Offset Mechanisms in Evaluation of Lumbar Medial Branch Blocks

NCT05961800 | Recruiting

• 1 other identifier: STUDY23040122
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Pain, Chronic; Facet Joint Pain; Pain, Procedural; Analgesia

Keywords

lumbar; medial branch block; offset analgesia; onset hyperalgesia; QST; quantitative sensory testing

Outcome Measures

Primary Outcomes (2)

• Offset analgesia and onset hyperalgesia

  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

  during this portion of the study visit (30 minutes)

• Low back pain intensity change

  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.

  Immediately after lumbar medial branch block and up to 16 hours after lumbar medial branch block

Secondary Outcomes (17)

• Duration of low back pain

  Baseline

• PEG: A Three-Item Scale Assessing Pain Intensity and Interference

  Baseline

• Baseline Back Pain Intensity

  Baseline

• PROMIS Pain Interference 4a

  Baseline

• PROMIS Physical Function- 6b

  Baseline

Study Arms (1)

Quantitative Sensory Testing

EXPERIMENTAL

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

Behavioral: Cutaneous Probe; Behavioral: Quantitative Sensory Testing; Behavioral: Computer Tasks

Interventions

Cutaneous Probe BEHAVIORAL

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

Quantitative Sensory Testing

Quantitative Sensory Testing BEHAVIORAL

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

Quantitative Sensory Testing

Computer Tasks BEHAVIORAL

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

Quantitative Sensory Testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

UPMC St. Margaret

Pittsburgh, Pennsylvania, 15215, United States

RECRUITING

MeSH Terms

Conditions

Chronic Pain; Pain, Procedural; Agnosia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Benedict J Alter, MD, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maya L Maurer, BS

CONTACT

412-665-8052; mam708@pitt.edu

Benedict J Alter, MD, PhD

CONTACT

412-677-0575; alterbj@upmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Quantitative Sensory Testing

Study Record Dates

• First Submitted: July 5, 2023
• First Posted: July 27, 2023
• Study Start: July 5, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will become available after publication per journal and funding entity protocols.
• Access Criteria: Data will be made available by reasonable request and/or per journal and funding entity protocols.

Locations

US (1)