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

Primary Purpose

Cervical Radiculopathy, Radicular Pain, Acute Neck Pain

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
FIR cervical collar with Acetaminophen
Conservative cervical collar with Acetaminophen
Acetaminophen only
Sponsored by
Taipei Medical University WanFang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Radiculopathy focused on measuring Cervical Radiculopathy, Radicular Pain, Acute neck pain, Cervicobrachial pain, Far-infrared ray, FIR, Cervical collar, Cervical device, FIR Device

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Taipei Medical University-Wan Fang Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

A

B

C

Arm Description

FIR cervical collar plus Acetaminophen

Conservative cervical collar plus Acetaminophen

Acetaminophen only

Outcomes

Primary Outcome Measures

Mean of change from baseline in Neck Disability Index after 2 weeks of treatment

Secondary Outcome Measures

Mean of change from baseline in Neck Disability Index after 4 weeks of treatment
Mean of change from baseline in Visual analog scale for neck pain after 2 and 4 weeks of treatment
Mean of change from baseline in nerve conduction velocity (NCV) tests after 4 weeks of treatment
Mean of change from baseline in Nerve Excitability Test (NET) after 2 and 4 weeks of treatment
Compare with Acetaminophen consuming of each arm after 4 weeks of treatment
Device-related serious adverse events

Full Information

First Posted
April 13, 2009
Last Updated
September 23, 2010
Sponsor
Taipei Medical University WanFang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00880828
Brief Title
Comparing Two Different Cervical Collars for the Treatment in Patient With Cervical Radiculopathy and Radicular Pain
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Unknown status
Study Start Date
August 2010 (undefined)
Primary Completion Date
April 2011 (Anticipated)
Study Completion Date
October 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Taipei Medical University WanFang Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Radiculopathy, Radicular Pain, Acute Neck Pain, Cervicobrachial Pain
Keywords
Cervical Radiculopathy, Radicular Pain, Acute neck pain, Cervicobrachial pain, Far-infrared ray, FIR, Cervical collar, Cervical device, FIR Device

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
FIR cervical collar plus Acetaminophen
Arm Title
B
Arm Type
Active Comparator
Arm Description
Conservative cervical collar plus Acetaminophen
Arm Title
C
Arm Type
Placebo Comparator
Arm Description
Acetaminophen only
Intervention Type
Other
Intervention Name(s)
FIR cervical collar with Acetaminophen
Intervention Description
FIR cervical collar with Acetaminophen QID/PRN for 4 weeks
Intervention Type
Other
Intervention Name(s)
Conservative cervical collar with Acetaminophen
Intervention Description
Conservative cervical collar with Acetaminophen QID/PRN for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Acetaminophen only
Intervention Description
Acetaminophen QID/PRN for 4 weeks
Primary Outcome Measure Information:
Title
Mean of change from baseline in Neck Disability Index after 2 weeks of treatment
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Mean of change from baseline in Neck Disability Index after 4 weeks of treatment
Time Frame
4 weeks
Title
Mean of change from baseline in Visual analog scale for neck pain after 2 and 4 weeks of treatment
Time Frame
4 weeks
Title
Mean of change from baseline in nerve conduction velocity (NCV) tests after 4 weeks of treatment
Time Frame
4 weeks
Title
Mean of change from baseline in Nerve Excitability Test (NET) after 2 and 4 weeks of treatment
Time Frame
4 weeks
Title
Compare with Acetaminophen consuming of each arm after 4 weeks of treatment
Time Frame
4 weeks
Title
Device-related serious adverse events
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kuo-Sheng Hung, MD, PhD
Organizational Affiliation
Taipei Medical University-Wan Fang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Medical University-Wan Fang Hospital
City
Taipei
ZIP/Postal Code
116
Country
Taiwan

12. IPD Sharing Statement

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

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