The Myofascial Massage in the Treatment of Chronic Non-specific Low Back Pain: the Experience of Contact
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Change of Visual Analogue Scale (VAS) from baseline to 12 weeks
研究概览
简要总结
The purpose of the study is to determine the effectiveness of an approach that combines massage therapy with elements of neurocognitive rehabilitation such as motor imagery and the words of the physiotherapist compared to a traditional massage therapy in reducing pain in patients with chronic low back pain (CLBP) and to evaluate if and how the pain reduction is linked to the interoceptive awareness and which is the patient's ability to relax through the measurement of the hearth rate variability (HRV).
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
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of chronic nonspecific low back pain for at least three months
- •Subjects aged between 18 and 50 years
排除标准
- •Presence of acute low back pain
- •Low back pain due to other causes (vertebral fractures, spondylolisthesis, herniated discs, lumbar canal stenosis)
- •Disorders of central and/or peripheral nervous system
- •Systemic inflammatory disease (eg rheumatoid arthritis)
- •Systemic infectious disease
- •Neoplastic disease
- •Previous Surgery
- •Cognitive impairment
- •Pregnancy
结局指标
主要结局
Change of Visual Analogue Scale (VAS) from baseline to 12 weeks
时间窗: baseline, 4 weeks, 12 weeks
It is a scale for the assessment of pain and it's based on a ten point scale, where 0 means no pain and 10 the greatest pain ever both at rest and during movements.
次要结局
- Change of Multidimensional Assessment of Interoceptive Awareness (MAIA) from baseline to 12 weeks(baseline, 4 weeks, 12 weeks)
- Change of SF-12 Health Survey Questionnaire from baseline to 12 weeks(baseline, 4 weeks, 12 weeks)
- Change of hearth rate variability (HRV) expressed as coherent ratio from baseline to 4 weeks(baseline, 4 weeks)
- Change of McGill Pain Questionnaire from baseline to 12 weeks(baseline, 4 weeks, 12 weeks)
- Change of Waddell Disability Index from baseline to 12 weeks(baseline, 4 weeks, 12 weeks)
研究者
Teresa Paolucci
Medical Director
University of Roma La Sapienza