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Clinical Trials/NCT05086159
NCT05086159
Completed
Not Applicable

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

Keller Army Community Hospital1 site in 1 country47 target enrollmentJuly 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Low Back Pain
Sponsor
Keller Army Community Hospital
Enrollment
47
Locations
1
Primary Endpoint
Numeric Pain Rating Scale (NPRS)
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2017
End Date
August 1, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Timothy Benedict

Associate Professor

Keller Army Community Hospital

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

Outcomes

Primary Outcomes

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."

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.

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.

Secondary Outcomes

  • Brief Survey of Pain Attitudes (SOPA-35)(8-weeks)
  • "Stressometer"(8-weeks)
  • Pain Self-Efficacy Questionnaire (PSEQ)(8-weeks)
  • Lumbar Spine Pain Pressure Threshold (PPT)(4-weeks)
  • Post-program questionnaire(8-weeks)
  • Pain Catastrophizing Scale (PCS)(8-weeks)
  • Spinal flexion(4-weeks)
  • Healthcare utilization, Invasive Procedures(12-months)
  • Suprascapular Pain Pressure Threshold (PPT)(4-weeks)
  • Healthcare utilization, Cost(12-months)

Study Sites (1)

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