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Photobiomodulation Effects on Fatigue and Muscle Damage Induced by NMES

2026年8月24日 更新者:Marco Aurélio Vaz, PhD、Federal University of Rio Grande do Sul

Effects of Photobiomodulation on Fatigue and Muscle Damage Induced by Neuromuscular Electrical Stimulation in Healthy Individuals: a Randomized Clinical Trial

Neuromuscular electrical stimulation (NMES) is widely used to improve muscle strength and mitigate atrophy. However, its clinical efficacy is often limited by early neuromuscular fatigue, muscle damage, and discomfort, which reduce patient tolerance and contraction time. Photobiomodulation (PBM) has emerged as a potential therapy to enhance muscle performance and accelerate recovery by minimizing fatigue and damage. Despite its potential, few studies have investigated the effects of PBM applied specifically before an NMES-evoked fatigue protocol. This randomized, double-blind, placebo-controlled trial aims to evaluate the acute effects of PBM on neuromuscular fatigue, muscle damage, and functional outcomes in healthy young subjects. Participants will receive either active PBM (cluster probe: 5 lasers 810nm/200mW; 4 LEDs 660nm/10mW; Total Energy: 249.6 J per limb) or sham treatment 5 minutes before a fatiguing NMES protocol (80 contractions at 20% MVIC, 80 Hz, 1ms pulse width) applied to the quadriceps muscle. Assessments will be performed at baseline, immediately post-intervention, and at 24h, 48h, and 72h post-intervention. Primary outcomes include maximum and evoked isometric strength, mechanical work, and electrical muscle activity. Secondary outcomes include muscle damage (ultrasound echo-intensity), delayed onset muscle soreness (DOMS), functional performance (unilateral vertical jump), and clinical discomfort. The study seeks to determine if PBM can effectively modulate NMES-induced fatigue and muscle damage, potentially optimizing its clinical application.

研究概览

研究类型

介入性

注册 (估计的)

36

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • Rio Grande do Sul
      • Porto Alegre、Rio Grande do Sul、巴西、90690200
        • 招聘中
        • Laboratório de Pesquisa do Exercício
        • 接触:
        • 首席研究员:
          • Marco A Vaz, PhD
        • 副研究员:
          • Gustavo N Petter, MSc

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

是的

描述

Inclusion Criteria:

  • Healthy male and female volunteers.
  • Age between 18 and 45 years.
  • Practice physical activity regularly
  • No history of musculoskeletal injuries in the lower limbs in the last 6 months
  • Ability to tolerate NMES

Exclusion Criteria:

  • Have sensory intolerable changes due to NMES
  • Consumed coffee or another stimulant in the last 12 hours
  • Have a body mass index (BMI) greater than 30 kg/m2 (grade I obesity)
  • Present any contraindication for the performance of maximum effort
  • Abnormal increase in blood pressure after maximal exertion

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:三倍

武器和干预

参与者组/臂
干预/治疗
实验性的:Photobiomodulation (PBM)
Participants in this arm will receive active photobiomodulation therapy.
Application of PBMT using a cluster probe (Thor-DD2; 5 laser diodes: 810nm, 200mW; 4 LEDs: 660nm, 10mW). The treatment involves 8 points on the quadriceps (2 on vastus medialis, 3 on vastus lateralis, and 3 on rectus femoris). Each point is irradiated for 30 seconds in continuous mode with direct contact and slight pressure. Total energy: 31.2 J per point and 249.6 J per limb. Both therapist and participant will wear protective goggles.
Neuromuscular Electrical Stimulation (Myomed 932) applied to the quadriceps. Parameters: 80 Hz frequency, 1 ms pulse width (biphasic rectangular pulse), 5s:10s ON:OFF ratio with 1s ramp-up/down. The protocol lasts 20 minutes, totaling 80 evoked isometric contractions. Current intensity is adjusted to generate an initial torque of 20% of the baseline Maximum Voluntary Isometric Contraction (MVIC).
假比较器:Sham PBM
Participants in this arm will receive an inactive (placebo) photobiomodulation treatment.
Neuromuscular Electrical Stimulation (Myomed 932) applied to the quadriceps. Parameters: 80 Hz frequency, 1 ms pulse width (biphasic rectangular pulse), 5s:10s ON:OFF ratio with 1s ramp-up/down. The protocol lasts 20 minutes, totaling 80 evoked isometric contractions. Current intensity is adjusted to generate an initial torque of 20% of the baseline Maximum Voluntary Isometric Contraction (MVIC).
The procedure is identical to the active PBMT (8 points, 30 seconds per point, same pressure and positioning), but the device will be turned off. To ensure blinding, participants will wear protective goggles and a blindfold to prevent visual perception of the light.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Maximal voluntary isometric contraction (MVIC)
大体时间:Baseline (pre-intervention) on Day 1; immediately after the fatigue protocol on Day 1; and at 24, 48, and 72 hours after the fatigue protocol (on Days 2, 3, and 4, respectively).

