Effect of Multidimensional Physiotherapy Based on Biopsychosocial Approach on Clinical Findings and Electroencephalography (EEG) Spectrum in Chronic Nonspecific Low Back Pain: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 3
- 主要终点
- Pain intensity(questionnaire): Numeric Rating Scale
研究概览
简要总结
This study compares the effect of multidimensional physiotherapy to usual evidence-based physiotherapy in the treatment of chronic nonspecific low back pain in adults. Half of the participants will receive multidimensional physiotherapy based on biopsychosocial approach while the other half will receive usual evidence based physiotherapy.
详细描述
multidimensional physiotherapy treatment include: psychoeducation based on cognitive behavioral therapy (CBT), education, graded exposure, postural correction exercise, lifestyle change, and electrotherapy.
usual evidence-based physiotherapy include: electrotherapy, education, and trunk general exercises.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18-50
- •Low back pain for 3 months or more
- •Disability based on Oswestry Disability Index (ODI) between 20-60
- •Fear of movement based on Tampa scale of kinesiophobia >37
- •Minimum level of education
- •Native Persian speaking
排除标准
- •Any evidence of e specific medical diagnosis
- •Rheumatoid disease,fibromyalgia, neuropathy, progressive neurological disease
- •History of headache, dizziness, nausea, epilepsy, migraines and mental disorder
- •Beck's Anxiety Inventory> 26
- •Beck's Depression Inventory II> 29
- •Pregnancy
- •Having other therapies during the present research
结局指标
主要结局
Pain intensity(questionnaire): Numeric Rating Scale
时间窗: At baseline
Self reported pain intensity based on Numeric Rating Scale,that is composed of 0 (no pain at all) to 10 (worst imaginable pain).
Change of Pain intensity(questionnaire): Numeric Rating Scale
时间窗: At 4 months
Self reported pain intensity based on Numeric Rating Scale,that is composed of 0 (no pain at all) to 10 (worst imaginable pain).
Change of Pain intensity (questionnaire): Numeric Rating Scale
时间窗: At 1 month
Self reported pain intensity based on Numeric Rating Scale,that is composed of 0 (no pain at all) to 10 (worst imaginable pain).
次要结局
- Change of Forward flexion range of motion (ROM)(At 4 months)
- Kinesiophobia(At 6 weeks, after 12 treatment sessions in 38 days)
- Change of Quality of Life(At 4 months)
- Change of Fear Avoidance Believes(At 4 months)
- Change of Brain function(At 4 months)
- Pain Catastrophizing(At baseline)
- Brain function(At baseline)
- Quality of Life assessment(At baseline)
- Fear Avoidance Believes(At baseline)
- Disability(At baseline)
- Forward flexion range of motion (ROM)(At baseline)
- Change in Quality of Life(At 6 weeks, after 12 treatment sessions in 38 days)
- Change of Pain Catastrophizing(At 4 months)
- Change of Disability(At 4 months)
- Change of Kinesiophobia(At 4 months)