TRARO (Traumeel® S in Rotator Cuff Syndrome)-Study
Condition: Rotator Cuff Syndrome; Shoulder Bursitis
MeSH terms: Bursitis; Syndrome; Rotator Cuff Injuries
Study type: Interventional
Phase: Phase 3

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
    

Detailed description: 
      Duration of the study were 16 weeks. Duration of Treatments were 15 days, applying one
      injection of 2 ml od study medication at days 1, 8, and 15. There was a follow up visit at
      day 22 (Primary endpoint), a telephone visit at week 9 and a final visit at week 15.

      Standard descriptive summary statistics were calculated for continuous variables (i.e.
      arithmetic mean, standard deviation, minimum value, median, maximum value, number of
      non-missing values). All statistical analyses in this study were of exploratory nature. The
      summaries of the efficacy parameters, the statistical analyses of the primary efficacy
      variable, and the statistical analyses of the secondary efficacy variables were performed on
      the PP Set. These summaries and analyses were supported by corresponding summaries and
      exploratory statistical analyses performed on the Full Analysis Set. Missing values for all
      efficacy parameters were imputed by the last observation carried forward (LOCF) approach. The
      Modified Per-Protocol (MPP) Set excluded from the PP Set also all patients having taken
      unallowed concomitant medication after Visit 5 and was used as a secondary population for the
      analysis of efficacy. All statistical tests were two-sided with a significance level of
      (alpha) = 0.05, unless specified otherwise. The primary efficacy variable was the change from
      baseline in VAS for abduction rotation pain at Visit 5 (Day 22) (Traumeel® S injections
      versus corticoid injections) for active external rotation.

      A one-sided test of non-inferiority of Traumeel® S with respect to dexamethasone at level
      0.025 was computed using an analysis of covariance (ANCOVA) model with treatment group as
      qualitative factor and the baseline value of the abduction rotation pain VAS for active
      external rotation as a covariate. The test decision was based on a one-sided 97.5% confidence
      interval for the corresponding treatment difference. The non-inferiority margin was set to 13
      mm on a 0 - 100 mm VAS scale.
    

Intervention name(s): Traumeel S inj; Fortecortin/Dexamethasone 8 mg/2 ml inj; Saline inj
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 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
Other intervention name(s): Traumeel; Dexamethasone 8 mg; Placebo inj
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; BB 1101
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment