Immediate Effects of a Spinal Lumbar Manipulation on the Threshold Pressure Pain and the Postural Control in Subjects With Non-specific Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- pressure pain threshold assessment (algometer)
研究概览
简要总结
Non-specific low back pain is defined as a pain with no specific vertebral-related cause, such as infectious disease, tumor, osteoporosis, fracture, structural abnormality, inflammatory disease, radicular compressive syndrome or cauda equine syndrome. Non-specific low back pain is a common disease in many countries. This musculoskeletal disorder is costly to public health systems. Therefore, the use of manual therapies is important in the treatment of this disease and studies show the effectiveness of this type of therapy.
Spinal manipulation is applied in manual therapies such as Osteopathy, Chiropractic and Physical Therapy and is widely used for acute and chronic non-specific low-back pain. There is moderate evidence that spinal manipulation is superior to sham spinal manipulation for improving short-term pain and function in chronic and acute non-specific low back pain. However the therapeutic mechanisms involved in this procedure are not well understood. Furthermore, while the high velocity and low amplitude spinal therapy has been shown to be effective in reducing pain and improving functional capacity in subjects with non-specific low back pain, the effect on postural variables have not been investigated. Therefore, the aim of this study is to evaluate the acute effect of lumbar manipulation on pain and postural variables.
Twenty-four individuals with non-specific low back pain will be randomly allocated to two groups. The intervention group will receive high velocity and low amplitude spinal therapy, while the control group will receive sham manipulation. Immediately before and after the respective manipulation protocol, both groups will be evaluated regarding pain level, using a visual-analogue scale and algometer, and postural variables, using center of pressure displacement measured with the aid of a force plate. While the patient and therapist manipulator will be aware of the protocol applied in each case, the evaluator will be blind. A statistical treatment will be used to compare the results.
详细描述
Mean and standard deviation are calculated for each variable of postural control, as well as the values obtained in the measurement of pain using the numeric pain rating scale and algometry data.
t-test or Mann-Whitney test will be used to compare data before and after the manipulation protocol.
Multiple One-Way ANOVAs will be used to compare the manipulation protocol, for each dependent variable: effects of pain and center of pressure displacement.. Statistical analysis will be conducted with a confidence interval of 95%, α value of 5%, p value of ≤ 0.05.
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
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •recurrent low back pain in the last three months;
- •medical diagnosis of non-specific low back pain, daily or almost daily;
- •subjects that will present at least four variables which encompass the clinical prediction rule: symptoms duration less than 16 days, Fear Avoidance-Beliefs Questionnaire score lower than 19 in the work subscale, segmental lumbar hypermobility test in prone decubitus, internal hip rotation higher than 35 degrees and symptoms that don't pass the knee.
排除标准
- •subjects presenting symptoms that pass the knee;
- •impairment of neurologic signs like sensibility, muscle force and deep tendon reflex;
- •a prior history of spondylolisthesis, spinal stenosis, inflammatory disease, cancer, musculoskeletal degenerative disease, pregnancy, disease and drugs that impairment the balance;
- •subjects who received a HVLA manipulation of the lumbar spine at least three months earlier;
- •will be excluded women older than 50 years, that don't will present a bone mineral density exam.
结局指标
主要结局
pressure pain threshold assessment (algometer)
时间窗: Within one day
An algometer will used to assess the pressure pain threshold at baseline and following the intervention
次要结局
- Clinical Prediction Rule(Within one day)
- Center of pressure displacement(Within one day)
- Subjective pain assessment(Within one day)
研究者
Jefferson Fagundes Loss
Professor
Federal University of Rio Grande do Sul