Actively Recruiting
Investigation of the Clinical Efficacy of Low-dose Ionizing Radiation in the Treatment of Osteoarthritis
Led by University of Erlangen-Nürnberg Medical School · Updated on 2024-02-13
132
Participants Needed
1
Research Sites
287 weeks
Total Duration
On this page
Sponsors
U
University of Erlangen-Nürnberg Medical School
Lead Sponsor
J
Johann Wolfgang Goethe University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
IMMO-LDRT02 is a prospective, placebo-controlled, double-blind, randomized trial to investigate the clinical efficacy of low dose radiation therapy (LDRT) in the treatment of arthrosis. Newly diagnosed or already existing arthroses of the fingers, wrists, shoulders, knees, ankles and feet will be enclosed. Finally, the evidence of clinical benefit from LDRT (6 x 0.5 Gy) will be compared to the placebo group (6 x 0 Gy), by determination via a visual analog scale and identification of immunological changes.
CONDITIONS
Official Title
Investigation of the Clinical Efficacy of Low-dose Ionizing Radiation in the Treatment of Osteoarthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed osteoarthritis according to ACR criteria affecting fingers, wrists, elbows, shoulders, knees, ankles, or feet
- First time receiving low-dose radiotherapy for the affected joint
- Willing and able to cooperate and accessible for treatment and follow-up care
You will not qualify if you...
- Diagnosis of any tumor diseases
- Persons capable of childbearing or procreation not using consistent contraceptive measures during therapy
- Persistent abuse of drugs, medication, or alcohol
- Participation not justified due to temporary withdrawal of standard medication
- Uncertain diagnosis of osteoarthritis in the affected joint based on ACR guidelines
- Previous radiation therapy for cancer treatment
AI-Screening
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Trial Site Locations
Total: 1 location
1
Department of Radiation Oncology, Universitätsklinikum Erlangen
Erlangen, Bavaria, Germany, 91054
Actively Recruiting
Research Team
B
Benjamin Frey, PD Dr.-Ing.
CONTACT
A
Anna-Jasmina Donaubauer, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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