Effects of Association of Trunk Stretching and Segmental Stabilization Exercises in Chronic Unspecific Low Back Pain: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 4
- 主要终点
- Change in pain through Pain visual analogue scale
研究概览
简要总结
The incidence of chronic nonspecific low back pain is the highest in the world population and can lead to disability. One of the standards treatments for this condition is the segmental stabilization exercises, as well as trunk stretching. However, there is no study that associates these two treatments for nonspecific low back pain. This study will be a controlled clinical trial, randomized, prospective, single-blind with a quantitative approach that compares the efficacy of the association between segmental stabilization + trunk stretching with segmental stabilization + placebo stretching in patients with chronic nonspecific low back pain.
详细描述
BACKGROUND: Chronic nonspecific low back pain (LCI) has a high incidence in the world population and can lead to disability. Several therapeutic approaches have been studied to treat this pathology, but most investigate only the efficacy of one form of treatment per group. Studies show the effect of Segmental Stabilization in patients with LCI, but there is a gap on the effects of the association of trunk stretches with segmental stabilization exercises on pain and disability with LCI. Therefore, the objective of this study is to investigate the effects of the association of trunk stretching and segmental stabilization exercises on chronic non-specific low back pain in the short and medium term.
Method / Design: It will be a controlled, randomized, prospective, blinded clinical trial with quantitative approach, performed at the Clinical School of Physiotherapy of the UFPB. Participants in the study were 34 subjects of both sexes, aged 18 to 80 years, with pain equal to or greater than 3 by the Numerical Pain Scale (0/10) randomized into two groups: Placebo Stretching Group + Segmental Stabilization (n = 17) who will only do exercises of placebo stretching and segmental stabilization; And Segmental Stretching-Stabilization Group (n = 17), submitted to segmental stabilization exercises associated with trunk stretches; Both groups with 12 sessions. The results on pain intensity, functional capacity, overall effect perception, and clinical-psycho-functional assessment, as per the IMMPACT recommendations for clinical trials of effectiveness and efficacy of treatment for chronic pain, will be made by a blind After the intervention, three and six months after randomization.
Discussion: Because of its design, it will be possible to blind the evaluator, the randomizer, and the patient. At the end of the research we hope to contribute to the clinical decision-making process in the choice of therapies that improve pain and disability in patients with non-specific chronic low back pain.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •individuals diagnosed with nonspecific chronic low back pain without radicular symptoms for a period exceeding 12 months,
- •pain intensity greater than 3/10 points in Numerical Pain Scale
排除标准
- •patients who have some contraindication to perform exercises according to the American College of Sports Medicine guidelines, such as severe spinal disease (nonunion or malunion, tumors and inflammatory diseases);
- •spine surgeries;
- •degenerative or inflammatory disorders of the shoulder;
- •patients who are in labor dispute; or are doing other types of physical therapy or drug treatment.
研究组 & 干预措施
SSASG
Stabilization and stretching group, 12 session, 60 minutes each. This group will perform stretching for back muscles in different positions, associated with stabilization exercises using a protocol developed by Richardson, 2005.
干预措施: SSASG (Other)
SSPSG
Stabilization Group, 12 session, 60 minutes each. This group will perform placebo stretching for upper limb muscles (the muscle is not stretched in it maximum extent) with stabilization exercises, using a protocol developed by Richardson, 2005.
干预措施: SSPSG (Other)
结局指标
主要结局
Change in pain through Pain visual analogue scale
时间窗: Before the treatment and after the treatment (immediately after the treatment, and 3 and 6 months after treatment)
次要结局
- Global Perceived Effect Scale(Before the treatment and after the treatment (immediately after the treatment, and 3 and 6 months after treatment))