Overview

This trial is active, not recruiting.

Conditions cervical radiculopathy, radicular pain, acute neck pain, cervicobrachial pain
Treatments fir cervical collar with acetaminophen, conservative cervical collar with acetaminophen, acetaminophen only
Sponsor Taipei Medical University WanFang Hospital
Start date August 2010
End date April 2011
Trial size 72 participants
Trial identifier NCT00880828, 2008WFCRC-02

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
FIR cervical collar plus Acetaminophen
fir cervical collar with acetaminophen
FIR cervical collar with Acetaminophen QID/PRN for 4 weeks
(Active Comparator)
Conservative cervical collar plus Acetaminophen
conservative cervical collar with acetaminophen
Conservative cervical collar with Acetaminophen QID/PRN for 4 weeks
(Placebo Comparator)
Acetaminophen only
acetaminophen only
Acetaminophen QID/PRN for 4 weeks

Primary Outcomes

Measure
Mean of change from baseline in Neck Disability Index after 2 weeks of treatment
time frame: 4 weeks

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 20 years old.

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

Additional Information

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
Principal investigator Kuo-Sheng Hung, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2010.
Information provided to ClinicalTrials.gov by Taipei Medical University WanFang Hospital.