Largest knee extensor torque generated isometrically and voluntarily on an isokinetic dynamometer.

Unit of Measure: Newton-meters (N.m)

Baseline (pre-intervention) on Day 1; immediately after the fatigue protocol on Day 1; and at 24, 48, and 72 hours after the fatigue protocol (on Days 2, 3, and 4, respectively).
Evoked fatigue
大体时间:Continuously during the 20-minute fatigue protocol.
Fall in the evoked torque during the fatigue protocol. Unit of Measure: Newton-meters (N.m)
Continuously during the 20-minute fatigue protocol.

次要结果测量

结果测量
措施说明
大体时间
Muscle Echo Intensity
大体时间:Baseline (pre-intervention) on Day 1; immediately after the fatigue protocol on Day 1; and at 24, 48, and 72 hours after the fatigue protocol (on Days 2, 3, and 4, respectively).

Quantitative analysis of muscle ultrasound images to assess changes in echo intensity, reflecting acute edema and changes in muscle quality. Analysis will be performed specifically on the Rectus Femoris (RF), Vastus Medialis (VM), and Vastus Lateralis (VL).

Unit of Measure: Arbitrary Units (au) on a 0-255 grayscale

Baseline (pre-intervention) on Day 1; immediately after the fatigue protocol on Day 1; and at 24, 48, and 72 hours after the fatigue protocol (on Days 2, 3, and 4, respectively).
Pressure Pain Threshold
大体时间:Baseline (pre-intervention) on Day 1; immediately after the fatigue protocol on Day 1; and at 24, 48, and 72 hours after the fatigue protocol (on Days 2, 3, and 4, respectively).
The minimum pressure at which a subject perceives a stimulus as painful, measured via pressure algometry on the quadriceps muscle bellies to quantify delayed onset muscle soreness (DOMS). Unit of Measure: Newtons (N)
Baseline (pre-intervention) on Day 1; immediately after the fatigue protocol on Day 1; and at 24, 48, and 72 hours after the fatigue protocol (on Days 2, 3, and 4, respectively).
Quadriceps Muscle Thickness
大体时间:Baseline (pre-intervention) on Day 1; immediately after the fatigue protocol on Day 1; and at 24, 48, and 72 hours after the fatigue protocol (on Days 2, 3, and 4, respectively).

Ultrasound assessment of structural changes in the quadriceps muscle group, for the Rectus Femoris (RF), Vastus Medialis (VM), and Vastus Lateralis (VL). This variable evaluates acute morphological changes or edema-induced swelling following the NMES protocol.

Unit of Measure: Millimeters (mm)

Baseline (pre-intervention) on Day 1; immediately after the fatigue protocol on Day 1; and at 24, 48, and 72 hours after the fatigue protocol (on Days 2, 3, and 4, respectively).
Countermovement Jump (CMJ) Height
大体时间:Baseline (pre-intervention) on Day 1; immediately after the fatigue protocol on Day 1; and at 24, 48, and 72 hours after the fatigue protocol (on Days 2, 3, and 4, respectively).

Measure Description: Maximum jump height achieved during a vertical countermovement jump on a force platform to assess dynamic muscle power.

