M15.1 M15.2 M17.1 M17.5 M18.1 M18.9 M19.0 M19.2 M19.8 M19.9
Conditions
Interventions
Group 1: Group 1: Radiotherapy
Patients receive radiotherapy twice a week (on Mondays and Fridays) using either the Orthovolt X-Strahl 200 machine or a linear accelerator. Depending on the indication,
Sponsors
Universitätsklinik für Strahlentherapie
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Inclusion criteria
Inclusion criteria: - ECOG 0–2, Karnofsky Index >70; - Clinical evidence of painful degenerative joint disease affecting the knee joints and small joints: wrist joints (Heberden’s nodes, Bouchard’s nodes, rhizarthrosis) or metatarsophalangeal joints (NRS =5 with pain lasting more than 3 months, and onset of pain symptoms >2 years); - Radiological evidence of degenerative joint disease; - Mental and physical readiness for treatment; - Capacity to understand and willingness to sign a written consent form.
Exclusion criteria
Exclusion criteria: - Participation in another ongoing study; - Previous radiotherapy in this area; - Other possible causes of pain (e.g. trauma); - Patients at risk of non-compliance; - Lymphoedema; - Pregnant and breastfeeding women; - Illness that may lead to discontinuation of treatment; - Patients who are unable to give informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to evaluate the efficacy of water-filtered infrared radiation (wIRA) in the treatment of osteoarthritis of small and large joints, comparing it with standard procedures (low-dose radiation therapy, LDRT) and the combination of both methods (wIRA + LDRT) in terms of pain relief. | — |
Secondary
| Measure | Time frame |
|---|---|
| - The assessment of treatment tolerability in all groups; - Patient satisfaction with the treatment in all groups; - The time to response to therapy in all groups; - The analysis of the therapeutic response at the cellular level; - Investigation of the correlation between changes in biomarkers and pain reduction; - Identification of biomarkers as predictors of treatment success; - Assessment of the correlation between changes in biomarkers and the duration of clinical improvement; - Changes in heart rate variability (HRV) during the intervention. | — |
Countries
Germany
Contacts
Public ContactTatiana Lushchaeva
Universitätsklinikum für Strahlentherapie
Outcome results
None listed