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

Tracking Information
First Submitted Date ICMJE	April 13, 2009
First Posted Date ICMJE	April 14, 2009
Last Update Posted Date	September 24, 2010
Study Start Date ICMJE	August 2010
Estimated Primary Completion Date	April 2011 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: April 13, 2009)	Mean of change from baseline in Neck Disability Index after 2 weeks of treatment [ Time Frame: 4 weeks ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00880828 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: April 13, 2009)	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 ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Comparing Two Different Cervical Collars for the Treatment in Patient With Cervical Radiculopathy and Radicular Pain
Official Title ICMJE	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
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 Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment
Condition ICMJE	Cervical Radiculopathy; Radicular Pain; Acute Neck Pain; Cervicobrachial Pain
Intervention ICMJE	Other: FIR cervical collar with Acetaminophen FIR cervical collar with Acetaminophen QID/PRN for 4 weeks; Other: Conservative cervical collar with Acetaminophen Conservative cervical collar with Acetaminophen QID/PRN for 4 weeks; Drug: Acetaminophen only Acetaminophen QID/PRN for 4 weeks
Study Arms	Experimental: A FIR cervical collar plus Acetaminophen Intervention: Other: FIR cervical collar with Acetaminophen; Active Comparator: B Conservative cervical collar plus Acetaminophen Intervention: Other: Conservative cervical collar with Acetaminophen; Placebo Comparator: C Acetaminophen only Intervention: Drug: Acetaminophen only
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Unknown status
Estimated Enrollment ICMJE; (submitted: April 13, 2009)	72
Original Estimated Enrollment ICMJE	Same as current
Estimated Study Completion Date	October 2011
Estimated Primary Completion Date	April 2011 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Age greater than 20 years; Cervical radiculopathy defined by neck pain irradiating to one arm with at least one of the following: Provocation by neck movements or sensory changes in one or more adjacent dermatomes or diminished deep tendon reflexes in the affected arm. 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
Sex/Gender	Sexes Eligible for Study: All
Ages	20 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Taiwan
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00880828
Other Study ID Numbers ICMJE	2008WFCRC-02
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Kuo-Sheng Hung, MD, PhD, Taipei medical University-Wan Fang Hospital
Study Sponsor ICMJE	Taipei Medical University WanFang Hospital
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Kuo-Sheng Hung, MD, PhD Taipei Medical University-Wan Fang Hospital
PRS Account	Taipei Medical University WanFang Hospital
Verification Date	September 2010
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP