Clinical trial NCT00880828: 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
Overall status: UNKNOWN
Phase: NA
Conditions: 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
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2009-04-14
Enrollment: 72
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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:

  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

Primary outcomes:
measure: Mean of change from baseline in Neck Disability Index after 2 weeks of treatment
timeFrame: 4 weeks
Secondary outcomes:
measure: Mean of change from baseline in Neck Disability Index after 4 weeks of treatment
timeFrame: 4 weeks
measure: Mean of change from baseline in Visual analog scale for neck pain after 2 and 4 weeks of treatment
timeFrame: 4 weeks
measure: Mean of change from baseline in nerve conduction velocity (NCV) tests after 4 weeks of treatment
timeFrame: 4 weeks
measure: Mean of change from baseline in Nerve Excitability Test (NET) after 2 and 4 weeks of treatment
timeFrame: 4 weeks
measure: Compare with Acetaminophen consuming of each arm after 4 weeks of treatment
timeFrame: 4 weeks
measure: Device-related serious adverse events
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University-Wan Fang Hospital
Study officials:
affiliation: Taipei Medical University-Wan Fang Hospital
name: Kuo-Sheng Hung, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: