- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03531619
The Relationship Between Dizziness and Neck Pain
Dizziness and Neck Pain - is There a Relationship and Does it Matter?
Both dizziness and neck pain are common complaints in the Norwegian population. The cervical spine has a highly developed proprioceptive system, which is involved in head and gaze stabilization as well as postural control. Thus, it has been argued that dizziness and/or unsteadiness can occur due to loss of or inadequate stimulation of neck receptors in patients with neck pain. Still, the notion of dizziness due to cervical dysfunction is a controversial topic. However, clinicians report that patients referred for dizziness often complain of neck pain, and vice versa.
This study is a multi-center study including patients referred to 1) a neuro-otologic clinic due to dizziness and 2) a rehabilitation clinic due to neck pain. Both clinics are tertiary care university clinics. The study explores the prevalence, severity and spectrum of symptoms as well as clinical findings in patients with various combinations of dizziness and neck pain. The aim is to see if these patient groups differ from each other in terms of clinical characteristics, symptoms and quality of life. Additionally, the aim is to examine if there is a relationship between neck dysfunction and dizziness, and last, if the symptoms persist longer in patients with both dizziness and neck pain.
Study Overview
Detailed Description
This is a longitudinal study with data collected at baseline, 6 months and 3 years follow-up.
Variables collected at baseline include age, sex, symptom variables including Dizziness Handicap Inventory, Vertigo Symptom Scale Short Form, Haukeland Dizziness Questionnaire, Visual analog scale, Hospital Anxiety and Depression Scale, RAND-12, dynamic posturography, video-based head impulse test, bithermal caloric tests, Neck Disability Index, as well as neck examinations including pressure algometry and measurements of the range of neck movements.
Follow-up data after 6 months include the same patient-reported outcomes as at baseline.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Bergen, Norway
- Haukeland University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
- Patients referred to the ENT department of Haukeland University Hospital due to vertigo with suspected vestibular origin will be divided into two groups depending on whether or not they report concurrent neck pain.
- Patients referred to the Nordås clinic due to chronic neck pain will be divided into two groups depending on whether or not the report concurrent dizziness.
The healthy controls will be recruited among employees at Haukeland University Hospital.
Description
Inclusion criteria for patients:
- Residence within the Health Region of Western Norway AND
- Referral to the ENT department of Haukeland University Hospital due to vertigo OR
- Referral to Nordås Outpatient Clinic due to neck pain lasting > 3 months
Exclusion criteria for patients:
- Severe orthopaedic or neurologic disease affecting postural balance
- Inability to undergo test protocol due to physical or language barriers
- Quaternary referrals (vestibular schwannomas or divers with vestibular disorders)
Inclusion criteria for healthy controls:
- Employees at Haukeland University Hospital
Exclusion criteria for healthy controls:
- Known neurologic or vestibular disease or ongoing ear disease.
- Neck pain within last 3 months
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Dizziness
Patients referred to a neuro-otological clinic due to dizziness who answer that they do not suffer from neck pain
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Dizziness and neck pain
Patients referred to a neuro-otological clinic due to dizziness who answer that they suffer from neck pain
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Neck pain
Patients referred to a rehabilitation center due to neck pain who answer that they do not suffer from dizziness
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Neck pain and dizziness
Patients referred to a rehabilitation center due to neck pain who answer that the suffer from dizziness
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Healthy Control
Healthy Controls without neck pain or dizziness
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Difference between Groups in the Dizziness Handicap Inventory (DHI)
Time Frame: Baseline and 6 months follow-up
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25-item symptom score.
0-100 Points on dizziness handicap severity
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Baseline and 6 months follow-up
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Difference betwee Groups in the Neck Disability Index (NDI)
Time Frame: Baseline and 6 months follow-up
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10-time symptom score.
0-50 Points on neck disabilty severity
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Baseline and 6 months follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Correlation between Posturography and neck pain
Time Frame: Baseline
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Path length is used as measure of steadiness.
Neck pain is measured With a pressure algometer, measuring the pressure pain threshold of the neck in kilo pascal.
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Baseline
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Stein Helge Glad Nordhal, Professor II, Norwegian National Advisory Unit on Vestibular Disorders
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017/783
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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