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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 主要终点
- Change in Oxford Shoulder Score (OSS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Paracetamol + Ibuprofen + Famotidine
Paracetamol and ibuprofen are administered in an alternating regimen over 14 days. Famotidine is given once daily during the same period. Patients on chronic pantoprazole therapy temporarily switch to famotidine during treatment.
干预措施: Paracetamol + Ibuprofen + Famotidine (Drug)
Paracetamol + Ibuprofen (No Famotidine)
Paracetamol and ibuprofen are administered concomitantly over 14 days without the addition of famotidine.
干预措施: Paracetamol + Ibuprofen (Drug)
结局指标
主要结局
Change in Oxford Shoulder Score (OSS)
时间窗: Baseline to 12 months
The Oxford Shoulder Score (OSS) is a validated patient-reported questionnaire assessing shoulder pain and function. It consists of 12 items, each scored from 0 to 4, with a total score range of 0 to 48, where higher scores indicate better shoulder function. The primary endpoint is the change in OSS from baseline to follow-up, comparing the two treatment groups.
次要结局
- Change in Pain Intensity (Visual Analog Scale, VAS)(Baseline, 2 weeks, 6 weeks, 3 months, and 12 months)
- Change in Size of Calcific Deposits on X-ray(Baseline to 3 months)
- Use of Additional Therapeutic Interventions(Up to 12 months)
- Incidence of Adverse Events(Baseline to 12 months)
- Change in Shoulder Range of Motion(2 weeks, 6 weeks, 3 months, and 12 months)
- Change in Shoulder Abduction Range of Motion (Degrees)(Baseline, 2 weeks, 6 weeks.)
- Change in Shoulder Flexion Range of Motion (Degrees)(Baseline, 2 weeks, 6 weeks)
研究者
Marin Glavčić
Principal Investigator
University Hospital Dubrava