Investigation of Efficacy of Botulinum Toxin A (Dysport) in Chronic Low Back Pain
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Proportion of Participants With Mild or no Pain on Visual Analog Scale (VAS)
研究概览
简要总结
The scientific aim of this study is to investigate the efficacy of abobotulinumtoxinA (Dysport - Ipsen Pharmaceuticals) in chronic low back pain.
The investigators hypothesis is that injection of Dysport brand of botulinum toxin type A into erector spinae muscles (extensors of the spine) can relieve low back pain through anti-spasm and analgesic effect of botulinum toxin.
详细描述
This is an investigator initiated, randomized, double blind, placebo-controlled study. A total of 90 patients will be enrolled in the study. The study will be conducted over 4 months. It includes 4 visits and 4 telephone calls. Patients with chronic low back pain (>3 months) who meet inclusion and exclusion criteria and wish to participate in the study may be enrolled. Those who become enrolled will be scheduled for a baseline visit (Week 0). During the baseline visit, subjects will be given the official approved consent form to read and ask questions. Participants to this study will also receive a copy of the Dysport Risk Evaluation and Mitigation Strategy (REMS) statement. After obtaining informed consent signed by the subject, the subjects will be randomization into the Dysport or placebo group. The randomizing will be performed by a nurse and the information will be kept in a pass-worded computer. Blinding means that neither the participant nor the clinical rater will know which group the participant has been initially been assigned.
Each subject will have a neurological examination and fill a demographic form and complete four rating questionnaires (appendix II-V). These include a visual analogue scale for pain (0 to 10) and three quality of life questionnaires which depict quality of life (the American Chronic Pain Association's Quality of Life Scale), how pain affects ability to manage everyday life (Oswestry Low Back Pain Disability Questionnaire), and overall physical and emotional health (Short Form-36). Patients will then receive an injection of either abobotulinumA (Dysport) or normal saline. Dysport or saline will be administered into the paraspinal muscles (extensors or erector spinae) at five levels (L1-L5), regardless of pain location. In the case of unilateral pain, this would amount to 500 units total, and in the case of bilateral pain, to 1000 units total, of Dysport per session.
The primary outcome of the study is number of patients with VAS < 4 ( no or subtle pain) at week 6 after placebo or Dysport injection.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Age 18-80, all ethnic groups, races, both sexes.
- •Diagnosis of chronic low back pain (longer than 3 months).
- •Pain of moderate to severe intensity (VAS 4 or higher).
- •Subjects who are able to read, speak, and understand English.
排除标准
- •Existing significant acute medical condition (i.e. cardiovascular, endocrine, hematologic, neoplastic, infectious, or autoimmune disorders).
- •Hypersensitivity to any botulinum toxin product or is recipient
- •Allergy to albumin. Lactose or cow milk protein
- •Infection in the proposed injection site.
- •Pregnancy or planned pregnancy (determined by urine pregnancy test). The women of childbearing age should use a reliable mode of contraception during the study period (abstinence, etc).
- •Active breast feeding.
- •Enrollment in any clinical trial (currently or within the past 3 months) in which treatments are imposed by a protocol.
- •Patients taking high doses of aminoglycosides or other drugs affecting the function of neuromuscular junction (anticholinergics , muscle relaxants)
- •Subjects who are younger than 18 years of age.
- •Neuromuscular-junction disorders and motor neuron disease such as Amyotrophic Lateral Sclerosis.
- •Evidence of acute pathology on neuro-imaging.
- •Axis I diagnosis determined by a neurologist or psychiatrist.
- •Anesthetic medications within two weeks and corticosteroid injections within 4 weeks of enrollment.
- •Received botulinum toxin injections in the past 3 months.
- •History of low back surgery , evidence of acute disc or severe lumbar stenosis in MRI
研究组 & 干预措施
Placebo
Subjects will be randomization to receive injections with either the study drug (abobotulinumtoxinA) or the placebo group. The subjects will be blinded to which intervention they will receive.
干预措施: Placebo (Drug)
AbobotulinumtoxinA Treatment
Subjects will be randomized to receive intervention injections with the study drug arbobotulinumtoxinA.
干预措施: AbobotulinumtoxinA Treatment (Drug)
结局指标
主要结局
Proportion of Participants With Mild or no Pain on Visual Analog Scale (VAS)
时间窗: 6 weeks
The primary outcome measure in this protocol is the proportion of subjects that have VAS \<4 (patients with no or mild pain) at week 6. The pain VAS is a continuous scale comprised of a line 10 centimeters in length, anchored by 2 verbal descriptors, one for each symptom extreme. For pain intensity, the scale is anchored by "no pain" (score of 0) and "worst imaginable pain" (score of 10).
次要结局
- Number of Patients With Improved Pain Using the Patient Global Impression of Change (PGIC)(6 weeks)
- Number of Subjects Showing Improvement on Quality of Life Scale for Pain(6 weeks)