Effect of Anticipated Pain on Corticospinal Excitability
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Change from baseline in corticospinal excitability
研究概览
简要总结
The purpose of this study is to investigate how the anticipation of pain, in the absence of real pain, affects the excitability of the corticospinal pathway. Corticospinal excitability reflects how responsive the motor areas of the brain are when sending signals to muscles.
In this study, healthy adult participants will be randomly assigned to one of two groups. Both groups will receive the application of an inert cream on the forearm. Participants in the experimental group will be told that the cream may cause pain, while participants in the control group will be informed that the cream is completely inactive. In reality, the cream has no physical effect in either group. This design allows the researchers to isolate the effect of pain anticipation (a nocebo effect) without exposing participants to actual pain.
Corticospinal excitability will be measured using transcranial magnetic stimulation (TMS), a non-invasive technique that stimulates the motor cortex to assess brain-to-muscle communication. Measurements will be taken before and after the application of the cream.
In addition, psychological factors related to catastrophizing and fear of movement will be assessed using validated questionnaires, and physiological responses associated with stress will be measured through heart rate variability.
The main question this study aims to answer is whether anticipating pain, even without experiencing real pain, alters corticospinal excitability, and whether this effect is influenced by fear of movement and catastrophizing. By improving our understanding of how pain-related expectations affect brain function, this research may contribute to better strategies for preventing maladaptive motor changes associated with chronic pain.
详细描述
Pain-related processes involve not only sensory inputs but also cognitive and emotional factors such as expectation, fear, and anticipation. Anticipating pain can influence motor behavior and emotional responses even in the absence of actual nociceptive stimulation. These anticipatory mechanisms are thought to contribute to maladaptive motor adaptations and may play a role in the development and maintenance of chronic pain conditions. However, the neurophysiological effects of pain anticipation, independently of real pain, remain insufficiently understood.
The aim of this study is to examine the effect of pain anticipation on corticospinal excitability, a neurophysiological marker of motor cortex responsiveness and brain-to-muscle communication. Corticospinal excitability is assessed using transcranial magnetic stimulation (TMS) applied over the primary motor cortex. This non-invasive technique allows evaluation of motor pathway function through the elicitation of motor evoked potentials recorded from a target hand muscle.
To specifically investigate anticipation-related effects, the study uses an experimental paradigm designed to manipulate pain expectancy without inducing actual pain. In addition to neurophysiological measures, psychological factors related to fear of movement and physiological markers of autonomic nervous system activity are considered, as they may influence the impact of pain anticipation on motor system function.
Procedures :
After providing informed consent, participants take part in a single experimental session conducted in a laboratory setting. The session begins with baseline assessments designed to characterize neurophysiological, psychological, and autonomic parameters prior to any experimental manipulation.
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
- None
盲法说明
A randomized number is allocated for all participants.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18 to 65 years.
- •No current pain at the time of inclusion and no pain episode or injury associated with pain within the past 3 months.
- •Ability to understand spoken and written French sufficient to follow study procedures.
- •Written informed consent obtained prior to participation.
- •Subjects affiliated with or receiving social security benefits
排除标准
- •History of psychiatric disorders (including intellectual disability or severe cognitive, behavioral, or affective impairment) that could interfere with understanding the study or providing informed consent.
- •History of neurological disorders, including epilepsy, stroke, brain or spinal cord surgery, or any neurological disease affecting motor or sensory function.
- •Inability to provide informed consent (e.g., dementia, significant hearing impairment, insufficient language proficiency).
- •Any pain condition within the past 3 months, regardless of origin.
- •Recent musculoskeletal injury or surgery within the past 3 months.
- •Contraindications to transcranial magnetic stimulation (TMS), including a history of epilepsy or the presence of intracranial metallic objects, cochlear implants, or other non-removable metallic implants in or near the head.
- •Use of analgesic or psychotropic medications.
- •Individuals under legal guardianship or curatorship.
- •Pregnant or breastfeeding women.
- •Presence of a cardiac pacemaker or other implanted electronic medical device.
- •Known allergy or history of skin reaction to any component of the inert cream used in the study (Medicafarm® Neutre Premium Longue Glisse).
研究组 & 干预措施
Control Group - Inert Cream (Neutral Information)
Participants in this control arm receive the application of an inert cream on the forearm. They are informed that the cream is inactive and will not produce any sensation or effect. This arm serves as a control condition for the manipulation of pain anticipation, with identical procedures and measurements as the experimental arm, except for the information provided about the expected effects of the cream.
干预措施: Pain Expectation Manipulation (Other)
Experimental Group - Inert Cream (Pain Expectation Information)
Participants in this experimental arm receive the application of an inert cream on the forearm. They are informed that the cream is expected to induce painful sensations after a delay, with pain gradually increasing in intensity over time. This information is used to induce anticipation of pain without actual nociceptive stimulation. All procedures and measurements are identical to those of the control arm, except for the information provided about the expected effects of the cream.
干预措施: Pain Expectation Manipulation (Other)
结局指标
主要结局
Change from baseline in corticospinal excitability
时间窗: During single session: baseline (pre-cream application), immediately post-cream application, and 10 minutes post-cream application
Corticospinal excitability will be assessed using transcranial magnetic stimulation (TMS) applied over the primary motor cortex. Single magnetic pulses of increasing intensity will be delivered to construct input-output (I/O) recruitment curves for each participant at baseline, immediately after cream application, and 10 minutes after cream application. Stimulation intensity will be increased in 3-5% steps, and 10 stimuli will be delivered at each intensity level. Motor evoked potentials elicited by TMS will be recorded using surface electromyography from the first dorsal interosseous muscle of the hand. I/O curves will be modeled using a Boltzmann sigmoidal function, and the slope, plateau, and S50 parameters will be extracted. Changes in corticospinal excitability will be compared between groups across these time points.
次要结局
- Fear-avoidance beliefs related to pain(Baseline)
- Kinesiophobia(Baseline)
- Change in heart rate variability from Baseline(During the single study session, from the baseline resting period through completion of the TMS procedure (up to 60 minutes))
- Pain catastrophizing related to pain(Baseline)
- Change from baseline in intracortical inhibition and facilitation (SICI and SICF)(During single session: baseline (pre-cream application), immediately post-cream application, and 10 minutes post-cream application)