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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age39+
SponsorUniversity of Erlangen-Nürnberg Medical School

About this trial

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 criteria

Qualifiers

Finger and wrist osteoarthritis

Elbow arthrosis

Shoulder arthrosis

Knee arthrosis

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • low dose radiotherapy (0.5 Gy)
  • mock radiation treatment
  • low dose radiotherapy (1.0 Gy)

Treatment groups

132 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Erlangen-Nürnberg Medical School

Lead sponsor

Johann Wolfgang Goethe University Hospital

Collaborator