A Phase 4 interventional study of 0.5% Lidocaine and Saline Solution (NaCl 0,9%) in Cervicogenic Dizziness, sponsored by Uniter Onlus. Enrolling by invitation at 1 site in Italy. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-07-08.
Sponsored by Uniter Onlus · Phase 4, Interventional, and Treatment
at least 42 patients affected by cervicogenic dizziness will be allocated to the experimental group or in the placebo group. in the first group patients will received 2 paravertebral intramuscular injection of lidocaine 0.5% while in the placebo group they will received saline solution with the same injection technique. patients will be evaluated by subjective and objective testing before the treatment, immediatly and 3 months after the treatment.
at least 42 patients affected by cervicogenic dizziness will be allocated to the experimental group or in the placebo group. in the first group patients will received 2 paravertebral intramuscular injection of lidocaine 0.5% while in the placebo group they will received saline solution with the same injection technique. patients will be evaluated by subjective and objective testing before the treatment, immediatly and 3 months after the treatment. subjective testing will include dizziness handicap inventory, Neck Disability Index, Neck Pain Intensity, Tampa Scale for Kinesiophobia, Hospital Anxiety and Depression Scale. Objective testing will include cervical range of motion, joint position error and static posturography testing.
1) presence of a subjective feeling of dizziness associated with pain, movement, rigidity, or certain positions of the neck at least from 3months; 2) Cervical pain, trauma, and/or disease (3) If from traumatic origin, there has to be a temporal proximity between the onset of dizziness and the neck injury.
Exclusion Criteria:
patients will received lidocaine paravertebral injection
Drug: 0.5% Lidocaine
patients will received saline solution paravertebral injection
Drug: Saline Solution (NaCl 0,9%)
0.5% lidocaine injection will be administered in the paravertebral intramuscular region with 12 mm, 30 G needle from C2 to C7 bilaterally
saline solution will be administered bilaterally in the paravertebral intamuscular region from C2 to C7 with 12 mm 30 G needle
Dizziness Handicap Inventory
Dizziness Handicap Inventory version comprises 25 questions designed to assess a patient's functional (9 questions), emotional (9 questions), and physical (7 questions) limitations on a three-point scale, with higher scores reflecting greater perceived handicap
Time frame: one monthe
Neck Disability Index
This is conceived in a single-factor structure including 10 items to survey different activities of daily living on a 6-point Likert-type scale (from 0 to 5). Higher values score more severe pain and worse disability.
Time frame: one month
Neck Pain Intensity
Neck Pain Intensity will be assessed by means of the visual analogue scale for pain. This reliable tool is conceived as a 100-mm horizontal line between the extremes 'no pain' and 'worst imaginable pain', on the left and on the right respectively.
Time frame: one month
Tampa Scale for Kinesiophobia
Within this 17 item self-report tool each question will be scored using a 4-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree); 4 questions (4, 8, 12 and 16) were negatively worded and reversely scored. Higher values score a higher degree of kinesiophobia.
Time frame: one month
Hospital Anxiety and Depression Scale.
This self-administered tool includes 14 questions, rated on a 4-point Likert type scale (from 0 to 3 points), with higher scores reflecting abnormal anxiety and depression levels. The questionnaire encompasses two subscales of seven items that evaluate anxiety and depression, respectively
Time frame: one month
The 36-item short form survey (SF-36)
The 36-item short form survey (SF-36) was used for general health-related quality of life (Qol) assessment. the sf-36 is an established, validated, generic instrument that measures health-related Qol in diverse patient populations. it is based on a 36-item questionnaire with eight subscales and two component summaries of physical and mental health related QOL.
Time frame: one month
Cervical range of motion
A cervical range of motion goniometer (Performance Attainment Associates, 3550 Lahore Rd, St Paul, MN), which has been shown to be a reliable tool with good validity, will be used to measure cervical spine movements. Active flexion, extension, left and right rotation, and left and right lateral flexion have been measured three times and then averaged
Time frame: one month
Static posturography testing
Each patient will be instructed to keep an upright position on a standardized platform for static posturography (ED800 Medi-Care Solutions S.R.L. Euroclinic). The recording period will be 60s for each test (eyes closed or open while standing on the stiff platform) and the sampling frequency in the time domain was 25Hz. The center of pressure will be monitored, while performing the test. The posturographic parameters considered in our study will be the trace length (length), the surface of the ellipse of confi dence (surface),
Time frame: one month
Cervical relocation test (CRT)
This test will be used to evaluate cervical proprioception. According to previous protocols, a headlamp with an integrated laser pointer is placed in the centre of the patient's forehead. The subject keeps a neutral head and neck position as he seats at 90cm from a wall in front of him. The point emitted by the laser pointer is then centred on a target fixed on the wall. We will use the target created by Rob Landel. With his eyes closed, the subject turns his head to the right, comes back to the initial position, and indicates verbally when he thinks his head is centred. Left rotation, flexion, and extension were also evaluated. Each movement is repeated three times and the patient opens his eyes and re-centers on the target between each measure. To assess the patient's result, we will calculated the mean distance in centimetres between eachpoint and the centre of the target, for each head position.
Time frame: one month
Plan to share: No
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