Somatosensory Profiling in Radicular Pain Patients And it's Correlation With Treatment Outcome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Pre-epidural Warm Sensation Quantitative Sensory Testing (QST) Results
研究概览
简要总结
The investigators hypothesize that there may exist different quantitative sensory profiles between radicular pain patients who respond and those who do not respond to the standard therapy of epidural steroid injections (ESI).
详细描述
The investigators are comparing warm/cold sensation, heat/cold pain threshold, heat/cold pain tolerance, wind-up, and conditioned pain modulation (CPM) as measured by Quantitative Sensory Testing (QST) between subjects with a radicular pain condition. The investigators are comparing those who respond and those who do not respond to standard therapy (ESI) before and after the treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of lower extremity radicular pain regardless of specific or suspected etiologies
- •scheduling an epidural steroid injection (ESI)
排除标准
- •a major psychiatric disorder requiring a recent (within one month) hospitalization, such as major depression, bipolar disorder, schizophrenia, anxiety disorder, and psychosis
- •subject is taking illicit or recreational drug detected through a urine toxicology screen
- •subject has had an interventional pain management procedures within the last eight weeks that may alter QST responses including neuraxial or local anesthetic block
- •subject had a change in dosage of neuromodulatory pain medication (including gabapentin, pregabalin, cymbalta, amitriptyline, nortriptyline, trileptal, etc) in the past two weeks
- •subject is pregnant
- •subject has pending litigation involving the current pain condition being treated and studied.
结局指标
主要结局
Pre-epidural Warm Sensation Quantitative Sensory Testing (QST) Results
时间窗: Baseline measurement before the epidural injection
QST tests for changes in spinal nerves. A small metal plate, called a thermode, is placed on the subject's arm. During the warm sensation test, the plate slowly increases in temperature.The subject will stop the test as soon as the plate feels warm. This temperature is recorded and can range from 32-53 degrees Celsius. The same test is repeated on the subject's leg that has radicular pain. The difference in temperatures from the test on the subject's arm and leg were analyzed.
Post-epidural Continued Pain Modulation (CPM)
时间窗: 4 weeks after the epidural injection
CPM is a type of QST where the thermode is placed on the subject's non painful arm. Heat stimulation (47 degrees C, 4 seconds) was delivered to the thermode 4 times and the subject rated the pain felt by the heat stimulation on a visual analog scale (VAS) of 0-10. During the second heat stimulation, the subject immersed their hand (opposite from the arm with the thermode) in 12 degree C water and then rated the pain felt by the heat on a VAS of 0-10 (10 is the worst pain a subject can imagine, 0 is no pain). The final 2 heat stimuli were delivered (without using the hand submerged in water). This same test was repeated with the thermode on the subject's leg with radicular pain. The subject placed their hand contralateral to the painful leg in the cold water during the second heat stimulation. The VAS scores from each heat stimulation were averaged for the non-painful arm and the painful leg. The difference in averages between the arm and leg were then analyzed.
Post-epidural Cold Pain Threshold QST Results
时间窗: 4 weeks after the epidural injection
The thermode is placed on the subject's arm. During the cold pain threshold test, the plate slowly decreases in temperature.The subject will stop the test when the plate is at their minimal tolerable temperature. This temperature is recorded and can range from 32-0 degrees Celsius. The same test is repeated on the subject's leg that has radicular pain. The difference in temperatures from the test on the subject's arm and leg were analyzed.
次要结局
未报告次要终点
研究者
Yi Zhang, MD
Principal Investigator
Massachusetts General Hospital