Evolution of Chronic Low Back Pain of Active Discopathy After Intradiscal Corticosteroid Infiltrations According to Modic 1 Distribution and Association With Degenerative Restructuring
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- Assessement of change in pain
研究概览
简要总结
The primary objective of the study is to demonstrate the difference in the reduction of pain at 1 month after intradiscal infiltration of corticosteroids depending on symmetrical or asymmetrical active discopathies with MRI examination. The difference should be judged significant if it ⩾ 2 points.
详细描述
As secondary objective, the study aims to study the correlation between pain reduction which will be assessed by numerical scale at 1 month and 6 months after intradiscal infiltration of corticosteroids and following parameters: the duration of chronic lumbago, the presence of associated root pains, the morphological characteristics with RMI examination of active discopathies, the co-existence of scoliosis, the sign of inter-somatic instability, the muscular trophicity of muscle erector of low back, the pelvic incidence, degree of lumbar lordosis, Cobb angle, wearing a corset.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ⩾ 18 years.
- •Chronic growing lumbago with duration > 3 mois.
- •Disabling lumbago with an average ⩾ 4/10 defined by numerical scale.
- •Common chronic low back pain that has been evolving for more than 3 months.
- •Disabling lumbalgia defined by an average numerical scale greater than or equal to 4/10 in the month preceding the inclusion.
- •Failure or intolerance to drug treatments (nonsteroidal anti-inflammatory drugs and systemic corticosteroids).
- •Absence of biological inflammatory syndrome.
- •Recent MRI of less than 6 months with active disc disease (Modic 1) defined by degenerative disc disease associated with mirror rearrangements of the subchondral bone of the adjacent vertebral endplates in hyposignal T1 and hypersignal T
- •Signed informed consent obtained.
- •Affiliation to social security.
排除标准
- •Pregnancy woman.
- •Immunosuppression.
- •History of allergy to iodinated contrast agents and / or prednisolone acetate.
- •Local or general infection.
- •Fever (temperature> 38).
- •History of disc surgery of less than 6 months.
- •History of infectious spondylodiscitis.
- •Unbalanced psychiatric disorders.
- •Severe coagulation disorders or impossible cessation of anticoagulation or anti platelet aggregation.
- •Impossibility to obtain signed consent form.
- •Patient under guardianship and/or curatorship.
结局指标
主要结局
Assessement of change in pain
时间窗: at 1 month
The change in pain will be evaluated by numerical scale NRS (numeric rating scale) by phone call after intradiscal infiltration of corticosteroids. NRS for pain: a scale from 0 (no pain) to 10 (worst pain). RMI examination will be performed 6 months before enrollment.
次要结局
- Assessement of pain reduction according to the duration of evolution of chronic lumbago(at 1 month and 6 months)
- Assessement of pain reduction according to the co-existence of scoliosis or not.(at 1 month and 6 months)
- Assessement of pain reduction according to the presence of signs of inter-somatic instability(at 1 month and 6 months)
- Assessement of pain reduction according to the presence of posterior articular osteoarthritis(at 1 month and 6 months)
- Assessement of pain reduction according to the presence of associated root pains or not.(at 1 month and 6 months)
- Assessement of pain reduction according to the muscle trophicity of the erector muscles of the lumbar spine(at 1 month and 6 months)