NCT00880828

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2010

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 14, 2009

Completed
1.3 years until next milestone

Study Start

First participant enrolled

August 1, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

September 24, 2010

Status Verified

September 1, 2010

Enrollment Period

8 months

First QC Date

April 13, 2009

Last Update Submit

September 23, 2010

Conditions

Cervical RadiculopathyRadicular PainAcute Neck PainCervicobrachial Pain

Keywords

Cervical RadiculopathyRadicular PainAcute neck painCervicobrachial painFar-infrared rayFIRCervical collarCervical deviceFIR Device

Outcome Measures

Primary Outcomes (1)

  • Mean of change from baseline in Neck Disability Index after 2 weeks of treatment

    4 weeks

Secondary Outcomes (6)

  • 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

  • Mean of change from baseline in nerve conduction velocity (NCV) tests after 4 weeks of treatment

    4 weeks

  • Mean of change from baseline in Nerve Excitability Test (NET) after 2 and 4 weeks of treatment

    4 weeks

  • Compare with Acetaminophen consuming of each arm after 4 weeks of treatment

    4 weeks

  • +1 more secondary outcomes

Study Arms (3)

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

FIR cervical collar with AcetaminophenOTHER

FIR cervical collar with Acetaminophen QID/PRN for 4 weeks

A
Conservative cervical collar with AcetaminophenOTHER

Conservative cervical collar with Acetaminophen QID/PRN for 4 weeks

B
Acetaminophen onlyDRUG

Acetaminophen QID/PRN for 4 weeks

C

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age greater than 20 years
  • Cervical radiculopathy defined by neck pain irradiating to one arm with at least one of the following:
  • Provocation by neck movements or sensory changes in one or more adjacent dermatomes or diminished deep tendon reflexes in the affected arm.
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Medical University-Wan Fang Hospital

Taipei, 116, Taiwan

Location

MeSH Terms

Conditions

Radiculopathy

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Kuo-Sheng Hung, MD, PhD

    Taipei Medical University-Wan Fang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 13, 2009

First Posted

April 14, 2009

Study Start

August 1, 2010

Primary Completion

April 1, 2011

Study Completion

October 1, 2011

Last Updated

September 24, 2010

Record last verified: 2010-09

Locations

TW(1)