Clinical trial NCT05086159: Effectiveness of Pain Neuroscience Education (PNE) to Veterans With Post-Traumatic Stress and Low Back Pain
Official title: Effectiveness of Pain Neuroscience Education (PNE) to Veterans With Post-Traumatic Stress and Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Post-traumatic Stress
Keywords: chronic low back pain
post-traumatic stress
physical therapy
pain neuroscience education
Lead sponsor: Keller Army Community Hospital
Sponsor class: FED
First posted: 2021-10-20
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: PTSD Check-list for Diagnostic and Statistical Manual of Mental Disorders (DSM 5) (PCL)
timeFrame: Baseline
measure: PTSD Check-list for Diagnostic and Statistical Manual of Mental Disorders (DSM 5) (PCL)
timeFrame: 4-weeks
measure: PTSD Check-list for Diagnostic and Statistical Manual of Mental Disorders (DSM 5) (PCL)
timeFrame: 8-weeks
measure: Roland-Morris Disability Questionnaire (RMDQ)
timeFrame: Baseline
measure: Roland-Morris Disability Questionnaire (RMDQ)
timeFrame: 4-weeks
measure: Roland-Morris Disability Questionnaire (RMDQ)
timeFrame: 8-weeks
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: Baseline
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: 4-weeks
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: 8-weeks
Secondary outcomes:
measure: "Stressometer"
timeFrame: Baseline
measure: "Stressometer"
timeFrame: 4-weeks
measure: "Stressometer"
timeFrame: 8-weeks
measure: Pain Catastrophizing Scale (PCS)
timeFrame: Baseline
measure: Pain Catastrophizing Scale (PCS)
timeFrame: 4-weeks
measure: Pain Catastrophizing Scale (PCS)
timeFrame: 8-weeks
measure: Brief Survey of Pain Attitudes (SOPA-35)
timeFrame: Baseline
measure: Brief Survey of Pain Attitudes (SOPA-35)
timeFrame: 4-weeks
measure: Brief Survey of Pain Attitudes (SOPA-35)
timeFrame: 8-weeks
measure: Pain Self-Efficacy Questionnaire (PSEQ)
timeFrame: Baseline
measure: Pain Self-Efficacy Questionnaire (PSEQ)
timeFrame: 4-weeks
measure: Pain Self-Efficacy Questionnaire (PSEQ)
timeFrame: 8-weeks
measure: Lumbar Spine Pain Pressure Threshold (PPT)
timeFrame: Baseline
measure: Lumbar Spine Pain Pressure Threshold (PPT)
timeFrame: 4-weeks
measure: Suprascapular Pain Pressure Threshold (PPT)
timeFrame: Baseline
measure: Suprascapular Pain Pressure Threshold (PPT)
timeFrame: 4-weeks
measure: Spinal flexion
timeFrame: Baseline
measure: Spinal flexion
timeFrame: 4-weeks
measure: Post-program questionnaire
timeFrame: 8-weeks
measure: Healthcare utilization, Cost
timeFrame: 12-months
measure: Healthcare utilization, Invasive Procedures
timeFrame: 12-months
Other outcomes:
Locations:
city: Lexington
country: United States
facility: Lexington VA Medical Center
state: Kentucky
Study officials:
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