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.
Author(s): Vanden Bossche L(1), Vanderstraeten G(2).
Affiliation(s): Author information:
(1)Physical and Rehabilitation Medicine, Sportsmedicine, Ghent University
Hospital, De Pintelaan 185, 9000, Ghent, Belgium. Luc.VandenBossche@UGent.be.
(2)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.
Publication date & source: 2015, BMC Musculoskelet Disord. , 16:8
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/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 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.
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.
|