Clinical trial NCT05961800: Offset Mechanisms in Evaluation of Lumbar Medial Branch Blocks
Official title: OMEGA Study: Offset Mechanisms in Evaluation of Lumbar Medial Branch Block
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain, Chronic
Facet Joint Pain
Pain, Procedural
Analgesia
Keywords: lumbar
medial branch block
offset analgesia
onset hyperalgesia
QST
quantitative sensory testing
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Quantitative Sensory Testing
Primary purpose: BASIC_SCIENCE

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).

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Offset analgesia and onset hyperalgesia
timeFrame: during this portion of the study visit (30 minutes)
measure: Low back pain intensity change
timeFrame: Immediately after lumbar medial branch block and up to 16 hours after lumbar medial branch block
Secondary outcomes:
measure: Duration of low back pain
timeFrame: Baseline
measure: PEG: A Three-Item Scale Assessing Pain Intensity and Interference
timeFrame: Baseline
measure: Baseline Back Pain Intensity
timeFrame: Baseline
measure: PROMIS Pain Interference 4a
timeFrame: Baseline
measure: PROMIS Physical Function- 6b
timeFrame: Baseline
measure: PROMIS Sleep Disturbance 6a
timeFrame: Baseline
measure: 6-item Pain Catastrophizing Scale
timeFrame: Baseline
measure: Patient Health Questionnaire (PHQ-2)
timeFrame: Baseline
measure: PROMIS 4-item Depression
timeFrame: Baseline
measure: PROMIS 4-item Anxiety
timeFrame: Baseline
measure: Areas of Pain Body Map
timeFrame: Baseline
measure: Treatment Expectancy
timeFrame: Baseline
measure: Patient Global Impression of Change
timeFrame: Immediately after lumbar medial branch block
measure: Situational pain catastrophizing scale (S-PCS)
timeFrame: Immediately after lumbar medial branch block
measure: Pain intensity during QST
timeFrame: during this portion of the study visit (60 minutes)
measure: Baseline back pain intensity
timeFrame: baseline
measure: Back pain intensity after lumbar medial branch block
timeFrame: Immediately after lumbar medial branch block and up to 16 hours after lumbar medial branch block
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC St. Margaret
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Benedict J Alter, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: