Paracetamol and Ibuprofen With or Without Famotidine for Calcific Tendinitis of the Shoulder
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: Paracetamol + Ibuprofen + Famotidine, Paracetamol + Ibuprofen.
- Кому может быть актуально
- Состояния в реестре: Calcific Tendinitis. Базовые параметры: от 18 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
- Список центров уточняется — проверьте первичный протокол.
- 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
Randomized Controlled Single-Centre Study Evaluating the Efficacy of Therapy With Paracetamol and Ibuprofen, With and Without Famotidine, in the Treatment of Calcific Tendinitis of the Shoulder
Обзор
This randomized, open-label, single-centre controlled study evaluates the efficacy and safety of combined paracetamol and ibuprofen therapy with versus without famotidine in the treatment of calcific tendinitis of the shoulder. Outcomes include pain reduction, functional improvement, radiological changes, and need for additional interventions over a 12-month follow-up period.
Подробное описание
Calcific tendinitis of the shoulder is a common cause of acute and chronic shoulder pain, often requiring multimodal treatment. Nonsteroidal anti-inflammatory drugs (NSAIDs) and analgesics such as paracetamol are frequently used as first-line therapy; however, gastrointestinal adverse effects remain a concern. Famotidine, a histamine H2 receptor antagonist, may improve gastrointestinal safety and potentially influence treatment tolerability.
This study is a randomized, open-label, single-centre controlled trial conducted in the emergency surgical outpatient setting. The objective is to compare the efficacy and safety of alternating paracetamol and ibuprofen therapy with the addition of famotidine versus the same analgesic regimen without famotidine in patients with calcific tendinitis of the shoulder.
Participants will be randomized into two groups:
Intervention group: alternating paracetamol (1000 mg) and ibuprofen (400 mg) for 14 days with famotidine 40 mg once daily Control group: paracetamol (1000 mg) and ibuprofen (400 mg) administered concomitantly for 14 days without famotidine Patients on chronic pantoprazole therapy will temporarily switch to famotidine during the intervention period.
The primary outcome is the change in pain and shoulder function measured by the Oxford Shoulder Score (OSS) over 12 months. Secondary outcomes include radiographic changes in calcifications, frequency of additional therapeutic interventions (physical therapy, extracorporeal shockwave therapy, corticosteroid injections, barbotage, and arthroscopic surgery), and treatment safety and tolerability.
Patients will be followed at 2 weeks, 6 weeks, 3 months, and 12 months. Assessments include Visual Analog Scale (VAS), OSS questionnaires, range of motion, and radiographic evaluation at 3 months. Adverse events will be monitored throughout the study.
Вмешательства
- Препарат Paracetamol + Ibuprofen + Famotidine
Participants receive alternating doses of paracetamol (1000 mg) and ibuprofen (400 mg) over a 14-day period, together with famotidine 40 mg once daily. Patients on chronic pantoprazole therapy temporarily switch to famotidine during this period. - Препарат Paracetamol + Ibuprofen
Participants receive paracetamol (1000 mg) and ibuprofen (400 mg) administered concomitantly over a 14-day period without the addition of famotidine.
Первичные конечные точки
- Change in Oxford Shoulder Score (OSS) [Срок оценки: Baseline to 12 months]
Вторичные конечные точки (7)
- Change in Pain Intensity (Visual Analog Scale, VAS) [Срок оценки: Baseline, 2 weeks, 6 weeks, 3 months, and 12 months]
- Change in Size of Calcific Deposits on X-ray [Срок оценки: Baseline to 3 months]
- Use of Additional Therapeutic Interventions [Срок оценки: Up to 12 months]
- Incidence of Adverse Events [Срок оценки: Baseline to 12 months]
- Change in Shoulder Range of Motion [Срок оценки: 2 weeks, 6 weeks, 3 months, and 12 months]
- Change in Shoulder Abduction Range of Motion (Degrees) [Срок оценки: Baseline, 2 weeks, 6 weeks.]
- Change in Shoulder Flexion Range of Motion (Degrees) [Срок оценки: Baseline, 2 weeks, 6 weeks]
Критерии участия
Критерии включения
- Age ≥18 years
- Clinical history of shoulder pain consistent with calcific tendinitis
- Presence of calcifications confirmed by shoulder X-ray
- Ability and willingness to comply with study procedures and follow-up
- Signed informed consent
Критерии исключения
- Known allergy or hypersensitivity to paracetamol, ibuprofen, or famotidine
- Active gastrointestinal disease contraindicating NSAID use
- Chronic dual antiplatelet therapy
- Current use of proton pump inhibitors other than pantoprazole (unless temporarily replaced)
- Severe systemic diseases that may interfere with study participation or outcomes
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
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT07539961 · 2025/1024-7