Balance Chiropractic Therapy for Cervical Spondylotic Radiculopathy: a Randomized Parallel-controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 240
- 主要终点
- Pain Scores as measured by the Visual Analog Scale
研究概览
简要总结
The purpose of this study is to evaluate the therapeutic effect and safety of the Balance Chiropractic Therapy(BCT) on Cervical Spondylotic Radiculopathy and to investigate the mechanism of which this efficacy is achieved.
详细描述
The investigators propose a multi center randomized, parallel-controlled trial to evaluate the efficacy and safety of the balance chiropractic therapy for CSR. Participants aged 18 to 65, who are in conformity with the diagnostic criteria of CSR and the pain score regarding visual analog scales is more than 4 points and less than 8 points, will be included and randomly allocated into two groups: test group and control group. Participants in the test group will be treated with the balance chiropractic therapy, while the control group will receive the traction therapy. The primary outcome is pain severity (measured with a visual analogue scale (VAS)). Secondary outcomes will include cervical curvature (measured by Borden index), a composite of functional status(measured by Neck Disability Index ,NDI), individual patients health status(evaluated by SF-36 health survey ), and adverse events as reported in the trial.
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 (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
- •Subjects who are in conformity with the diagnostic criteria of CSR;
- •Aged between18 and 65 years old;
- •The pain score regarding visual analog scales is more than 4 points and less than 8 points;
- •sign the informed consent.
排除标准
- •Subjects will be excluded if they have disorders such as vague diagnosis of acute spinal cord injury or acute spinal cord inflammation,or cervical vertigo symptom and checking for abnormal changes on transcranial doppler(TCD).
- •Subjects will also be excluded if they have combined liver, kidney, hematopoietic system, endocrine system, cardiovascular system, nervous system and other severe primary disease,or fractures,osteoarticular tuberculosis, osteomyelitis, bone tumor, severe osteoporosis,or mental disabilities,
- •A weak body can not withstand the stimulation of the balance chiropractic therapy .
- •Individuals who have acute infectious disease, stomach or duodenal ulcer with acute perforation,or treated areas with severe skin damage or skin diseases.
- •Subjects that have received surgical treatment or neck injury, or radiofrequency of cervical intervertebral disc, or minimally invasive, or ozone, or acupuncture and moxibustion, or other manipulations or block therapy within two weeks
- •Lactating or pregnant patients.
- •Subjects who are participating in other clinical trials related to cervical spondylosis.
结局指标
主要结局
Pain Scores as measured by the Visual Analog Scale
时间窗: Three months
次要结局
- cervical curvature as measured by Borden method(three months)
- composite of functional status as measured by Neck Disability Index(three months)
- Health Related Quality of Life as measured by SF-36(three months)
研究者
Feng Yang
Principal Investigator
Shaanxi University of Chinese Medicine