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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Taipei Medical University WanFang Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier:
NCT00880828
First received: April 13, 2009
Last updated: September 23, 2010
Last verified: September 2010
History of Changes
  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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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:

U.S. FDA Resources

Further study details as provided by Taipei Medical University WanFang 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: August 2010
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Locations
Taiwan
Taipei Medical University-Wan Fang Hospital
Taipei, Taiwan, 116
Sponsors and Collaborators
Taipei Medical University WanFang Hospital
Investigators
Principal Investigator: Kuo-Sheng Hung, MD, PhD Taipei Medical University-Wan Fang Hospital
  More Information

No publications provided

Responsible Party: Kuo-Sheng Hung, MD, PhD, Taipei medical University-Wan Fang Hospital
ClinicalTrials.gov Identifier: NCT00880828     History of Changes
Other Study ID Numbers: 2008WFCRC-02
Study First Received: April 13, 2009
Last Updated: September 23, 2010
Health Authority: Taiwan: Department of Health

Keywords provided by Taipei Medical University WanFang Hospital:
Cervical Radiculopathy
Radicular Pain
Acute neck pain
Cervicobrachial pain
Far-infrared ray
 FIR
Cervical collar
Cervical device
FIR Device

Additional relevant MeSH terms:
Neck Pain
Radiculopathy
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Peripheral Nervous System Diseases
Neuromuscular Diseases
Acetaminophen
 Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013