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Lumbar Medial Branch Blocks for Facet Joint Pain (OMEGA Trial)

N/A
Recruiting
Led By Benedict J Alter, MD, PhD
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Low back pain intensity of > 3/10
Must meet the minimum criteria for cognitive function using the PROMIS 2-item cognitive screener (>3)
Must not have
History of spine surgery at the level of the lumbar MBB
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights
No Placebo-Only Group

Summary

This trial studies how a nerve-numbing injection in the lower back helps reduce chronic pain. It focuses on patients with ongoing low back pain and examines how well this treatment works by blocking pain signals.

Who is the study for?
This trial is for adults over 18 with chronic low back pain daily for at least 3 months, who are scheduled for a lumbar medial branch block (MBB) at UPMC Pain Management clinics. Participants must be able to understand English, complete questionnaires, and handle study-related phone calls. Those with past spine surgery at the MBB level or active compensation claims can't join.
What is being tested?
The study investigates how the central nervous system's pain inhibition relates to relief after a lumbar MBB procedure. It involves using a cutaneous probe, quantitative sensory testing, and computer tasks to assess this relationship in participants undergoing the treatment.
What are the potential side effects?
While not explicitly listed in the provided information, typical side effects of procedures like an MBB may include temporary discomfort at injection site, bleeding or bruising where the needle was inserted, infection risk and rarely nerve damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My lower back pain is more than 3 out of 10 in intensity.
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My cognitive function is above the minimum required level.
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I have had chronic back pain mostly in my spine area for at least 3 months.
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I am older than 18 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had spine surgery in my lower back.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately after lumbar medial branch block
This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately after lumbar medial branch block for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Low back pain intensity change
Offset analgesia and onset hyperalgesia
Secondary study objectives
6-item Pain Catastrophizing Scale
Areas of Pain Body Map
Back pain intensity after lumbar medial branch block
+14 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Quantitative Sensory TestingExperimental Treatment3 Interventions
Participants with chronic low back pain and a scheduled lumbar medial branch block undergo quantitative sensory testing.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Quantitative Sensory Testing
2017
N/A
~950

Find a Location

Who is running the clinical trial?

University of PittsburghLead Sponsor
1,790 Previous Clinical Trials
16,359,770 Total Patients Enrolled
Benedict J Alter, MD, PhDPrincipal InvestigatorUniversity of Pittsburgh

Media Library

Quantitative Sensory Testing Clinical Trial Eligibility Overview. Trial Name: NCT05961800 — N/A
Facet Joint Pain Research Study Groups: Quantitative Sensory Testing
Facet Joint Pain Clinical Trial 2023: Quantitative Sensory Testing Highlights & Side Effects. Trial Name: NCT05961800 — N/A
Quantitative Sensory Testing 2023 Treatment Timeline for Medical Study. Trial Name: NCT05961800 — N/A
~9 spots leftby Jun 2025
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