TRARO (Traumeel® S in Rotator Cuff Syndrome)-Study
Condition: Rotator Cuff Syndrome; Shoulder Bursitis
MeSH terms: Bursitis; Syndrome; Rotator Cuff Injuries
Intervention: Traumeel S inj; Fortecortin/Dexamethasone 8 mg/2 ml inj; Saline inj
Intervention description: Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15; Fortecortin/Dexamethasone 8 mg/2 ml inj. subacromial 3 times at days 1, 8 and 15; Saline inj. 2 ml. subacromial 3 times at days 1, 8 and 15
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; BB 1101
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 175.0
Sex: All
Minimum age: 40 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      To evaluate functional, clinical, and subjective parameters in patients with rotator cuff
      syndrome and bursitis treated with Traumeel® S injections versus corticosteroid injections
      and versus placebo. 160 patients are planned to be randomised (i.e., 64 patients per active
      treatment group and 32 patients in the placebo group) in 9 investigator sites in Germany,
      Belgium and Spain.

      Finally 176 patients have been randomized (73 Traumeel, 67 Fortecortin and 36 Placebo) and
      175 of them received at least one dosage of treatment
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male and female patients with acute episodes of chronic rotator cuff syndrome and/or
             bursitis: tendinopathy of the supraspinatus tendon, bursitis, or partial degenerative
             tears of the supraspinatus and/or infraspinatus tendon (differentiation by
             ultrasonography)

          2. Age 40 to 65 years, inclusive

          3. Willing and able to understand and sign an approved informed consent form

          4. Not pregnant (as proven by negative pregnancy test before first study drug
             administration) or breast-feeding. Females of childbearing potential (including those
             less than one year post-menopausal) must agree to maintain reliable birth control
             throughout the study, i.e. an established use of oral, injected or implanted hormonal
             contraception, female sterilization by hysterectomy, bilateral oophorectomy, or
             bilateral tubal exeresis, intrauterine device ([IUD] or coil or barrier method (e.g.
             diaphragm, cervical/vault cap) plus spermicidal cream/gel

        Exclusion Criteria:

          1. Calcifications in shoulder joint

          2. Complete rotator cuff tears

          3. Treatment with non-steroidal anti-inflammatory drugs (NSAIDs). Previous treatment with
             NSAIDs is allowed, with a wash-out period of 1 week; paracetamol can be taken until 48
             hours before baseline visit

          4. Corticoid therapy by mouth or by injection within the previous 3 months prior to
             screening

          5. Any contraindication for corticoid therapy

          6. Physical Therapy, acupuncture, transcutaneous electrical nerve stimulation (TENS) and
             shock-wave therapy (within 30 days prior to screening)

          7. Treatment with anticoagulants (except low-dose aspirin)

          8. Diabetic patients including borderline cases (glycosylated fraction of hemoglobin
             [HbA1c] > 7.0% at screening)

          9. Clinically significant shoulder joint deformities

         10. Major injury, including sports-related injury, to the shoulder within the past year

         11. Significant osteoarthritis of the shoulder

         12. Cervical spine disorder (that could confound the clinical assessment) that has been
             symptomatic and required active treatment within the past three months before
             screening

         13. Any active musculoskeletal disease that could confound the diagnosis/evaluation of the
             painful shoulder, any neurological aetiology of the pain, or any acute infection of
             the shoulder joint

         14. Any major surgery, arthroplasty, or arthroscopy in the signal shoulder within 6 months
             of screening or planned surgery within the duration of the study

         15. Prior history of any malignancy (with the exception of basal cell carcinoma) treated
             less than 2 years ago

         16. Patients with rheumatic polymyalgia

         17. Known or suspected allergies against one or any particular ingredients of Traumeel® S
             or of other study preparations

         18. Presence of serious gastrointestinal, renal, hepatic, pulmonary, cardiovascular,
             neurological disease or other known systemic disease (like leukemia, tuberculosis,
             immune mediated diseases, multiple sclerosis, Acquired Immuno Deficiency Syndrome,
             Human Immunodeficiency Virus-infections or other chronic virus-infections) that might
             interfere with the outcome of the study or the patient's ability to comply with study
             requirements.

         19. Presence of infections and/or skin diseases in the area of the injection site
             (including psoriasis)

         20. Clinically significant abnormal laboratory values (as judged of the investigator) at
             the screening visit

         21. Consumption of any investigational product within one month prior to the screening
             visit

         22. Patients who are likely to be non-compliant or uncooperative during the study, as
             judged by the investigator.