"Efficacy of Botulinum Toxin Injection in Reducing Limb Pain in Patients With Complex Regional Pain Syndrome"
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Reduction in the VAS score will be the primary outcome measure.
研究概览
简要总结
Objective: The primary aim is to evaluate the efficacy of botulinum toxin A in reducing overall limb pain in patients with complex regional pain syndrome (CRPS). Additionally the investigators would like to see if quality of life is improved and disability scores decreased.
Research Design:
This is a double blinded, randomized cross-over study that will be conducted over a 7 month period. It is a pilot study that will include twenty subjects recruited from the Neurology CRPS clinic at VA Connecticut and from outside VA hospitals within a 150 mile radius. Subjects will receive an intramuscular injection Treatment A which is only 1% lidocaine or Treatment B which is mixture of botulinum toxin A + 1% lidocaine in the affected limb only. This is a cross over study where patients will receive Treatment A or B initially during the first of four study visits and during the third study visit while receive whichever treatment not given during the first visit. Dr. Sameer Ali, VA neurology fellow, will be blinded when administering the treatments. Dr. Hajime Tokuno, VA neurologist who is the principal investigator of the trial will prepare the treatments. Clinical pharmacy will be randomizing the treatments. Dr. Tokuno will not be blinded as he needs to know which treatment has been given in case of complications.
Impact/Significance: The significance of this study is the possible discovery of a new, safer, less invasive, and more efficacious therapeutic option for patients suffering from CRPS. Currently medical management with neuropathic pain meds, interventions such as sympathetic nerve blocks and ketamine infusion has helped some patients and not others. The investigators are trying to see whether either of the two treatments and especially the treatment with botulinum toxin may be a more viable alternative than existing modalities.
详细描述
PROJECT DESCRIPTION Principal Investigator: Hajime Tokuno, MD
Project Title: "Efficacy of botulinum toxin injection in reducing limb pain in patients with Complex Regional Pain Syndrome"
Purpose: Complex Regional Pain Syndrome is a condition affecting anywhere from 1 to 5 million Americans including members of our veteran population for which there are woefully few effective therapeutics options. The investigators hypothesize that they can reduce overall pain levels in patients with Complex Regional Pain Syndrome (CRPS) using botulinum toxins. Reduction in the VAS score will be the primary outcome measure. Additionally they hypothesize that the quality of life will improve and disability will decrease, thus these two parameters both quality of life and disability will serve as the main secondary outcome measures. Additional secondary outcome measures include thermography, goniometry, algometry, electrical impedance myography, and a modified VAS scale designed by the investigators.
Background:
CRPS is a poorly defined medical entity that consists of a number of different signs and symptoms including neuropathic pain (or allodynia), ischemic pain, sympathetically mediated pain, and myofascial pain. There have been a number of therapeutic options such as anticonvulsants to treat neuropathic pain. Sympathetic mediated central pain has been treated with sympathetic ganglion blocks.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patients with documented diagnosis of CRPS per International Pain Society Guidelines. Diagnosis must be made or confirmed in the neurology CRPS clinic prior to recruitment.
- •Patients ages 18-
- •Patients may or may not have tried other therapeutics, will not affect study.
- •Veterans enrolled in the Veterans Hospital system of the United States.
- •Patients enrolled either type I or II CRPS of either upper or lower extremity.
排除标准
- •Prior history of adverse side effects with use of botulinum toxin.
- •Prior adverse reaction to lidocaine use.
- •CRPS involving multiple extremities.
- •Myasthenia gravis, myopathy, severe polyneuropathy or other causes of chronic muscle weakness.
- •History of severe mental illness or dementia.
研究组 & 干预措施
Phase 1
In Phase 1, subjects will receive either Treatment A (Lidocaine alone) or Treatment B (Botox+Lidocaine )
干预措施: Botox + Lidocaine (Drug)
Phase 1
In Phase 1, subjects will receive either Treatment A (Lidocaine alone) or Treatment B (Botox+Lidocaine )
干预措施: Lidocaine alone (Drug)
Phase 2
In Phase 2, subjects will receive either Treatment B (Botox+Lidocaine) or Treatment A (Lidocaine alone) -- the opposite of what was administered in Phase 1
干预措施: Botox + Lidocaine (Drug)
Phase 2
In Phase 2, subjects will receive either Treatment B (Botox+Lidocaine) or Treatment A (Lidocaine alone) -- the opposite of what was administered in Phase 1
干预措施: Lidocaine alone (Drug)
结局指标
主要结局
Reduction in the VAS score will be the primary outcome measure.
时间窗: 7 months
The VAS score will be obtained using the VAS at each of the four study visits. Zero is no pain and ten is maximum pain on the zero to ten scale.
次要结局
- Quality of Life as a measure of function with pain.(7 months)
- Thermography(7 months)
- Disability(7 months)
- Modified VAS Score(7 months)
- Goniometry(7 months)
- Algometry(7 months)
- Electrical Impedence Myography(7 months)