NCT07122011

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Aug 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 4, 2025

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 6, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 14, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 19, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 19, 2026

Completed
Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

7 months

First QC Date

August 6, 2025

Last Update Submit

April 28, 2026

Conditions

Keywords

Blood flow restriction trainingExercise-induced hypoalgesiaPain modulationQuantitative sensory testing

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    At baseline and immediately after the intervention session.

Secondary Outcomes (2)

  • Thermal sensitivity thresholds

    Immediately before and immediately after the intervention session.

  • TS Score

    Immediately before and immediately after the intervention session.

Study Arms (1)

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.

Other: Low-Intensity Resistance Training with BFR

Interventions

Warm-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.

Single Group - Low-Intensity Resistance Training with BFR

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Center for Assistance, Teaching and Research (CUADI)

Rosario, Santa Fe Province, 2000, Argentina

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single-arm, pre-post experimental study assessing within-subject changes in sensory pain thresholds after a low-load resistance training session with BFR.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

August 6, 2025

First Posted

August 14, 2025

Study Start

August 4, 2025

Primary Completion

February 19, 2026

Study Completion

February 19, 2026

Last Updated

May 4, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Yes, the statistical analysis plan and informed consent form.

Shared Documents
SAP, ICF
Time Frame
From first date of publication of journal article.
Access Criteria
IPD will be provided upon request.

Locations