Impact of Local Lidocaine Paravertebral Cervical Injection on Cervicogenic Dizziness Symptoms

NCT ID: NCT07053176

Last Updated: 2025-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE4

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-01

Study Completion Date

2025-09-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cervicogenic Dizziness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Lidocaine

patients will received lidocaine paravertebral injection

Group Type EXPERIMENTAL

0.5% Lidocaine

Intervention Type DRUG

0.5% lidocaine injection will be administered in the paravertebral intramuscular region with 12 mm, 30 G needle from C2 to C7 bilaterally

Sham

patients will received saline solution paravertebral injection

Group Type PLACEBO_COMPARATOR

Saline Solution (NaCl 0,9%)

Intervention Type DRUG

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

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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

1. 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
2. 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.
3. allergy to lidocaine
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Uniter Onlus

OTHER

Sponsor Role lead

Responsible Party

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Alessandro Micarelli

UNITER ONLUS

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Uniter Onlus

Fara in Sabina, Rieti, Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 28125435 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31656108 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32772608 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23839118 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29988746 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18351035 (View on PubMed)

Other Identifiers

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NeuralCGD1

Identifier Type: -

Identifier Source: org_study_id

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