NCT06866587

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
121

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 14, 2019

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

February 27, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 10, 2025

Completed
Last Updated

March 10, 2025

Status Verified

March 1, 2025

Enrollment Period

5.8 years

First QC Date

February 27, 2025

Last Update Submit

March 7, 2025

Conditions

Keywords

elastographyneck paincervical dizziness

Outcome Measures

Primary Outcomes (3)

  • 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."

    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).

    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.

    Patients were invited for follow-up visits at 2, 6, 8 weeks and at 3, 4, 6, and 12 months.

Study Arms (1)

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.

Other: exercise therapy

Interventions

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.

Patients diagnosed with cervical dizziness

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yüzüncü yıl University Faculty of Medicine Dursun Odabas Medical Center

Van, Tuşba, 65090, Turkey (Türkiye)

Location

MeSH Terms

Conditions

DizzinessNeck Pain

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPain

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
asst.prof.dr

Study Record Dates

First Submitted

February 27, 2025

First Posted

March 10, 2025

Study Start

April 14, 2019

Primary Completion

February 1, 2025

Study Completion

February 1, 2025

Last Updated

March 10, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations