Using low-dose radiation to treat osteoarthritis
Investigation of the Clinical Efficacy of Low-dose Ionizing Radiation in the Treatment of Osteoarthritis
NA · University of Erlangen-Nürnberg Medical School · NCT05887284
This study is testing if low-dose radiation therapy can help people with osteoarthritis feel less pain compared to a placebo treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 132 (estimated) |
| Ages | 39 Years and up |
| Sex | All |
| Sponsor | University of Erlangen-Nürnberg Medical School (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Erlangen, Bavaria) |
| Trial ID | NCT05887284 on ClinicalTrials.gov |
What this trial studies
This trial investigates the effectiveness of low-dose radiation therapy (LDRT) in treating osteoarthritis, a common degenerative joint condition. It is a prospective, placebo-controlled, double-blind, randomized trial that includes patients with newly diagnosed or existing arthrosis in various joints such as fingers, wrists, and knees. Participants will receive either LDRT or a placebo treatment, and their pain relief will be assessed using a visual analog scale, alongside monitoring immunological changes. The goal is to provide evidence for the clinical benefits of LDRT compared to standard therapies.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with osteoarthritis in specific joints who have not previously received low-dose radiation therapy.
Not a fit: Patients with tumor diseases or those who are unable to adhere to contraceptive measures during therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new, effective option for pain relief in osteoarthritis patients who do not respond well to conventional therapies.
How similar studies have performed: While there is limited evidence from previous studies on the effectiveness of low-dose radiation therapy for osteoarthritis, this trial aims to fill a gap in the existing research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosed osteoarthritis according to ACR criteria (exclusion of other other arthritides and chronic rheumatoid arthritis via laboratory tests): * Finger and wrist osteoarthritis * Elbow arthrosis * Shoulder arthrosis * Knee arthrosis * Ankle and foot joint arthrosis * First time application of low-dose radiotherapy (LDRT) of the affected joint. * Willingness to cooperate and accessibility of the patients (geographical proximity) for treatment and Follow-up care Exclusion Criteria: * Patients with tumor diseases * People capable of childbearing or procreation who do not take consistent contraceptive measures during therapy * Persistent drug, medication or alcohol abuse * Patients for whom, in the physician's judgment, participation is not justifiable with regard to their well-being due to temporary withdrawal of standard medication. * Patients in whom the diagnosis of osteoarthritis of the affected joint cannot be made without doubt. To establish the diagnosis, the guidelines of the American College of Rheumatology (ACR) are followed. * Earlier radiation therapy for treatment of cancer
Where this trial is running
Erlangen, Bavaria
- Department of Radiation Oncology, Universitätsklinikum Erlangen — Erlangen, Bavaria, Germany (RECRUITING)
Study contacts
- Principal investigator: Benjamin Frey, PD Dr.-Ing. — Translational Radiobiology, Department of Radiation Oncology, Uniklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg
- Study coordinator: Benjamin Frey, PD Dr.-Ing.
- Email: benjamin.frey@uk-erlangen.de
- Phone: +49 9131 85
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Arthrosis, Osteoarthritis, low dose radiotherapy, LDRT