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Идёт набор NCT06133712

Dexmedetomidine, Ozone and Dexamethasone Local Injection in Carpal Tunnel Syndrome for Pain Relief

Без фазы С лечением Carpal Tunnel Dexmedetomidine Ozone Dexamethasone

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Dexmedetomidine, Ozone, Dexamethasone.
Кому может быть актуально
Состояния в реестре: Carpal Tunnel, Dexmedetomidine, Ozone, Dexamethasone. Базовые параметры: 20 лет — 60 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Египет
Следующий шаг
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Официальное название

A Comparative Study Between Dexmedetomidine, Ozone and Dexamethasone Local Injection in Carpal Tunnel Syndrome for Long- Term Pain Relief

Обзор

The aim of the present study is to compare the analgesic efficacy of Dexmedetomidine, Ozone and Dexamethasone regional injection in carpal tunnel syndrome.

Подробное описание

Carpal tunnel syndrome (CTS) is a collection of symptoms and signs associated with median neuropathy at the carpal tunnel. Most CTS is related to idiopathic compression of the median nerve as it travels through the wrist at the carpal tunnel.

Corticosteroid injection is an extensively used and accepted treatment in mild to moderate CTS according to the guidelines of the American Academy of Orthopedic Surgeons as corticosteroids reduce the inflammation and edema associated with CTS. However, there is no guideline as to which corticosteroid has to be used as the standard treatment in CTS.

Triamcinolone acetonide, a commonly used steroid for this indication, is a particulate steroid, which can cause permanent nerve injury if accidentally injected into the nerve.

Local ozone injection as a therapeutic option in some musculoskeletal conditions; ozone (O3) gas is a molecule consisting of three oxygen atoms in a dynamically unstable structure. Ozone therapy has been utilized and studied for more than a century.

Вмешательства

  • Препарат Dexmedetomidine
    Patients will receive injection of 1 microgram/kg dexmedetomidine average (70-100-microgram) (0.7-1ml) plus 4ml lidocaine injection nearby median nerve.
  • Препарат Ozone
    Participants will receive a single local injection of 4 ml ozone (10 micrograms/ml) plus to 1 ml lidocaine (1%) using a 25 G needle.
  • Препарат Dexamethasone
    Patients will receive a single local injection of 5 mL (3 mL lidocaine (1%) and 2 mL \[8 mg\] dexamethasone) via the same technique.

Первичные конечные точки

  • The analgesic efficacy and functional status improvement of Dexmedetomidine, Ozone and Dexamethasone regional injection in carpal tunnel syndrome [Срок оценки: Each patient will be assessed at the baseline (before injection) , at 1week, 4weeks, 12weeks, and 24weeks intervals after injection date]
Вторичные конечные точки (3)
  • Median motor nerve conduction study(NCS) evaluation [Срок оценки: Each patient will be assessed at the baseline (before injection) , at 1week, 4weeks, 12weeks, and 24weeks intervals after injection date]
  • Sensory nerve conduction study(NCS) evaluation [Срок оценки: Each patient will be assessed at the baseline (before injection) , at 1week, 4weeks, 12weeks, and 24weeks intervals after injection date]
  • Analgesic requirement [Срок оценки: First 48 hours post injection .]

Критерии участия

Критерии включения

  • Age from 20 to 60 years.
  • Both sexes.
  • Patients with ultrasonographic evidence of mild-to-moderate carpal tunnel syndrome (CTS).
  • Inclusion criteria will include numbness and pain in the median nerve (MN) distribution persisting for minimum of 3 months , nerve conduction studies (NCS) consistent with carpal tunnel syndrome (CTS) as per the American Association of Neuromuscular and Electro diagnostic Medicine (AANEM) guidelines, and an median nerve (MN) cross-sectional area (CSA)at the wrist >12 mm2 suggesting mild-to-moderate CTS forms.

Критерии исключения

  • Patient refusal.
  • Patients with severe symptoms and signs of CTS as identified per the American Association of Neuromuscular and Electro diagnostic Medicine (AANEM) guidelines,\[14\] as this is an indication for surgery,
  • Patients who show improvement on medical treatment,
  • Previous surgical or injectional CTS treatment,
  • Pregnancy ,co existence of brachial plexopathy, or thoracic outlet syndrome, polyneuropathy, radiculopathy and peripheral nerve lesion in upper limb.
  • Severe cardiovascular disease
  • Morbid obese patients (body mass index (BMI) of >35 kg/m2)
  • Infection at site of injection.
  • Bleeding diathesis.
  • History of thyroid deficiency, uncontrolled diabetes mellitus , rheumatoid arthritis and history of glucose-6-phosphate dehydrogenase (G6PD) deficiency
  • History of Ozone or Dexmedetomidine allergy.
  • End stage renal and hepatic disease.
  • History of inflammatory joint , connective tissue disorders, , burns, any local tissue contractures and history of wrist trauma.
  • Patients who will not consent to completing The visual analogue scale (VAS) for pain or nerve conduction study before and after injection.

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
Двойное слепое
Основная цель
Лечение

Центры проведения

Египет · 1 центр
  • Faculty of Medicine — Tanta

Идентификаторы

NCT: NCT06133712 · 36226/12/22

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