Offset Mechanisms in Evaluation of Lumbar Medial Branch Blocks

Analgesia Clinical Trial

— OMEGA  

Official title:

OMEGA Study: Offset Mechanisms in Evaluation of Lumbar Medial Branch Block

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05961800
• Other study ID #: STUDY23040122
• Status: Recruiting
• Phase: N/A
• Start date: July 5, 2023
• Est. completion date: June 2025

Study information

• Verified date: July 2023
• Source: University of Pittsburgh
• Contact: Maya L Maurer, BS
• Phone: 412-665-8052
• Email: mam708[@]pitt.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Analgesia
• Arthralgia
• Chronic Pain
• Facet Joint Pain
• Pain, Chronic
• Pain, Procedural

Intervention

Behavioral:
• Cutaneous Probe
A computer-controlled probe delivers temperatures to the skin to measure pain, offset analgesia and onset hyperalgesia.
• Quantitative Sensory Testing
Standard methods involving pinprick, pressure, heat, and cold applied to the skin are used to measure sensation and pain
• Computer Tasks
Quantitative Sensory Testing (QST) and computer tasks are used to measure changes in pain intensity.

Locations

Country	Name	City	State
United States	UPMC St. Margaret	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Duration of low back pain	Participant self-reports the number of years they have experienced low back pain. The number of years for each participant will be reported.	Baseline
Secondary	PEG: A Three-Item Scale Assessing Pain Intensity and Interference	Assessment for self-reported average pain and pain interference within past 7 days. Responses range from 0 (no pain) to 10 (pain as bad as you can imagine). Total scores range from 0-30, and higher scores indicate more pain interference.	Baseline
Secondary	Baseline Back Pain Intensity	Assessment for determining how much a person hurts with a question ranked on a 11-point scale, from "0 = no pain" to "10 = worst imaginable pain." The minimum raw summed score is 0 and the maximum score is 10. Lower raw response scores suggest lower pain intensity and better outcomes.	Baseline
Secondary	PROMIS Pain Interference 4a	Assessment for self-reported consequences of pain with 4 questions ranked on a 5-point scale, from "not at all" to "very much". The minimum raw summed score is 4 and the maximum score is 20. Lower scores suggest better outcomes.	Baseline
Secondary	PROMIS Physical Function- 6b	Assessment for self-reported capability with 6 qualitatively scaled questions ranked on a 5-point scale, from "without any difficulty" to "unable to do" or "not at all" to "cannot do." The minimum raw summed score is 6 and the maximum score is 30.	Baseline
Secondary	PROMIS Sleep Disturbance 6a	Assessment for self-reported perceptions of sleep quality and sleep depth with 6 questions ranked on a 5-point scale. The minimum raw summed score is 6 and the maximum score is 30. Lower scores suggest better outcomes.	Baseline
Secondary	6-item Pain Catastrophizing Scale	Standardized survey score assessing pain perception before the study procedures begin. Rumination subscale score ranges from 0-16. Magnification subscale score ranges 0-12. Helplessness subscale score ranges from 0-24. Total score can be calculated by summing subscales. Total score ranges from 0-52, with higher scores indicating more pain catastrophizing.	Baseline
Secondary	Patient Health Questionnaire (PHQ-2)	The PHQ-2 inquires about the frequency of depressed mood and anhedonia over the past two weeks. The PHQ-2 includes the first two items of the PHQ-9. A PHQ-2 score ranges from 0-6. The authors identified a score of 3 as the optimal cutpoint when using the PHQ-2 to screen for depression.; If the score is 3 or greater, major depressive disorder is likely.	Baseline
Secondary	PROMIS 4-item Depression	Assessment for self-reported negative mood and views of self with 4 questions ranked on a 5-point scale, from "never" to "always". The minimum raw summed score is 4 and the maximum score is 20. Lower t-scores suggest better outcomes.	Baseline
Secondary	PROMIS 4-item Anxiety	Assessment for self-reported fear, anxious misery, hyperarousal, and somatic symptoms with 4 questions ranked on a 5-point scale, from "never" to "always". The minimum raw summed score is 4 and the maximum score is 20. Lower scores suggest better outcomes.	Baseline
Secondary	Areas of Pain Body Map	The digital body figure contains 36 anterior regions and 38 posterior regions on which participants can mark areas in which they experience chronic pain. The number of pain areas each participant recorded will be reported, with a possibility of 74 total regions.	Baseline
Secondary	Treatment Expectancy	Assessment for the subject's expectations of treatment effec prior to lumbar medial branch block. Scores range from 0 (not at all) to 4 (very much), with total scores ranging from 0-24. Higher scores indicate higher expectations of the low back pain treatement.	Baseline
Secondary	Patient Global Impression of Change	The subject's impression of the impact of the lumbar medial branch block on their pain and function will be measured with a 7-item scale (1 = very much worse, 2 = much worse, 3 = minimally worse, 4 = no change, 5 = minimally improved, 6 = much improved, 7 = very much improved).	Immediately after lumbar medial branch block
Secondary	Situational pain catastrophizing scale (S-PCS)	Standardized survey score assessing pain perception immediately following the lumbar medial branch block. Scores range from 0-24, with higher scores representing more pain catastrophizing.	Immediately after lumbar medial branch block
Secondary	Pain intensity during QST	Changes in pain intensity during quantitative sensory tests measured on a 0-100 sliding scale (0 is no pain, 100 is the most intense pain imaginable)	during this portion of the study visit (60 minutes)
Secondary	Baseline back pain intensity	Patients respond to the question "How would you rate your back pain on average?" from 0 (no pain) to 10 (worst imaginable pain) to see how intense their back pain is before the lumbar medial branch block.	baseline
Secondary	Back pain intensity 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.	Immediately after lumbar medial branch block and up to 16 hours after lumbar medial branch block