Paracetamol and Ibuprofen With or Without Famotidine for Calcific Tendinitis of the Shoulder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Paracetamol + Ibuprofen + Famotidine, Paracetamol + Ibuprofen.
- Who it may be relevant to
- Registry conditions: Calcific Tendinitis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Detailed description
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.
Interventions
- Drug 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. - Drug Paracetamol + Ibuprofen
Participants receive paracetamol (1000 mg) and ibuprofen (400 mg) administered concomitantly over a 14-day period without the addition of famotidine.
Primary outcome measures
- Change in Oxford Shoulder Score (OSS) [Time frame: Baseline to 12 months]
Secondary outcome measures (7)
- Change in Pain Intensity (Visual Analog Scale, VAS) [Time frame: Baseline, 2 weeks, 6 weeks, 3 months, and 12 months]
- Change in Size of Calcific Deposits on X-ray [Time frame: Baseline to 3 months]
- Use of Additional Therapeutic Interventions [Time frame: Up to 12 months]
- Incidence of Adverse Events [Time frame: Baseline to 12 months]
- Change in Shoulder Range of Motion [Time frame: 2 weeks, 6 weeks, 3 months, and 12 months]
- Change in Shoulder Abduction Range of Motion (Degrees) [Time frame: Baseline, 2 weeks, 6 weeks.]
- Change in Shoulder Flexion Range of Motion (Degrees) [Time frame: Baseline, 2 weeks, 6 weeks]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07539961 · 2025/1024-7