The Interaction Between NGF-induced Muscle Sensitivity and Acute Exercise-induced Ischemia
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 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 pain evoked responses and facilitation of NGF-induced mechanical muscle hyperalgesia over time following an acute exercised-induced ischemic condition in a NGF-sensitized muscle.
详细描述
Assessing evoked pain responses and muscle hyperalgesia following contractions during acute ischemia in a NGF-sensitized muscle may clarify whether an interaction between NGF sensitization and acidic stimulation exist.
It is hypothesized that acute ischemic exercise with the NGF-sensitized TA muscle, in contrast to ischemic exercise in a non-sensitized would: 1) potentiate pain-evoked responses, and 2) facilitate NGF-induced muscle hyperalgesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
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
NGF condition + Control condition
All participants will receive five injections with NGF (1ug/0.5ml) into the tibialis anterior muscle in their non-dominant leg
After 4 weeks:
All participants will receive five injections with isotonic saline (9%/0.5ml) into the tibialis anterior muscle in their non-dominant leg
干预措施: NGF (Drug)
NGF condition + Control condition
All participants will receive five injections with NGF (1ug/0.5ml) into the tibialis anterior muscle in their non-dominant leg
After 4 weeks:
All participants will receive five injections with isotonic saline (9%/0.5ml) into the tibialis anterior muscle in their non-dominant leg
干预措施: Isotonic saline (Drug)
Control condition + NGF condition
All participants will receive five injections with isotonic saline (9%/0.5ml) into the tibialis anterior muscle in their non-dominant leg
After 4 weeks:
All participants will receive five injections with NGF (1ug/0.5ml) into the tibialis anterior muscle in their non-dominant leg
干预措施: NGF (Drug)
Control condition + NGF condition
All participants will receive five injections with isotonic saline (9%/0.5ml) into the tibialis anterior muscle in their non-dominant leg
After 4 weeks:
All participants will receive five injections with NGF (1ug/0.5ml) into the tibialis anterior muscle in their non-dominant leg
干预措施: Isotonic saline (Drug)
结局指标
主要结局
Muscle sensitivity
时间窗: Change from baseline at 1 week
Pressure pain thresholds (PPTs) are assessed over the non-dominant tibialis anterior muscle using a handhold pressure algometer.
次要结局
- Functional muscle pain(Change from baseline at 1 week)
- Muscle pain diary(Change from baseline at 1 week)
- Ischemic-induced pain intensity(Assessed right after the dorsiflexions have been performed)
研究者
Line Bay Sørensen
PhD. stud.
Aalborg University