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

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.

Study Overview

• Status: Unknown
• Conditions: Cervical Radiculopathy; Radicular Pain; Acute Neck Pain; Cervicobrachial Pain
• Intervention / Treatment: Other: FIR cervical collar with Acetaminophen; Other: Conservative cervical collar with Acetaminophen; Drug: Acetaminophen only

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 Type: Interventional
• Enrollment (Anticipated): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 116
    • Taipei Medical University-Wan Fang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A; FIR cervical collar plus Acetaminophen	Other: FIR cervical collar with Acetaminophen; FIR cervical collar with Acetaminophen QID/PRN for 4 weeks
Active Comparator: B; Conservative cervical collar plus Acetaminophen	Other: Conservative cervical collar with Acetaminophen; Conservative cervical collar with Acetaminophen QID/PRN for 4 weeks
Placebo Comparator: C; Acetaminophen only	Drug: Acetaminophen only; Acetaminophen QID/PRN for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean of change from baseline in Neck Disability Index after 2 weeks of treatment	4 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Taipei Medical University WanFang Hospital
• Investigators: Principal Investigator: Kuo-Sheng Hung, MD, PhD, Taipei Medical University-Wan Fang Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Anticipated): April 1, 2011
• Study Completion (Anticipated): October 1, 2011

Study Registration Dates

• First Submitted: April 13, 2009
• First Submitted That Met QC Criteria: April 13, 2009
• First Posted (Estimate): April 14, 2009

Study Record Updates

• Last Update Posted (Estimate): September 24, 2010
• Last Update Submitted That Met QC Criteria: September 23, 2010
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Keywords: Radicular Pain; Cervical Radiculopathy; Cervical collar; Acute neck pain; Cervicobrachial pain; Far-infrared ray; FIR; Cervical device; FIR Device
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neck Pain; Radiculopathy; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Acetaminophen
• Other Study ID Numbers: 2008WFCRC-02