Cervical Radiculopathy Clinical Trial
Official title:
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
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.
Status | Active, not recruiting |
Enrollment | 72 |
Est. completion date | October 2011 |
Est. primary completion date | April 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years and older |
Eligibility |
Inclusion Criteria: - Age greater than 20 years - Cervical radiculopathy defined by neck pain irradiating to one arm with at least one of the following: 1. Provocation by neck movements or sensory changes in one or more adjacent dermatomes or diminished deep tendon reflexes in the affected arm. 2. 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 Exclusion Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Taiwan | Taipei Medical University-Wan Fang Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
Taipei Medical University WanFang Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean of change from baseline in Neck Disability Index after 2 weeks of treatment | 4 weeks | No | |
Secondary | Mean of change from baseline in Neck Disability Index after 4 weeks of treatment | 4 weeks | No | |
Secondary | Mean of change from baseline in Visual analog scale for neck pain after 2 and 4 weeks of treatment | 4 weeks | No | |
Secondary | Mean of change from baseline in nerve conduction velocity (NCV) tests after 4 weeks of treatment | 4 weeks | No | |
Secondary | Mean of change from baseline in Nerve Excitability Test (NET) after 2 and 4 weeks of treatment | 4 weeks | No | |
Secondary | Compare with Acetaminophen consuming of each arm after 4 weeks of treatment | 4 weeks | No | |
Secondary | Device-related serious adverse events | 4 weeks | Yes |
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