EUCTR2012-003393-12-ES进行中（未招募）不适用
Treatment of rotator cuff syndrome and bursitis: A double blind, controlled trial to assess the efficacy and safety of Traumeel® S injection versus corticosteroid injections and versus placebo - TRARO (Traumeel S in Rotator Cuff Syndrome)-Study
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 160
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •The patients have to meet all of the following 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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 160
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 160
排除标准
- •Exclusion Criteria:
- •Potential study patients will be excluded if one of the following exclusion criteria is present:
- •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 systemic diseasesknown 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.
研究者
相似试验
进行中（未招募）
不适用
Treatment of rotator cuff damage and bursitis (inflammation of the soft tissue around muscles and bones): A double-blind controlled trial to assess the efficacy and safety of Traumeel® S injections versus corticosteroid injections and versus placeborotator cuff syndrome and bursitisMedDRA version: 16.1Level: PTClassification code 10006811Term: BursitisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersMedDRA version: 16.1Level: PTClassification code 10039227Term: Rotator cuff syndromeSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersMedDRA version: 16.1Level: LLTClassification code 10040611Term: Shoulder bursitisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersEUCTR2012-003393-12-DEBiologische Heilmittel Heel GmbH175
进行中（未招募）
1 期
Treatment of rotator cuff damage and bursitis (inflammation of the soft tissue around muscles and bones): A double-blind controlled trial to assess the efficacy and safety of Traumeel® S injections versus corticosteroid injections and versus placeboEUCTR2012-003393-12-BEBiologische Heilmittel Heel GmbH175
已完成
3 期
TRARO (Traumeel® S in Rotator Cuff Syndrome)-StudyRotator Cuff SyndromeShoulder BursitisNCT01702233Biologische Heilmittel Heel GmbH175
进行中（未招募）
不适用
Treatment of chronic rotator cuff tendinopathy with local steroid injection or hypertermia. A Randomized, prospective, clinical study. - NDEUCTR2008-003952-31-ITPOLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
尚未招募
1 期
Clinical study on the treatment of rotator cuff injury by Electroacupuncture at Tiaokou point combined with joint mobilizatiorotator cuff injuryITMCTR1900002691Shanghai Hospital of Traditional Chinese Medicine