A multi-center, double-blind, randomized, placebo-controlled trial protocol to assess Traumeel injection vs XXXX injection in @entity717 : the TRAumeel in @entity717 (TRARO) study protocol.

@entity1 @entity228 @entity730 @entity619 @entity11535 @entity158 @entity2585 @entity717 @entity1443
BACKGROUND: Shoulder @entity158 is a common musculoskeletal symptom with a wide range of potential causes; however, the majority of conditions can be managed with conservative treatment. The aim of this study is to assess the efficacy and safety of Traumeel injections versus @entity228 injections and placebo in the treatment of @entity717 and @entity2585 and expand the current evidence base for the conservative treatment of @entity717 . METHODS/DESIGN: This is a multi-center, randomized, double-blind, 16-week, three-arm, parallel-group, active- and placebo-controlled trial to assess the efficacy and safety of Traumeel 2 ml injection versus @entity619 8 mg injection versus placebo (saline solution). @entity1 will be randomly allocated to Traumeel, @entity619 or placebo in a 2:2:1 randomization. After 1 week screening, @entity1 will receive 3 injections at weekly intervals (days 1, 8 and 15) with additional follow-up assessments on day 22, a telephone consultation in week 9 and a final visit at week 15. Male and female @entity1 aged 40 to 65 years, inclusive, will be recruited if they have acute episodes of @entity717 and/or @entity2585 . @entity1 with @entity730 in the shoulder joint or a complete rotator cuff tear will be excluded. At least 160 @entity1 will be recruited. All subacromial injections will be performed under ultrasound guidance utilizing a common technique. The only rescue medication permitted will be @entity1443 ( @entity1443 ), with usage recorded. The primary endpoint is change from baseline in abduction-rotation @entity158 visual analog scale (0-100 mm scale, 0 corresponds to no @entity158 and 100 to extreme @entity158 ) at day 22 (Traumeel injections versus @entity619 injections) for active external rotation. Secondary efficacy parameters include @entity11535 , disability of arm, shoulder, hand score and @entity1 's/investigator's global assessment. Clinical efficacy will be assessed as non-inferiority of Traumeel with respect to @entity619 regarding the primary efficacy parameter. DISCUSSION: It is hoped that the results of this trial will expand the treatment options and evidence base available for the management of rotator cuff disease. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01702233 . EudraCT number: 2012-003393-12.
