Efficacy of Trans Cranial Direct Current Stimulation (tDCS) Along With Craniosacral Therapy (CST) on Sleep Disturbances in Patients With Chronic Low Back Pain (CLBP)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 主要终点
- Pittsburgh sleep quality Index scale.
研究概览
简要总结
Sleep problems in patients with CLBP are a very common complication and is the most neglected part of the management. Though previous literature suggested that sleep problems need to be managed in patients with CLBP, no physical therapy or manual therapy techniques has been checked for their efficacy to manage the same. Therefore, there is a need to check the efficacy of various physical therapy and manual therapy techniques so that sleep problems associated with CLBP can be managed effectively by physical means. The main purpose of the study is to check the efficacy of tDCS and CST to improve sleep, pain and quality of life in patients with CLBP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, 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
- 否
入选标准
- •People with chronic low back pain (more than 3 months)
- •Both males and females.
- •18-50 years
- •Able to follow verbal commands.
排除标准
- •Diagnosed with primary sleep disorders
- •Taking any medication for a psychological disorder
- •Acute or subacute LBP
- •Diagnosed with any other systemic disorder.
- •Spinal tumour.
- •Radicular pain and nerve root compression.
- •Severe spinal stenosis, spondylolisthesis, fibromyalgia.
- •Unstable angina and other cardiovascular disorders.
- •Malignancy.
- •History of other systemic and inflammatory disease.
研究组 & 干预措施
tDCS-Group
Participants of this arm will receive tDCS and Conventional therapy for 2 weeks.
干预措施: Trans cranial Direct Current Stimulation (tDCS) (Device)
CST- Group
Participants of this arm will receive CST and Conventional therapy for 2 weeks.
干预措施: Craniosacral therapy (CST) (Other)
combination of tDCS and CST
Participants of this arm will receive CST+ tDCS and Conventional therapy for 2 weeks.
干预措施: tDCS+ CST (Other)
结局指标
主要结局
Pittsburgh sleep quality Index scale.
时间窗: changes between baseline to 2 weeks and 6 weeks
Qualitative assessment of sleep will be recorded by this scale
Polysomnography
时间窗: changes between baseline to 2 weeks and 6 weeks
Polysomnographic parameters will be recorded.
次要结局
- Modified Oswestry disability index(changes between baseline to 2 weeks and 6 weeks)
- NPRS(changes between baseline to 2 weeks and 6 weeks)
研究者
Subhasish Chatterjee
Subhasish Chatterjee
Maharishi Markendeswar University (Deemed to be University)