Comparing Two Different Cervical Collars for the Treatmen... | NCT00880828

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

NCT00880828

Sponsor

Taipei Medical University WanFang Hospital

Status

Unknown status

Last Update Posted

Sep 24, 2010Estimated

Enrollment

72Estimated

Phase

Not Applicable

Conditions

Cervical Radiculopathy
Radicular Pain
Acute Neck Pain
Cervicobrachial Pain

Interventions

FIR cervical collar with Acetaminophen
Conservative cervical collar with Acetaminophen
Acetaminophen only

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Sep 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2010

Primary Completion Date

Apr 2011Estimated

Completion Date

Oct 2011Estimated

First Submitted Date

Apr 13, 2009

First Submission Date that Met QC Criteria

Apr 13, 2009

First Posted Date

Apr 14, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 23, 2010

Last Update Posted Date

Sep 24, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

72Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental	FIR cervical collar plus Acetaminophen	Other: FIR cervical collar with Acetaminophen
B	Active Comparator	Conservative cervical collar plus Acetaminophen	Other: Conservative cervical collar with Acetaminophen
C	Placebo Comparator	Acetaminophen only	Drug: Acetaminophen only

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FIR cervical collar with Acetaminophen	Other	FIR cervical collar with Acetaminophen QID/PRN for 4 weeks	A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean of change from baseline in Neck Disability Index after 2 weeks of treatment		4 weeks

Secondary Outcomes

Measure	Description	Time Frame
Mean of change from baseline in Neck Disability Index after 4 weeks of treatment		4 weeks
Mean of change from baseline in Visual analog scale for neck pain after 2 and 4 weeks of treatment		4 weeks

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases

ID	Term
D000083	Acetanilides
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814	Aniline Compounds
D000588	Amines