DizzinessdizzinessNCT06866587
Cervical Dizziness in Patients With Acute Non-specific Neck Pain
A study testing exercise therapy in people with Dizziness and Neck Pain, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
Acute non-specific neck pain (ANSNP) is one of the causes of cervicogenic dizziness (CD).To investigate the severity of CD in patients with ANSNP and to determine the efficacy of the treatment and follow-up. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Dizziness, Neck Pain, Elastography
- What is being tested?
- exercise therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Apr 2019to 1 Feb 2025
- Phase
- Interventional
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Inclusion criteria were as follows: pain on palpation in the neck area, neck stiffness, tension and tenderness in the neck muscles, and cervical movement limitation. All the patients included in the study had no history of a maneuver for dizziness, no history of ototoxic drug use, and had normal hearing.
Who cannot join
- Exclusion criteria included presence of benign paroxysmal positional vertigo (BPPV), Meniere's disease, migraine-associated vertigo, vertebrobasilar insufficiency, postural hypotension, a history of trauma to the cervical region, myofascial pain syndrome, and neurological, rheumatological, and systemic diseases. Additionally, patients detected with neck-related conditions (cervical spondylosis, cervical disc hernia, fracture, dislocation, spondylolisthesis, scoliosis) and fibromyalgia in cervical magnetic resonance imaging (MRI) were also excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Yüzüncü yıl University Faculty of Medicine Dursun Odabas Medical Center
Van, Tuşba, 65090
About this study
Official title: Evaluation of Proprioceptive Sense in Patients With Acute Non-specific Neck Pain and Elucidation of Its Relationship With Cervical Vertigo.
Acute non-specific neck pain (ANSNP) is one of the causes of cervicogenic dizziness (CD).To investigate the severity of CD in patients with ANSNP and to determine the efficacy of the treatment and follow-up.
Read the detailed description
The primary aim of this study was to investigate the contribution of cervical proprioception impairment to the development of cervical dızzıness in patients with acute non specific neck pain and to determine the efficacy of the treatment and follow-up performed in patients coexisting with cervical dizziness and nonspecific neck pain. Our hypothesis was that the objective measurement of muscle stiffness with shear-wave elastography could aid in the differential diagnosis in patients coexisting with cervical dizziness and non specific neck pain.
- Conditions
- Dizziness, Neck Pain, Elastography
- Being tested
- exercise therapy
- Keywords
- elastography, neck pain, cervical dizziness
- Medical subject headings
- Dizziness, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise therapyOther
Priorities of the treatment included care and interventions to avoid inappropriate neck positions and to provide a regular exercise program for neck muscles and ergonomics training (ergonomic arrangements for desk setup, reading position, computer and mobile phone use, handcrafts, television watching, and pillow height). Of note, patients were advised to avoid cold exposure, particularly in the neck area (air-conditioned environments, wet hair, and holding the hair dryer too close to the scalp). Patients that did not show improvement after training and regular exercise were initiated on medical treatment after the second week and were given myorelaxant gel and oral tablets (diclofenac sodium) for the neck area.
| Study group | Role | What they receive |
|---|---|---|
| Patients diagnosed with cervical dizziness | Other | A patient-specific, comprehensive clinical examination was performed in each patient. In addition, a detailed patient history was obtained from each patient. To diagnose CD, Head- Neck Differentiation Test (HNDT) and Cervical Torsion Test (CTT) were performed using Frenzel lenses. Patients that were found to be positive in either of these two tests after the exclusion of other peripheral and central causes were diagnosed with cervical Dizziness. Receives: Other: exercise therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck pain Visual analog scale scores
Neck Pain Visual Analogue Scale (Neck-VAS) consists of an 11-point numerical rating scale, in which 0 indicates "no pain at all" and 10 indicates "worst possible pain."
Measured: Patients were invited for follow-up visits at 2, 6, 8 weeks and at 3, 4, 6, and 12 months.
