title: 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.
abstract: BACKGROUND
  Shoulder pain 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 corticosteroid injections and placebo in the treatment of rotator cuff syndrome and bursitis and expand the current evidence base for the conservative treatment of rotator cuff syndrome.
  
  
  METHODS
  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 dexamethasone 8 mg injection versus placebo (saline solution). Patients will be randomly allocated to Traumeel, dexamethasone or placebo in a 2:2:1 randomization. After 1 week screening, patients 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 patients aged 40 to 65 years, inclusive, will be recruited if they have acute episodes of chronic rotator cuff syndrome and/or bursitis. Patients with calcifications in the shoulder joint or a complete rotator cuff tear will be excluded. At least 160 patients will be recruited. All subacromial injections will be performed under ultrasound guidance utilizing a common technique. The only rescue medication permitted will be paracetamol (acetaminophen), with usage recorded. The primary endpoint is change from baseline in abduction-rotation pain visual analog scale (0-100 mm scale, 0 corresponds to no pain and 100 to extreme pain) at day 22 (Traumeel injections versus dexamethasone injections) for active external rotation. Secondary efficacy parameters include range of motion, disability of arm, shoulder, hand score and patient's/investigator's global assessment. Clinical efficacy will be assessed as non-inferiority of Traumeel with respect to dexamethasone regarding the primary efficacy parameter.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT01702233 . EudraCT number: 2012-003393-12.
authors: Physical and Rehabilitation Medicine, Sportsmedicine, Ghent University Hospital, De Pintelaan 185, 9000, Ghent, Belgium. Luc.VandenBossche@UGent.be.
authors: Luc
authors: L
authors: Vanden Bossche
authors: Department of Rehabilitation Sciences and Physical Therapy, Faculty of Medicine and Health Sciences, Ghent University Hospital, De Pintelaan 185, 9000, Ghent, Belgium. Guy.Vanderstraeten@Ugent.be.
authors: Guy
authors: G
authors: Vanderstraeten
mesh_terms: D000328:Adult; D003907:Dexamethasone / Q000008:administration & dosage*; D004311:Double-Blind Method; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage*; D006705:Homeopathy; D006801:Humans; D015552:Injections, Intralesional; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D008903:Minerals / Q000008:administration & dosage*; D010352:Patient Dropouts; D010936:Plant Extracts / Q000008:administration & dosage*; D016059:Range of Motion, Articular; D012107:Research Design; D017006:Rotator Cuff / Q000503:physiopathology; D000070636:Rotator Cuff Injuries; D018401:Sample Size; D020069:Shoulder Pain / Q000188:drug therapy*; D013577:Syndrome; D016896:Treatment Outcome
chemical_list: D005938:Glucocorticoids; D008903:Minerals; D010936:Plant Extracts; C433370:Traumeel S; D003907:Dexamethasone
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