The Effects of the Dopamine Agonist (Apomorphine) on Experimental and Clinical Pain in Patients With Chronic Radicular Pain: a Randomized, Double-blind, Placebo-controlled, Cross-over Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Experimental and clinical cold pain tolerance measured in seconds
研究概览
简要总结
The study aimed to explore the effect of the dopamine agonist apomorphine on spontaneous pain intensity and evoked cold clinical and experimental pain in patients with lumbar radicular neuropathic pain (NP). Patients received either apomorphine or placebo in a randomized double-blinded manner.
详细描述
Although evidence suggests that dopaminergic systems are involved in pain processing, the efficacy of dopaminergic interventions in reducing pain remains questionable. This randomized, double blinded, placebo-controlled, cross-over study was aimed to explore the effect of the dopamine agonist apomorphine on spontaneous pain intensity and evoked cold clinical and experimental pain in patients with lumbar radicular neuropathic pain (NP).
Data was collected from 35 patients (18 men, mean age 56.2±13.1 years). The following five pain measures were tested before (baseline) and 30, 75 and 120 min subsequent to subcutaneous injection of 1.5 mg apomorphine or placebo in two separate sessions: spontaneous pain intensity, threshold and tolerance to cold pain in the most painful site in the affected leg and in a remote healthy site in the dominant hand.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Presence of radicular pain for at least 3 months;
- •Average pain level during the last week prior to enrollment > 40 (0-100);
- •No use of a new analgesic drug within 30 days prior to entry to the study and
- •Adults who were capable of understanding the purpose and instructions of the study and signing an informed consent.
排除标准
- •Pregnancy or breastfeeding;
- •Presence of Parkinson's disease or any other extra-pyramidal diseases;
- •History of allergy to the investigational drugs: Apomorphine or Domperidone;
- •History of polyneuropathy and
- •Respiratory depression, dementia, psychotic diseases or hepatic insufficiency
研究组 & 干预措施
apomorphine
1.5 mg apomorphine, administered subcutaneously
干预措施: Apomorphine (Drug)
Normal saline
saline, administered subcutaneously
干预措施: Normal Saline (Drug)
结局指标
主要结局
Experimental and clinical cold pain tolerance measured in seconds
时间窗: Up to 120 minutes after drug administration
次要结局
- Spontaneous clinical pain intensity measured on a numeric pain scale (NPS, 0-100)(Up to 120 minutes after drug administration)
- Experimental and clinical cold pain threshold measured in seconds(Up to 120 minutes after drug administration)
研究者
Eisenberg Elon MD
Head of pain research unit, Institute of pain
Rambam Health Care Campus