Calcific Tendinitis
Conditions
Keywords
Calcific tendinitis, Shoulder pain, NSAIDs, Famotidine
Brief summary
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
DRUGParacetamol + 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.
Participants receive paracetamol (1000 mg) and ibuprofen (400 mg) administered concomitantly over a 14-day period without the addition of famotidine.
Sponsors
University Hospital Dubrava
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Oxford Shoulder Score (OSS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Intensity (Visual Analog Scale, VAS) | Baseline, 2 weeks, 6 weeks, 3 months, and 12 months | 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 | Baseline to 3 months | 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 | Up to 12 months | 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 | Baseline to 12 months | Number and type of treatment-related adverse events, including gastrointestinal symptoms and other drug-related side effects, recorded throughout the study period. |
| Change in Shoulder Range of Motion | 2 weeks, 6 weeks, 3 months, and 12 months | Clinical assessment of active range of motion of the affected shoulder (e.g., abduction, flexion, rotation), evaluated over time and compared between groups. |
| Change in Shoulder Abduction Range of Motion (Degrees) | Baseline, 2 weeks, 6 weeks. | 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. |
| Change in Shoulder Flexion Range of Motion (Degrees) | Baseline, 2 weeks, 6 weeks | 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. |
Contacts
CONTACTMarin Glavčić, MD
Outcome results
None listed