Back to resultsOffset Mechanisms in Evaluation of Lumbar Medial Branch Blocks (OMEGA)
Primary Purpose
Pain, Chronic, Facet Joint Pain, Pain, Procedural
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cutaneous Probe
Quantitative Sensory Testing
Computer Tasks
Sponsored by
About this trial
This is an interventional basic science trial for Pain, Chronic focused on measuring lumbar, medial branch block, offset analgesia, onset hyperalgesia, QST, quantitative sensory testing
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
Sites / Locations
- UPMC St. MargaretRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Quantitative Sensory Testing
Arm Description
Participants with chronic low back pain and a scheduled lumbar medial branch block undergo quantitative sensory testing.
Outcomes
Primary Outcome Measures
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
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.
Secondary Outcome Measures
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.
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 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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.
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)
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05961800
Brief Title
Offset Mechanisms in Evaluation of Lumbar Medial Branch Blocks
Acronym
OMEGA
Official Title
OMEGA Study: Offset Mechanisms in Evaluation of Lumbar Medial Branch Block
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 5, 2023 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Chronic, Facet Joint Pain, Pain, Procedural, Analgesia
Keywords
lumbar, medial branch block, offset analgesia, onset hyperalgesia, QST, quantitative sensory testing
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Quantitative Sensory Testing
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Quantitative Sensory Testing
Arm Type
Experimental
Arm Description
Participants with chronic low back pain and a scheduled lumbar medial branch block undergo quantitative sensory testing.
Intervention Type
Behavioral
Intervention Name(s)
Cutaneous Probe
Intervention Description
A computer-controlled probe delivers temperatures to the skin to measure pain, offset analgesia and onset hyperalgesia.
Intervention Type
Behavioral
Intervention Name(s)
Quantitative Sensory Testing
Intervention Description
Standard methods involving pinprick, pressure, heat, and cold applied to the skin are used to measure sensation and pain
Intervention Type
Behavioral
Intervention Name(s)
Computer Tasks
Intervention Description
Quantitative Sensory Testing (QST) and computer tasks are used to measure changes in pain intensity.
Primary Outcome Measure Information:
Title
Offset analgesia and onset hyperalgesia
Description
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
Time Frame
during this portion of the study visit (30 minutes)
Title
Low back pain intensity change
Description
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.
Time Frame
Immediately after lumbar medial branch block and up to 16 hours after lumbar medial branch block
Secondary Outcome Measure Information:
Title
Duration of low back pain
Description
Participant self-reports the number of years they have experienced low back pain. The number of years for each participant will be reported.
Time Frame
Baseline
Title
PEG: A Three-Item Scale Assessing Pain Intensity and Interference
Description
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.
Time Frame
Baseline
Title
Baseline Back Pain Intensity
Description
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.
Time Frame
Baseline
Title
PROMIS Pain Interference 4a
Description
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.
Time Frame
Baseline
Title
PROMIS Physical Function- 6b
Description
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.
Time Frame
Baseline
Title
PROMIS Sleep Disturbance 6a
Description
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.
Time Frame
Baseline
Title
6-item Pain Catastrophizing Scale
Description
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.
Time Frame
Baseline
Title
Patient Health Questionnaire (PHQ-2)
Description
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.
Time Frame
Baseline
Title
PROMIS 4-item Depression
Description
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.
Time Frame
Baseline
Title
PROMIS 4-item Anxiety
Description
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.
Time Frame
Baseline
Title
Areas of Pain Body Map
Description
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.
Time Frame
Baseline
Title
Treatment Expectancy
Description
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.
Time Frame
Baseline
Title
Patient Global Impression of Change
Description
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).
Time Frame
Immediately after lumbar medial branch block
Title
Situational pain catastrophizing scale (S-PCS)
Description
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.
Time Frame
Immediately after lumbar medial branch block
Title
Pain intensity during QST
Description
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)
Time Frame
during this portion of the study visit (60 minutes)
Title
Baseline back pain intensity
Description
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.
Time Frame
baseline
Title
Back pain intensity after lumbar medial branch block
Description
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.
Time Frame
Immediately after lumbar medial branch block and up to 16 hours after lumbar medial branch block
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maya L Maurer, BS
Phone
412-665-8052
Email
mam708@pitt.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Benedict J Alter, MD, PhD
Phone
412-677-0575
Email
alterbj@upmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benedict J Alter, MD, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
UPMC St. Margaret
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maya L Maurer, BS
Phone
412-665-8052
Email
mam708@pitt.edu
First Name & Middle Initial & Last Name & Degree
Benedict J Alter, MD, PhD
Phone
412-677-0575
Email
alterbj@upmc.edu
First Name & Middle Initial & Last Name & Degree
Benedict J Alter, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
Data will become available after publication per journal and funding entity protocols.
IPD Sharing Access Criteria
Data will be made available by reasonable request and/or per journal and funding entity protocols.
Learn more about this trial
Offset Mechanisms in Evaluation of Lumbar Medial Branch Blocks
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