Impact of Local Lidocaine Paravertebral Cervical Injection on Cervicogenic Dizziness Symptoms

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 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
• Препарат 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

Первичные конечные точки

• Dizziness Handicap Inventory [Срок оценки: one monthe]

Вторичные конечные точки (8)

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

Критерии участия

Критерии включения

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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

• Uniter Onlus — Fara in Sabina

Публикации

• 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

Идентификаторы

NCT: NCT07053176 · NeuralCGD1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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