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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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline

Awards & highlights

OMEGA Trial Summary

This trial looks at how a lumbar MBB affects how the body experiences pain.

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.Check my eligibility

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.See study design

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.

OMEGA Trial 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.

OMEGA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Low back pain intensity change

Offset analgesia and onset hyperalgesia

Secondary outcome measures

6-item Pain Catastrophizing Scale

Areas of Pain Body Map

Back pain intensity after lumbar medial branch block

+14 more

OMEGA 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

~840

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of PittsburghLead Sponsor

1,723 Previous Clinical Trials

16,343,116 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper limit of patients who are taking part in this experiment?

"Affirmative. The clinical trial's information, which was first posted on July 5th 2023 and recently updated on the 23rd of July, is currently recruiting volunteers from 1 centre in need of 40 individuals to participate."

Answered by AI

Are there any open slots for enrollment in this trial at present?

"This research endeavor, which was first announced on July 5th 2023 and recently updated on the 23rd of same month, is presently recruiting according to data hosted by clinicaltrials.gov."

Answered by AI

What are the main goals that this medical investigation seeks to achieve?

"During this visit (30 minutes), the primary objective of the trial is to observe a decrease in lumbar pain intensity. Secondary goals include self-reported average pain and interference within past 7 days via The Pain Experiences Questionnaire (PEG) scale, determining baseline back pain intensity on an 11-point scale, and assessing consequences of discomfort through PROMIS Pain Interference 4a with 5 responses from "not at all" to "very much"."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Offset Mechanisms in Evaluation of Lumbar Medial Branch Blocks

Benedict Alter 2023. "Offset Mechanisms in Evaluation of Lumbar Medial Branch Blocks". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05961800.