Repetitive Transcranial Magnetic Stimulation Alone and in Combination With Motor Control Exercise for the Treatment of Patients With Chronic Non-specific Low Back Pain (ExTraStim Trial): Study Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Pain intensity (average pain over the last week)
研究概览
简要总结
The aim of this study is to evaluate the efficacy of repetitive transcranial magnetic stimulation alone and in combination with motor control exercises on pain and disability for patients with chronic non-specific low back pain.
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
- Single (Outcomes Assessor)
盲法说明
Participants will be masked to rTMS intervention (real or sham) but cannot be blinded to the exercise intervention. However, participants will not be aware of the study design (other arms).
Therapist delivering the exercise intervention will be masked to rTMS intervention (active vs. sham) but cannot be blinded to exercise intervention (yes vs. no).
Experimenter delivering the rTMS intervention will be masked to exercise intervention but not to rTMS intervention (real or sham).
Outcomes assessor will be completely masked to all interventions as all outcomes are questionnaires that will be completed online. Data will be de-identified and the data analyst will be masked to participants and group allocation.
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
- •chronic low back pain, defined as "pain in the low back area with or without leg pain above the knee limiting activities or daily routine which has been present for more than 3 months";
- •a minimal average pain intensity of 3 out of 10 during the preceding week on a pain numerical rating scale;
- •a minimal score of 10 points on the Oswestry disability index (ODI).
排除标准
- •specific spinal pathology (fracture, tumor, radiculopathy, spinal infection, etc.);
- •a history of back surgery;
- •a major orthopedic, neurological, cardiovascular or psychiatric illness;
- •low back pain is not the main pain complaint;
- •currently using an exercise program to treat their LBP;
- •presenting with any specific TMS/rTMS-related exclusion criteria such as previous seizure/convulsion, cochlear implant, specific medication and pregnancy;
- •previous use of repetitive transcranial magnetic stimulation.
结局指标
主要结局
Pain intensity (average pain over the last week)
时间窗: Change from baseline to 4 weeks, 8 weeks, 12 weeks and 24 weeks
Pain score on a 11-point pain numerical rating scale (PNRS) ranging from 0 to 10, with 0 meaning no pain and 10 the worst pain imaginable.
次要结局
- Disability (ODI)(Change from baseline to 4 weeks, 8 weeks, 12 weeks and 24 weeks)
- Tampa scale of kinesiophobia (TSK)(Change from baseline to 8 weeks, 12 weeks and 24 weeks)
- Global rating of change(Change from baseline to 8 weeks)
研究者
Hugo Massé-Alarie
Associate Professor, Medicine Faculty, Department of Rehabilitation
Laval University