The Efficacy of Botulinum Toxin Type A in the Treatment of Allodynic-Type Neuropathic Pain in People With Spinal Cord Injury or Multiple Sclerosis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Brief Pain Inventory
研究概览
简要总结
This study will examine the efficacy of Botulinum Toxin Type A ("Botox") in treating Allodynic-type neuropathic pain in people with spinal cord injury or multiple sclerosis.
Neuropathic pain is pain initiated or caused by injury to or disease of the nervous system, and is common in spinal cord injury patients or people with multiple sclerosis.
Allodynia is a type of neuropathic pain caused by something that normally would not cause pain, such as light touch, pressure from clothing, or bed sheets brushing against the skin.
Botox has been used to treat the muscle overactivity that causes spasticity in spinal cord injured patients. It has been noticed to exert some analgesic(pain relieving) effect, and has recently been studied as a treatment for neuropathic pain.
We want to see if Botox, injected intradermally, will relieve the symptoms of allodynic-type neuropathic pain.
24 volunteers are to be enrolled, with 16 receiving active treatment, and 8 "controls" receiving placebo.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fulfills the criteria for neuropathic pain causing allodynia according to IASP pain terminology.
- •Allodynia that is resistant to, or has failed, the standard level of care measures for more that six months.
- •Allodynia pain on a daily basis.
- •Allodynia pain that scores at least 4/10 on a pain numerical scale.
- •Other pain medications(including antidepressants and anticonvulsants)have been maintained at a stable dose for at least 2 months prior to enrollment.
- •Ability to communicate in English.
排除标准
- •Presence of other pain syndromes (e.g.,fibromyalgia, ongoing peripheral neuropathic pain.
- •Allergy to Botulinum Toxin Type A.
- •Allergy to albumin.
- •Use of Botulinum Toxin Type A for other treatment indications in the 3 months prior to enrollment.
- •Renal failure.
- •Hepatic failure.
- •Neuromuscular junction disorders.
- •Bleeding diathesis.
- •Cognitive impairment, dementia, major depression or psychotic disorder.
- •Pregnant or breastfeeding.
- •Infection at the injection site.
- •Active alchohol or substance abuse.
研究组 & 干预措施
Arm 1: Botulinum Toxin Type A
200 units of Botulinum Toxin Type a will be administered intradermally to the allodynic area chosen for study.The allodynic area will be mapped, and the number of injections needed to cover the allodynic area without exceeding 40 injection sites will be determined.
All participants will receive a cream formulation of lidocaine and prilocaine (EMLA) applied to the painful area 60 minutes before the injections to minimize any discomfort caused by the injections.
干预措施: Botulinum Toxin Type A (Drug)
Arm 2: Normal Saline for Injection
Normal saline for intradermal injection will be prepared by the Investigational Pharmacy in a manner as to be indistinguishable from active drug. The allodynic area will be mapped so as to determine the number of injections needed to cover the whole allodynic area without exceeding 40 injection sites. All participants will receive a cream formulation of lidocaine and prilocaine (EMLA) applied to the painful area 60 minutes before the injections to minimize any pain caused by the injections.
干预措施: Normal Saline for Injection (Drug)
结局指标
主要结局
Brief Pain Inventory
时间窗: Baseline and daily until study completion at 13 weeks
The primary outcome measure will be the self-reported average pain intensity from each morning's record in a diary. The average(self-reported) pain intensity will be measured at the screening visit, then the daily diary will be dispensed. The diary will ask for the average pain intensity of the last 24 hours using an 11-point numerical scale, with 0 representing no pain and 10 representing the worst pain imaginable
次要结局
- The Hospital Anxiety and Depression Scale(Baseline and follow-up visits (at weeks 1, 4, 8 and 13).)
- Neuropathic Pain Symptom Inventory(Baseline and follow-up visits(at weeks 1, 4, 8 and 13))
- Patient's Global Impression Scale(Final visit at week 13)
- Daily Sleep Interference Scale(Baseline and daily during study period until week 13.)
- Clinician Global Impression Scale(Final visit at week 13)
研究者
Dr. Karen Ethans
Director, Spinal Cord Injury Rehabilitation Program
University of Manitoba