Cortical Neuroplasticity by Muscle Pain and Non-invasive Modulation of Pain-induced Plasticity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Pain rating
研究概览
简要总结
The purpose of this study is to investigate the sensory-motor cortical excitability response to delayed onset muscle soreness (DOMS) on Extensor Carpi Radialis (ECR) muscle during muscle hyperalgesia provoked by nerve growth factor (NGF).
详细描述
The purpose of this study is to assess changes in sensory-motor cortical excitability during experimental muscle hyperalgesia across several days provoked by injections of nerve growth factor (NGF) into the Extensor Carpi Radialis (ECR) muscle and delayed onset muscle soreness (DOMS) of the ECR muscle.
It was hypothesized that muscle hyperalgesia across several days would result in:
i) Increased sensory cortical excitability, based on somatosensory evoked potentials by means of electrical stimulation of the radial nerve, (increase of central-parietal evoked-potential P45 and decrease of frontal evoked-potential N30); ii) Increased corticomotor excitability of a ECR (increase map volume and number of active sites), assessed as motor evoked potentials induced by transcranial magnetic stimulation in primary motor cortex (M1); iii) Reduction of alpha oscillation based on nociceptive stimulus-evoked suppression of alpha activity in sensory regions (recording electrodes on contra-lateral parietal area);
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy men and women
- •Speak and understand English.
排除标准
- •Drug addiction defined as the use of cannabis, opioids or other drugs
- •Previous neurologic, musculoskeletal or mental illnesses
- •Lack of ability to cooperate
- •History of chronic pain or current acute pain
- •Previous experience with rTMS
- •Contraindications to rTMS application (history of epilepsy, metal in the head or jaw etc.).
- •Failure to pass the "TASS questionnaire" (TASS = Transcranial Magnetic Stimulation Adult Safety Screen)
研究组 & 干预措施
Nerve growth factor group
Three injections of sterile solutions of recombinant human nerve growth factor (NGF) will be performed in the right extensor carpi radialis muscle to induce muscle hyperalgesia.
干预措施: Sterile solutions of recombinant human nerve growth factor (NGF) (Drug)
Nerve growth factor group + delayed onset muscle soreness
Injections of nerve growth factor and eccentric exercise of the extensor carpi radialis muscle will be performed to induce muscle hyperalgesia.
干预措施: Sterile solutions of recombinant human nerve growth factor (NGF) (Drug)
结局指标
主要结局
Pain rating
时间窗: Change from baseline at 2 weeks
Pain on an 11-point numerical rating scale (0 = no pain, 10 = most intense pain imaginable)
次要结局
- Muscle soreness(Change from baseline at 2 weeks)
- Pressure pain thresholds(Change from baseline at 2 weeks)
- Motor evoked potentials(Change from baseline at 1 week)
- Sensory evoked potentials(Change from baseline at 1 week)
- Alpha oscillations(Change from baseline at 1 weeks)
- Patient-rated Tennis Elbow Evaluation(Change from baseline at 2 weeks)
研究者
Enrico De Martino
Medical Doctor
Aalborg University