DRKS00017293招募中未知
Percutaneous Bioelectric Current Stimulation (PBCS) in the treatment of chronic achillodynia - A multicenter, two-armed, randomized, controlled, clinical trial - PBCS-ACH3
MEOCLINIC GmbH0 个研究点目标入组 72 人开始时间: 2022年2月1日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 72
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
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 65 Years(—)
- 性别
- All
入选标准
- •1. medically confirmed diagnosis: Achillodynia;
- •2. pain of the Achilles tendon in the area of the Achilles tendon approx. 2-7 cm from the calcaneus attachment;
- •3. painfulness: at least 4 points on the 11-point NRS on at least one day within the last 7 days before the start of therapy;
- •4. age 18 to 65 years;
- •5. disease duration: =3 months;
- •6. adequate communication skills;
- •7. the patient must be able to recognise the nature, significance and scope of the clinical trial and be able to align his/her will accordingly;
排除标准
- •1. needle phobia (including discontinuation after the first therapy session (see discontinuation criteria));
- •2. previous PBCS therapy or eccentric training (as specified in this study) of the affected Achilles tendon;
- •3. duration of illness longer than 2 years;
- •4. BMI> 30 (Grade I obesity);
- •5. in women: pregnancy;
- •6. intensity of pain: = 9 points on the 11-point NRS on one day within the last 7 days before the start of therapy;
- •7. inability to technically complete the visa score;
- •8. current pension applications;
- •9. pacemaker;
- •10. pre-operated Achilles tendon;
- •11. cortisone injections to the Achilles tendon in the last 3 months;
- •12. chronic pain with ongoing pain management of other causes;
- •13. anticoagulation therapy (Marcumar, Noax) within 7 days before the start of therapy (intake of acetylsalicylic acid up to 100 mg/day is not an exclusion criterion);
- •14. taking opiates within the last 4 weeks before the start of therapy;
- •15. treatment with fluoroquinolone, antibiotics or statins within the last 6 months
- •16. dependence on painkillers, drugs or opiates;
- •17. alcoholism;
- •18. local infection;
- •19. diabetes mellitus;
- •20. kidney disease requiring dialysis;
- •21. autoimmune diseases;
- •22. vascular disease;
- •23. peripheral neuropathy;
- •24. other nerve compression syndromes of the lower extremities;
- •25. radiculitis;
- •26. rheumatoid arthritis;
- •27. Reiter's disease;
- •28. other medical reasons as determined by the study doctor;
研究者
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