NCT05887284

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 132 (estimated)
• Sponsor: University of Erlangen-Nürnberg Medical School · Academic / Other
• Sex: All
• Age: 39 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• Arthrosis
• Osteoarthritis

Interventions

Type	Name	Description
RADIATION	low dose radiotherapy (0.5 Gy)	12 times 0.5 Gy
RADIATION	mock radiation treatment	6 times 0.0 Gy
RADIATION	low dose radiotherapy (1.0 Gy)	6 times 1.0 Gy

Timeline

• Start date: 2023-07-01
• Primary completion: 2026-09-30
• Completion: 2028-12-31
• First posted: 2023-06-02
• Last updated: 2024-02-13

Locations

1 site across 1 country: Germany