Clinical trial NCT03531619: The Relationship Between Dizziness and Neck Pain
Official title: Dizziness and Neck Pain - is There a Relationship and Does it Matter?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dizziness
Vertigo
Neck Pain
Keywords: posturography
quality of life
pressure algometry
cervicogenic dizziness
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
First posted: 2018-05-22
Enrollment: 370
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. 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.
2. 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.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Difference between Groups in the Dizziness Handicap Inventory (DHI)
timeFrame: Baseline and 6 months follow-up
measure: Difference betwee Groups in the Neck Disability Index (NDI)
timeFrame: Baseline and 6 months follow-up
Secondary outcomes:
measure: Correlation between Posturography and neck pain
timeFrame: Baseline
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
Study officials:
affiliation: Norwegian National Advisory Unit on Vestibular Disorders
name: Stein Helge Glad Nordhal, Professor II
role: STUDY_DIRECTOR
References:
citation: Knapstad MK, Goplen FK, Ask T, Skouen JS, Nordahl SHG. Associations between pressure pain threshold in the neck and postural control in patients with dizziness or neck pain - a cross-sectional study. BMC Musculoskelet Disord. 2019 Nov 10;20(1):528. doi: 10.1186/s12891-019-2922-4.