Spread of Muscle Hyperalgesia and Pain in a Low Dose NGF-induced Pain Model
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Muscle sensitivity
研究概览
简要总结
The purpose of this study is to investigate and determine the time course and distribution on muscle hyperalgesia and muscle pain in a repeated, low dose NGF model. It is hypothesized that low dosages i.m injections of NGF are able to induce mechanical hyperalgesia and muscle soreness in a same manner (effect of duration) as for dosages previously used in NGF studies. Furthermore, it is also speculated if several injections of low dose NGF into the muscle combined are able to course immediate pain sensation and spreading of muscle hypersensitivity.
详细描述
Effects of pain responses, symptom development and pattern (time course and distribution) following 5 i.m low dose injections of NGF injected into the tibialis anterior muscle will be compared to a high dose i.m injection of NGF injected into the contralateral side in healthy pain-free subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
盲法说明
Double blind
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy and pain free volunteers
排除标准
- •Pregnancy
- •Drug addiction defined as the use of cannabis, opioids or other drugs
- •Previous neurologic, mental illnesses, or psychiatric diseases.
- •Past history of chronic pain in the musculoskeletal system (muscle, joint, cartilage, connective tissue)
- •Participation in other pain trials throughout the study period
- •Lack of ability to cooperate
- •Taking any analgesic 24 hours before the injections
- •Performing any strenuous leg exercise through out the study period causing sore muscles
研究组 & 干预措施
Low dose
All participants will receive 5 i.m injections of NGF (1 ug/0.5ml) into the tibialis anterior muscle (either left or right leg)
干预措施: NGF (Drug)
High dose
All participants will receive 1 high dose i.m bolus injection of NGF (5 ug/0.5ml) and 4 injections of saline (control/same volume) into the tibialis anterior muscle (either left or right leg)
干预措施: NGF (Drug)
结局指标
主要结局
Muscle sensitivity
时间窗: Change from baseline at 3 weeks
Pressure pain thresholds (PPTs) are assessed over the tibialis anterior muscles using a handhold pressure algometer.
次要结局
- Pressure-induced referred pain(Change from baseline at 3 weeks)
- Muscle soreness Diary(Change from baseline at 3 weeks)
- Pain intensity(Assessed continuously at 0-5 min during the injections at each leg)
- Activity-induced muscle soreness(Change from baseline at 3 weeks)
- Activity-induced muscle soreness Diary(Change from baseline at 1 week)
研究者
Line Bay Sørensen
Ph.d. stud.
Aalborg University