At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Treatment of Rotator Cuff Syndrome and Bursitis: A Double Blind, Controlled Trial to Assess the Efficacy and Safety of Traumeel® S Injection Versus Corticosteroid Injections and Versus Placebo
In Brief
A Phase 3 clinical trial evaluating Traumeel S inj, Fortecortin/Dexamethasone 8 mg/2 ml inj, and 1 other intervention for Rotator Cuff Syndrome and Shoulder Bursitis. Completed, enrolled 175 participants across 1 site.
Detailed Summary
To evaluate functional, clinical, and subjective parameters in patients with rotator cuff syndrome and bursitis treated with Traumeel® S injections versus corticosteroid injections and versus placebo. 160 patients are planned to be randomised (i.e., 64 patients per active treatment group and 32 patients in the placebo group) in 9 investigator sites in Germany, Belgium and Spain. Finally 176 patients have been randomized (73 Traumeel, 67 Fortecortin and 36 Placebo) and 175 of them received at least one dosage of treatment
Study Details
Timeline
Interventions
Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15
Fortecortin/Dexamethasone 8 mg/2 ml inj. subacromial 3 times at days 1, 8 and 15
Saline inj. 2 ml. subacromial 3 times at days 1, 8 and 15