Offset Mechanisms in Evaluation of Lumbar Medial Branch Blocks

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05961800
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Pittsburgh
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Benedict J Alter, MD, PhD
Principal Investigator Affiliation	University of Pittsburgh
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Pain, Chronic, Facet Joint Pain, Pain, Procedural, Analgesia

Additional Details

This study examines the relationship between central nervous system (CNS) mechanisms of pain inhibition and the pain relief that occurs following a commonly-performed nerve block used to diagnose and treat chronic low back pain. Patients scheduled for lumbar medial branch blocks as part of routine clinical care will arrive to clinic prior to the block for quantitative sensory testing procedures that measure CNS pain modulation. Patients will then undergo treatment as usual with their block, subsequently reporting low back pain intensity in a pain diary.

Arms & Interventions

Arms

Experimental: Quantitative Sensory Testing

Participants with chronic low back pain and a scheduled lumbar medial branch block undergo quantitative sensory testing.

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

UPMC St. Margaret, Pittsburgh, Pennsylvania

Status

Recruiting

Address

UPMC St. Margaret

Pittsburgh, Pennsylvania, 15215

Site Contact

Maya L Maurer, BS

[email protected]

412-665-8052

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