Mechanisms of Exercise-induced Hypoalgesia

April 22, 2025 updated by: Université Catholique de Louvain

Disentangling Peripheral and Central Mechanisms of Exercise-induced Hypoalgesia in Healthy Adults Males.

This project aims to clarify the mechanisms underpinning the acute analgesic effect of exercise in healthy humans-a phenomenon called "Exercise-induced hypoalgesia" (EIH). This study will characterize, using a within-subject cross-over design, the effects of a single session of aerobic exercise vs. a control condition on the sensitivity to stimuli preferentially activating mechano vs. heat-sensitive nociceptors of the skin vs. muscle, within vs. outside exercising body parts. The investigators hypothesize (1) that EIH will be greater in the exercise session compared to the control session, (2) that EIH will be greater at the local site compared to the remote site if local changes in nociceptive sensitivity contribute to EIH, and (3) that exercise will preferentially affect blunt pressure-induced pain if EIH involves specific changes in sensitivity of muscle nociceptors.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Belgium
      • Brussels, Belgium, 1200
        • Institute of Neuroscience, UCLouvain

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Males aged between 18 and 30 years
  • Lack of risks for physical exercise assessed using the Physical Activity Readiness Questionnaire (PAR-Q)
  • Ability to provide written informed consent
  • Fluency in French
  • BMI between 17 and 30

Exclusion Criteria:

  • Regular tobacco use
  • Not willing or able to abstain from alcohol, recreational drugs, coffee, or tea from 24 hours prior to each experimental session.
  • Not willing or able to restrain from physical activity > 24h prior to each experimental session, and to be in a fasted state on the day of each experimental session.
  • Any neurological, cardio-vascular, respiratory, inflammatory, endocrine, psychiatric, oncological, rheumatological conditions. Such condition could put the participants at risk during maximal exercise testing and/or interfere with pain assessment.
  • Presence of any medical devices (e.g., cardiac pacemaker) implants or prothesis unless it is beyond discussion that these will not put the subject's safety during the study at risk and will not interfere with the results of the study.
  • Any chronic pain condition or recent history thereof (i.e. within the preceeding 2 years).
  • Wounds or skin alteration on testing sites.
  • Impaired hearing. This would affect ability to detect the control auditory stimuli.
  • Surgery < 12 months
  • Any drug intake in the past 2 weeks including antibiotics, herbal medicines and other remedies except the following drugs that will be allowed up to 48 hours prior to the experiments: oral paracetamol or ibuprofen for a self-limiting condition (e.g. toothache, bruise). Oral antihistaminics and nasal aerosol and topical treatments for seasonal allergy up to 1 week before the experimental session.
  • Any physical activity contraindication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental condition
Participants will complete an experimental exercise that will consist in 25 minutes of cycling between 60-80 Revolution Per Minute (RPM) on a cycle ergometer (CST BX40; Cardiostrong; Germany) at ≥ 70% of the Heart Rate Reserve (HRR).
Behavioral: Cycling exercise
Participants will complete an experimental exercise that will consist in 25 minutes of cycling between 60-80 Revolution Per Minute (RPM) on a cycle ergometer (CST BX40; Cardiostrong; Germany) at ≥ 70% of the Heart Rate Reserve (HRR).
Sham Comparator: Control condition
The control condition will include an exercise design similar to the experimental condition except that the resistance will be kept at 25 W and the RPM below 50. The intensity of the exercise will be kept at minimal levels by ensuring that the heart rate does not increase >25% from baseline
Behavioral: Cycling control
The control condition will include an exercise design similar to the experimental condition except that the resistance will be kept at 25 W and the RPM below 50. The intensity of the exercise will be kept at minimal levels by ensuring that the heart rate does not increase >25% from baseline.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in pressure pain threshold
Time Frame: Throughout the entire study, approximately during 6 months
The investigators will use blunt pressure to preferentially activate the mechano-sensitive deep-tissue nociceptors. The stimuli will be delivered with a manual digital algometer with a contact surface area of 1cm2 (FPIX; Wagner Instruments, Greenwich, USA) connected to a laptop computer through a USB-serial port. A bespoke Matlab (The Mathworks, USA, mathworks.com) script will provide visual feedback of the force application rate to the examinator. The participants will be asked to report the first onset of pain by pressing on a keyboard key. The procedure is safe, and there are no side effects to the stimulation. This outcome will measured before and after each of the condition of the study (experimental exercise vs. control exercise)-relative and absolute change will then be computed.
Throughout the entire study, approximately during 6 months
Change in cold detection threshold and heat pain threshold
Time Frame: Throughout the entire study, approximately during 6 months
The investigators will apply thermal stimuli to the skin to activate selectively heat-sensitive Aδ- and C-cutaneous fibre afferents. The thermal stimuli will be produced by a contact thermode based on Peltier elements (TCS-2; QST.lab, Strasbourg). The cold detection threshold (CDT) will be estimated by asking participants to press a button as soon as a decrease in skin temperature is noticed. The heat pain threshold (HPT) will be estimated by asking participants to press a button as soon as the increase in skin temperature becomes painful. This device is safe and routinely used for diagnostic purposes. The thermal stimulators will be used, in accordance with safety guidelines. If requested by the participant, the stimulation procedure can be stopped at any time, with no after effect. This outcome will measured before and after each of the condition of the study (experimental exercise vs. control exercise)-relative and absolute change will then be computed.
Throughout the entire study, approximately during 6 months
Change in rating of mechanical activation of cutaneous nociceptive afferents
Time Frame: Throughout the entire study, approximately during 6 months
The investigators will use calibrated mechanical pinprick stimulators with a small surface probe to selectively activate the skin mechanosensitive nociceptors (The PinPrick; MRC Systems GmbH, Heidelberg, Germany). Upon each stimulation, the participants will be asked to provide a rating of pain on a 100mm Visual Analogue Scale (VAS) anchored from "No sensation" to "Worst pain imaginable" with a mark in the middle denoting the transition from unpainful to painful sensations. To avoid sensitization/habituation of the skin, the location of the stimulus will be slightly changed for each stimulation. The sensation perceived by pinprick stimulation are most often described as pricking and sometimes like a touch sensation. The procedure is safe, and there are no side effects to the stimulation. This outcome will measured before and after each of the condition of the study (experimental exercise vs. control exercise)-relative and absolute change will then be computed.
Throughout the entire study, approximately during 6 months
Change in auditory detection threshold
Time Frame: Throughout the entire study, approximately during 6 months
The auditory stimulation will consist in a progressively increasing tone delivered at a comfortable hearing level using a pair of commercially available headphones. The participants will report the perception of the sound by pressing on a keyboard key. This outcome will measured before and after each of the condition of the study (experimental exercise vs. control exercise)-relative and absolute change will then be computed.
Throughout the entire study, approximately during 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Université Catholique de Louvain

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: André Mouraux, Full professor, MD, Institute of Neuroscience, UCLouvain

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 26, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 6, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 27, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EIH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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