Core Stability (Therapeutic) Exercise Alone or in Combination With Manual Therapy or Kinesio Tape in Patients With Chronic Low Back Pain: Randomized Control Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Oswestry Disability Index.
研究概览
简要总结
Non-specific low back pain in one of the main causes of disability for health care worldwide. The effectiveness of therapeutic exercise, of kinesio tape and of manual therapy in the treatment of low back pain is evaluated, but not a comparison of these techniques. Moreover, can these techniques be combined?
详细描述
Non-specific low back pain is one of the main causes of disability for health care worldwide. Nowadays, the mostly used technique to research low back muscular activity in electromyography.
Among the published studies, the effectiveness of therapeutic exercise, of kinesio tape and of manual therapy in the treatment of low back pain is evaluated, but not a comparison of these techniques.
Therefore, the purpose of this study was to investigate the effects of core stability exercise alone or in combination with manual therapy or kinesiotape on pain, dysfunction, psychosocial factors and pressure pain threshold (PPTs) in patients with low back pain in ODI stage 2. The investigators hypothesized that exercise combined with manual therapy would provide greater changes and benefits than exercise alone.
This study's population will be composed by at least 15 individuals per group, both the male and female, with ages among 20 and 60.
Participants will be randomly and blindly divided in three groups of intervention. The three groups will be: Exercise group or ET (realize therapeutic exercise alone), manual therapy group o ETmanualtherapy (realize manual therapy prior therapeutic exercise), and kinesiotape group or ETkinesiotape (realize therapeutic exercise plus kinesiotape).
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, Care Provider)
盲法说明
The groups will be arranged randomly and the masking technique to be used will be the doble blind procedure. The subjects will be randomly selected through the EPIDAT 4.2 program. The random allocation to each group will be made just by one external researcher, this way, neither the main researcher, nor the participants, will know their allocation. Furthermore, the inspector who will collect the evaluation data won´t know the allocation of each subject.
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
- •Medical diagnosis of CLBP confirmed by an orthopaedic specialist Classification at Stage 2 by ODI Not receiving pharmacological treatment such as anti-inflammatories or corticosteroids.
排除标准
- •Previous or scheduled surgeries in the low back and abdominal area
- •Presence of severe fractures or pathologies.
- •Diagnosis of radiculopathy or neuropathy (with or without spinal canal stenosis).
- •Structural deformity in the spinal column.
- •Neurological or psychiatric disorder.
- •Presence or suspicion of pregnancy.
结局指标
主要结局
Oswestry Disability Index.
时间窗: 12 weeks
The Oswestry Disability Index (ODI) test will be made to all participants at three months. Divided into 10 sections (each is scored from zero to five, with higher scores meaning higher disability), it is self-administered to assess the limitations of different activities of daily living. That is why, it has been established that all participants in Stage 2 of the test are subsidiaries to make all the treatment modes of the study (manual therapy, kinesiotape and exercise). This way, we are able to rise the homogeneity that imposes a diagnostic label such as the chronic low back pain.
次要结局
- Visual analog scale (VAS)(12 weeks)
- Self-efficacy:questionnaire(12 weeks)
- Pressure pain threshold(12 weeks)
- Kinesiophobia (TKS)(12 weeks)
- Catastrophism (PCS)(12 weeks)
- Electromyography(12 weeks)