Comparing Two Different Cervical Collars for the Treatment in Patient With Cervical Radiculopathy and Radicular Pain

Taipei Medical University WanFang Hospital72 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Cervical Radiculopathy Radicular Pain Acute Neck Pain Cervicobrachial Pain

Interventions

FIR cervical collar with AcetaminophenOTHER

FIR cervical collar with Acetaminophen QID/PRN for 4 weeks

Conservative cervical collar with AcetaminophenOTHER

Conservative cervical collar with Acetaminophen QID/PRN for 4 weeks

Acetaminophen onlyDRUG

Acetaminophen QID/PRN for 4 weeks

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (1)

Taipei Medical University-Wan Fang Hospital

Taipei, Taiwan

Outcomes

Primary Outcomes

Mean of change from baseline in Neck Disability Index after 2 weeks of treatment

Time frame: 4 weeks

Secondary Outcomes

Mean of change from baseline in Neck Disability Index after 4 weeks of treatment

Time frame: 4 weeks

Mean of change from baseline in Visual analog scale for neck pain after 2 and 4 weeks of treatment

Time frame: 4 weeks

Mean of change from baseline in nerve conduction velocity (NCV) tests after 4 weeks of treatment

Time frame: 4 weeks

Mean of change from baseline in Nerve Excitability Test (NET) after 2 and 4 weeks of treatment

Time frame: 4 weeks

Compare with Acetaminophen consuming of each arm after 4 weeks of treatment

Time frame: 4 weeks

Device-related serious adverse events

Time frame: 4 weeks

Data from ClinicalTrials.gov

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