Investigation of the Clinical Efficacy of Low-dose Ionizing Radiation in the Treatment of Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- Identification of immunological changes, which contribute to the success of therapy and are specifically found in the test group.
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
double-blind clinical trial.
入排标准
- 年龄范围
- 39 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Identification of immunological changes, which contribute to the success of therapy and are specifically found in the test group.
时间窗: 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).
Longitudinal Immunophenotyping of the patients: Detection of about 30 distinct immune cell (sub)types together with their activation markers during treatment.
Improvement in general pain (determined by visual analog scale (VAS) score) after LDRT compared to the placebo.
时间窗: 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).
Determination of the general pain level by determining a so-called pain score which is calculated from the parameters pain level (VAS) and pain history (duration, frequency, maximum, quality and occurrence of pain). VAS is determined from 0 (no pain) to 10 (maximum pain). Pain history will also assessed bei an scale from 1 to 10.
次要结局
- Analysis of the efficacy of LDRT against placebo in modulating patient's well-being.(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.(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).)
- Evidence of an objectionable clinical benefit of LDRT for finger/wrist osteoarthritis.(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.(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(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.(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.(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.(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.(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.(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(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(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).)