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

Not Applicable

• Conditions: Cervical Radiculopathy; Radicular Pain; Acute Neck Pain; Cervicobrachial Pain
• Interventions: Other: FIR cervical collar with Acetaminophen; Other: Conservative cervical collar with Acetaminophen; Drug: Acetaminophen only

• Registration Number: NCT00880828
• Lead Sponsor: Taipei Medical University WanFang Hospital

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.

Study Timeline

• Study First Submitted: 2009-04-13
• Study First Submitted QC: 2009-04-13
• Study First Posted: 2009-04-14
• Study Start: 2010-08
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-23
• Last Update Posted: 2010-09-24
• Primary Completion: 2011-04
• Study Completion: 2011-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	FIR cervical collar with Acetaminophen	FIR cervical collar plus Acetaminophen
B	Conservative cervical collar with Acetaminophen	Conservative cervical collar plus Acetaminophen
C	Acetaminophen only	Acetaminophen only

Primary Outcome Measures

Name	Time	Method
Mean of change from baseline in Neck Disability Index after 2 weeks of treatment	4 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Taipei Medical University-Wan Fang Hospital; 🇨🇳 Taipei, Taiwan