DRKS00031611招募中Unknown
Single-arm feasibility trial to assess the technical/medical performance and safety of locally applied electromagnetic frequency therapy in patients with knee osteoarthritis (OA) - e.CHIGonA1
Praxis für Sport-Chirurgie0 个研究点目标入组 28 人开始时间: 2023年11月28日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 28
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 80 Years（—）
- 性别
- All
入选标准
- •1. confirmed diagnosis of osteoarthritis of the knee joint
- •2. Diagnosis confirmed by imaging (knee x-ray) not older than 3 months;
- •3. Kellgren-Lawrence score grade II to III;
- •4. average pain intensity during the last 3 days of at least 5 out of 10 points on the 11-point NRS;
- •5. disease duration = 6 weeks;
- •6. age 18 to 80 years;
- •7. adequate communication skills;
- •8. the patient must be able to understand the nature, significance and scope of the clinical trial and to give informed consent accordingly;
排除标准
- •1. BMI > 35 (obesity grade II);
- •2. Disease duration longer than 5 years;
- •3. indication for knee arthroplasty;
- •4. in women: Pregnancy;
- •5. participation in another interventional study within the last 30 days prior to the start of therapy;
- •6. current pension applications;
- •7. cardiac pacemaker;
- •8. previous electromagnetic frequency therapy using the e.CHI FrequencyChip on the affected knee within the last year;
- •9. any type of injection into the affected knee joint (e.g. cortisone, hyaluronic acid, etc.) within the 12 weeks prior to the start of treatment
- •10. use of systemic analgesics within the last 24 hours prior to starting therapy;
- •11. use of systemically acting cortisone preparations within the last 12 weeks prior to the start of therapy;
- •12. use of opiates within the last 6 months prior to starting therapy;
- •13. any surgery, including arthroscopy, on the knee joint to be treated during the previous 3 months;
- •14. any history of fracture of the knee joint to be treated
- •15. any history of systemic or inflammatory joint disease (e.g. rheumatoid or autoimmune arthritis or Reiter's disease)
- •17. pain syndromes of other aetiologies (lumboischialgia, hip pain, etc.)
- •18. spinal cord syndromes (e.g. radiculitis)
- •19. lower extremity nerve compression syndromes;
- •20. organic cerebral psychosyndrome;
- •21. alcoholism;
- •22. addiction to analgesics, drugs or opiates;
- •23. local infections;
- •24. peripheral neuropathy;
- •25. renal disease requiring dialysis;
- •26. known diabetes mellitus;
- •27. arterial or venous occlusive disease of the lower extremities;
- •28. lymphoedema in the area of the affected joints;
- •29. other medical reasons as determined by the investigator;
研究者
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