Investigation of the Clinical Efficacy of Low-dose Ionizing Radiation in the Treatment of Osteoarthritis — IMMO-LDRT02  

Osteoarthritis Clinical Trial

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

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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). ;

Related Conditions & MeSH terms

• Arthrosis
• Osteoarthritis

• NCT number: NCT05887284
• Study type: Interventional
• Source: University of Erlangen-Nürnberg Medical School
• Contact: Benjamin Frey, PD Dr.-Ing.
• Phone: +49 9131 85
• Email: benjamin.frey@uk-erlangen.de
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2023
• Completion date: December 31, 2028