Effectiveness of Transcranial Direct Current Stimulation in Chronic Pain Related to Lumbar Spinal Stenosis
试验速览
- 阶段
- 不适用
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Changes in Pain as measured by Visual Analog Scale
研究概览
简要总结
Transcranial Direct Current Stimulation (tDCS) is a promising non-invasive brain stimulation technique in chronic pain. There is no study investigating the effectiveness of tDCS in radiating chronic lower extremity pain related to lumbar spinal stenosis (LSS). The aim of this study is to investigate the effects of tDCS on pain, walking capacity, functional status and quality of life in patients with chronic pain related to LSS.
32 patients diagnosed with chronic pain related to LSS will be enrolled in this prospective, randomized, double blind, placebo-controlled study according to inclusion/exclusion criteria. Patients in active group will receive 10 sessions of anodal tDCS delivered over primary motor cortex (M1) with a constant current of 2 miliAmpers for 20 minutes. Patients will be evaluated at baseline, on day 1, 5 and 10 (after the session) and 5 days, 1 month and 3 months after treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Magnetic resonance imaging evidence of narrowing of the central canal, lateral recess, and/or foramen.
- •Persistent leg pain for at least 3 months
- •An average pain intensity score (during walking) of at least 4 out of 10 on the Visual Analog Scale at screening and randomisation
- •Persistent neurogenic claudication for at least 3 months
- •stable pharmacological treatment for pain and sleep disorders for at least 1 month before the study and throughout the trial
- •If present, coexisting low back pain intensity should be less than leg pain intensity.
排除标准
- •Patients with other neurological or psychiatric disorders including ongoing major depression (Beck Depression Score>14)
- •Uncontrolled/unstable endocrinologic, cardiovascular, pulmonary, hematologic, hepatic, renal disease
- •Inflammatory diseases, cancer
- •Severe hip and/or knee osteoarthritis that affects Treadmill Walking Test
- •Absolute/relative contraindications of tDCS (past head trauma resulting with loss of consciousness, epilepsy, past neurosurgical intervention, intracranial hypertension, implanted devices, migraine, chronic-severe headache episodes, a history of side effects with non-invasive brain stimulation techniques, skin diseases, pregnancy)
研究组 & 干预措施
Sham
Sham stimulation over M1
干预措施: sham tDCS (Device)
Active
Active stimulation over M1
干预措施: active tDCS (Device)
结局指标
主要结局
Changes in Pain as measured by Visual Analog Scale
时间窗: 12 weeks
The visual analog scale for pain is a straight line, 10 centimeters (10 cm) in length with one end meaning no pain and the other end meaning the worst pain imaginable. A patient marks a point on the line that matches the amount of pain he or she feels. A higher score indicates greater pain intensity (0 (min)-10 (max)) .
Walking Duration and Distance
时间窗: 12 weeks
Patients will be asked to walk on a treadmill at zero angle and a self-selected speed until they have to stop due to symptoms of LSS or until a time limit of 30 minutes has been reached. To start the test, the investigator slowly increases the speed to 1.9 km per hour. The subjects will be then allowed to modify the speed during the test to maintain a pace that is comfortable for them. Subjects will be asked to notify the investigator when they first experience a change in symptoms. Subjects will be also asked to avoid holding the handle bars. Total distance and time, distance and time to onset of symptoms will be measured.
次要结局
- Changes in Functional Status(12 weeks)
- Changes in Quality of Life: Short Form-36(12 weeks)
研究者
Enes Efe Is
Principal Investigator
Istanbul University