Neurophysiological and Functional Effects of Manipulative Therapy and Pain Education in Individuals With Chronic Nonspecific Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Pain Intensity
研究概览
简要总结
The burden of low back pain more than doubled in the last 20 years, probably caused by biopsychosocial factors. Some noninvasive treatments have been applied in individuals with chronic nonspecific low back pain as spinal manipulation and pain education. However, it is not already clear the neurophysiological effects of these treatments.The purpose of this research is to verify the effects of the technique of spinal manipulation and pain education in individuals with chronic low back pain
详细描述
The outcomes will be subjective pain (measured by Numeric Pain Rating Scale), pressure pain threshold (measured by Algometer), disability (measured by Roland-Morris Disability Questionnaire), fear and avoidance beliefs (measured by Fear Avoidance Beliefs Questionnaire), risk of poor prognosis (measured by STarT Back Screening Tool), quality of life (measured by Short Form-12v2) and blood biomarkers (measured by ELISA). The data will be collected by a blinded assessor.
Individuals eligibility is going to be assessed by blinded assessor to determine if they are or not eligible for this research. Then, they will be informed about the objectives of this study and asked to sign the consent form. Afterward, the sociodemographic data will be recorded. The data related to the research outcomes will be collected by the blinded assessor at baseline assessment, after six weeks and three months.
Random Allocation Before the treatment begins, one of the researchers not involved in the recruiting and assessment will allocate the individuals in one of the groups. Block randomization will be used; it is going to generate by randomization.com, this site will create a list with the randomization sequence, which will be only seen by the physical therapists that will treat the individuals.
Statistical Methods
Sample size calculation The sample size calculation was calculated with the A-priori test with the following specifications: Statistical test ANCOVA, the effect size of 0.25, the statistical power of 80%, and an alpha level of 5%. As a result, the study requires a sample size of 64 per group or 128 individuals in total.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic episodes of nonspecific LBP for at least six months
- •Pain on movement for at least one direction (flexion, extension, side bending or rotation of the trunk)
- •At least score 3 in NPRS.
排除标准
- •Previous history of lumbar myelopathy, rheumatic disease, tumors, peripheral or central neurological disorders
- •Historical of trauma, fracture or surgery in lumbar region;
- •Nerve root compression signs: important muscle weakness affecting lower limb, decrease or abolish of patellar and calcaneus reflex and decrease of dermatomes sensibility of lower limbs.
研究组 & 干预措施
Manipulative Treatment
Subjects will receive Manipulative Therapy
干预措施: Manipulative Therapy (Other)
Manipulative Treatment
Subjects will receive Manipulative Therapy
干预措施: Pain Education (Other)
Pain Education
Subjects will receive Pain Education and manual contact over lumbar region
干预措施: Pain Education (Other)
Pain Education
Subjects will receive Pain Education and manual contact over lumbar region
干预措施: Sham (Other)
结局指标
主要结局
Pain Intensity
时间窗: 6 weeks after randomization
Numeric Pain Rating Scale (NPRS)
次要结局
- Pain Intensity(Baseline, 6 weeks and 3 months)
- Disabilty(baseline, 6 weeks and 3 months)
- Pressure Pain Threshold(Baseline, 6 weeks and 3 months)
- Fear and Beliefs about pain(Baseline, 6 weeks and 3 months)
- Risk of poor prognosis(Baseline, 6 weeks and 3 months)
- Quality of Life(Baseline, 6 weeks and 3 months)
- Serum Level of Cytokines(Baseline, 6 weeks)
研究者
Clecio Vier
Principal Investigator
Santa Catarina Federal University