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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
121

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Turkey
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: exercise therapy
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yuzuncu Yıl University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 14, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 27, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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