Acute Neck Pain, Cervical Radiculopathy, Cervicobrachial Pain, Radicular Pain
Conditions
Keywords
Cervical Radiculopathy, Radicular Pain, Acute neck pain, Cervicobrachial pain, Far-infrared ray, FIR, Cervical collar, Cervical device, FIR Device
Brief summary
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.
Detailed description
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.
Interventions
OTHERFIR cervical collar with Acetaminophen
FIR cervical collar with Acetaminophen QID/PRN for 4 weeks
OTHERConservative cervical collar with Acetaminophen
Conservative cervical collar with Acetaminophen QID/PRN for 4 weeks
DRUGAcetaminophen only
Acetaminophen QID/PRN for 4 weeks
Sponsors
Taipei Medical University WanFang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean of change from baseline in Neck Disability Index after 2 weeks of treatment | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 Neck Disability Index after 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 |
| Mean of change from baseline in Nerve Excitability Test (NET) after 2 and 4 weeks of treatment | 4 weeks |
Countries
Taiwan
Outcome results
None listed