Examining pain relief mechanisms after lumbar nerve blocks
OMEGA Study: Offset Mechanisms in Evaluation of Lumbar Medial Branch Block
This study is testing how well lumbar nerve blocks can relieve chronic low back pain and how the body's nervous system affects that relief in patients who are about to receive the treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT05961800 on ClinicalTrials.gov |
What this trial studies
This study investigates how central nervous system mechanisms influence pain relief following lumbar medial branch blocks, a common procedure for chronic low back pain. Patients scheduled for this nerve block will undergo quantitative sensory testing to assess their pain modulation capabilities before receiving the treatment. They will then track their pain intensity in a diary to evaluate the effectiveness of the procedure. The goal is to better understand the relationship between CNS pain inhibition and the outcomes of the nerve block.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with chronic axial low back pain lasting at least three months and a pain intensity of greater than 3 out of 10.
Not a fit: Patients with a history of spine surgery at the lumbar level or those with unstable systemic illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of pain management strategies for patients with chronic low back pain.
How similar studies have performed: While the specific mechanisms of offset analgesia in lumbar medial branch blocks may be novel, similar studies have explored pain modulation and nerve blocks with varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Scheduled for lumbar MBB in UPMC Pain Management clinics * Age \> 18 years old * Predominantly axial chronic low back pain at least 3 months on a daily basis * Must meet the minimum criteria for cognitive function using the PROMIS 2-item cognitive screener (\>3) * Low back pain intensity of \> 3/10 * Willing and able to receive study-related phone calls Exclusion Criteria: * History of spine surgery at the level of the lumbar MBB * Active worker's compensation or litigation claims * New pain and/or psychiatric treatments within 2 weeks of enrollment * Not fluent in English and/or not able to complete the questionnaires * Any clinically unstable systemic illness that is judged to interfere with the study
Where this trial is running
Pittsburgh, Pennsylvania
- UPMC St. Margaret — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Benedict J Alter, MD, PhD — University of Pittsburgh
- Study coordinator: Maya L Maurer, BS
- Email: mam708@pitt.edu
- Phone: 412-665-8052
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.