Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05961800

Offset Mechanisms in Evaluation of Lumbar Medial Branch Blocks

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).

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cutaneous Probe

Behavioral

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

Quantitative Sensory Testing

Behavioral

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

Computer Tasks

Behavioral

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

Primary outcomes

  1. Offset analgesia and onset hyperalgesia

    Time frame: during this portion of the study visit (30 minutes)

    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

  2. Low back pain intensity change

    Time frame: Immediately after lumbar medial branch block and up to 16 hours 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.

Secondary outcomes

  1. Duration of low back pain

    Time frame: Baseline

    Participant self-reports the number of years they have experienced low back pain. The number of years for each participant will be reported.

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

    Time frame: Baseline

    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.

  3. Baseline Back Pain Intensity

    Time frame: Baseline

    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.

  4. PROMIS Pain Interference 4a

    Time frame: Baseline

    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.

  5. PROMIS Physical Function- 6b

    Time frame: Baseline

    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.

  6. PROMIS Sleep Disturbance 6a

    Time frame: Baseline

    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.

  7. 6-item Pain Catastrophizing Scale

    Time frame: Baseline

    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.

  8. Patient Health Questionnaire (PHQ-2)

    Time frame: Baseline

    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.

  9. PROMIS 4-item Depression

    Time frame: Baseline

    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.

  10. PROMIS 4-item Anxiety

    Time frame: Baseline

    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.

  11. Areas of Pain Body Map

    Time frame: Baseline

    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.

  12. Treatment Expectancy

    Time frame: Baseline

    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.

  13. Patient Global Impression of Change

    Time frame: Immediately after lumbar medial branch block

    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).

  14. Situational pain catastrophizing scale (S-PCS)

    Time frame: Immediately after lumbar medial branch block

    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.

  15. Pain intensity during QST

    Time frame: during this portion of the study visit (60 minutes)

    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)

  16. Baseline back pain intensity

    Time frame: baseline

    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.

  17. Back pain intensity after lumbar medial branch block

    Time frame: Immediately after lumbar medial branch block and up to 16 hours 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Benedict J Alter, MD, PhD

CONTACT

[email protected]

412-677-0575

Maya L Maurer, BS

CONTACT

[email protected]

412-665-8052

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Official study title

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

Acronym: OMEGA

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Jul 27, 2023
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.