Exploration of Gait Biomechanics and Muscle Pain of the Lower Extremity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Infrared marker XYZ coordinates
研究概览
简要总结
This interventional study aims to test gait biomechanics in healthy individuals with and without experimental muscle pain in the lower extremities. The study aims to:
A) Examine how experimental muscle pain in different types of muscles (ankle plantar-flexion, knee extension, and flexion muscles) affects kinematics, kinetics, and muscle activation
Participants will receive six muscle injections: a) Hypertonic saline (painful condition) and b) Isotonic saline (control condition) in 1) m. gastrocnemius, 2) m. semitendinosus, and 3) m. biceps femoris.
详细描述
The proposed study will be a randomized, crossover design in which experimental pain will be induced in healthy subjects using hypertonic saline injections to three muscles of the lower extremities: The gastrocnemius muscle, the vastus medialis muscle, and the semitendinosus muscle. Participants will be block-randomized to receive an injection in each of the three muscles and will receive either the painful or control condition first for each muscle. The participant will always be blinded to the type of injection received.
Following the injection, there will typically be a 15-minute window of pain (45). Within this timeframe, motion capture will be carried out for both the control and painful conditions. During motion capture, the participants will perform multiple walking trials of approximately 10 meters. The participants will be equipped with electromyography (EMG) sensors on key muscles of the lower extremities. The participants will be asked for NRS ratings every 30 seconds throughout the 15 minutes with expected pain. There will be a 15-minute washout between the muscle injections.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy men and women aged 18-45 years
排除标准
- •Pregnancy
- •Drug addiction, defined as the use of cannabis, opioids, or other drugs
- •Previous or current neurologic or musculoskeletal illnesses
- •Current pain
- •Lack of ability to cooperate
结局指标
主要结局
Infrared marker XYZ coordinates
时间窗: Baseline.
Marker-based motion capture with infrared cameras will be used to estimate placement of reflective markers in the XYZ planes measured in millimeters. Reflective markers will be placed from head-to-toe on anatomical landmarks.
Pain intensity (NRS 0-10)
时间窗: Baseline.
Pain during intervention is measured continuously every 30 seconds on a numeric rating scale from 0 'no pain' to 10 'the worst pain imaginable'
次要结局
- Ground reaction moments(Baseline.)
- Muscle activation(Baseline.)
- Pain sensitivity.(Baseline.)
- Ground reaction forces(Baseline.)
- Ground contact XZ location(Baseline.)
研究者
Kristian Kjær Petersen
Associate professor
Aalborg University