NCT00395798

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2004

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

November 2, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 3, 2006

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

July 6, 2011

Status Verified

May 1, 2006

First QC Date

November 2, 2006

Last Update Submit

July 3, 2011

Conditions

Cervical Radicular Pain

Keywords

cervical intervertebral disc displacementcervical spondylosisradiculopathyneck collarbracephysiotherapytreatmentrehabilitation

Outcome Measures

Primary Outcomes (1)

  • painscore on visual analog scale 0-100mm after 6weeks treatment

Secondary Outcomes (3)

  • painscore visual analog scale 0-100mm after 3weeks,3months,1year

  • Functional status on Neck pain and disability index after 3weeks,6weeks,3months,1 year

  • Quality of life score, Cantrils Ladder Scale 3 weeks,6weeks,3 months,1 year

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ullevaal University Hospital

Oslo, 0407, Norway

Location

MeSH Terms

Conditions

SpondylosisRadiculopathy

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Vibeke Graver, PhD

    Ullevaal University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 2, 2006

First Posted

November 3, 2006

Study Start

January 1, 2004

Study Completion

August 1, 2007

Last Updated

July 6, 2011

Record last verified: 2006-05

Locations

NO(1)