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

NCT05887284 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2024-02-13

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Johann Wolfgang Goethe University Hospital

    collaborator OTHER

  • University of Erlangen-Nürnberg Medical School

    lead OTHER

Principal Investigators

  • Oliver Ott, Prof. Dr · Department of Radiation Oncology, Uniklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg

  • Benjamin Frey, PD Dr.-Ing. · Translational Radiobiology, Department of Radiation Oncology, Uniklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg

  • Thomas Weissmann, Dr. · Department of Radiation Oncology, Uniklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg

  • Rainer Fietkau, Prof. Dr. · Department of Radiation Oncology, Uniklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
39 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-01
Primary Completion
2026-09-30
Completion
2028-12-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05887284 on ClinicalTrials.gov