The Effects of Transcranial Direct Current Stimulation Combined With Pilates Based Exercise in the Treatment of Patients With Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 入组人数
- 42
- 主要终点
- Functional performance associated to back pain
研究概览
简要总结
The purpose of this study is to evaluate the effects of transcranial direct current stimulation combined with Pilates based exercise on chronic low back pain. This is a randomized clinical trial composed of two arms.
详细描述
Chronic low back pain may be associated with pathoanatomical, neurophysiological, physical, psychological and social factors. Treatments that relieve the symptoms of these patients are of great importance to improve the quality of life of these individuals. Thus, this study aims to evaluate the effects of transcranial direct current stimulation combined with Pilates based exercise on chronic low back pain. This is a randomized clinical trial that will be composed of men and women between 18 and 65 years of age, with a history of low back pain for more than 12 weeks and a minimum pain intensity equal to 3 cm on the numerical pain scale. The volunteers will be randomized into two distinct groups: stimulation + exercise group (EG - will perform a Pilates based exercise protocol combined with transcranial direct current stimulation) and sham stimulation + exercise group (SG - will perform the same exercise program combined with sham stimulation). The interventions, regardless of the group, will be carried out three times a week for four weeks. Participants will be submitted to three assessments: the first (T0) will be performed before the treatment protocols; the second (T1) will be performed after the four weeks of intervention; and the third (T2) will be a follow-up one month after the end of the treatment protocol. Pain sensation, functional performance, central sensitization, quality of life, pressure pain threshold, global impression of change, adverse events and medication use will be evaluated. For the statistical analysis, a mixed model ANOVA will be performed for the inter and intragroup comparison, with Tukey's post hoc, considering a significance level of 5%.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women with chronic nonspecific low back pain (for more than 12 weeks) and minimum pain intensity of 3 on numerical pain rating scale.
排除标准
- •diagnosis of fracture and spine pathologies, fibromyalgia, spine surgery in the last year;
- •low cognitive level assessed by the Mini Mental State Examination;
- •presence of central neurological diseases (such as Parkinson's and stroke) or psychiatric (such as depression or schizophrenia);
- •history of epileptic illness;
- •seizure history;
- •brain implants;
- •pacemaker;
- •pregnancy.
结局指标
主要结局
Functional performance associated to back pain
时间窗: Change from baseline in functional performance at four weeks after intervention and 1 month of follow-up
Functional performance associated with low back pain measured by Roland Morris Disability Questionnaire (24 itens)
Pain intensity
时间窗: Change from baseline in pain intensity at four weeks after intervention and 1 month of follow-up
Pain intensity measured by numerical pain rating scale (11 points scale)
次要结局
- Adverse events(Up to 4 weeks of intervention and 1 month of follow-up.)
- Central Sensitization(Change from baseline of central sensitization at four weeks after intervention and 1 month of follow-up.)
- Pressure pain threshold(Change from baseline in pressure pain threshold at four weeks after intervention and 1 month of follow-up)
- Patient global impression of change(Change from baseline in Patient global impression of change at each intervention day and at four weeks of intervention and 1 month of follow-up.)
- Individual quality of life(Change from baseline in quality of life questionnaires at four weeks after intervention and 1 month of follow-up)
- Use of medications(Up to 4 weeks of intervention and 1 month of follow-up.)
研究者
Liane de Brito Macedo
Professor
Universidade Federal do Rio Grande do Norte