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Selecting Effective Combinations of Treatment for Low Back Pain

Jun 5, 2019

Overview

The #1 contributor to to United States disability claims is chronic back pain – specifically lower back pain (CLBP). Since CLBP research has recently been selected as a priority area of research, this clinical trial examines early stages in CLBP (treatments for the lumbar spinal structure) and later stages (such as behavioral interventions that lessen the extent of pain in the lower back region), as well as how it affects functionality and quality of life.

 

Study Information

This is a triple-blind, randomized, controlled factorial assessment with two procedural and two behavioral interventions/treatments. There are an estimated 30 participants. The study began on November 1, 2018 and is estimated to be completed by June 30, 2020.

 

Inclusion Criteria

  • All sexes, ages 18 & older
  • Chronic low back pain lasting at least 3 months
  • Low back pain intensity numerical rating scale (NRS) > 4 (must be 5 or higher)
  • Has failed 1st line rehabilitative treatments, including physical therapy, yoga, tai chi, chiropractic or osteopathic manipulation, and/or massage
  • Must be able to provide informed consent and complete the assessment instruments accurately
  • Must have access to a computer, tablet, or smartphone with internet access at home or at work
  • ‘Positive responses’ to 2 separate sets of lumbar medial branch blocks (MBBs: low volume anesthetic blocks of the medial branches of the dorsal rami using 0.5cc or less of lidocaine or bupivacaine), including at least 50% pain improvement of typical low back pain, with onset of typical lumbar back pain relief within 30 mins and relief lasting at least 30 mins after the onset of initial pain relief
  • Considered a candidate for unilateral or bilateral lower radiofrequency ablation (LRFA) at 2-4 spinal levels (between L1 and S1)

 

Exclusion Criteria

  • Clinical suspicion that the current low back pain symptoms have a significant and sustained component that is attributed to specific lumbar spine-related syndromes including lumbosacral radicular syndrome (radiculopathy), symptomatic lumbar spinal stenosis (neurogenic claudication), with confirmatory imaging findings, spinal instability requiring surgery, or other ‘red flag’ conditions (infection/ malignancy/ fracture)
  • Pregnant
  • Prisoners
  • Cognitively impaired
  • Prior lumbar radiofrequency ablation (RFA)
  • Prior lumbar spine surgery which involved the levels where LRFA is to be performed, within the past 2 years
  • Lumbar fusion or instrumentation which involved the levels where LRFA is to be performed
  • Prior controlled behavioral therapy (CBT) for chronic pain
  • Primary psychotic or major thought disorder (lifetime), any active suicidal/homicidal ideation (past 6 months), or unstable or severe psychiatric/behavioral conditions (e.g. delirium, mania, psychosis)
  • Hospitalization for psychiatric reasons involving psychosis other than suicidal ideation, homicidal ideation, and/or PTSD, in the past 5 years
  • Cognitive limitations that would prevent participation
  • Two or more severe medical comorbidities posing major functional limitations in walking and function
  • Medical prognosis, including metastatic cancer or vascular, pulmonary or coronary artery disease

 

Location

You may participate in this study at VA Puget Sound Health Care System Seattle Division, in Seattle, Washington, United States, 98108. If you have any questions or concerns feel free to contact Pradeep Suri, MD at 206-314-3256 or at Pradeep.Suri@va.gov.

 

Sponsors/Collaborators

This study is being sponsored by the VA Puget Sound Health Care System, Seattle Division, with Pradeep Suri, MD as the Principal Investigator.

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