- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06866587
Cervical Dizziness in Patients With Acute Non-specific Neck Pain (dizziness)
March 7, 2025 updated by: Semra Ağırbaş, Yuzuncu Yıl University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
121
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tuşba
-
VAN, Tuşba, Turkey, 65090
- Yüzüncü yıl University Faculty of Medicine Dursun Odabas Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Patients diagnosed with cervical dizziness
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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."
|
Patients were invited for follow-up visits at 2, 6, 8 weeks and at 3, 4, 6, and 12 months.
|
|
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).
|
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),
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.
|
Patients were invited for follow-up visits at 2, 6, 8 weeks and at 3, 4, 6, and 12 months.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 14, 2019
Primary Completion (Actual)
February 1, 2025
Study Completion (Actual)
February 1, 2025
Study Registration Dates
First Submitted
February 27, 2025
First Submitted That Met QC Criteria
March 7, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
March 7, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 04.04.2019/ 2019-07
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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