HealthyNCT07122011
Neural Contributions to Exercise-Induced Hypoalgesia With Blood Flow Restriction
A study testing Low-Intensity Resistance Training with BFR in people with Healthy, run by University of Gran Rosario at 1 site in Argentina.
Trial summary
This experimental study explores the neurophysiological mechanisms associated with pain modulation following a single session of low-intensity resistance exercise combined with BFR in healthy young adults. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Low-Intensity Resistance Training with BFR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteArgentina
- Study dates
- 4 Aug 2025to 19 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Asymptomatic at the time of evaluation.
- Able to provide written informed consent.
- Available to attend a single evaluation and intervention session at the research center.
Who cannot join
- Bilateral knee symptoms or suspected patellar tendinopathy.
- Increased symptoms with dynamic loading.
- Neurological disorders.
- Inflammatory rheumatic diseases.
- Cardiac diseases.
- Any surgery within the last 3 months.
Show all 17Show fewer
- Pregnancy.
- Alcohol consumption on the day of participation.
- Hypertension (systolic blood pressure ≥140 mmHg).
- History of deep vein thrombosis.
- History of endothelial dysfunction.
- Peripheral vascular disease.
- Diabetes.
- Active infection.
- Spinal or referred pain.
- Previous experience with blood flow restriction (BFR) training.
- Overweight or obesity.
Trial locations and contacts
1 site in 1 country.
Argentina1 site
University Center for Assistance, Teaching and Research (CUADI)
Rosario, Santa Fe Province, 2000
About this study
Official title: Exploration of Neurophysiological Mechanisms of Exercise-Induced Hypoalgesia With Blood Flow Restriction in Healthy Adults
This experimental study explores the neurophysiological mechanisms associated with pain modulation following a single session of low-intensity resistance exercise combined with BFR in healthy young adults. The study evaluates changes in sensory thresholds before and after the intervention using validated quantitative sensory testing (QST) methods. These include pressure pain thresholds, conditioned pain modulation, thermal thresholds, and temporal summation. The findings may contribute to a better understanding of the role of the nervous system in exercise-induced hypoalgesia, particularly in response to BFR protocols, with implications for future research in pain and rehabilitation.
Read the detailed description
Exercise-induced hypoalgesia (EIH) is a physiological response characterized by reduced pain sensitivity following physical activity. Several central and peripheral mechanisms have been proposed to explain EIH, including activation of descending inhibitory pathways and peripheral nociceptor modulation. BFR training involves the application of controlled vascular occlusion during low-load exercise and has shown promising results in enhancing both muscle function and pain modulation.
This is a single-arm, pre-post experimental study involving healthy adults aged 18-35 years. All participants undergo a single session of low-intensity resistance exercise involving the lower limbs, performed under 60% limb occlusion pressure. QST is performed before and immediately after the intervention, including:
Pressure Pain Thresholds (PPT) measured with a digital algometer
Conditioned Pain Modulation (CPM) using cold-water immersion
Thermal thresholds assessed with a computer-controlled thermode
Temporal summation (TS) of pain via repeated pressure stimuli
The aim of this study is to explore the involvement of neurophysiological mechanisms-both central and peripheral-in the pain modulatory response following BFR exercise. This study is conducted at CUADI (Centro Universitario de Asistencia, Docencia e Investigación) in Rosario, Argentina. The results will contribute to basic science knowledge on pain physiology in healthy individuals and may inform future applied research in rehabilitation contexts.
Sample size considerations:
The estimated sample size is approximately 20 participants. This number is based on a preliminary power analysis conducted from pilot data on PPT changes following cold water immersion, which showed a mean difference of 0.77 kgf with a standard deviation of 0.33 kgf. Using G*Power software (v3.1), the calculated sample size for a paired comparison with 95% power and alpha of 0.05 was 16 subjects. To account for potential data loss or dropouts, we plan to include at least 20 individuals. This sample size is considered adequate for a mechanistic, single-arm pre-post design focusing on within-subject changes in pain modulation outcomes.
- Conditions
- Healthy
- Being tested
- Low-Intensity Resistance Training with BFR
- Keywords
- Blood flow restriction training, Exercise-induced hypoalgesia, Pain modulation, Quantitative sensory testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Intensity Resistance Training with BFROther
Warm-up: Five minutes of light-intensity cycling on a stationary bike.
Exercises:
- Bilateral half squat (0°-90°)
- Single-leg step-down from a 20 cm step
- Knee extension (90°-0°) at 30% of one-repetition maximum (1RM)
- Single-leg shallow squat (0°-45°)
Protocol: One set of 30 repetitions (or until volitional fatigue) followed by three sets of 15 repetitions for each exercise.
Rest periods: One minute between sets and two minutes between exercises.
BFR Application: Pneumatic cuff (The Occlusion Cuff Pro®) placed proximally on the dominant thigh, inflated to 60% of complete arterial occlusion (determined via Doppler ultrasound). The cuff remains inflated during sets and rest periods, and is deflated after completion of each exercise.
| Study group | Role | What they receive |
|---|---|---|
| Single Group - Low-Intensity Resistance Training with BFR | Experimental | A single session of low-intensity resistance training combined with BFR applied to the proximal thigh of the dominant leg at 60% of total arterial occlusion pressure. Sensory and pain modulation assessments (PPT, CPM, TS, and thermal thresholds) performed immediately before and after the training session. Receives: Other: Low-Intensity Resistance Training with BFR |
What is being measured
The primary outcome is the main question the study is designed to answer.
CPM
Changes in CPM will be assessed by immersing the hand up to the wrist in a cold water bath (0.6-0.8°) with a circulating water pump.The dominant arm for healthy participants will be immersed in the cold-water bath. In general, the conditioning stimulus will be applied for 2 min or maximum tolerance (whichever comes first). A computerized, custom-made visual analog scale will be used to continuously track the response profile to conditional stimuli across participants during the application of CPM. A numeric rating scale ranging from 0 to 100, where 0 represents no perception, 30 represents pain threshold (defined as the time to reach a painful sensation at the predefined stimulation intensity) and 100 represents the tolerance threshold (defined as the sensation of pain when becomes intolerable). Before and immediately after the immersion, PPT measurements will be assessed on medial joint line of the dominant knee and dorsal forearm contralateral to the knee.
Measured: Baseline (before intervention) and immediately after the intervention session.
PPT
Change in PPT will be assessed using a digital algometer (1 cm² round tip) applied perpendicularly to the skin at a rate of 1 kg/s until pain is first perceived. Three measurements will be averaged for each site. Measurement sites include the medial joint line of the dominant knee and the dorsal forearm contralateral to the knee. Each measurement will be performed at 30-second intervals.
Measured: At baseline and immediately after the intervention session.
Secondary outcomes (2)
Thermal sensitivity thresholds
Changes in heat detection thresholds (HDT, in °C), heat pain thresholds (HPT), and heat pain tolerance thresholds (HTPT) will be assessed by applying heat stimuli to the volar aspect of the non-dominant forearm. Tests will be performed in randomized order. Stimuli will be delivered using a thermode with a 9 cm² contact surface. The baseline temperature will be set at 30 °C, and the skin will be heated at a rate of 1 °C/sec until the first sensation of heat is perceived (HDT), the onset of pain is perceived (HPT), and the pain becomes intolerable (HTPT). The minimum stimulus temperature will be 0 °C, and the maximum will be 50 °C. After reaching the target threshold, the thermode will return to 30 °C at a rate of 5 °C/sec. A 30-second rest interval will be provided before the next measurement. Each test will be repeated three times at each assessment point, with a 30-second interstimulus interval.
Measured: Immediately before and immediately after the intervention session.
TS Score
Changes in TS will be evaluated at the knee and forearm by delivering 10 consecutive pressure pulses at the previously determined PPT intensity, each lasting one second with a one-second interval between pulses. Pain intensity will be rated for the first, fifth, and tenth pulses on a 0-100 numeric rating scale. The TS score will be calculated as the difference between the ratings of the tenth and first pulses.
Measured: Immediately before and immediately after the intervention session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start4 Aug 2025
- Primary completion19 Feb 2026
- Study completion19 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm, pre-post experimental study assessing within-subject changes in sensory pain thresholds after a low-load resistance training session with BFR.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Gran Rosario
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leonardo Intelangelo, University of Gran Rosario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07122011
- Sponsor's protocol ID
- Universidad del Gran Rosario
- Status last verified
- Apr 2026
- First submitted
- 6 Aug 2025
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Yes, the statistical analysis plan and informed consent form.
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of Neurophysiological Mechanisms of Exercise-Induced Hypoalgesia With Blood Flow Restriction in Healthy Adults
- ClinicalTrials.gov ID
- NCT07122011
- Acronym / sponsor ID
- Universidad del Gran Rosario
- Conditions
- Healthy
- Keywords
- Blood flow restriction training, Exercise-induced hypoalgesia, Pain modulation, Quantitative sensory testing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Gran RosarioUniversity, hospital or other
- Study start
- 4 Aug 2025 (actual)
- Primary completion
- 19 Feb 2026 (actual)
- Study completion
- 19 Feb 2026 (actual)
- First posted
- 14 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This experimental study explores the neurophysiological mechanisms associated with pain modulation following a single session of low-intensity resistance exercise combined with BFR in healthy young adults. The study evaluates changes in sensory thresholds before and after the intervention using validated quantitative sensory testing (QST) methods. These include pressure pain thresholds, conditioned pain modulation, thermal thresholds, and temporal summation. The findings may contribute to a better understanding of the role of the nervous system in exercise-induced hypoalgesia, particularly in response to BFR protocols, with implications for future research in pain and rehabilitation.
Detailed description
Exercise-induced hypoalgesia (EIH) is a physiological response characterized by reduced pain sensitivity following physical activity. Several central and peripheral mechanisms have been proposed to explain EIH, including activation of descending inhibitory pathways and peripheral nociceptor modulation. BFR training involves the application of controlled vascular occlusion during low-load exercise and has shown promising results in enhancing both muscle function and pain modulation.
This is a single-arm, pre-post experimental study involving healthy adults aged 18-35 years. All participants undergo a single session of low-intensity resistance exercise involving the lower limbs, performed under 60% limb occlusion pressure. QST is performed before and immediately after the intervention, including:
Pressure Pain Thresholds (PPT) measured with a digital algometer
Conditioned Pain Modulation (CPM) using cold-water immersion
Thermal thresholds assessed with a computer-controlled thermode
Temporal summation (TS) of pain via repeated pressure stimuli
The aim of this study is to explore the involvement of neurophysiological mechanisms-both central and peripheral-in the pain modulatory response following BFR exercise. This study is conducted at CUADI (Centro Universitario de Asistencia, Docencia e Investigación) in Rosario, Argentina. The results will contribute to basic science knowledge on pain physiology in healthy individuals and may inform future applied research in rehabilitation contexts.
Sample size considerations:
The estimated sample size is approximately 20 participants. This number is based on a preliminary power analysis conducted from pilot data on PPT changes following cold water immersion, which showed a mean difference of 0.77 kgf with a standard deviation of 0.33 kgf. Using G*Power software (v3.1), the calculated sample size for a paired comparison with 95% power and alpha of 0.05 was 16 subjects. To account for potential data loss or dropouts, we plan to include at least 20 individuals. This sample size is considered adequate for a mechanistic, single-arm pre-post design focusing on within-subject changes in pain modulation outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm, pre-post experimental study assessing within-subject changes in sensory pain thresholds after a low-load resistance training session with BFR.
| Arm | Type | Receives |
|---|---|---|
| Single Group - Low-Intensity Resistance Training with BFR | Experimental | Other: Low-Intensity Resistance Training with BFRA single session of low-intensity resistance training combined with BFR applied to the proximal thigh of the dominant leg at 60% of total arterial occlusion pressure. Sensory and pain modulation assessments (PPT, CPM, TS, and thermal thresholds) performed immediately before and after the training session. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Asymptomatic at the time of evaluation.
- Able to provide written informed consent.
- Available to attend a single evaluation and intervention session at the research center.
Key exclusion criteria (17 listed)
- Bilateral knee symptoms or suspected patellar tendinopathy.
- Increased symptoms with dynamic loading.
- Neurological disorders.
- Inflammatory rheumatic diseases.
- Cardiac diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-Intensity Resistance Training with BFRWarm-up: Five minutes of light-intensity cycling on a stationary bike. Exercises: 1. Bilateral half squat (0°-90°) 2. Single-leg step-down from a 20 cm step 3. Knee extension (90°-0°) at 30% of one-repetition maximum (1RM) 4. Single-leg shallow squat (0°-45°) Protocol: One set of 30 repetitions (or until volitional fatigue) followed by three sets of 15 repetitions for each exercise. Rest periods: One minute between sets and two minutes between exercises. BFR Application: Pneumatic cuff (The Occlusion Cuff Pro®) placed proximally on the dominant thigh, inflated to 60% of complete arterial occlusion (determined via Doppler ultrasound). The cuff remains inflated during sets and rest periods, and is deflated after completion of each exercise. | Other | Single Group - Low-Intensity Resistance Training with BFR |
Primary outcome
CPM
Time frame: Baseline (before intervention) and immediately after the intervention session.
Changes in CPM will be assessed by immersing the hand up to the wrist in a cold water bath (0.6-0.8°) with a circulating water pump.The dominant arm for healthy participants will be immersed in the cold-water bath. In general, the conditioning stimulus will be applied for 2 min or maximum tolerance (whichever comes first). A computerized, custom-made visual analog scale will be used to continuously track the response profile to conditional stimuli across participants during the application of CPM. A numeric rating scale ranging from 0 to 100, where 0 represents no perception, 30 represents pain threshold (defined as the time to reach a painful sensation at the predefined stimulation intensity) and 100 represents the tolerance threshold (defined as the sensation of pain when becomes intolerable). Before and immediately after the immersion, PPT measurements will be assessed on medial joint line of the dominant knee and dorsal forearm contralateral to the knee.
PPT
Time frame: At baseline and immediately after the intervention session.
Change in PPT will be assessed using a digital algometer (1 cm² round tip) applied perpendicularly to the skin at a rate of 1 kg/s until pain is first perceived. Three measurements will be averaged for each site. Measurement sites include the medial joint line of the dominant knee and the dorsal forearm contralateral to the knee. Each measurement will be performed at 30-second intervals.
2 secondary outcomes
Thermal sensitivity thresholds
Time frame: Immediately before and immediately after the intervention session.
TS Score
Time frame: Immediately before and immediately after the intervention session.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: Yes. Yes, the statistical analysis plan and informed consent form.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-Intensity Resistance Training with BFR in people with Healthy, run by University of Gran Rosario at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CPM (time frame: Baseline (before intervention) and immediately after the intervention session.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.