An interventional study of Cutaneous Probe and Quantitative Sensory Testing in Pain, Chronic, Facet Joint Pain and Pain, Procedural, sponsored by University of Pittsburgh. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-27.
Sponsored by University of Pittsburgh · Not applicable, Interventional, and Basic science
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).
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.
3,227 studies on the registry are indexed under Chronic Pain; 729 are open to participants now.
This study's planned enrollment of 40 is below the median of 60 across 2,388 interventional studies indexed under Chronic Pain.
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Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.
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Exclusion Criteria:
Participants with chronic low back pain and a scheduled lumbar medial branch block undergo quantitative sensory testing.
Behavioral: Cutaneous Probe · Behavioral: Quantitative Sensory Testing · Behavioral: Computer Tasks
A computer-controlled probe delivers temperatures to the skin to measure pain, offset analgesia and onset hyperalgesia.
Standard methods involving pinprick, pressure, heat, and cold applied to the skin are used to measure sensation and pain
Quantitative Sensory Testing (QST) and computer tasks are used to measure changes in pain intensity.
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
Time frame: during this portion of the study visit (30 minutes)
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.
Time frame: Immediately after lumbar medial branch block and up to 16 hours after lumbar medial branch block
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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).
Time frame: Immediately after lumbar medial branch block
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.
Time frame: Immediately after lumbar medial branch block
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)
Time frame: during this portion of the study visit (60 minutes)
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.
Time frame: baseline
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.
Time frame: Immediately after lumbar medial branch block and up to 16 hours after lumbar medial branch block
Plan to share: Yes — 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 information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, 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.
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