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临床试验/DRKS00017293
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

发起方
MEOCLINIC GmbH

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