Dizziness Handicap Inventory,
Disability Index (NDI), developed as a modification of the Oswestry Disability Index, was used to assess neck pain-specific disability. NDI consists of 10 items including (i) pain, (ii) personal care, (iii) lifting, (iv) reading, (v) headaches, (vi) concentration, (vii) work, (viii) driving, (ix) sleeping, and (x) recreation. Each item is rated on a 6-point Likert scale (0= no disability, 5= total disability) and the scoring intervals for interpretation include 0-4 (no limitation), 5-14 (mild limitation), 15-24 (moderate limitation), 25-34 (severe limitation), and above 34 (completely limited).
Measured: Patients were invited for follow-up visits at 2, 6, 8 weeks and at 3, 4, 6, and 12 months.
Vertigo Dizziness Imbalance Symptom Scale (VDI-SS),
Vertigo Dizziness Imbalance Symptom Scale (VDI-SS) is used to assess head imbalance and the severity and frequency of dizziness symptoms. The scale consists of 14 items scored between 0 and 5. Vertigo Dizziness Imbalance Quality of Life Scale (VDI- QOLS) consists of 22 items scored between 0 and 5 and the severity of the symptoms is evaluated based on the total score.
Measured: Patients were invited for follow-up visits at 2, 6, 8 weeks and at 3, 4, 6, and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start14 Apr 2019
- Primary completion1 Feb 2025
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A number of questionnaires were administered to the patients, including Demographic Data Form, Neck Pain Visual Analogue Scale (Neck-VAS), Neck Disability Index (NDI), Dizziness Handicap Inventory (DHI), Dizziness Visual Analogue Scale (Dizziness-VAS), Vertigo Dizziness Imbalance Symptom Scale (VDI-SS), and Quality of Life Scale (VDI-QOLS) both before and after treatment. Patients that had a recurrent attack of CD during the follow-up period underwent shear-wave elastography (SWE) for the assessment of the stiffness of neck muscles.
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Semra Ağırbaş, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06866587
- Sponsor's protocol ID
- 04.04.2019/ 2019-07
- Acronym
- dizziness
- Status last verified
- Mar 2025
- First submitted
- 27 Feb 2025
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Proprioceptive Sense in Patients With Acute Non-specific Neck Pain and Elucidation of Its Relationship With Cervical Vertigo.
- ClinicalTrials.gov ID
- NCT06866587
- Acronym / sponsor ID
- dizziness / 04.04.2019/ 2019-07
- Conditions
- Dizziness, Neck Pain, Elastography
- Keywords
- elastography, neck pain, cervical dizziness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 14 Apr 2019 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 10 Mar 2025 (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.
Acute non-specific neck pain (ANSNP) is one of the causes of cervicogenic dizziness (CD).To investigate the severity of CD in patients with ANSNP and to determine the efficacy of the treatment and follow-up.
Detailed description
The primary aim of this study was to investigate the contribution of cervical proprioception impairment to the development of cervical dızzıness in patients with acute non specific neck pain and to determine the efficacy of the treatment and follow-up performed in patients coexisting with cervical dizziness and nonspecific neck pain. Our hypothesis was that the objective measurement of muscle stiffness with shear-wave elastography could aid in the differential diagnosis in patients coexisting with cervical dizziness and non specific neck pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A number of questionnaires were administered to the patients, including Demographic Data Form, Neck Pain Visual Analogue Scale (Neck-VAS), Neck Disability Index (NDI), Dizziness Handicap Inventory (DHI), Dizziness Visual Analogue Scale (Dizziness-VAS), Vertigo Dizziness Imbalance Symptom Scale (VDI-SS), and Quality of Life Scale (VDI-QOLS) both before and after treatment. Patients that had a recurrent attack of CD during the follow-up period underwent shear-wave elastography (SWE) for the assessment of the stiffness of neck muscles.
| Arm | Type | Receives |
|---|---|---|
| Patients diagnosed with cervical dizziness | Other | Other: exercise therapyA patient-specific, comprehensive clinical examination was performed in each patient. In addition, a detailed patient history was obtained from each patient. To diagnose CD, Head- Neck Differentiation Test (HNDT) and Cervical Torsion Test (CTT) were performed using Frenzel lenses. Patients that were found to be positive in either of these two tests after the exclusion of other peripheral and central causes were diagnosed with cervical Dizziness. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Inclusion criteria were as follows: pain on palpation in the neck area, neck stiffness, tension and tenderness in the neck muscles, and cervical movement limitation. All the patients included in the study had no history of a maneuver for dizziness, no history of ototoxic drug use, and had normal hearing.
