OMEGA Study: Offset Mechanisms in Evaluation of Lumbar Medial Branch Block
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Offset analgesia and onset hyperalgesia
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Quantitative Sensory Testing
Participants with chronic low back pain and a scheduled lumbar medial branch block undergo quantitative sensory testing.
干预措施: Cutaneous Probe (Behavioral)
Quantitative Sensory Testing
Participants with chronic low back pain and a scheduled lumbar medial branch block undergo quantitative sensory testing.
干预措施: Quantitative Sensory Testing (Behavioral)
Quantitative Sensory Testing
Participants with chronic low back pain and a scheduled lumbar medial branch block undergo quantitative sensory testing.
干预措施: Computer Tasks (Behavioral)
结局指标
主要结局
Offset analgesia and onset hyperalgesia
时间窗: 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
时间窗: 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.
次要结局
- PEG: A Three-Item Scale Assessing Pain Intensity and Interference(Baseline)
- Patient Health Questionnaire (PHQ-2)(Baseline)
- Treatment Expectancy(Baseline)
- Pain intensity during QST(during this portion of the study visit (60 minutes))
- Baseline Back Pain Intensity(Baseline)
- PROMIS Pain Interference 4a(Baseline)
- PROMIS Physical Function- 6b(Baseline)
- Situational pain catastrophizing scale (S-PCS)(Immediately after lumbar medial branch block)
- Duration of low back pain(Baseline)
- PROMIS Sleep Disturbance 6a(Baseline)
- 6-item Pain Catastrophizing Scale(Baseline)
- PROMIS 4-item Depression(Baseline)
- PROMIS 4-item Anxiety(Baseline)
- Areas of Pain Body Map(Baseline)
- Patient Global Impression of Change(Immediately after lumbar medial branch block)
- Baseline back pain intensity(baseline)
- Back pain intensity after lumbar medial branch block(Immediately after lumbar medial branch block and up to 16 hours after lumbar medial branch block)
研究者
Benedict Alter
Assistant Professor
University of Pittsburgh