Comparing Two Different Cervical Collars for the Treatment in Patient With Cervical Radiculopathy and Radicular Pain - Full Text View

Sponsor:	Taipei Municipal Wan Fang Hospital
Information provided by:	Taipei Municipal Wan Fang Hospital
ClinicalTrials.gov Identifier:	NCT00880828

Purpose

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.

Condition	Intervention
Cervical Radiculopathy Radicular Pain Acute Neck Pain Cervicobrachial Pain	Other: FIR cervical collar with Acetaminophen Other: Conservative cervical collar with Acetaminophen Drug: Acetaminophen only

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Neck Injuries and Disorders

Drug Information available for: Acetaminophen CT 2584

U.S. FDA Resources

Further study details as provided by Taipei Municipal Wan Fang Hospital:

Primary Outcome Measures:

Mean of change from baseline in Neck Disability Index after 2 weeks of treatment [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Mean of change from baseline in Neck Disability Index after 4 weeks of treatment [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Mean of change from baseline in Visual analog scale for neck pain after 2 and 4 weeks of treatment [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Mean of change from baseline in nerve conduction velocity (NCV) tests after 4 weeks of treatment [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Mean of change from baseline in Nerve Excitability Test (NET) after 2 and 4 weeks of treatment [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Compare with Acetaminophen consuming of each arm after 4 weeks of treatment [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Device-related serious adverse events [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	72
Study Start Date:	June 2009
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental FIR cervical collar plus Acetaminophen	Other: FIR cervical collar with Acetaminophen FIR cervical collar with Acetaminophen QID/PRN for 4 weeks
B: Active Comparator Conservative cervical collar plus Acetaminophen	Other: Conservative cervical collar with Acetaminophen Conservative cervical collar with Acetaminophen QID/PRN for 4 weeks
C: Placebo Comparator Acetaminophen only	Drug: Acetaminophen only Acetaminophen QID/PRN for 4 weeks

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.

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00880828

Contacts

Contact: Kuo-Sheng Hung, MD, PhD

+886-2-2930-7930 ext 2546

kshung25@gmail.com

Locations

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

Sponsors and Collaborators

Taipei Municipal Wan Fang Hospital

Investigators

Principal Investigator:

Kuo-Sheng Hung, MD, PhD

Taipei Medical University-Wan Fang Hospital

More Information

No publications provided

Responsible Party:	Taipei medical University-Wan Fang Hospital ( Kuo-Sheng Hung, MD, PhD )
Study ID Numbers:	2008WFCRC-02
Study First Received:	April 13, 2009
Last Updated:	April 13, 2009
ClinicalTrials.gov Identifier:	NCT00880828 History of Changes
Health Authority:	Taiwan: Department of Health

Keywords provided by Taipei Municipal Wan Fang Hospital:

Cervical Radiculopathy
Radicular Pain
Acute neck pain
Cervicobrachial pain
Far-infrared ray

FIR
Cervical collar
Cervical device
FIR Device

Additional relevant MeSH terms:

Physiological Effects of Drugs
Neck Pain
Nervous System Diseases
Pain
Pharmacologic Actions
Signs and Symptoms
Neuromuscular Diseases
Analgesics, Non-Narcotic
Sensory System Agents

Therapeutic Uses
Peripheral Nervous System Diseases
Radiculopathy
Neurologic Manifestations
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Acetaminophen

ClinicalTrials.gov processed this record on February 08, 2010