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临床试验/NCT07327593
NCT07327593招募中不适用

Exercise Induced Hypoalgesia in Pain-free Stroke and Healthy Populations: a Cohort Study

Neuron, Spain2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
2
主要终点
Pressure pain thresholds

研究概览

简要总结

Exercise has shown multiple beneficial effects in both healthy and post-stroke populations. One of these is the acute reduction in sensitivity to painful stimuli, called exercise-induced hypoalgesia (EIH). This phenomenon has been studied since 1979 and has shown improvements in pain thresholds with both aerobic and resistance training in healthy, pain-free populations and different chronic pain conditions.

Although there has been extensive research on EIH in healthy populations and those with chronic musculoskeletal pain, surprisingly little attention has been given to individuals with neurological pathologies. Chronic pain is found in more than 50% of patients after stroke, and 70% of affected individuals experience pain on daily activities. Reported prevalences of post-stroke pain (PSP) between different studies, but there is a general consensus that it is an underreported phenomenon. Patients with pain experience greater cognitive and functional decline, fatigue, depression and lower quality of life.

Multiple factors contribute to PSP, and various approaches exist to treat all the variables influencing it. This study aims to compare the effects of exercise on pain perception in healthy individuals and stroke patients without pain, using the same cardiovascular training protocol, to better understand the mechanisms of EIH and its maintenance after stroke, ultimately aiming to improve the treatment of people with stroke.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Care Provider, Outcomes Assessor)

盲法说明

Outcome assessors will be blinded to intervention. Care providers will be blinded to the evaluation data.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy cohort:
  • Age > 18 years
  • No neurological damage
  • No medical conditions that could affect the test
  • Post-stroke cohort:
  • Age > 18 years
  • Ischemic or hemorrhagic stroke (time since onset > 3 months)

排除标准

  • Healthy cohort:
  • Any medical condition that could affect the test (respiratory, cardiovascular, metabolic diseases, for example)
  • Pain in any location, of duration > 1 week in the 3 months preceding the trial.
  • Post-stroke cohort:
  • Unable to participate in the test (no possibility of transfer or active pedaling)
  • Medical contraindication to cardiovascular training for any reason
  • Inability to follow instructions or communicate sensations during training
  • Other neurological pathology, cardiac pathology (unstable angina, arrhythmias, aortic or left ventricular problems, myocarditis, pericarditis), pulmonary pathology that affects the test (pulmonary embolisms, pulmonary hypertension, etc.), renal or metabolic problems (severe renal dysfunction, uncontrolled diabetes, etc.), acute infection or fever, neurosurgery within 6 weeks prior to inclusion in the study
  • Pain in any location, lasting > 1 week in the 3 months prior to the trial.
  • Use of beta-blockers, antidepressants, or any medication that may alter heart rate measurements

结局指标

主要结局

Pressure pain thresholds

时间窗: Before the cardiovacular training, inmediately after the training, and 30 minutes after

Pressure pain thresholds (PPT) are the most used pain sensitivity measure for these paradigms, and represent a static measure of pain, indicating the basal state of pain perception. It is usually measured with an algometer, which is pressured into the body of the participant, who is informed to warn in the moment when pressure starts to be painful. EIH has shown little differences between local and general effects, so we will measure PPT in both rectus femoris (local effects) and first dorsal interosseous (general effects), marking the exact points for ensuring the replicability of the measure after the exercise program. In the post-stroke cohort, this assessment will be performed on the non-paretic side, so that the possible loss of sensitivity due to the condition does not influence the measurements.

Conditioned pain modulation

时间窗: Before the cardiovascular training, inmediately after the training and 30 minutes after

Conditioned pain comulation (CPM) is the terminology used to describe the effect of endogenous pathways to enhance or diminish the afferent noxious stimuli. For this assessment the "cuff test" methodology will be carried out over the healthy arm of post-stroke participants. This methodology employs a test stimulus (TS) using pressure pain threshold measurement. Subsequently, an inflatable pressure cuff is applied, and its pressure is increased until the patient reports a pain sensation of 6 out of 10. While the cuff is inflated, the pressure pain threshold measurement is repeated to obtain a a conditioned stimulus (CS). The test result is then calculated by subtracting the pressures obtained on the algometer, thus calculating the CS-TS difference. CPM will be measured in the dominant side in the healthy cohort and in the healthy side in the post-stroke cohort.

次要结局

未报告次要终点

研究者

发起方
Neuron, Spain
申办方类型
Other
责任方
Sponsor

研究点 (2)

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