ISRCTN12525856已完成不适用
Open-label trial of intra-articular injections of Hymovis nto the glenohumeral articular space for the treatment of chronic painful shoulder with limitation of motion due to glenohumeral joint osteoarthritis
Fidia Farmaceutici S.p.A.0 个研究点目标入组 50 人开始时间: 2015年4月17日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Male or female aged 45 years or older
- •2. Patient with chronic shoulder pain (due to OA). Chronic shoulder pain is defined as follows:
- •2.1. Persistence for a period of at least 6 months, but not greater than 5 years
- •2.2. Perceived by the patient with a frequency of at least 50% of the days in the month preceding the inclusion visit
- •3. Kellgren-Lawrence Grade 2 or 3 of glenohumeral joint confirmed by a X-ray performed within 3 months from the inclusion visit
- •4. Evidence of glenohumeral concentricity
- •5. At baseline, pain during activity of the target shoulder measured by VAS presenting a score included between 40 and 80 mm
- •6. At baseline, VAS pain of the contralateral shoulder needs to be at least 10 mm less than the target joint and no more than 40 mm
- •7. At inclusion, patient with a limitation of shoulder motion in at least one direction for the following active range of motions:
- •7.1. Abduction with scapula fixed must be = 80°
- •7.2. Internal rotation in abduction must be = 55°
- •7.3. External rotation in abduction must be = 80°
- •These limitations of the shoulder are in comparison to normal expected ranges
- •8. Patient who failed to adequately respond to conservative non-pharmacologic therapy and simple analgesic intake
- •9. Willing and able to understand and sign an approved Informed Consent form
- •10. No pregnancy, nor breastfeeding. Females of childbearing potential (including those less than 1 year post-menopausal) must agree to maintain reliable birth control throughout the study
排除标准
- •1. Presence of adhesive capsulitis by clinical evaluation
- •2. Evidence of rotator cuff lesions
- •3. Presence of primary extra-articular shoulder syndromes (e.g. impingement, bursitis, tendinitis)
- •4. Detection of clinically significant shoulder joint deformities
- •5. Shoulder X-ray findings of acute fractures, severe loss of bone density and/or severe deformity
- •6. Diagnosis of Calcium Pyrophosphate Dihydrate Crystal Deposition Disease (CPPD) or Chondrocalcinosis of the shoulder
- •7. Presence of cervical spine disorder (that could confound the clinical assessment) that have been symptomatic and required active treatment within the past 3 months from inclusion
- •8. Presence of any active musculoskeletal disease that could confound the diagnosis/evaluation of the painful shoulder, or any neurological ethiology of the pain and any acute infection of the joint
- •9. Presence of any major surgery, arthroplasty or arthroscopy in the target shoulder within 6 months of inclusion/or planned surgery within the duration of the study
- •10. Patient in treatment with local radiotherapy for breast cancer
- •11. Patient with rheumatic polymyalgia
- •12. Prior history of any malignancy (with the exception of basal cell carcinoma) of the skin treated less than 2 years ago
- •13. Medical history of recurrent severe allergic or immune-mediated reactions
- •14. Presence of infections and/or skin diseases in the area of the injection site; psoriasis
- •15. Presence of serious gastrointestinal, renal, hepatic, pulmonary, cardiovascular, neurological disease that might interfere with the outcome of the study or the patient’s incapacity to comply with study requirements
- •16. Known or suspected allergic reactions to hyaluronate preparations or paracetamol
- •17. Assumption of i.a. HA products, within 1 month prior to the inclusion visit
- •18. Assumption of bisphosphonates, and/or oral pharmaceutical products containing glucosamine and/or chondroitin sulphate and/or diacerein (e.g., Chondrosulf, Structum 500, Dona, Viatril, Fisiodar, Artrodar etc.) within 1 month prior to the inclusion visit unless on a stable dose for at least 2 months at inclusion visit
- •19. i.a. corticosteroid injections to the target joint in the 3 months prior to inclusion visit
- •20. i.a. corticosteroid injections to any other joint in the month prior to inclusion visit
- •21. Assumption of oral corticosteroid in the month prior to the inclusion visit (inhalator corticosteroid is allowed only)
- •22. Prior use of HA in the target shoulder joint in the 6 months prior to inclusion
- •23. Changes in the physical therapy in the month preceding the inclusion visit or unwillingness to maintain stable regimen
- •24. Patient with history of thyroid insufficiency
- •25. Patient under treatment with anticoagulant drugs
- •26. Patient under treatment with phenobarbital prior to inclusion in the study
- •27. Assumption of analgesic drug (NSAIDs, opioid analgesics, topical analgesics) for any other condition that may interfere with the evaluation of the target shoulder
- •28. Assumption of any other 'investigational' product within 1 month prior to the inclusion visit
- •29. Patient who, in the judgement of the clinical investigator, are likely to be non-compliant or uncooperative during the study
- •30. Female who is pregnant or breastfeeding or not using recognised contraceptive measures
研究者
相似试验
进行中（未招募）
不适用
effectiveness of autologous platelet rich plasma intra articular injection in knee paiCTRI/2022/05/042778ICMR PG THESIS GRANT
已完成
不适用
A phase II study on periarticular injection of Anti-cytokine therapy Magnetic for the treatment of osteoarthritic knee pain.JPRN-UMIN000015666Dept. of Orthopaedic Surgery, Graduate School of Medicine, Chiba University60
进行中（未招募）
1 期
A randomised control trial of knee injections for relief of pain in osteoarthritis: A comparison of corticosteroid and NSAID injectionsKnee osteoarthritis is the condition of interest. Osteoarthritis is a common musculoskeletal complaint, with an underlying pathogenesis related to bio-mechanical stress loading, resulting in initial changes within the articular cartilage, progressing to develop cartilage fibrillationvertical clefts and eventual exposure of subchondral bone and eburnationMedDRA version: 19.0Level: LLTClassification code 10023476Term: Knee osteoarthritisSystem Organ Class: 100000004859EUCTR2016-001906-41-IERoyal College of Surgeons in Ireland
招募中
2 期
Comparison of injection of steroid vs hypertonic dextrose in knee for pain relief in patients of knee arthritisCTRI/2018/05/014227Shashank Kumar
已完成
不适用
A Pilot Study of a Single Intra-articular Injection of Autologous Protein Solution (APS) in Patients with Osteoarthritis (OA) of the Knee.bad kneeOsteoarthritis (OA) of the Knee10023213NL-OMON38437BioMet10