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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

April 13, 2009
September 23, 2010
August 2010
April 2011   (final data collection date for primary outcome measure)
Mean of change from baseline in Neck Disability Index after 2 weeks of treatment [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00880828 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Cervical Radiculopathy
  • Radicular Pain
  • Acute Neck Pain
  • Cervicobrachial Pain
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
72
October 2011
April 2011   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT00880828
2008WFCRC-02
No
Kuo-Sheng Hung, MD, PhD, Taipei medical University-Wan Fang Hospital
Taipei Medical University WanFang Hospital
Not Provided
Principal Investigator: Kuo-Sheng Hung, MD, PhD Taipei Medical University-Wan Fang Hospital
Taipei Medical University WanFang Hospital
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP