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
117 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
Researchers are evaluating the use of low dose radiation therapy (LDRT) for treating arthrosis, including osteoarthritis affecting fingers, wrists, shoulders, knees, ankles, and feet. This randomized, placebo-controlled, double-blind trial aims to compare the clinical benefits of LDRT with a placebo, addressing the need for more evidence on pain relief and immunological effects of LDRT, which has shown potential for long-lasting pain reduction with few side effects. Participants are assigned to one of two groups: the test group receives six sessions of low dose radiotherapy (0.5 Gy each) over three weeks, with two sessions per week, totaling 3.0 Gy. After three months, if symptoms have not improved, participants may receive a second series of radiotherapy with the same schedule, totaling 6.0 Gy. The control group receives sham radiation (0 Gy) for the first series, then may receive a second series of radiotherapy at a higher dose (1.0 Gy per session) under the same schedule. During the study, participants undergo pain assessments using a visual analog scale (VAS) at several time points from treatment start through final follow-up at approximately 11 months. Immunological changes related to therapy success are also monitored. Medication use, side effects, and drop-out rates are tracked throughout. The study evaluates clinical efficacy in different joint areas and compares pain and immune responses between treatment and placebo over the full trial period.
CONDITIONS
Brief 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 including finger, wrist, elbow, shoulder, knee, ankle, or foot joint arthrosis
- First time receiving low-dose radiation therapy for the affected joint
- Willingness and ability to cooperate and attend treatment and follow-up visits
- Geographical proximity allowing accessibility for treatment and follow-up care
You will not qualify if you...
- Presence of tumor or cancer diseases
- Individuals capable of childbearing who do not use consistent contraceptive measures during therapy
- Persistent abuse of drugs, medication, or alcohol
- Patients for whom participation is not justifiable due to temporary withdrawal of standard medication
- Uncertain osteoarthritis diagnosis of the affected joint according to ACR guidelines
- Previous radiation therapy for cancer treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 10 weeks including both treatment series
Participants receive low-dose radiotherapy or mock radiation treatment in two series, each consisting of six fractions over 3 weeks with 2 treatments per week. After the first treatment series and follow-up, participants may receive a second treatment series based on symptom improvement and consultation with the study physician.
2 series of 6 treatment sessions each, with 2 sessions per week over 3 weeks per series
Duration - Up to 9 months after treatment completion
Participants are monitored for clinical efficacy, pain improvement, immunological changes, and side effects up to 12 months after treatment completion.
Follow-up visits at 3 months, 5 months, 7 months, and 11 months after the start of the trial
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.
A
Anna-Jasmina Donaubauer, Dr.
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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