Enrolling by invitation NCT07053176

Impact of Local Lidocaine Paravertebral Cervical Injection on Cervicogenic Dizziness Symptoms

Phase IV Interventional Cervicogenic Dizziness

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: 0.5% Lidocaine, Saline Solution (NaCl 0,9%).
Who it may be relevant to: Registry conditions: Cervicogenic Dizziness. Basic parameters: 18 years — 80 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Italy
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

Drug 0.5% Lidocaine
0.5% lidocaine injection will be administered in the paravertebral intramuscular region with 12 mm, 30 G needle from C2 to C7 bilaterally
Drug Saline Solution (NaCl 0,9%)
saline solution will be administered bilaterally in the paravertebral intamuscular region from C2 to C7 with 12 mm 30 G needle

Primary outcome measures

Dizziness Handicap Inventory [Time frame: one monthe]

Secondary outcome measures (8)

Neck Disability Index [Time frame: one month]
Neck Pain Intensity [Time frame: one month]
Tampa Scale for Kinesiophobia [Time frame: one month]
Hospital Anxiety and Depression Scale. [Time frame: one month]
The 36-item short form survey (SF-36) [Time frame: one month]
Cervical range of motion [Time frame: one month]
Static posturography testing [Time frame: one month]
Cervical relocation test (CRT) [Time frame: one month]

Eligibility criteria

Inclusion criteria

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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Triple blind
Primary purpose: Treatment

Study locations

Italy · 1 center

Uniter Onlus — Fara in Sabina

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 31656108

Identifiers

NCT: NCT07053176 · NeuralCGD1

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