Exercise Induced Hypoalgesia in Pain-free Stroke and Healthy Populations: a Cohort Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNeuron, Spain
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age > 18 years
No neurological damage
No medical conditions that could affect the test
Age > 18 years
Disqualifiers
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.
Unable to participate in the test (no possibility of transfer or active pedaling)
Medical contraindication to cardiovascular training for any reason
Trial design
Design model
Parallel
Treatments tested in this trial
Cardiovascular training
Other interventionThe cardiovascular training protocol will consist of a 5-minute warm-up aimed at reaching 70% of maximum heart rate (MHR) followed by 20 minutes of sustained work at this intensity (since maintaining this intensity is difficult, especially in the stroke cohort, we will allow for a margin of ±2-3% of MHR and provide feedback to increase or decrease the heart rate). We will aim to keep the heart rate below 73% of maximum heart rate, maintain blood pressure within safe ranges, and keep the effort level between 14/20 and 16/20
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Healthy cohortActive comparator 1 intervention
Group B: Post-stroke pain free cohortExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Pressure pain thresholds
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.
Time frame
Before the cardiovacular training, inmediately after the training, and 30 minutes after2
Conditioned pain modulation
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.
Time frame
Before the cardiovascular training, inmediately after the training and 30 minutes afterSponsors and contacts
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Source ClinicalTrials.gov