Investigation of the Clinical Efficacy of Low-dose Ionizing Radiation in the Treatment of Osteoarthritis (IMMO-LDRT02)

University of Erlangen-Nürnberg Medical School

Status: Enrolling

Conditions: Osteoarthritis; Arthrosis

Treatments: Radiation: mock radiation treatment; Radiation: low dose radiotherapy (0.5 Gy); Radiation: low dose radiotherapy (1.0 Gy)

Study type: Interventional

Funder types: Other

Identifiers

NCT05887284

IMMO-LDRT02

Details and patient eligibility

About

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.

Full 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).

Enrollment: 132 estimated patients

Sex: All

Ages: 39+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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.
• Patients in whom the diagnosis of osteoarthritis of the affected joint cannot be made without doubt. To establish the diagnosis, the guidelines of the American College of Rheumatology (ACR) are followed.
• Earlier radiation therapy for treatment of cancer

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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132 participants in 2 patient groups, including a placebo group

Low dose Radiation Therapy

Experimental group

Description:

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).

Treatment:

Radiation: low dose radiotherapy (0.5 Gy)

Mock Radiation Therapy

Placebo Comparator group

Description:

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).

Treatment:

Radiation: low dose radiotherapy (1.0 Gy)

Radiation: mock radiation treatment