Unit of Measure: Centimeters (cm)

Baseline (pre-intervention) on Day 1; immediately after the fatigue protocol on Day 1; and at 24, 48, and 72 hours after the fatigue protocol (on Days 2, 3, and 4, respectively).
Lower Limb Joint Kinematics During Jump
大体时间:Baseline (pre-intervention) on Day 1; immediately after the fatigue protocol on Day 1; and at 24, 48, and 72 hours after the fatigue protocol (on Days 2, 3, and 4, respectively).

Measure Description: Sagittal plane kinematic analysis for the ankle, knee, hip, and trunk joints to evaluate movement strategies and joint range of motion during the countermovement jump.

Unit of Measure: Degrees (°)

Baseline (pre-intervention) on Day 1; immediately after the fatigue protocol on Day 1; and at 24, 48, and 72 hours after the fatigue protocol (on Days 2, 3, and 4, respectively).
Force-Time Curve Dynamics During Jump
大体时间:Baseline (pre-intervention) on Day 1; immediately after the fatigue protocol on Day 1; and at 24, 48, and 72 hours after the fatigue protocol (on Days 2, 3, and 4, respectively).
Analysis of the vertical ground reaction force-time curve during the propulsion phase of the countermovement jump. The primary parameter will be the Vertical Impulse, calculated as the integral of force over time. Unit of Measure: Newton-seconds (N.s)
Baseline (pre-intervention) on Day 1; immediately after the fatigue protocol on Day 1; and at 24, 48, and 72 hours after the fatigue protocol (on Days 2, 3, and 4, respectively).
Muscle Activation
大体时间:Baseline (pre-intervention) on Day 1; immediately after the fatigue protocol on Day 1; and at 24, 48, and 72 hours after the fatigue protocol (on Days 2, 3, and 4, respectively).
Surface electromyography (sEMG) to assess muscle activation amplitude during MVIC. Unit of Measure: Microvolts (uV)
Baseline (pre-intervention) on Day 1; immediately after the fatigue protocol on Day 1; and at 24, 48, and 72 hours after the fatigue protocol (on Days 2, 3, and 4, respectively).
Vastus Lateralis Fascicle Length
大体时间:Continuously during the 20-minute fatigue protocol on Day 1.

Measure Description: Assessment of real-time changes in the fascicle length of the Vastus Lateralis muscle during the fatigue protocol using continuous ultrasound imaging.

Unit of Measure: Millimeters (mm)

Continuously during the 20-minute fatigue protocol on Day 1.

其他结果措施

结果测量
措施说明
大体时间
Vastus Lateralis Pennation Angle
大体时间:Continuously during the 20-minute fatigue protocol on Day 1.

Measure Description: Assessment of real-time changes in the pennation angle of the Vastus Lateralis muscle during the fatigue protocol using continuous ultrasound imaging.

Unit of Measure: Degrees (°)

Continuously during the 20-minute fatigue protocol on Day 1.
Adipose Tissue Thickness
大体时间:Baseline
Measurement of the fat layer thickness overlying the Rectus Femoris, Vastus Medialis, and Vastus Lateralis using ultrasound imaging. This measure is used to characterize the sample's morphology and will serve as a covariate to adjust the delivered PBM dose and NMES current penetration analysis. Unit of Measure: Millimeters (mm)
Baseline

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 学习椅:Marco A Vaz, PhD、Federal University of Rio Grande do Sul
  • 研究主任:Marco A Vaz, PhD、Federal University of Rio Grande do Sul
  • 首席研究员:Marco A Vaz, PhD、Federal University of Rio Grande do Sul

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年6月1日

初级完成 (估计的)

2026年8月30日

研究完成 (估计的)

2026年9月30日

研究注册日期

首次提交

2026年4月27日

首先提交符合 QC 标准的

2026年5月15日

首次发布 (实际的)

2026年5月22日

研究记录更新

最后更新发布 (实际的)

2026年8月25日

上次提交的符合 QC 标准的更新

2026年8月24日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

其他研究编号

  • 5.309.992(1)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

A final decision regarding the sharing of individual participant data has not yet been made. The study team intends to evaluate this possibility following the primary data analysis, in accordance with institutional guidelines and ethical committee requirements.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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