DizzinessNCT03531619
The Relationship Between Dizziness and Neck Pain
An observational study of Dizziness and Vertigo, run by Haukeland University Hospital at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 to 67 yearsHealthy volunteers can take part
- How many people
- 370 participants
- Where
- 1 siteNorway
- Study dates
- 11 Jul 2017to 1 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 67 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
- Employees at Haukeland University Hospital
Who cannot join
- 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)
- Known neurologic or vestibular disease or ongoing ear disease.
- Neck pain within last 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Keywords
- posturography, quality of life, pressure algometry, cervicogenic dizziness
- Medical subject headings
- Dizziness, Vertigo, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between Groups in the Dizziness Handicap Inventory (DHI)
25-item symptom score. 0-100 Points on dizziness handicap severity
Measured: Baseline and 6 months follow-up
Difference betwee Groups in the Neck Disability Index (NDI)
10-time symptom score. 0-50 Points on neck disabilty severity
Measured: Baseline and 6 months follow-up
Secondary outcomes (1)
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2018
- Study start11 Jul 2017
- Primary completion1 Feb 2024 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DizzinessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 370 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stein Helge Glad Nordhal, Professor II, Study director, Norwegian National Advisory Unit on Vestibular Disorders
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03531619
- Sponsor's protocol ID
- 2017/783
- Status last verified
- Apr 2023
- First submitted
- 12 Mar 2018
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31707980
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dizziness and Neck Pain - is There a Relationship and Does it Matter?
- ClinicalTrials.gov ID
- NCT03531619
- Acronym / sponsor ID
- 2017/783
- Keywords
- posturography, quality of life, pressure algometry, cervicogenic dizziness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 370 participants (estimated)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Study start
- 11 Jul 2017 (actual)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 22 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
- Employees at Haukeland University Hospital
Key exclusion criteria (5 listed)
- 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)
- Known neurologic or vestibular disease or ongoing ear disease.
- Neck pain within last 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
1 secondary outcome
Correlation between Posturography and neck pain
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Derived from this study: PubMed 31707980Knapstad 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.
Related trials for Dizziness
Recruiting
Incremental Vestibulo-ocular Reflex Adaptation as a Novel Treatment for Dizziness in People With Multiple Sclerosis
Multiple Sclerosis
Not yet recruitingObservational study
Validation of the Vestibular Migraine Patient Assessment Tool and Handicap Inventory (VM-PATHI) for Adolescents
Vestibular Migraine
RecruitingEarly Phase 1
Virtual Reality and Biofeedback for Adolescents With Chronic Dizziness
Persistent Postural Perceptual Dizziness, Vestibular Migraine
Recruiting
Effectiveness of Epley Maneuver Versus Semont Maneuver on Dizziness and Balance in Stroke Survivors With Posterior Canal BPPV
Stroke
RecruitingObservational study
Cisplatin-induced Cochlear and Vestibular Damage in Head and Neck Cancer
Ototoxic Hearing Loss, Ototoxicity, Drug-Induced
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stein Helge Glad Nordhal, Professor II study director
Norwegian National Advisory Unit on Vestibular Disorders
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dizziness and Vertigo, run by Haukeland University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between Groups in the Dizziness Handicap Inventory (DHI) (time frame: Baseline and 6 months follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03531619, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2023.