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Cervicogenic DizzinessPhase 4NCT07053176

Impact of Local Lidocaine Paravertebral Cervical Injection on Cervicogenic Dizziness Symptoms

A Phase 4 study testing 0.5% Lidocaine and Saline Solution (NaCl 0,9%) in people with Cervicogenic Dizziness, run by Uniter Onlus at 1 site in Italy.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Cervicogenic Dizziness
What is being tested?
0.5% Lidocaine and Saline Solution (NaCl 0,9%)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
42 participants
Where
1 siteItaly
Study dates
1 Aug 2025to 15 Sep 2025
Phase
Phase 4
Are there results?
Not yet: the study is under way

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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Exclusion of these differential diagnoses: (a) Migrainous vertigo (b) Vertigo of central origin (c) Benign paroxysmal positional vertigo (d) Meniere disease (e) Vestibular neuritis (f) Vertigo induced by drugs (g) Psychogenic vertigo (anxiety and/or panic disorder and/or phobia) (h) Orthostatic hypotension
  • presence of trauma or recent surgery in the head, face, neck, or chest; an otorhinolaryngological diagnosis of central or peripheral vertigo, and receiving physiotherapy or other treatment during the study period.
  • allergy to lidocaine

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Italy1 site

  • Uniter Onlus

    Fara in Sabina, Rieti, 02032

Other trials in Italy

About this study

Official title: Usefullnes of Local Lidocaine Paravertebral Cervical Injection on Cervicogenic Dizziness Symptoms Management: a Randomzied Clinical Trial

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.

Read the detailed description

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.

Being tested
0.5% Lidocaine, Saline Solution (NaCl 0,9%)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 0.5% LidocaineDrug

    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 (NaCl 0,9%)Drug

    saline solution will be administered bilaterally in the paravertebral intamuscular region from C2 to C7 with 12 mm 30 G needle

Study groups in NCT07053176
Study groupRoleWhat they receive
LidocaineExperimentalpatients will received lidocaine paravertebral injection
Receives: Drug: 0.5% Lidocaine
ShamPlacebo comparatorpatients will received saline solution paravertebral injection
Receives: Drug: Saline Solution (NaCl 0,9%)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: one monthe

Secondary outcomes (8)

  1. 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.

    Measured: one month

  2. 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.

    Measured: one month

  3. 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.

    Measured: one month

  4. 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

    Measured: one month

  5. 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.

    Measured: one month

  6. 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

    Measured: one month

  7. 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),

    Measured: one month

  8. 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.

    Measured: one month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2025
  2. Study start1 Aug 2025 (estimated)
  3. Primary completion15 Sep 2025 (estimated)
  4. Study completion15 Sep 2025 (estimated)

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07053176
Sponsor's protocol ID
NeuralCGD1
Status last verified
Jun 2025
First submitted
26 Jun 2025
Last updated
8 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Micarelli A, Viziano A, Carlino P, Granito I, Micarelli RX, Alessandrini M. Reciprocal roles of joint position error, visual dependency and subjective perception in cervicogenic dizziness. Somatosens Mot Res. 2020 Dec;37(4):262-270. doi: 10.1080/08990220.2020.1803257. Epub 2020 Aug 10.

    PubMed 32772608

  • Karadas O, Inan LE, Ulas U, Odabasi Z. Efficacy of local lidocaine application on anxiety and depression and its curative effect on patients with chronic tension-type headache. Eur Neurol. 2013;70(1-2):95-101. doi: 10.1159/000350619. Epub 2013 Jul 2.

    PubMed 23839118

  • Raeissadat SA, Rayegani SM, Sadeghi F, Rahimi-Dehgolan S. Comparison of ozone and lidocaine injection efficacy vs dry needling in myofascial pain syndrome patients. J Pain Res. 2018 Jun 29;11:1273-1279. doi: 10.2147/JPR.S164629. eCollection 2018.

    PubMed 29988746

  • Mellick LB, Mellick GA. Treatment of acute orofacial pain with lower cervical intramuscular bupivacaine injections: a 1-year retrospective review of 114 patients. J Orofac Pain. 2008 Winter;22(1):57-64.

    PubMed 18351035

  • Ferrara PE, Ronconi G, Viscito R, Pascuzzo R, Rosulescu E, Ljoka C, Maggi L, Ferriero G, Foti C. Efficacy of mesotherapy using drugs versus normal saline solution in chronic spinal pain: a retrospective study. Int J Rehabil Res. 2017 Jun;40(2):171-174. doi: 10.1097/MRR.0000000000000214.

    PubMed 28125435

  • Micarelli A, Viziano A, Augimeri I, Micarelli B, Capoccia D, Alessandrini M. Diagnostic route of cervicogenic dizziness: usefulness of posturography, objective and subjective testing implementation and their correlation. Disabil Rehabil. 2021 Jun;43(12):1730-1737. doi: 10.1080/09638288.2019.1680747. Epub 2019 Oct 26.

    PubMed 31656108

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing 0.5% Lidocaine and Saline Solution (NaCl 0,9%) in people with Cervicogenic Dizziness, run by Uniter Onlus at 1 site in Italy.

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 3 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: enrolling by invitation, as of the sponsor's last update on 8 Jul 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 Italy. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

Dizziness Handicap Inventory (time frame: one monthe). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07053176, which also lists 6 linked publications.

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 8 Jul 2025.

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