Effect of Cervical Collar in Cervical Radicular Pain. | NCT00395798

Studies
Effect of Cervical Collar in Cervical Radicular Pain.

NCT00395798

Sponsor

Ullevaal University Hospital

Status

Completed

Last Update Posted

Jul 6, 2011Estimated

Enrollment

120

Phase

Phase 2

Conditions

Cervical Radicular Pain

Interventions

Soft or stiff cervical collar(device), neck school(behavior)

Countries

Norway

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

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2004

Primary Completion Date

Not provided

Completion Date

Aug 2007

First Submitted Date

Nov 2, 2006

First Submission Date that Met QC Criteria

Nov 2, 2006

First Posted Date

Nov 3, 2006Estimated

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

Jul 3, 2011

Last Update Posted Date

Jul 6, 2011Estimated

Name	Class
Norwegian Fund for Postgraduate Training in Physiotherapy	OTHER

Description Module

Brief Summary

Objectives:The purpose of this study is to determine if use of nech collar (stiff or soft)will improve the possibility to obtain painrelief in patients with cervical radicular pain. We will compare short term (six weeks and three months) and long term ( one year) effect of six weeks use of neck collar (stiff or soft)together with "neck school information" with "neck school information" alone.

Detailed Description

Not provided

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

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120

Name	Type	Description	Arm Group Labels	Other Names
Soft or stiff cervical collar(device), neck school(behavior)	Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
painscore on visual analog scale 0-100mm after 6weeks treatment

Secondary Outcomes

Measure	Description	Time Frame
painscore visual analog scale 0-100mm after 3weeks,3months,1year
Functional status on Neck pain and disability index after 3weeks,6weeks,3months,1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

cervical radicular pain caused by herniated disc og spondolytic spurs
written consent from patient

Exclusion Criteria:

previous necksurgery
whiplash or other necktrauma
serious diseases somatic or psychiatric
patients not able to speak and read Norwegian well
insufficient correlation between clinical and radiological findings

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Vibeke Graver, PhD	Ullevaal University Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ullevaal University Hospital		Oslo		0407	Norway

Condition Browse Module

MeSH Terms

ID	Term
D055009	Spondylosis
D011843	Radiculopathy

Ancestor Terms

ID	Term
D013122	Spinal Diseases
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D010523	Peripheral Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided