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

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 39
Healthy Volunteers: f
View:

• Diagnosed osteoarthritis according to ACR criteria (exclusion of other other arthritides and chronic rheumatoid arthritis via laboratory tests):

‣ Finger and wrist osteoarthritis

⁃ Elbow arthrosis

⁃ Shoulder arthrosis

⁃ Knee arthrosis

⁃ Ankle and foot joint arthrosis

• First time application of low-dose radiotherapy (LDRT) of the affected joint.

• Willingness to cooperate and accessibility of the patients (geographical proximity) for treatment and Follow-up care

Locations
Other Locations
Germany
Department of Radiation Oncology, Universitätsklinikum Erlangen
RECRUITING
Erlangen
Contact Information
Primary
Benjamin Frey, PD Dr.-Ing.
benjamin.frey@uk-erlangen.de
+49 9131 85
Backup
Anna-Jasmina Donaubauer, Dr.
anna-jasmina.donaubauer@uk-erlangen.de
+49 9131 85
Time Frame
Start Date: 2023-07-01
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 132
Treatments
Experimental: Low dose Radiation Therapy
In the test group, patients receive radiotherapy with six fractions of 0.5 Gy each over a period of 3 weeks, with 2 doses applied per week (total dose 3.0 Gy). After the 1st follow-up (3 months after radiotherapy), patients receive the patients in both arms have the option to receive a 2nd series of radiotherapy in consultation with the study physician if no improvement in symptoms has occurred or patients are still not sufficiently satisfied with the outcome (this decision is still made by the physician and patient in a blinded manner). The patients from the test group receive another irradiation series with six fractions of 0.5 Gy each according to the same schedule as before (total dose 3.0 Gy and in sum with the first series 6.0 Gy).
Placebo_comparator: Mock Radiation Therapy
In the control group, patients receive sham irradiation with six fractions of 0.0 Gy each over a period of 3 weeks, with 2 treatments per week. After the 1st follow-up (3 months after radiotherapy), patients receive the patients in both arms have the option to receive a 2nd series of radiotherapy in consultation with the study physician if no improvement in symptoms has occurred or patients are still not sufficiently satisfied with the outcome (this decision is still made by the physician and patient in a blinded manner). The patients in the control group, on the other hand, now also receive a radiotherapy with six fractions of 1.0 Gy each over a period of 3 weeks with 2 fractions per week (total dose 6.0 Gy).
Related Therapeutic Areas
Sponsors
Leads: University of Erlangen-Nürnberg Medical School
Collaborators: Johann Wolfgang Goethe University Hospital

This content was sourced from clinicaltrials.gov