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.
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
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)
Parallel
Paracetamol + Ibuprofen + Famotidine
DrugParticipants 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.
Paracetamol + Ibuprofen
DrugParticipants receive paracetamol (1000 mg) and ibuprofen (400 mg) administered concomitantly over a 14-day period without the addition of famotidine.
Change in Oxford Shoulder Score (OSS)
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.
Change in Pain Intensity (Visual Analog Scale, VAS)
Pain intensity is measured using a Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). The outcome is defined as the change in VAS score from baseline across follow-up time points.
Change in Size of Calcific Deposits on X-ray
Radiographic assessment of calcific deposits in the shoulder using standard X-ray imaging. The outcome measure is the change in size of calcifications (measured in millimeters) from baseline to 3 months.
Use of Additional Therapeutic Interventions
The proportion of patients requiring additional treatments, including physical therapy, extracorporeal shockwave therapy (ESWL), corticosteroid injections, ultrasound-guided barbotage, or arthroscopic surgery.
Incidence of Adverse Events
Number and type of treatment-related adverse events, including gastrointestinal symptoms and other drug-related side effects, recorded throughout the study period.
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