Offset Mechanisms in Evaluation of Lumbar Medial Branch Blocks (OMEGA)

• ClinicalTrials.gov Identifier: NCT05961800
• Recruitment Status: Recruiting
• First Posted: July 27, 2023
• Last Update Posted: July 27, 2023
• Sponsor: University of Pittsburgh
• Information provided by (Responsible Party): Benedict Alter, University of Pittsburgh

Tracking Information

• First Submitted Date: July 5, 2023
• First Posted Date: July 27, 2023
• Last Update Posted Date: July 27, 2023
• Actual Study Start Date: July 5, 2023
• Estimated Primary Completion Date: June 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 23, 2023)

• 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
• 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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: July 23, 2023)

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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).
• 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.
• 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)
• 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.
• 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Offset Mechanisms in Evaluation of Lumbar Medial Branch Blocks
• Official Title: OMEGA Study: Offset Mechanisms in Evaluation of Lumbar Medial Branch Block
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

Quantitative Sensory Testing

Masking: None (Open Label)
Primary Purpose: Basic Science

Condition

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

Intervention

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

Study Arms

Experimental: Quantitative Sensory Testing

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

Interventions:

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: July 23, 2023): 40
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 2025
• Estimated Primary Completion Date: June 2025 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Maya L Maurer, BS; 412-665-8052; mam708@pitt.edu

Contact: Benedict J Alter, MD, PhD; 412-677-0575; alterbj@upmc.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05961800
• Other Study ID Numbers: STUDY23040122
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: Individual participant data will be available, including data dictionaries, after publication per journal and funding protocols. The statistical analysis plan and analytic code will also be available per the same protocols.
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Informed Consent Form (ICF)
• Supporting Materials: Clinical Study Report (CSR)
• Supporting Materials: 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.

• Current Responsible Party: Benedict Alter, University of Pittsburgh
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Pittsburgh
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Benedict J Alter, MD, PhD; University of Pittsburgh

• PRS Account: University of Pittsburgh
• Verification Date: July 2023