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

NCT ID: NCT00880828

Last Updated: 2010-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2011-10-31

Brief Summary

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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

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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.

Conditions

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Cervical Radiculopathy Radicular Pain Acute Neck Pain Cervicobrachial Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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A

FIR cervical collar plus Acetaminophen

Group Type EXPERIMENTAL

FIR cervical collar with Acetaminophen

Intervention Type OTHER

FIR cervical collar with Acetaminophen QID/PRN for 4 weeks

B

Conservative cervical collar plus Acetaminophen

Group Type ACTIVE_COMPARATOR

Conservative cervical collar with Acetaminophen

Intervention Type OTHER

Conservative cervical collar with Acetaminophen QID/PRN for 4 weeks

C

Acetaminophen only

Group Type PLACEBO_COMPARATOR

Acetaminophen only

Intervention Type DRUG

Acetaminophen QID/PRN for 4 weeks

Interventions

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FIR cervical collar with Acetaminophen

FIR cervical collar with Acetaminophen QID/PRN for 4 weeks

Intervention Type OTHER

Conservative cervical collar with Acetaminophen

Conservative cervical collar with Acetaminophen QID/PRN for 4 weeks

Intervention Type OTHER

Acetaminophen only

Acetaminophen QID/PRN for 4 weeks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Medical University WanFang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Taipei medical University-Wan Fang Hospital

Principal Investigators

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Kuo-Sheng Hung, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Taipei Medical University-Wan Fang Hospital

Locations

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Taipei Medical University-Wan Fang Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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2008WFCRC-02

Identifier Type: -

Identifier Source: org_study_id