Evaluation of Efficacy and Safety of Intradiscal Gelified Ethanol in Refractory Cervical Discogenic Pain

Официальное название

Intradiscal Gelified Ethanol in Refractory Cervical Discogenic Pain : a Interventional, Prospective, Multi-center, Open-label Study.

Обзор

The purpose of this study is to assesse safety and efficacy of the Intradiscal Gelified Ethanol for treatment in refractory cervical discogenic pain.

Подробное описание

After being informed about the study and potential tisks, all patients giving written informed consent will undergo a inclusion visit (CT scan and X ray at least) for study entry. At Day 0, operation with Intradiscal Gelified Ethanol will be performed by the investigator. Follow visit will be performed at 3 months and 12 months

Вмешательства

• Устройство Intradiscal Gelified Ethanol (Discogel)
  Intradiscal percutaneous injection of an intradiscal Gelified Ethanol

Первичные конечные точки

• the mean change in pain intensity assessed by a verbal local rating scale (pain intensity numerical scale) between the pre-treatment measurement (inclusion visi) and the post-treatment measurement (Visit 2 at the 3 months) [Срок оценки: 3 months]

Вторичные конечные точки (5)

• Change in pain cervical intensity using the verbal local rating scale [ [Срок оценки: 12 months]
• Change of consumption of painkillers [Срок оценки: 12 months]
• Incidence of complication and adverse event rates [Срок оценки: 12 months]
• Change in ability to manage everyday-life activity (Neck Disability Index (NDI) scale) [Time Frame : inclusion, 3 and 12 months after treatment]. [Срок оценки: 12 months]
• Subjective evaluation MacNab [Срок оценки: 12 months after treatment]

Критерии участия

Критерии включения

• Patient 18 years or older;
• Pain refractory to conservative treatments for more than 2 months, non-surgical patients
• Cervicobrachialgia due to disc herniation
• Chronic discogenic pain (1 or 2 cervical discs) with concordant MRI;
• Patient agreeing to participate in the study and having given written consent;
• Patient enrolled in a health insurance plan.

Критерии исключения

• Prior surgical treatment of the disc(s) studied;
• Sick leave of more than 12 months secondary to painful symptoms;
• Patient with Modic 1 score or more
• History of cognitive-behavioral disorders that could affect the completion of self-questionnaires;
• Local or systemic infection, or suspicion of infection;
• Severe coagulation disorders;
• Other inflammatory rheumatic disease;
• Severe underlying pathology with life expectancy <1 year;
• Women of childbearing age who are pregnant at the inclusion visit or who wish to become pregnant before the administration of the treatment (V0);
• Known allergy to contrast material and/or local anesthetic substances;
• Patients who cannot read or write Italian;
• Major person benefiting from a legal protection regime (guardianship, curatorship, safeguard of justice);

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Италия · 2 центра

• Santissima Trinità Hospital Ascagliari — Cagliari
• Azienda Ospedaliera Universitaria — Siena

Идентификаторы

NCT: NCT05969392 · CLI01068

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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