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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00880828
Other study ID # 2008WFCRC-02
Secondary ID
Status Active, not recruiting
Phase N/A
First received April 13, 2009
Last updated September 23, 2010
Start date August 2010
Est. completion date October 2011

Study information

Verified date September 2010
Source Taipei Medical University WanFang Hospital
Contact n/a
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 72
Est. completion date October 2011
Est. primary completion date April 2011
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Intervention

Other:
FIR cervical collar with Acetaminophen
FIR cervical collar with Acetaminophen QID/PRN for 4 weeks
Conservative cervical collar with Acetaminophen
Conservative cervical collar with Acetaminophen QID/PRN for 4 weeks
Drug:
Acetaminophen only
Acetaminophen QID/PRN for 4 weeks

Locations

Country Name City State
Taiwan Taipei Medical University-Wan Fang Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
Taipei Medical University WanFang Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean of change from baseline in Neck Disability Index after 2 weeks of treatment 4 weeks No
Secondary Mean of change from baseline in Neck Disability Index after 4 weeks of treatment 4 weeks No
Secondary Mean of change from baseline in Visual analog scale for neck pain after 2 and 4 weeks of treatment 4 weeks No
Secondary Mean of change from baseline in nerve conduction velocity (NCV) tests after 4 weeks of treatment 4 weeks No
Secondary Mean of change from baseline in Nerve Excitability Test (NET) after 2 and 4 weeks of treatment 4 weeks No
Secondary Compare with Acetaminophen consuming of each arm after 4 weeks of treatment 4 weeks No
Secondary Device-related serious adverse events 4 weeks Yes
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