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Table 3 Statistical analyses to be performed

From: A multi-center, double-blind, randomized, placebo-controlled trial protocol to assess Traumeel injection vs dexamethasone injection in rotator cuff syndrome: the TRAumeel in ROtator cuff syndrome (TRARO) study protocol

ANCOVA with treatment group and center as qualitative factors and baseline value as covariate Applicable for analyses at visits 5 and 7 for both treatment comparisons Tr14 injection solution against the comparators dexamethasone and placebo, respectively
• Change from baseline in abduction-rotation pain VAS for active external rotation
• Changes from baseline in ROM for abduction rotation as goniometry in degrees (active external, active internal, passive external, passive internal rotation)
• Changes from baseline in ROM for hand-back range and hand-neck range as distance measurement in cm
• Changes in DASH
Repeated measurements ANCOVA with treatment group, center, visit and treatment-by-visit interaction as qualitative factors and baseline value as covariate Visits 5 and 7 included in analysis; both treatment comparisons Tr14 injection solution against the comparators dexamethasone and placebo, respectively:
• Change from baseline in abduction-rotation pain VAS for active external rotation
Logistic regression model with treatment group, center and baseline value (positive/negative) as qualitative factors Applicable for analyses at visits 5 and 7 for both treatment comparisons Tr14 injection solution against the comparators dexamethasone and placebo, respectively:
• Jobe
• Painful arc
Cochran-Mantel-Haenszel (CMH) test for ordered categorical responses stratified by center Applicable for analyses at visits 5 and 7 for both treatment comparisons Tr14 injection solution against the comparators dexamethasone and placebo, respectively:
• Patient’s global assessment
• Investigator’s global assessment
  1. ANCOVA = analysis of covariance; DASH = disability of arm, shoulder, hand; ROM = range of motion; Tr14 = Traumeel; VAS = visual analog scale.