A Single-Center, Prospective, Randomized, Active Controlled, Single Blind, Parallel Design, Three Arms Trial Comparing Two Different Cervical Collar Combine With Acetaminophen and Acetaminophen Along for the Treatment in Patient With Cervical Radiculopathy and Radicular Pain
试验速览
- 阶段
- 不适用
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Mean of change from baseline in Neck Disability Index after 2 weeks of treatment
研究概览
简要总结
The primary objective of the study is to investigate the efficacy of device with far-infrared (FIR) irradiation in these patients with acute cervical radiculopathy.
详细描述
Acute neck pain is a relatively common experience that usually declines and disappears within a couple weeks. Some patients do not recover and with time develop chronic cervical pain and nerve root compression which may result in cervical radiculopathy.
Far-infrared (FIR) ray is one of the topics in energy medicine which is tremendously studied for the past few years. A variety of FIR applications showed an enhancement of beneficial effects on healing therapy, even though there is limited technical approach and systemic study placed on the theoretical study of FIR ceramics processing and the emissivity optimizing.
The evident difficulties in finding the appropriate cervical radiculopathy therapy initiated the current study. The aim of the study is to evaluate the efficacy of the FIR cervical collar in patients with long-lasting cervicobrachial pain; in whom the pain had a distribution that corresponded to a specific nerve root compression revealed by MRI or electrophysiological study.
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 (Participant)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than 20 years
- •Cervical radiculopathy defined by neck pain irradiating to one arm with at least one of the following:
- •Provocation by neck movements or sensory changes in one or more adjacent dermatomes or diminished deep tendon reflexes in the affected arm.
- •Muscle weakness in one or more adjacent myotomes.
- •Neck Disability Index (NDI) score greater than or equal to 10 points
- •Visual analog scale (VAS) score for neck pain greater than or equal to 40mm
- •C-spine X-ray signs judge by investigator
- •Prolong Neck pain for one week or longer
- •Written consent from patient
排除标准
- •Serious somatic or psychiatric disease(s)
- •History of spinal tumors or spinal infection
- •Ongoing physical therapy within 4 weeks
- •Cervical instability judge by investigator
- •History of contact dermatitis or known allergic reaction to collar material
- •Known allergic reaction to acetaminophen
- •Any other clinical condition which, in the opinion of the principal investigator, would not allow completion of this study
研究组 & 干预措施
A
FIR cervical collar plus Acetaminophen
干预措施: FIR cervical collar with Acetaminophen (Other)
B
Conservative cervical collar plus Acetaminophen
干预措施: Conservative cervical collar with Acetaminophen (Other)
C
Acetaminophen only
干预措施: Acetaminophen only (Drug)
结局指标
主要结局
Mean of change from baseline in Neck Disability Index after 2 weeks of treatment
时间窗: 4 weeks
次要结局
- Mean of change from baseline in Neck Disability Index after 4 weeks of treatment(4 weeks)
- Mean of change from baseline in Visual analog scale for neck pain after 2 and 4 weeks of treatment(4 weeks)
- Mean of change from baseline in nerve conduction velocity (NCV) tests after 4 weeks of treatment(4 weeks)
- Mean of change from baseline in Nerve Excitability Test (NET) after 2 and 4 weeks of treatment(4 weeks)
- Compare with Acetaminophen consuming of each arm after 4 weeks of treatment(4 weeks)
- Device-related serious adverse events(4 weeks)