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

Last updated: February 12, 2024
Sponsor: University of Erlangen-Nürnberg Medical School
Overall Status: Active - Recruiting

Phase

N/A

Condition

Osteoarthritis

Treatment

low dose radiotherapy (1.0 Gy)

low dose radiotherapy (0.5 Gy)

mock radiation treatment

Clinical Study ID

NCT05887284
IMMO-LDRT02
  • Ages > 39
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosed osteoarthritis according to ACR criteria (exclusion of other otherarthritides 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

Exclusion

Exclusion Criteria:

  • Patients with tumor diseases
  • People capable of childbearing or procreation who do not take consistent contraceptivemeasures during therapy
  • Persistent drug, medication or alcohol abuse
  • Patients for whom, in the physician's judgment, participation is not justifiable withregard to their well-being due to temporary withdrawal of standard medication.
  • Patients in whom the diagnosis of osteoarthritis of the affected joint cannot be madewithout doubt. To establish the diagnosis, the guidelines of the American College ofRheumatology (ACR) are followed.
  • Earlier radiation therapy for treatment of cancer

Study Design

Total Participants: 132
Treatment Group(s): 3
Primary Treatment: low dose radiotherapy (1.0 Gy)
Phase:
Study Start date:
July 01, 2023
Estimated Completion Date:
December 31, 2028

Study 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).

Connect with a study center

  • Department of Radiation Oncology, Universitätsklinikum Erlangen

    Erlangen, Bavaria 91054
    Germany

    Active - Recruiting

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