Cupping Therapy in the Treatment of Individuals With Nonspecific Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Change from Numeric Rating Scale (NRS) of Pain
研究概览
简要总结
Introduction: Low back pain is a very prevalent condition in the population and windsurf therapy has been presented as a non-pharmacological treatment currently used in this population. However, there is a lack of studies that evaluate such effects, besides a standardization of application of the technique in this condition. This protocol describes a placebo-controlled, randomized, double-blind study that aims to assess the effectiveness of windsurf therapy in improving pain and other symptoms of individuals with chronic non-specific back pain. Methods: Ninety individuals with chronic nonspecific and localized chronic low back pain from 18 to 59 years, will be recruited according to the inclusion criteria. Afterwards they will be randomized to one of the 2 groups: intervention group (GI) where it will be submitted applied to the windspiration with 2 suctions; and placebo group (GP) with simulated application. Both applications will occur in parallel to the vertebrae from L1 to L5 bilaterally. The application will be performed once a week for eight weeks. The volunteers will be evaluated before treatment (T0), immediately after the first intervention (T1), 4 weeks after treatment (T4) and 8 weeks after treatment (T8). The primary endpoint will be pain, and the secondary ones will be kinesiophobia, physical function, lumbar range of motion, sleep quality, patient expectation, quality of life, and psychological factors. Discussion: This is the first protocol that proposes to evaluate the effect of windsotherapy on lumbar ROM, sleep quality, kinesiophobia and psychological problems. Few studies have been done on windsurfing individuals with low back pain, requiring further studies with good methodological quality. Because there is no consensus on the use of windsurf therapy in individuals with nonspecific chronic low back pain, our protocol will be the basis for the use of the technique by health professionals and for new studies to be performed.
详细描述
This study will involve 4 researchers; 1 researcher responsible for evaluations; 1 researcher responsible for interventions; 1 researcher responsible for the interview, initial screening and randomization of participants, and 1 researcher who will perform the statistical analysis.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •female and male individuals aged between 18 and 59 years, normal BMI, presenting localized and non-specific lower back pain for more than 3 months;
- •have not used cupping therapy before;
- •report pain between 3 and 8 by NRS;
- •individuals who are not under physiotherapeutic treatment during the intervention;
- •individuals without neurological, vestibular, visual or auditory deficits that make evaluations impossible.
排除标准
- •Individuals with cutaneous lesions in the region where they will be applied to cupping therapy,
- •Individuals with uncontrolled diabetes and hypertension;
- •Irradiated and sacral lumbar pain;
- •Individuals with contraindication to windsurf therapy, are: cancer, renal failure, hepatic and cardiac insufficiency, pacemaker, pregnancy;
- •Individuals with severe spinal pathology (including fractures, inflammatory diseases and tumors);
- •Travel planning in the next 2 months
结局指标
主要结局
Change from Numeric Rating Scale (NRS) of Pain
时间窗: T0 -baseline, T4 (four week) and T8 (eight week)
The patients are asked to circle the number between 0 and 10. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'
次要结局
- Change from Oswestry Disability Index (ODI)(T0 -baseline and T8 (eight week))
- Range of motion of the lower back (ROM)(T0 -baseline, T4 (four week) and T8 (eight week))
- Short-Form 36 questionnaire (SF-36)(T0 -baseline and T8 (eight week))
- Timed Up and Go Test (TUG):(T0 -baseline and T8 (eight week))
- Global Perceived Effect Scale (GPE)(T8 (eight week))
- Hospital Anxiety and Depression Scale (HADS)(T0 -baseline and T8 (eight week))
- Medication consumption(T8 (eight week))
研究者
Marcelo Cardoso de Souza, PT, PhD.
Professor
Universidade Federal do Rio Grande do Norte