Health TrialsbyHealthPanel

Offset Mechanisms in Evaluation of Lumbar Medial Branch Blocks

ConditionsPain, ChronicFacet Joint PainPain, ProceduralAnalgesia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Pittsburgh

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Quantitative Sensory TestingExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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)
2

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Pittsburgh

Lead sponsor

Source ClinicalTrials.gov
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