Prediction of Inter-individual Differences in the Response to Morphine by Psychophysical Assessment of Pain Enhancing and Inhibiting Mechanisms in Patients With Chronic Neuropathic Pain
试验速览
- 阶段
- 2 期
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Neuropathic pain intensity (NPS)
研究概览
简要总结
Clinical, psychophysical, behavioral or genetic factor will predict the response to opioid treatment in patients with chronic neuropathic pain.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with moderate to severe chronic neuropathic pain or patients with radiculitis between 18 and 75 years of age.
- •Candidates for chronic opioid therapy for nonmalignant pain as determined by treating physician.
- •Patients treated with non-opioid analgetics, anti- inflammatory drugs or low opioid dosage (< 30 mg of oral morphine-equivalents per day).
- •Ability to understand the purpose and instructions of the study and to sign an informed consent.
排除标准
- •1.Diabetic Neuropathy 2.Pain in upper limbs 3.Receiving anti- depressants and/or anticonvulsants 4.Pregnant women 5.Inability to comply with study protocol. 6.Allergy to Opioids 7.A diagnosis of Raynaud's Syndrome 8.History of substance abuse
研究组 & 干预措施
Morphine
Morphine in changing dosages (range between 10-60 mg twice a day). Opioid titration proceeds as follows: starting at an oral dose of 10 mg twice per day, followed every 5 days by a dose increase of 10 mg twice per day until (1) adequate analgesia had been achieved (as determined by the patients), (2) side effects (severe sedation, nausea or vomiting, constipation, sleep disturbances) limited further titration, or (3) a total of 120 mg per day had been reached.
干预措施: Morphine (Drug)
Milnacipran
Milnacipran (Ixel)- a serotonin-norepinephrine reuptake inhibitor (SNRI), will be administrated in changing dosages (range between 12.5-75 mg twice daily). SNRI titration proceeds as follows: starting at an oral dose of 12.5 mg twice per day, followed every 5 days by a dose increase of 12.5 mg twice per day until (1) adequate analgesia had been achieved (as determined by the patients), (2) side effects (severe sedation, nausea or vomiting, constipation, sleep disturbances) limited further titration, or (3) a total of 150 mg per day had been reached.
干预措施: Milnacipran (Drug)
结局指标
主要结局
Neuropathic pain intensity (NPS)
时间窗: 1 month
次要结局
- Heat pain intensity in a remote area (Opioid induced hyperalgesia)(1 month)
- The McGill Pain Questionnaire(At baseline and at the end of 4-week treatment period)
- Assessment of Adverse events(Ongoing throughout the entire study period, an expected average of 4 weeks.)
研究者
Eisenberg Elon MD
Director, Pain Research Unit
Rambam Health Care Campus