M76.6
Conditions
Interventions
Sponsors
MEOCLINIC GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 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;
Exclusion criteria
Exclusion criteria: 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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VISA-A-Score (Victorian Institute of Sports Assessment-Achilles): Statistical evaluation of intra-individual differences between values at the beginning of therapy and values 12 weeks after initial treatment after verum therapy compared to control. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. VISA-A-Score including all subscales: Statistical evaluation of intra-individual differences between values at the beginning of therapy and week 4, 12, 26, and 52 after verum therapy compared to the control. 2. Pain Disability Index (PDI) including all subscales: Statistical evaluation of intra-individual differences between values at the beginning of therapy and week 4, 12, 26, and 52 after Verum therapy compared to the control. 3. Load pain after 30 sec. one-legged stand (11-point NRS): Statistical evaluation of intra-individual differences between values at the beginning of therapy and before each therapy and week 4, 12, 26, and 52 after verum therapy compared to control. 4. Average pain at average load in the last week (11-points NRS): Statistical evaluation of intraindividual differences between values at the beginning of therapy and before each therapy and week 4, 12, 26, and 52 after Verum therapy compared to control. 5. Return to physical activity: Statistical evaluation of intra-individual differences between values at the beginning of therapy and week 4, 12, 26, and 52 after verum therapy compared to control. 6. Therapy response: Statistical evaluation of verum therapy compared to control. 7. Consumption of emergency medication within one week: Statistical evaluation of intra-individual differences between values at the beginning of therapy and week 4, 12, 26, and 52 after verum therapy compared to the control. | — |
Countries
Germany
Contacts
Public ContactHarry R. Merk
MEOCLINIC GmbH
Outcome results
None listed