NCT02070172

Brief Summary

Motion limitations have been previously reported in people with headaches originating from the neck/cervicogenic headaches. A test involving flexing and rotating the neck has been found useful to diagnose this type of headache. This observational study investigates this neck motion test when performed actively by the patient and passively by the examiner, then compares the results of motion attained.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2009

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

February 1, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

February 20, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 25, 2014

Completed
Last Updated

February 25, 2014

Status Verified

February 1, 2014

Enrollment Period

1.9 years

First QC Date

February 20, 2014

Last Update Submit

February 21, 2014

Conditions

Keywords

headache diagnosisflexion rotation testrange of motionupper cervical

Outcome Measures

Primary Outcomes (1)

  • Cervical Range of Motion in degrees with the Flexion Rotation Test

    Two versions of this test were examined. A motion analysis system was used to measure degrees of motion. The test was done in two ways on each subject. Subjects sat in a chair, looked downward, then rotated their head/neck each direction. Subjects laid on their back while an examiner lifted their head, then rotated it each direction (same motion as described for the active test in the previous sentence). Within session reliability was also examined.

    Baseline only

Secondary Outcomes (1)

  • Northwick park neck disability index

    Baseline only

Study Arms (2)

Cervicogenic Headache Group

This group of subjects is considered the symptomatic group. No intervention was provided in this study so there are no intervention groups.

Healthy, Asymptomatic Group

Subjects in this group had no headache symptoms. Their neck motion was compared to subjects in the headache group. No intervention was provided to subjects in either group for this study.

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

two groups of subjects were included; those with cervicogenic headaches and an asymptomatic group of healthy volunteers

You may qualify if:

  • One-sided headaches
  • Headaches caused by neck movement or sustained head positioning
  • Neck, shoulder, or arm pain
  • Intermittent headaches at least one headache per week for greater than 2 months
  • Headaches of moderate intensity

You may not qualify if:

  • A diagnosis of rheumatoid arthritis
  • Current pregnancy
  • International Headache Society criteria for other headache forms (such as tension or migraine)
  • Cervical radiculopathy
  • Treatment for headaches by a physical therapist, chiropractor, massage therapist, or osteopath in the past month
  • Positive test for vertebral artery insufficiency or cranial-vertebral ligament instability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Des Moines University

Des Moines, Iowa, 50312, United States

Location

Biospecimen

Retention: NONE RETAINED

This study compares observation of neck range of motion measures during the flexion rotation test (combining neck flexion with neck rotation) in two groups of subjects, one group has headaches and one groups is a healthy, asymptomatic group.

MeSH Terms

Conditions

Post-Traumatic Headache

Condition Hierarchy (Ancestors)

Headache Disorders, SecondaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Shannon Petersen, PT, DScPT

    Des Moines University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Doctor of Physical Therapy Program

Study Record Dates

First Submitted

February 20, 2014

First Posted

February 25, 2014

Study Start

February 1, 2009

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

February 25, 2014

Record last verified: 2014-02

Locations