Activating Motor System to Relieve Pain in Elderly: What is the Role of Physical Exercise and Transcranial Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Changes in Pain intensity
研究概览
简要总结
Physical exercises are known to reduce chronic pain in elderly individuals by activating the motor system. However, it seems that exercises are not effective for everyone. The investigators believe that elderly individuals with altered corticospinal tract will be those in whom the exercise alone are not sufficient to relieve pain. For those patients, adding an exogenous stimulation of the motor system such as transcranial direct current stimulation (tDCS) would facilitate the corticospinal tract, and consequently, would help exercises to relieve chronic pain. The investigators hypothesize that combining tDCS with the exercises will be more effective than exercises alone, but only in individuals who initially show low corticospinal projections.
详细描述
Prevalence and intensity of chronic pain increases substantially with age. According to several studies, physical exercises are effective to reduce chronic pain in elderly. However, it seems that exercises are not effective for everyone. One of the hypotheses raised is that the people in whom the exercises have no effect would be those with an alteration of the corticospinal tract. Transcranial direct current stimulation (tDCS) is a non-invasive neurostimulation technique known to facilitate the corticospinal tract when applied over the motor cortex.
Elderly suffering from chronic pain will be recruited in this double-blind, parallel-group, randomised control trial. Participants will be randomized to receive exercises combined to real tDCS (5 daily sessions, 2 mA, 20 minutes) or to sham tDCS. Intervention will last 8 weeks at a rate of 3 workouts per week.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To have musculoskeletal chronic pain
- •Not to change medication and life habits during the study
排除标准
- •People physically active before the study (more then 150 min of moderate to vigorous exercise par week)
- •To have an uncontrolled cardiovascular disease
- •To have orthopedic limitation or contraindication to physical exercise
- •To have contraindication to tDCS
- •To have contraindication to TMS
- •To have contraindication to MRI
研究组 & 干预措施
Exercise + real tDCS
Intervention will last 8 weeks where participants will be trained at a rate of 3 workouts per week.
For the first week, participants will receive 5 daily sessions of anodal tDCS (2 mA, 20 min).
干预措施: transcranial direct current stimulation (Other)
Exercise + real tDCS
Intervention will last 8 weeks where participants will be trained at a rate of 3 workouts per week.
For the first week, participants will receive 5 daily sessions of anodal tDCS (2 mA, 20 min).
干预措施: Physical exercise (Other)
Exercise + Sham tDCS
Intervention will last 8 weeks where participants will be trained at a rate of 3 workouts per week.
For the first week, participants will receive 5 daily sessions of sham tDCS.
干预措施: Physical exercise (Other)
结局指标
主要结局
Changes in Pain intensity
时间窗: Before intervention (T1), First week of intervention (T2), Week 4 (T3), Week 8 (T4), Follow-up 1 week after intervention (T5), Follow-up 1 month after intervention (T6)
Pain intensity will be assessed with a pain logbook containing a numerical rating scale from 0 to 10
次要结局
- Corticospinal excitability (TMS)(Before intervention, Follow-up 1 week after, Follow-up 1 month after)
- Corticospinal excitability (dMRI)(Before intervention, Follow-up 1 week after, Follow-up 1 month after)
- Functional connectivity(Before intervention, Follow-up 1 week after intervention, Follow-up 1 month after intervention)
- McGill pain questionnaire(Before intervention, Follow-up 1 week after intervention, Follow-up 1 month after intervention)
- Brief pain inventory(Before intervention, Follow-up 1 week after intervention, Follow-up 1 month after intervention)
- Beck depression inventory(Before intervention, Follow-up 1 week after intervention, Follow-up 1 month after intervention)
- Beck anxiety inventory(Before intervention, Follow-up 1 week after intervention, Follow-up 1 month after intervention)
- Margolis pain drawing and scoring system(Before intervention, Follow-up 1 week after intervention, Follow-up 1 month after intervention)
- Patient global impression of change questionnaire(Before intervention, Follow-up 1 week after intervention, Follow-up 1 month after intervention)
- Tampa questionnaire(Before intervention, Follow-up 1 week after intervention, Follow-up 1 month after intervention)
- Pain catastrophizing scale(Before intervention, Follow-up 1 week after intervention, Follow-up 1 month after intervention)
研究者
Guillaume Léonard
Professor
Université de Sherbrooke