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The Relationship Between Dizziness and Neck Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03531619
Recruitment Status : Active, not recruiting
First Posted : May 22, 2018
Last Update Posted : August 26, 2021
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease
Dizziness Vertigo 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.

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Study Type : Observational
Estimated Enrollment : 370 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Dizziness and Neck Pain - is There a Relationship and Does it Matter?
Actual Study Start Date : July 11, 2017
Estimated Primary Completion Date : February 1, 2022
Estimated Study Completion Date : March 1, 2022

Resource links provided by the National Library of Medicine


Group/Cohort
Dizziness
Patients referred to a neuro-otological clinic due to dizziness who answer that they do not suffer from neck pain
Dizziness and neck pain
Patients referred to a neuro-otological clinic due to dizziness who answer that they suffer from neck pain
Neck pain
Patients referred to a rehabilitation center due to neck pain who answer that they do not suffer from dizziness
Neck pain and dizziness
Patients referred to a rehabilitation center due to neck pain who answer that the suffer from dizziness
Healthy Control
Healthy Controls without neck pain or dizziness



Primary Outcome Measures :
  1. Difference between Groups in the Dizziness Handicap Inventory (DHI) [ Time Frame: Baseline and 6 months follow-up ]
    25-item symptom score. 0-100 Points on dizziness handicap severity

  2. Difference betwee Groups in the Neck Disability Index (NDI) [ Time Frame: Baseline and 6 months follow-up ]
    10-time symptom score. 0-50 Points on neck disabilty severity


Secondary Outcome Measures :
  1. Correlation between Posturography and neck pain [ Time Frame: Baseline ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 67 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03531619


Locations
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Norway
Haukeland University Hospital
Bergen, Norway
Sponsors and Collaborators
Haukeland University Hospital
Investigators
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Study Director: Stein Helge Glad Nordhal, Professor II Norwegian National Advisory Unit on Vestibular Disorders
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT03531619    
Other Study ID Numbers: 2017/783
First Posted: May 22, 2018    Key Record Dates
Last Update Posted: August 26, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Haukeland University Hospital:
posturography
quality of life
pressure algometry
cervicogenic dizziness
Additional relevant MeSH terms:
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Vertigo
Neck Pain
Dizziness
Pain
Neurologic Manifestations
Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Nervous System Diseases
Sensation Disorders