Investigation of the Clinical Efficacy of Low-dose Ionizing Radiation in the Treatment of Osteoarthritis

The prevalence of chronic degenerative and inflammatory disorders, such as osteoarthritis, is constantly rising. As not all patients do respond adequately to the standard therapies, alternative treatment options such as low dose radiation therapy (LDRT) has gained further importance. LDRT is known to induce a long-lasting pain reduction, while having few side effects. Nonetheless, the detailed biological and immunological modes of action remain mostly elusive. In addition, there is a lack in placebo controlled randomised controlled trials (RCTs) proofing the pain-relieving effects of LDRT. So, the prospective, placebo-controlled, double-blind, randomized IMMO-LDRT02 trial to investigate the clinical efficacy of LDRT in the treatment of arthrosis should close this gap. 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 (VAS) and identification of immunological changes, which contribute to the success of therapy and are specifically found in the test group (IMMO-LDRT01 trial; ClinicalTrials.gov Identifier: NCT02653079).

• Evidence of an objectionable clinical benefit of LDRT for finger/wrist osteoarthritis. [Срок оценки: 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).]
• Analysis of the efficacy of LDRT against placebo in modulating patient's well-being. [Срок оценки: 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).]
• Analysis of the clinical efficacy of LDRT against placebo in fingers / wrists. [Срок оценки: 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).]
• Analysis of the clinical efficacy of LDRT against placebo in shoulders. [Срок оценки: 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).]
• Analysis of the clinical efficacy of LDRT against placebo in knees. [Срок оценки: 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).]
• Analysis of the clinical efficacy of LDRT against placebo in foot and ankle joints. [Срок оценки: 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).]
• Documentation and examination of general medication and pain medication. [Срок оценки: From Randomisation (day 0) till end of the trial (day 336), assessed every 7 days from day 0 to day 336..]
• Investigation of the drop-out rate in the test and control group. [Срок оценки: Fraom day of randomisation (day 0) till patient's independent trial abort or day 336, whichever came first.]
• Comparison of the two series with single doses 0.5 Gy against one series with single dose 1.0 Gy with regard to pain score reduction and immunological changes [Срок оценки: 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).]
• Modulation-matrix of immune cell function. [Срок оценки: 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).]
• Detection of chromosome aberrations [Срок оценки: 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).]
• Investigation of side effect profile of LDRT [Срок оценки: 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).]