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Table 2 Schedule of study procedures and events

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

  Visit 1 Screening (max. –7 days) Visit 2 Baseline Day 1 Visit 3 Day 8 ± 1 day Visit 4 Day 15 ± 1 day Visit 5 Day 22 ± 1 day Telephone Week 9 ± 3 days Visit 7 Week 15 ± 3 days
Informed consent X       
Inclusion/exclusion review X X      
Body weight and height X       
Physical examination X       X
Vital signs X X X X X   X
Medical history X*       
Randomization   X      
Shoulder ultrasonography X X**** X**** X****    
Urine for pregnancy test X X      
Clinical laboratory tests X     X   
Telephone visit       X  
Shoulder examination including***        
VAS score X X X X X   X
DASH score
Range of motion*****
Jobe/painful arc test
Patient’s global assessment      X   X
Investigator’s global assessment      X   X
Shoulder injections   X X X    
Previous and concomitant treatments* X* X X X X X X
Rescue medication dispensation X X X X X   
Patient diary dispensation X       
Rescue medication consumption**   X X X X   X
Patient diary collection        X
Study drug accountability   X X X X   X
AEs X X X X X X X
  1. *Patients are to be instructed to discontinue their current pain medication (NSAIDs, analgesics, COX-2 inhibitors) one week prior to baseline visit. No chondroprotective medication is allowed (e.g., among others, glucosamine, chondroitin sulfate, hyaluronic acid, diacerein, native collagen and so-called USA-300 preparation).
  2. **The usage of study rescue medication is generally not allowed within 48 hours before a study visit. At each visit, the patient has to bring the diary with documentation of daily consumption to the site.
  3. ***Bilateral shoulder examination at screening (VAS in target shoulder only).
  4. ****Ultrasound-guidance of subacromial periarticular study drug injections.
  5. *****Range of motion includes abduction rotation (active external, active internal, passive external, passive internal) measured by goniometry and hand-back range and hand-neck range both measured in cm. The active external abduction rotation must be the first movement during shoulder examination for pain VAS determination.
  6. AE = adverse event; COX-2 = cyclo-oxygenase type 2 inhibitors; DASH = Disability of arm, shoulder, hand; NSAID = non-steroidal anti-inflammatory drug; VAS = visual analog scale.