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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03531619
Other study ID # 2017/783
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date July 11, 2017
Est. completion date March 1, 2024

Study information

Verified date April 2023
Source Haukeland University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 370
Est. completion date March 1, 2024
Est. primary completion date February 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 67 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Norway Haukeland University Hospital Bergen

Sponsors (1)

Lead Sponsor Collaborator
Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Difference between Groups in the Dizziness Handicap Inventory (DHI) 25-item symptom score. 0-100 Points on dizziness handicap severity Baseline and 6 months follow-up
Primary Difference betwee Groups in the Neck Disability Index (NDI) 10-time symptom score. 0-50 Points on neck disabilty severity Baseline and 6 months follow-up
Secondary Correlation between Posturography and neck pain 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. Baseline
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