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

Table 2 Schedule of study procedures and events

	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

*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).
**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.
***Bilateral shoulder examination at screening (VAS in target shoulder only).
****Ultrasound-guidance of subacromial periarticular study drug injections.
*****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.
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.

ISSN: 1471-2474