Impact of Local Lidocaine Paravertebral Cervical Injection on Cervicogenic Dizziness Symptoms

NCT07053176 | Enrolling By Invitation Phase 4

• 1 other identifier: NeuralCGD1
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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 technique. patients will be evaluated by subjective and objective testing before the treatment, immediatly and 3 months after the treatment.

Conditions

Cervicogenic Dizziness

Outcome Measures

Primary Outcomes (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

  one monthe

Secondary Outcomes (8)

• Neck Disability Index

  one month

• Neck Pain Intensity

  one month

• Tampa Scale for Kinesiophobia

  one month

• Hospital Anxiety and Depression Scale.

  one month

• The 36-item short form survey (SF-36)

  one month

Study Arms (2)

Lidocaine

EXPERIMENTAL

patients will received lidocaine paravertebral injection

Drug: 0.5% Lidocaine

Sham

PLACEBO COMPARATOR

patients will received saline solution paravertebral injection

Drug: Saline Solution (NaCl 0,9%)

Interventions

0.5% Lidocaine DRUG

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

Lidocaine

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

Sham

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Uniter Onlus: lead

Study Sites (1)

Uniter Onlus

Fara in Sabina, Rieti, 02032, Italy

Location

Related Publications (6)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Interventions

Lidocaine; Saline Solution

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: UNITER ONLUS

Study Record Dates

• First Submitted: June 26, 2025
• First Posted: July 8, 2025
• Study Start: August 1, 2025
• Primary Completion: September 15, 2025
• Study Completion: September 15, 2025
• Last Updated: July 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)