low back pain, post-traumatic stress, physical therapy, pain neuroscience education