Evaluation of Pain Level Reduction After Low-dose Radiation in Symptomatic Facet Joint Arthritis - A Prospective Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Change in pain level, measured on a numeric rating scale (NRS)
研究概览
简要总结
The goal of this clinical trial is to compare low-dose radiation therapy (LDRT) with intra-articular steroid injections in participants suffering from chronic lower back pain as cause of facet joint arthritis (FJA).
The main question[s] it aims to answer are:
- Is LDRT non-inferior to intra-articular steroid injections in terms of pain reduction
- Is there a difference in long-term pain reduction between LDRT and intra-articular steroid injections Participants will be randomly assigned to one of the two treatment groups.
详细描述
However, there has been no published study providing scientific evidence by prospective randomized data on the effect of LDRT in patient suffering from facet osteoarthritis. LDRT seems a viable treatment method with anti-inflammatory potential and possible long-lasting benefit in pain resolution for patients with facet joint arthritis (FJA), which can prevent from an ultimate surgical treatment.
The rationale of this trial is to generate scientific evidence that LDRT is an alternative non-invasive treatment option for FJA, whose primary outcome "pain reduction" is equivalent to the most common treatment intra-articular steroid injections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with degenerative symptomatic facet joint osteoarthritis confirmed by MRI (lumbar spine) and standing X-ray
- •Patients who underwent treatment for facet joint syndrome at the Dept. of Orthopaedic Surgery and Traumatology of KSA (Kantonsspital Aarau) or Dept. of Rheumatology of KSA or Dept. of Neurosurgery of KSA, onset of symptoms and treatment with pain medication and physiotherapy
- •The informed consent form for participation in the study was signed
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Age ≥ 45 years
- •Karnofsky Performance Status (KPS) ≥ 80 %
- •Ability to take steroids and bridge or pause NOAC (New oral anticoagulants) / Marcoumar
- •Show a positive Tracer-Uptake in the SPECT-CT in max. 4 facet joints of the lumbar spine (regardless of radiologic changes in MRI or CT)
- •Immediate ≥ 70% pain reduction after 1 positive diagnostic infiltration of the suspected facet joint(s)
- •Negative middle-/long-term effect (4-12 weeks after first steroid injection, defined as "NRS 5-10 at 4-12 weeks")
排除标准
- •Any previous infiltration therapy in the suspected spine region (+/- 3 segments) within the last 3 years
- •Any previous radiotherapy, radiofrequency ablation, other pain modulating interventions (e.g. thermos/-cryoablation or spinal cord stimulators) or surgery in the suspected spine region (+/- 3 segments)
- •Prior or concurrent malignancy (≤ 5 years prior to enrolment in study) except: nonmelanoma skin cancer, cervix carcinoma in situ, prostatic intraepithelial neoplasia) Contraindications to radiotherapy (for example connective tissue disorders such as scleroderma)
- •Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
- •Pregnancy, desire to have own children or lactation during study participation.
研究组 & 干预措施
Intra-articular steroid injections
The intra-articular steroid injections are the most common standard of care to treat the lower back pain resulting from FJA.
干预措施: Intra-articular steroid injections (Drug)
Low-dose radiation therapy
LDRT is commonly used as treatment for benign degenerative inflammatory disorders
干预措施: Low-dose radiation therapy (Radiation)
结局指标
主要结局
Change in pain level, measured on a numeric rating scale (NRS)
时间窗: Baseline and 3 month after randomization
Difference in pain score on a numeric rating scale (NRS) with values from 0 to 10 (0 = no pain, 10 = highest imaginable pain)
次要结局
- Percentage of patients with NRS<4 (equals responders) after six months(At six months)
- Number of reported (serious) adverse events ((S)AE)(Up to 12 months)
- Change in pain level, measured on a numeric rating scale (NRS)(Baseline, at 6 and 12 months after randomization)
- Percentage of patients with NRS<4 (equals responders) after first treatment session(Up to 3.5 weeks)
- Change in quality of life measured by the Short Form Health (SF)-36 questionnaire(Baseline, at 3, 6 and 12 months after randomization)
研究者
Silvia Gomez Ordonez
Dr. med.
Kantonsspital Aarau