NCT05961800 · University of Pittsburgh
Offset Mechanisms in Evaluation of Lumbar Medial Branch Blocks
(OMEGA)
What this study is about
This study examines the relationship between central nervous system (CNS) mechanisms of pain inhibition and the pain relief that occurs following a lumbar medial branch block (MBB).
View original scientific description
This study examines the relationship between central nervous system (CNS) mechanisms of pain inhibition and the pain relief that occurs following a lumbar medial branch block (MBB).
Interventions
BEHAVIORAL
Cutaneous Probe
A computer-controlled probe delivers temperatures to the skin to measure pain, offset analgesia and onset hyperalgesia.
BEHAVIORAL
Quantitative Sensory Testing
Standard methods involving pinprick, pressure, heat, and cold applied to the skin are used to measure sensation and pain
BEHAVIORAL
Computer Tasks
Quantitative Sensory Testing (QST) and computer tasks are used to measure changes in pain intensity.
Primary outcome measures
Offset analgesia and onset hyperalgesia
Time frame: during this portion of the study visit (30 minutes)
Pain intensity difference during heat stimuli measured on a 0-100 sliding scale (0 is no pain, 100 is the most intense pain imaginable) at baseline
Low back pain intensity change
Time frame: Immediately after lumbar medial branch block and up to 16 hours after lumbar medial branch block
Patients respond to the question "How would you rate your back pain right now?" from 0 (no pain) to 10 (worst imaginable pain) to see how intense their back pain is each hour after the lumbar medial branch block.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Pittsburgh, Pennsylvania
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 4, 2026 · Source of record for eligibility and locations