Immediate and Short-term Effects of Single-session Repetitive Transcranial Magnetic Stimulation on Pain Thresholds In Patients With Chronic Low Back Pain - A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pain thresholds
研究概览
简要总结
Chronic low back pain (CLBP) is a common reason for which patients are treated with opioids. Because the misuse of prescription opioids has become a serious problem in the Uinted States, finding effective alternative non-pharmaceutical interventions for chronic pain management has become an urgent matter. A phenomenon termed central sensitization (i.e. mal-adaption of the brain) has been hypothesized to be an underlying mechanism for the development of chronic pain, leading to sensory hypersensitivity to extremal stimuli. Therefore, non-invasive brain stimulation, such as repetitive transcranial magnetic stimulation (rTMS) may be an effective intervention to regulate brain excitability, thus reducing chronic pain. However, research has shown inconclusive evidence regarding the rTMS effects on chronic pain reduction, partly due to the heterogeneity of participants in studies to date. Therefore, the primary purpose of this study is to investigate the immediate and short-term effects of rTMS on neurosensory changes (i.e., pain thresholds) in patients with CLBP. The secondary purpuse of the study is to explore the relationship between changes of cortical excitability (TMS parameters) and changes of pain thresholds after the rTMS intervention in patients with CLBP.
详细描述
Research Design
A pre- and post-test research design will be used to examine the immediate and one-week carry-over effects of a single-session of rTMS intervention on individuals with CLBP. The primary outcome measures, including PPT, cold pain threshold (CPT), heat pain threshold (HPT), and heat-generated temporal summation (TS), will be collected three times: before the rTMS intervention, immediately after the intervention, and one week after the intervention.
Participants
Eligible participants are adults 18 years of age or older and who have had LBP for more than 6 months. According to the Centers for Disease Control and Prevention, chronic pain is defined as pain lasts more than 3 months or past the time of normal tissue healing. In order to ensure the development of central sensitization in the investigator's participants, only individuals with LBP for more than 6 months will be enrolled in this study.
Participants will be excluded from the study if they have previous low back surgery, systemic joint disease (e.g. rheumatoid arthritis), evidence of red flags (e.g. fracture, infection, tumor, cauda equina syndrome), cancer, neurological disorders, neuropathy, Raynaud's Disease or pregnancy, and inability to maintain the testing and treatment positions (i.e. sitting, supine hook-lying and prone-lying) for 15 minutes at a time. Additional exclusion criteria for the rTMS intervention include: 1) history of significant head trauma, 2) electrical, magnetic, or mechanical implantation (e.g. cardiac pacemakers or intracerebral vascular clip), 3) metal implantation in the head and neck areas, 4) history of seizures or unexplained loss of consciousness, 5) immediate family member with epilepsy, 6) use of seizure threshold lowering medicine, 7) current abuse of alcohol or drugs, and 8) history of psychiatric illness requiring medication controls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 是
入选标准
- •Adults 18 years of age or older
- •Have LBP for more than 6 months
排除标准
- •Previous low back surgery, systemic joint disease (e.g. rheumatoid arthritis),
- •Fracture,
- •Infection
- •Tumor or cancer
- •Cauda equina syndrome
- •neurological disorders
- •Neuropathy
- •Raynaud's Disease
- •pregnancy,
- •Inability to maintain the testing and treatment positions (i.e. sitting, supine hook-lying and prone-lying) for 15 minutes at a time.
- •History of significant head trauma,
- •Electrical, magnetic, or mechanical implantation (e.g. cardiac pacemakers or intracerebral vascular clip)
- •Metal implantation in the head and neck areas
- •History of seizures or unexplained loss of consciousness,
- •Immediate family member with epilepsy
- •Use of seizure threshold lowering medicine
- •Current abuse of alcohol or drugs
- •History of psychiatric illness requiring medication controls
研究组 & 干预措施
Intervention
repetitive transcranial magnetic stimulation
干预措施: repetitive transcranial magnetic stimulation (rTMS) (Procedure)
结局指标
主要结局
Pain thresholds
时间窗: before intervention, immediate after intervention, and one week after intervention
pressure pain thresholds, cold pain thresholds, and heat pain thresholds, and heat-generated temporal summation using a A Medoc TSA II Neurosensory Analyzer (Medoc ltd., Ramat Yishai, Israel).
次要结局
- Cortical Excitability(before intervention and immediate after intervention)
研究者
Sharon Wang-Price
Professor
Texas Woman's University