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临床试验/NCT07387276
NCT07387276
尚未招募
不适用

"Effects of Multiple Muscle Recovery Techniques on Pain, Force, Temperature, and Muscle Oxygenation in Professional Athletes: A Randomized Crossover Trial"

Sierra Varona SL0 个研究点目标入组 20 人开始时间: 2026年6月1日最近更新:

概览

阶段
不适用
状态
尚未招募
入组人数
20
主要终点
Muscle Oxygen Saturation (SmO2)

概览

简要总结

The goal of this clinical trial is to evaluate the impact of various passive post-exercise recovery techniques on professional athletes. The main questions it aims to answer are:

Do passive recovery modalities significantly improve muscle oxygenation and tissue temperature immediately following high-intensity effort?

Which specific technique is most effective in reducing perceived pain, measured by the pressure pain threshold, and restoring muscle strength?

Researchers will compare six different therapeutic interventions-Transfer of Energy Capacitive and Resistive therapy, manual massage, intermittent negative pressure therapy, extracorporeal shockwave therapy, percussion therapy, and pneumatic pressotherapy-to determine which provides a superior immediate physiological and functional recovery effect.

Participants will:

Perform a high-intensity physical effort designed to induce peripheral fatigue.

Be randomly assigned to receive one of the six recovery protocols.

Undergo objective measurements immediately after the intervention, including near-infrared spectroscopy to assess muscle oxygen saturation, tissue thermography, algometry, and dynamometry.

详细描述

This project is designed as a randomized, double-blind (outcome assessor and statistician), crossover clinical trial. The study aims to address the critical need for evidence-based recovery strategies in high-demand sports such as basketball, where muscle overload is a primary risk factor for injury.The investigation will focus on the immediate physiological and functional effects of six widely utilized physiotherapy modalities:Capacitive and Resistive Energy Transfer (TECAR) Therapy: Utilized to improve tissue perfusion and modulate inflammatory responses through deep endogenous thermotherapy.Percussive Massage Therapy: Applied via mechanical vibration to reduce muscular stiffness and enhance explosive force restoration.Extracorporeal Shockwave Therapy (ESWT): Evaluated for its capacity to enhance muscular microcirculation and accelerate immediate tissue metabolic activity.Intermittent Pneumatic Compression (Pressotherapy): Targeted at reducing perceived pain and the sensation of limb heaviness through mechanical fluid drainage.Intermittent Negative Pressure Therapy (Vacuum Therapy): Investigated for its role in localized blood flow enhancement and pain modulation.Manual Sports Massage: Defined as the traditional manual intervention for reducing perceived muscle soreness and improving soft tissue flexibility.Physiological monitoring will be conducted using Near-Infrared Spectroscopy (NIRS) to measure muscle oxygen saturation ($SmO_2$) and total hemoglobin, providing direct data on muscle oxidative metabolism. Functional outcomes will be assessed through pressure pain thresholds (PPT) via algometry and maximal isometric strength via dynamometry to determine the effectiveness of each technique in restoring neuromuscular homeostasis.The study will be conducted at the Sierra Varona Physiotherapy Clinic (Toledo, Spain) between February and March 2026..

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

Due to the nature of the physical interventions-such as manual massage, extracorporeal shockwave therapy, and intermittent negative pressure-participants and therapists cannot be blinded to the treatment assignment. To mitigate potential bias, a double-blind approach will be implemented for data collection and statistical analysis.

The Outcome Assessor, responsible for recording measurements from near-infrared spectroscopy, algometry, and dynamometry, will remain blinded to the specific recovery modality administered to the athlete during each period. To maintain this blinding, the assessment will take place in a separate area from the intervention site. Furthermore, the statistical analysis will be conducted by an independent investigator using a coded dataset, ensuring that group allocation remains concealed until the final results are processed.

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Professional or Semi-professional athletes (specifically basketball players or endurance athletes) with a minimum of 2 years of competitive experience.
  • Aged between 18 and 35 years.
  • Healthy individuals with no current musculoskeletal injuries in the lower limbs.
  • Regular training frequency of at least 4-5 sessions per week.
  • Signed informed consent to participate in the study and follow the 6-week crossover protocol.
  • Commitment to maintain similar nutritional and sleep habits throughout the duration of the study.

