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.
Finger and wrist osteoarthritis
Elbow arthrosis
Shoulder arthrosis
Knee arthrosis
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.
Crossover
low dose radiotherapy (0.5 Gy)
Radiation12 times 0.5 Gy
mock radiation treatment
Radiation6 times 0.0 Gy
low dose radiotherapy (1.0 Gy)
Radiation6 times 1.0 Gy
Improvement in general pain (determined by visual analog scale (VAS) score) after LDRT compared to the placebo.
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.
Longitudinal Immunophenotyping of the patients: Detection of about 30 distinct immune cell (sub)types together with their activation markers during treatment.
Evidence of an objectionable clinical benefit of LDRT for finger/wrist osteoarthritis.
Analysis of the pain-free finger and hand force by using finger and hand strength meter.
Analysis of the efficacy of LDRT against placebo in modulating patient's well-being.
Determination of disease activity and pain using the international accepted EuroQol Research Foundation questionnaire EQ-5D-5L (IMMOLDRT02/EQ-5D-5L). Scale of EQ-5D-5L is from 5 (perfect well being) to 25 (illness with pain).
Analysis of the clinical efficacy of LDRT against placebo in fingers / wrists.
Determination of disease activity and pain in treated Fingers / Wrists using international disease specific questionnaires (AUSCAN score). Scaled on 5-point Likert, 100mm Visual Analog and 11-box Numerical Rating Scales, the AUSCAN™ 3.1 is a valid, reliable and responsive measure of outcome. Scale from 0 (no pain) to 100 (worst pain).
Analysis of the clinical efficacy of LDRT against placebo in shoulders.
Determination of disease activity and pain in treated shoulders using international disease specific questionnaires (Oxford Shoulder Questionnaire (OSS). Score from 12 (no trouble) to 60 impossible to do).
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University of Erlangen-Nürnberg Medical School
Lead sponsor
Johann Wolfgang Goethe University Hospital
Collaborator
