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

Cervical Radiculopathy Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00880828
• Other study ID #: 2008WFCRC-02
• 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

Related Conditions & MeSH terms

• Acute Neck Pain
• Cervical Radiculopathy
• Cervicobrachial Pain
• Neck Pain
• Radicular Pain
• Radiculopathy

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