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.
Eligibility
Sex
ALL
Min age
39 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Improvement in general pain (determined by visual analog scale (VAS) score) after LDRT compared to the placebo. — Day 0 till end of the trial at the distinct time points of end of first LDRT series (day 28), first follow up (day 112), end of second LDRT series (day 140), second follow up (day 224), final follow up (day336). Determination of the general pain level by determining a so-called pain score which is calculated from the parameters pain level (VAS) and pain history (duration, frequency, maximum, quality and occurrence of pain). VAS is determined from 0 (no pain) to 10 (maximum pain). Pain history will also assessed bei an scale from 1 to 10.
Identification of immunological changes, which contribute to the success of therapy and are specifically found in the test group. — Day 0 till end of the trial at the distinct time points of end of first LDRT series (day 28), first follow up (day 112), end of second LDRT series (day 140), second follow up (day 224), final follow up (day336). Longitudinal Immunophenotyping of the patients: Detection of about 30 distinct immune cell (sub)types together with their activation markers during treatment.
Trial sites (1)
Facility
City
Region
Status
Department of Radiation Oncology, Universitätsklinikum Erlangen
Erlangen
Bavaria
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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