Effects of an Online Pilates Protocol in Individuals With Chronic Low Back Pain: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 78
- 主要终点
- Pain sensation
研究概览
简要总结
The purpose of this study is to evaluate the effects of the Pilates method, performed online, in individuals with chronic low back pain. This is a randomized controlled trial consisting of two arms.
详细描述
Low back pain is one of the main causes of disability in the world, and physical inactivity is associated with its development. In this sense, Pilates can be used both in the treatment and preventively for this symptomatology. Thus, the aim of this study is to evaluate the effects of the Pilates method, performed online, in individuals with chronic low back pain. This is a randomized controlled trial involving men and women between 18 and 60 years of age with a history of non-specific chronic low back pain and a minimum pain intensity equal to 3 points on the numeric pain scale. Research participants will perform a pre-intervention (EV1) and post-intervention (EV2) assessment, both online. Pain sensation, functional performance, kinesiophobia and perception of global change will be the outcomes evaluated through the following instruments: Numerical Pain Scale, Roland Morris Questionnaire, Tampa Scale for kinesiophobia and Patient Global Impression of Change Scale. Participants included in the study will be randomized into two groups with separate interventions, both lasting eight weeks: online Pilates group and control group. The control group will receive information about self-management of low back pain, pain education, and changes in lifestyle habits; the Pilates group, besides having access to the same information as the control group, will undergo 16 Pilates sessions performed online (2 times/week). The statistical analysis will be done through the independent t test and the Mann-whitney test to investigate the differences between the groups (Pilates online x control), while the paired t test and the Wilcoxon test will be applied to evaluate the effect of the time variable (Pre x Post), 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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women with a history of 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
- •Symptoms related to serious pathologies (such as fever, changes in sensibility, weight loss, constant pain);
- •Recent history of spinal fracture, cancer, inflammatory diseases, nerve root involvement, spinal pathologies (such as ankylosing spondylitis, herniated disc with radiculopathy, advanced osteoporosis, spondylolysis, spondylolisthesis);
- •Central neurological diseases (such as Parkinson's and stroke), psychiatric (such as depression or schizophrenia);
- •Autoimmune diseases;
- •Orthopedic surgery in the last year;
- •Severe cardiovascular diseases;
- •Decompensated metabolic diseases;
- •Pregnancy.
结局指标
主要结局
Pain sensation
时间窗: Change from baseline in pain sensation at eight weeks after the intervention
Painful sensation measured by numerical pain rating scale (11 points scale)
次要结局
- Functional performance associated to back pain(Change from baseline in functional performance at eight weeks after the intervention)
- Kinesiophobia(Change from baseline in kinesiophobia at eight weeks after the intervention)
- Patient global impression of change(The Patient global impression of change after eight weeks of intervention)
研究者
Liane de Brito Macedo
Professor
Universidade Federal do Rio Grande do Norte