Offset Mechanisms in Evaluation of Lumbar Medial Branch Blocks

NCT ID: NCT05961800

Last Updated: 2025-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-05

Study Completion Date

2026-06-30

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Pain, Chronic Facet Joint Pain Pain, Procedural Analgesia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Quantitative Sensory Testing
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Quantitative Sensory Testing

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

Group Type EXPERIMENTAL

Cutaneous Probe

Intervention Type BEHAVIORAL

A computer-controlled probe delivers temperatures to the skin to measure pain, offset analgesia and onset hyperalgesia.

Quantitative Sensory Testing

Intervention Type BEHAVIORAL

Standard methods involving pinprick, pressure, heat, and cold applied to the skin are used to measure sensation and pain

Computer Tasks

Intervention Type BEHAVIORAL

Quantitative Sensory Testing (QST) and computer tasks are used to measure changes in pain intensity.

Interventions

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Cutaneous Probe

A computer-controlled probe delivers temperatures to the skin to measure pain, offset analgesia and onset hyperalgesia.

Intervention Type BEHAVIORAL

Quantitative Sensory Testing

Standard methods involving pinprick, pressure, heat, and cold applied to the skin are used to measure sensation and pain

Intervention Type BEHAVIORAL

Computer Tasks

Quantitative Sensory Testing (QST) and computer tasks are used to measure changes in pain intensity.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Benedict Alter

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Benedict J Alter, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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UPMC St. Margaret

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Maya L Maurer, BS

Role: CONTACT

412-665-8052

Benedict J Alter, MD, PhD

Role: CONTACT

412-677-0575

Facility Contacts

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Maya L Maurer, BS

Role: primary

412-665-8052

Benedict J Alter, MD, PhD

Role: backup

412-677-0575

Other Identifiers

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STUDY23040122

Identifier Type: -

Identifier Source: org_study_id

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