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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
200
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.
Participants 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.
Time frame: Baseline to 12 months
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.
Time frame: Baseline, 2 weeks, 6 weeks, 3 months, and 12 months
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.
Time frame: 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.
Time frame: Up to 12 months
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.
Time frame: Baseline to 12 months
Change in Shoulder Range of Motion
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Clinical assessment of active range of motion of the affected shoulder (e.g., abduction, flexion, rotation), evaluated over time and compared between groups.
Time frame: 2 weeks, 6 weeks, 3 months, and 12 months
Change in Shoulder Abduction Range of Motion (Degrees)
Active shoulder abduction range of motion is measured in degrees using a goniometer. The outcome measure is the change from baseline at each follow-up time point.
Time frame: Baseline, 2 weeks, 6 weeks.
Change in Shoulder Flexion Range of Motion (Degrees)
Active shoulder flexion range of motion is measured in degrees using a goniometer. The outcome measure is the change from baseline at each follow-up time point.
Time frame: Baseline, 2 weeks, 6 weeks