Are Paraspinous Intramuscular Injections of Botulinum Toxin A (BoNT-A) Efficient in the Treatment of Chronic Low-back Pain?
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- effect of paravertebral injections of BoNT-A, 30 days after its administration in chronic LBP sufferers.
研究概览
简要总结
Studying the therapeutic effect of paravertebral injections of BoNT-A (botulinum toxin A) requires further studies to confirm the reported short-term therapeutic effect and to determine potential predictive factors of efficacy.
详细描述
This study was a randomized, double-blinded, placebo-controlled phase 3 trial comparing BoNT-A Type A injections to a placebo in patients with chronic Low-back Pain (LBP). This superiority trial obtained support from the French Hospital Clinical Research Project (PHRC) and the approval of a French ethics committee (2003/02) ("Comité Sud-Ouest et Outre-Mer III", consent obtained in February 2003).
The number of participants included in the study was chosen to be similar as those included in previous studies, that showed a strong positive effect of BoNT-A injections on LBP. Furthermore, the design of our study (i.e. a crossover) increased the power of the statistical analysis. A scientific committee has been solicited at this step, after including 19 patients, to assess the results.
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
- Double (Participant, Investigator)
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
- •LBP defined as a pain located between the thoracic lumbar hinge and the gluteal sulcus, where pain had evolved over a period of 6 months despite well conducted medical treatment, self-assessed lumbar pain intensity over 50 millimeters long on a visual analogue scale of 100 millimeters (0=no pain; 100=maximal pain),
- •having been on sick leave for 60 or more days in the year preceding the inclusion (in order to include patients with high consequences of chronic low-back pain on their work),
- •same long-term chronic pain treatment for at least 6 weeks
排除标准
- •age under 18 or over 55 years (to avoid secondary causes of low back pain, like spinal tumor),
- •ongoing pregnancy or breast-feeding,
- •a neuromuscular pathology (myasthenia gravis, amyotrophic lateral sclerosis, myopathy, polymyositis), aminoglycoside treatment at the time of inclusion,
- •skin infection at injection points,
- •diabetes and alcoholism (in order to avoid other etiologies of chronic pain),
- •a history of injecting BoNT-A A,
- •anticoagulation treatment, sciatica,
- •suspected spinal inflammatory disorder (spondylitis, inflammatory rheumatism, tumoral pathology),
- •a failed back surgery syndrome (when surgery failed to relieve low-back pain), - incapacity to stand, cardiorespiratory deficiency which does not allow the isokinetic exploration of the spinal muscles,
- •cognitive disorders limiting patient participation,
- •conflicts of interest owing to existing pain (unconsolidated work accident, ongoing damage compensation).
- •Spine infection, tumour or trauma had been specifically excluded by an MRI done by all patients before the inclusion in the present study.
- •No patient was allowed to take opiates during the time of the study,
- •facet joint injections were also not permitted during the study period.
研究组 & 干预措施
botulinum toxin A
干预措施: Botox (Drug)
Placebo
干预措施: Placebos (Drug)
结局指标
主要结局
effect of paravertebral injections of BoNT-A, 30 days after its administration in chronic LBP sufferers.
时间窗: Day 30
Pain intensity was measured on a horizontal visual analogue scale (VAS) 100 mm long, with " no pain " written on one end and " maximum pain " on the other. The question asked was: "How was the intensity of your LBP over the last 8 days?"
次要结局
- Evaluate the analgesic effect of paravertebral injections of BoNT-A, 90 days after its administration in chronic LBP sufferers.(Day 90)
- Measure the impact of paravertebral injections of 200 IU of BoNT-A in a single administration on lumbar stiffness and on spinal extensor muscle strength in patients with chronic LBP.(Day 120)