Effects of Shortwave Diathermy and Pilates Exercises in Patients With Chronic Non-specific Low Back Pain: a Protocol of a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Change in pain through Pain visual analogue scale
研究概览
简要总结
The aim of this study is to verify the effectiveness of the association of Shortwave Diathermy and Pilates exercises in patients with chronic non-specific low back pain, on the reduction of pain, functional disability and improvement of the quality of life.
详细描述
The drawing of the study will be a prospective, randomized controlled trial and double-blind with quantitative approach. Study participants 36 subjects diagnosed with non-specific chronic low back pain, which will be divided in two groups with 18 subjects in each: experimental group, which will be submitted to placebo + exercise shortwave diathermy and the control group to do active + exercise shortwave diathermy. There will be 12 one-hour sessions twice a week. The subjects will apply Shortwave Diathermy for 20 minutes, followed by Pilates mat.
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •individuals diagnosed with chronic non-specific low back pain for a period of more than 3 months, without irradiation for lower limbs;
- •who present pain intensity greater than 3 points in the Numerical Pain Scale;
- •to sign the Free and Informed Consent Form.
排除标准
- •BMI> 30;
- •previous surgeries in the spine;
- •severe spinal affection (tumors, infection, unconsolidated or vicious consolidation fractures, inflammatory diseases);
- •rheumatic disease;
- •contraindication to performing the exercises according to the American College of Sports Medicine Guidelines;
- •degenerative or inflammatory joint and other body segments;
- •patients who are in labor litigation;
- •pregnancy;
- •patients who are undergoing other type of physiotherapeutic or drug treatment.
结局指标
主要结局
Change in pain through Pain visual analogue scale
时间窗: Before the treatment, up to 3, 6 and 18 weeks
Scale with 11 centimeters is used for evaluate pain intensity, being "0" no pain and "10" the worst possible pain
Change in pain through The McGill pain questionnaire
时间窗: Before the treatment, up to 3, 6 and 18 weeks
It is organized in four categories: sensory, affective, evaluative and mixed, with 20 subcategories and 78 words descriptors of pain, describing the quality of pain. The pain evaluation index is the sum of the values added, and each word chosen in each dimension is the maximum score of each category: Sensory = 34, Affective = 17, Evaluative = 5, Mixed = 11, Total = 67.
次要结局
- Functional disability(Before the treatment, up to 3, 6 and 18 weeks)
- Patient Satisfaction: The MedRisk scale(Patients will be evaluated up to 6 weeks)
- Perception of global effect(Before the treatment, up to 3, 6 and 18 weeks)
- Emotional Functioning(Before the treatment, up to 3, 6 and 18 weeks)
- Depressive Symptom(Before the treatment, up to 3, 6 and 18 weeks)
- Symptoms and adverse events(Before the treatment, up to 3, 6 and 18 weeks)
- Patients' perceptions of their health-related quality of life: The Short-Form Health Survey questionnaire (SF-36)(Before the treatment, up to 3, 6 and 18 weeks)
研究者
Raquel A. Casarotto
Principal Investigator
University of Sao Paulo General Hospital