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Recruiting NCT05887284

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

No phase Interventional Arthrosis Osteoarthritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: low dose radiotherapy (0.5 Gy), mock radiation treatment, low dose radiotherapy (1.0 Gy).
Who it may be relevant to
Registry conditions: Arthrosis, Osteoarthritis. Basic parameters: from 39 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Detailed 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).

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

Primary outcome measures

  • Improvement in general pain (determined by visual analog scale (VAS) score) after LDRT compared to the placebo. [Time frame: Day 0 till end of the trial at the distinct time points of end of first LDRT series (day 28), first follow up (day 112), end of second LDRT series (day 140), second follow up (day 224), final follow up (day336).]
  • Identification of immunological changes, which contribute to the success of therapy and are specifically found in the test group. [Time frame: Day 0 till end of the trial at the distinct time points of end of first LDRT series (day 28), first follow up (day 112), end of second LDRT series (day 140), second follow up (day 224), final follow up (day336).]
Secondary outcome measures (12)
  • Evidence of an objectionable clinical benefit of LDRT for finger/wrist osteoarthritis. [Time frame: Day 0 till end of the trial at the distinct time points of end of first LDRT series (day 28), first follow up (day 112), end of second LDRT series (day 140), second follow up (day 224), final follow up (day336).]
  • Analysis of the efficacy of LDRT against placebo in modulating patient's well-being. [Time frame: Day 0 till end of the trial at the distinct time points of end of first LDRT series (day 28), first follow up (day 112), end of second LDRT series (day 140), second follow up (day 224), final follow up (day336).]
  • Analysis of the clinical efficacy of LDRT against placebo in fingers / wrists. [Time frame: Day 0 till end of the trial at the distinct time points of end of first LDRT series (day 28), first follow up (day 112), end of second LDRT series (day 140), second follow up (day 224), final follow up (day336).]
  • Analysis of the clinical efficacy of LDRT against placebo in shoulders. [Time frame: Day 0 till end of the trial at the distinct time points of end of first LDRT series (day 28), first follow up (day 112), end of second LDRT series (day 140), second follow up (day 224), final follow up (day336).]
  • Analysis of the clinical efficacy of LDRT against placebo in knees. [Time frame: Day 0 till end of the trial at the distinct time points of end of first LDRT series (day 28), first follow up (day 112), end of second LDRT series (day 140), second follow up (day 224), final follow up (day336).]
  • Analysis of the clinical efficacy of LDRT against placebo in foot and ankle joints. [Time frame: Day 0 till end of the trial at the distinct time points of end of first LDRT series (day 28), first follow up (day 112), end of second LDRT series (day 140), second follow up (day 224), final follow up (day336).]
  • Documentation and examination of general medication and pain medication. [Time frame: From Randomisation (day 0) till end of the trial (day 336), assessed every 7 days from day 0 to day 336..]
  • Investigation of the drop-out rate in the test and control group. [Time frame: Fraom day of randomisation (day 0) till patient's independent trial abort or day 336, whichever came first.]
  • Comparison of the two series with single doses 0.5 Gy against one series with single dose 1.0 Gy with regard to pain score reduction and immunological changes [Time frame: Day 0 till end of the trial at the distinct time points of end of first LDRT series (day 28), first follow up (day 112), end of second LDRT series (day 140), second follow up (day 224), final follow up (day336).]
  • Modulation-matrix of immune cell function. [Time frame: Day 0 till end of the trial at the distinct time points of end of first LDRT series (day 28), first follow up (day 112), end of second LDRT series (day 140), second follow up (day 224), final follow up (day336).]
  • Detection of chromosome aberrations [Time frame: Day 0 till end of the trial at the distinct time points of end of first LDRT series (day 28), first follow up (day 112), end of second LDRT series (day 140), second follow up (day 224), final follow up (day336).]
  • Investigation of side effect profile of LDRT [Time frame: Day 0 till end of the trial at the distinct time points of end of first LDRT series (day 28), first follow up (day 112), end of second LDRT series (day 140), second follow up (day 224), final follow up (day336).]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Triple blind
Primary purpose
Treatment

Study locations

Germany · 1 center
  • Department of Radiation Oncology, Universitätsklinikum Erlangen — Erlangen

Identifiers

NCT: NCT05887284 · IMMO-LDRT02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