Effectiveness of Facet Joint Infiltration in Low Back Pain
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- pain visual analogic scale
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of facet joint infiltration with corticosteroids in the treatment of low back pain due to facet joint osteoarthritis.
详细描述
Sixty subjects with diagnostic of facet joint syndrome will be enrolled in the study.
They were randomized into experimental and control groups. The experimental group will be submitted to intra-articular infiltration of six facet joints. The control group will be submitted to intramuscular injection of six lumbar paravertebral points. After the randomization, all subjects will be assessed by an investigator blinded to the groups. The assessment will be taken just before the interventions (T0) and them 7 , 30 , 90 and 180 days after the interventions. The following assessment instruments will be used: pain visual analogical scale (VAS) (0-10cm), pain visual analogical scale during extension of the spine (VAS E) (0-10cm), Likert scale for improving (0-5), percentage scale of subjective improving perception(0-100%), Rolland-Morris questionnaire (0-24), short health survey questionnaire (SF36), accountability of medications taken for back pain: analgesics and non-steroidal antiinflammatories (NSAIDs).
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •low back pain up to 3 months
- •pain on back extension
- •radiologic findings of facet joint osteoarthritis
排除标准
- •other causes of back pain
- •fibromyalgia
- •diabetes, arterial hypertension or glaucoma not well controlled
- •patients with contrast allergy
研究组 & 干预措施
facet joint infiltration
The experimental group will be submitted to intra-articular infiltration of six facet joints (L3/L4;L4/L5;L5/S1 bilaterally) with triamcinolone hexacetonide
干预措施: Cortisone (Drug)
intramuscular injection
The control group which were submitted to triamcinolone acetonide intramuscular injection of six lumbar paravertebral points
干预措施: Cortisone (Drug)
结局指标
主要结局
pain visual analogic scale
时间窗: 24 weeks
pain visual analogic scale graduated 0--10
次要结局
- Rolland Morris questionnaire(24 weeks)
- SF-36 questionnaire(24 weeks)