Glucocorticoid, Ozone and 5% Dextrose Local Injection for Pain Relief in Carpal Tunnel Syndrome
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Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Perineural injection with 5% dextrose (D5W)., Local ozone injection, Local glucocorticoid injection (dexamethasone)..
- Кому может быть актуально
- Состояния в реестре: Carpal Tunnel Syndrome (CTS), Glucocorticoid, Pain, Dextrose. Базовые параметры: 18 лет — 65 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
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
A Comparative Study Between Glucocorticoid, Ozone and 5% Dextrose Local Injection for Pain Relief in Carpal Tunnel Syndrome
Обзор
This study aims to compare the efficacy and outcomes of perineural injection with 5% dextrose, local ozone and glucocorticoid injection in the management of carpal tunnel syndrome.
Подробное описание
Carpal Tunnel Syndrome is one of the most common peripheral entrapment neuropathies caused by compression of the median nerve within the carpal tunnel. This condition manifests as pain, numbness, tingling, and weakness, primarily in the thumb, index, and middle fingers. The condition significantly impairs daily activities and diminishes the quality of life, often prompting patients to seek medical interventions .
The pathophysiology of Carpal Tunnel Syndrome involves increased pressure within the carpal tunnel, leading to ischemia and dysfunction of the median nerve. Risk factors include repetitive wrist motions, systemic diseases like diabetes and rheumatoid arthritis, obesity, and hormonal changes during pregnancy .Early identification and treatment are essential to prevent irreversible nerve damage and functional impairment .
Traditional management strategies for Carpal Tunnel Syndrome vary depending on the severity of symptoms. Conservative approaches, including wrist splinting, activity modification, and physical therapy, are typically recommended for mild to moderate cases . However, these methods often provide limited relief, and invasive treatments, such as corticosteroid injections or surgical decompression, may be required for advanced or refractory cases .
In recent years, less invasive alternatives like perineural injection therapies have gained attention as promising options for carpal Tunnel Syndrome management . These therapies aim to reduce inflammation, relieve nerve compression, and promote tissue healing. The substances under investigation in this study include 5% dextrose, ozone, and glucocorticoids .
Dextrose acts as a neuroprotective and anti-inflammatory agent by modulating nociceptive pathways .It promotes tissue repair through proliferative and regenerative mechanisms, reducing local pain and inflammation. While hyperosmolar dextrose solutions may stabilize nerve function by deterring the release of pro-inflammatory cytokines, the effects of Dextrose 5% are primarily attributed to its role as an energy source for neuronal cells and its involvement in metabolic processes associated with neural repair.
Ozone, when used in medical-grade concentrations, exhibits potent anti-inflammatory and antioxidative effects. It neutralizes reactive oxygen species, reduces oxidative stress, and improves local oxygenation. These effects can enhance nerve function and reduce ischemia within the carpal tunnel .
Glucocorticoids, such as dexamethasone, exert their effects by suppressing local inflammatory responses. They inhibit the release of pro-inflammatory mediators, such as prostaglandins and cytokines, providing rapid symptom relief. However, their short-term efficacy and potential for symptom recurrence necessitate careful evaluation.
Despite the availability of these treatments, there is a lack of robust comparative studies to determine their relative efficacy and outcomes. This research aims to fill this gap by comparing the effectiveness of perineural injections with 5% dextrose, local ozone, and glucocorticoids in the management of Carpal Tunnel Syndrome.
Primary outcomes
• Evaluation of electrodiagnostic parameters (median nerve distal motor latency and sensory conduction velocity) at 3 months.
Secondary outcomes
* Evaluation of analgesic efficacy of Dextrose 5%, Ozone and Glucocorticoid local injection in carpal tunnel syndrome via assessment of Visual Analog Scale pain scores after injection by 1 and 3 months. * Evaluation of Analgesic drugs requirement.
Вмешательства
- Препарат Perineural injection with 5% dextrose (D5W).
Group 1: Perineural injection with 5% dextrose (D5W). - Препарат Local ozone injection
Group 2: Local ozone injection - Препарат Local glucocorticoid injection (dexamethasone).
Group 3: Local glucocorticoid injection (dexamethasone).
Первичные конечные точки
- median nerve distal motor latency [Срок оценки: 3 months]
Вторичные конечные точки (1)
- Evaluation of analgesic efficacy via assessment of Visual Analog Scale [Срок оценки: At 1 and 3 months.]
Критерии участия
Критерии включения
- Adults aged 18-65 years with a clinical diagnosis of mild to moderate Carpal Tunnel Syndrome .
- Clinical diagnosis of mild to moderate Carpal Tunnel Syndrome , as classified by Bland neurophysiological classification scale: Mild Carpal Tunnel Syndrome : Slow Distal Sensory Latency(≥3.6 ms), Normal Distal Motor Latency(< 4.5 ms)
- Moderate Carpal Tunnel Syndrome : Slow Distal Sensory Latency (≥ 3.6 ms), Slow Distal Motor Latency (4.5 - 6.4 ms)
- Failure to respond to conservative treatments (e.g., splinting, activity modification, or oral medications) for at least 6 weeks.
Критерии исключения
- Patient refusal.
- Severe Carpal Tunnel Syndrome requiring surgical intervention, as defined by the Bland neurophysiological classification scale: Severe Carpal Tunnel Syndrome: Absent Distal Sensory Latency and Slow Distal Motor Latency (4.5 - 6.4 ms)
- Previous corticosteroid injection for Carpal Tunnel Syndrome within the last 6 months.
- History of wrist trauma, surgery or anatomical abnormalities.
- Systemic conditions such as diabetes mellitus, thyroid dysfunction or rheumatoid arthritis.
- Pregnancy or lactation.
- Contraindications to any of the study interventions (e.g., allergy to glucocorticoids or ozone).
- Infection at wrist.
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
- Профилактика
Центры проведения
Египет · 1 центр
- Tanta University — Tanta
Идентификаторы
NCT: NCT07498998 · 36264MS877/3/25