排除标准

  • Presence of any acute or chronic injury in the gastrocnemius or Achilles tendon in the last 6 months.
  • Contraindications for specific therapies:
  • For Shockwave Therapy: Blood clotting disorders or use of anticoagulants.
  • For TECAR/Diathermy: Metal implants in the lower limbs or pacemakers.
  • For Cupping: Acute skin infections or dermatological hypersensitivity.
  • Consumption of performance-enhancing drugs, anti-inflammatory medication (NSAIDs), or stimulants that could affect muscle oxygenation (SmO2) or pain perception.
  • Recent surgery in the lower extremities (within the last year).
  • Inability to complete the standardized fatigue protocol or attend all 6 intervention sessions.

研究组 & 干预措施

TECAR Therapy -

Experimental

Application of diathermy using the Fisiowarm 300 system (Golden Star, Italy). The treatment will be administered for 15 minutes using a combination of capacitive and resistive modes at a frequency of 500 kHz. Intensity will be set at a thermal level (Type III) to promote deep vasodilation and metabolic clearance in the calf muscles.

干预措施: TECAR Therapy (Device)

Expert Manual Sports Massage

Experimental

A standardized sports massage session lasting 15-20 minutes will be performed by a senior physiotherapist with more than 20 years of experience in elite sports. The protocol will include deep effleurage, petrissage, and transverse friction techniques to alleviate muscle tension and improve blood flow in the gastrocnemius muscle.

干预措施: Manual Massage (Other)

Pressotherapy

Experimental

Application of pressotherapy using the Hermes Professional system. The treatment will last 20 minutes with a sequential six-chamber inflation cycle at a pressure of 70-80 mmHg, aiming to accelerate venous return and reduce post-exercise edema.

干预措施: Pressotherapy (Device)

Extracorporeal Shockwave Therapy (ESWT)

Experimental

Application of radial shockwave therapy using the Longest LGT-2500S device. A total of 2,000 pulses will be delivered to the gastrocnemius muscle (medial and lateral heads) at a pressure of 2.5 bar and a frequency of 10-15 Hz. The intervention aims to improve local microcirculation and reduce myofascial stiffness.

干预措施: Extracorporeal Shockwave Therapy (ESWT) (Device)

Percussive Therapy - Massage Gun

Experimental

Application of percussive massage using the Hyperice Hypervolt 2 Pro device. The intervention will last 5-10 minutes and will be applied to the gastrocnemius muscle at a frequency of 50 Hz (Level 3), focusing on the muscle-tendon junction to enhance neuromuscular recovery.

干预措施: Massage Gun (Device)

Intermittent Negative Pressure

Experimental

Application of intermittent negative pressure using the Physium System (multimodal vacuum therapy). The protocol consists of a 10-minute session applied to the gastrocnemius area to decompress tissue layers, enhance lymphatic drainage, and modulate mechanoreceptors to reduce pain.

干预措施: cupping (Device)

结局指标

主要结局

Muscle Oxygen Saturation (SmO2)

时间窗: immediately post-effort (fatigue), and immediately post-intervention (recovery).

Measured using Moxy Monitor (Near-Infrared Spectroscopy - NIRS). It evaluates the percentage of hemoglobin/myoglobin oxygenated in the gastrocnemius muscle.

Pressure Pain Threshold (PPT)

时间窗: immediately post-effort (fatigue), and immediately post-intervention (recovery).

Measured using a digital pressure algometer. It quantifies the minimum pressure (in kg/cm²) at which a participant perceives the stimulus as painful in the gastrocnemius.

Maximum Isometric Muscle Strength

时间窗: immediately post-effort (fatigue), and immediately post-intervention (recovery).

Measured using a handheld dynamometer. It evaluates the peak force (in Newtons) during a maximum voluntary isometric contraction of the calf muscles.

次要结局

  • Muscle Surface Temperature(immediately post-effort (fatigue), and immediately post-intervention (recovery).)
  • Participant Satisfaction and Perceived Recovery(5 minutes after each recovery intervention.)

研究者

申办方类型
Other
责任方
Sponsor

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