Key exclusion criteria (1 listed)
- Exclusion criteria included presence of benign paroxysmal positional vertigo (BPPV), Meniere's disease, migraine-associated vertigo, vertebrobasilar insufficiency, postural hypotension, a history of trauma to the cervical region, myofascial pain syndrome, and neurological, rheumatological, and systemic diseases. Additionally, patients detected with neck-related conditions (cervical spondylosis, cervical disc hernia, fracture, dislocation, spondylolisthesis, scoliosis) and fibromyalgia in cervical magnetic resonance imaging (MRI) were also excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercise therapyPriorities of the treatment included care and interventions to avoid inappropriate neck positions and to provide a regular exercise program for neck muscles and ergonomics training (ergonomic arrangements for desk setup, reading position, computer and mobile phone use, handcrafts, television watching, and pillow height). Of note, patients were advised to avoid cold exposure, particularly in the neck area (air-conditioned environments, wet hair, and holding the hair dryer too close to the scalp). Patients that did not show improvement after training and regular exercise were initiated on medical treatment after the second week and were given myorelaxant gel and oral tablets (diclofenac sodium) for the neck area. | Other | Patients diagnosed with cervical dizziness |
Primary outcome
Neck pain Visual analog scale scores
Time frame: Patients were invited for follow-up visits at 2, 6, 8 weeks and at 3, 4, 6, and 12 months.
Neck Pain Visual Analogue Scale (Neck-VAS) consists of an 11-point numerical rating scale, in which 0 indicates "no pain at all" and 10 indicates "worst possible pain."
Dizziness Handicap Inventory,
Time frame: Patients were invited for follow-up visits at 2, 6, 8 weeks and at 3, 4, 6, and 12 months.
Disability Index (NDI), developed as a modification of the Oswestry Disability Index, was used to assess neck pain-specific disability. NDI consists of 10 items including (i) pain, (ii) personal care, (iii) lifting, (iv) reading, (v) headaches, (vi) concentration, (vii) work, (viii) driving, (ix) sleeping, and (x) recreation. Each item is rated on a 6-point Likert scale (0= no disability, 5= total disability) and the scoring intervals for interpretation include 0-4 (no limitation), 5-14 (mild limitation), 15-24 (moderate limitation), 25-34 (severe limitation), and above 34 (completely limited).
Vertigo Dizziness Imbalance Symptom Scale (VDI-SS),
Time frame: Patients were invited for follow-up visits at 2, 6, 8 weeks and at 3, 4, 6, and 12 months.
Vertigo Dizziness Imbalance Symptom Scale (VDI-SS) is used to assess head imbalance and the severity and frequency of dizziness symptoms. The scale consists of 14 items scored between 0 and 5. Vertigo Dizziness Imbalance Quality of Life Scale (VDI- QOLS) consists of 22 items scored between 0 and 5 and the severity of the symptoms is evaluated based on the total score.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Dizziness
Recruiting
Fall Risk Assessment and Speech Intelligibility Enhancement Using In-ear Device
Hearing Loss, Dizziness
Recruiting
Incremental Vestibulo-ocular Reflex Adaptation as a Novel Treatment for Dizziness in People With Multiple Sclerosis
Multiple Sclerosis
RecruitingEarly Phase 1
Virtual Reality and Biofeedback for Adolescents With Chronic Dizziness
Persistent Postural Perceptual Dizziness, Vestibular Migraine
Not yet recruitingObservational study
Validation of the Vestibular Migraine Patient Assessment Tool and Handicap Inventory (VM-PATHI) for Adolescents
Vestibular Migraine
Recruiting
Effectiveness of Epley Maneuver Versus Semont Maneuver on Dizziness and Balance in Stroke Survivors With Posterior Canal BPPV
Stroke
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise therapy in people with Dizziness and Neck Pain, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 10 Mar 2025. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Neck pain Visual analog scale scores (time frame: Patients were invited for follow-up visits at 2, 6, 8 weeks and at 3, 4, 6, and 12 months.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Mar 2025.