Rotator Cuff Syndrome Clinical Trial
Official title:
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
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
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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