M17.0
Conditions
Interventions
Group 1: Electromagnetic frequency therapy with the e.CHI FrequencyChip".
The therapy medium is applied to the skin in the area of the pain. This creates an electromagnetic field that continuously rel
Sponsors
Praxis für Sport-Chirurgie
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 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;
Exclusion criteria
Exclusion criteria: 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) 16. gout; 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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Average pain within the last 7 days (11-point NRS): Statistical evaluation of intraindividual differences between values at baseline and month 3. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. average pain within the last 7 days (11-point NRS): statistical evaluation of intra-individual differences between baseline and week 6. 2. maximum pain within the last 7 days (11-point NRS): statistical evaluation of intra-individual differences between baseline and week 6 and month 3. 3. average pain at rest within the last 7 days (11-point NRS): statistical evaluation of intra-individual differences between baseline and week 6 and month 3. 4. all KOOS subscales of the KOOS score: statistical evaluation of intra-individual differences between baseline and week 6 and month 3. 5. Pain Disability Index (PDI) including all subscales: statistical evaluation of intra-individual differences between baseline and week 6 and month 3. 6. treatment response: statistical evaluation after week 6 and month 3. 7. use of rescue medication within one week: statistical evaluation after week 6 and month 3. | — |
Countries
Austria
Contacts
Public ContactReinhard Schmidt
Praxis für Sport-Chirurgie
Outcome results
None listed