- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07387276
"Recovery Techniques on Pain, Force and Muscle Oxygenation in Athletes: A Crossover Trial"
"Effects of Multiple Muscle Recovery Techniques on Pain, Force, Temperature, and Muscle Oxygenation in Professional Athletes: A Randomized Crossover Trial"
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.
Study Overview
Status
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: ALBERTO SANCHEZ SIERRA
- Phone Number: 608801238
- Email: alberto.sanchez@uclm.es
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Extracorporeal Shockwave Therapy (ESWT)
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.
|
Application of acoustic pulses to the gastrocnemius muscle to modulate tissue mechanotransduction and improve local microcirculation.
|
|
Experimental: Percussive Therapy - Massage Gun
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.
|
Mechanical vibration applied to the calf muscles to promote myofascial release and neuromuscular recovery through high-frequency percussion.
|
|
Experimental: TECAR Therapy -
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.
|
Application of high-frequency electromagnetic energy (diathermy) to the lower limb to induce deep endogenous heat and accelerate metabolic waste removal.
|
|
Experimental: Expert Manual Sports Massage
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.
|
Systematic manipulation of soft tissues using manual techniques (effleurage and petrissage) focused on reducing muscle tension and perceived soreness.
|
|
Experimental: Intermittent Negative Pressure
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.
|
Controlled suction therapy applied to the gastrocnemius to create space between fascial layers and stimulate lymphatic and venous drainage.
|
|
Experimental: Pressotherapy
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.
|
External pneumatic compression through a sequential inflation system to facilitate venous return and reduce lower limb edema post-effort.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle Oxygen Saturation (SmO2)
Time Frame: 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.
|
immediately post-effort (fatigue), and immediately post-intervention (recovery).
|
|
Pressure Pain Threshold (PPT)
Time Frame: 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.
|
immediately post-effort (fatigue), and immediately post-intervention (recovery).
|
|
Maximum Isometric Muscle Strength
Time Frame: 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.
|
immediately post-effort (fatigue), and immediately post-intervention (recovery).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle Surface Temperature
Time Frame: immediately post-effort (fatigue), and immediately post-intervention (recovery).
|
Measured using a digital infrared thermography camera.
It assesses the changes in skin surface temperature over the gastrocnemius muscle area, reflecting changes in local blood flow.
|
immediately post-effort (fatigue), and immediately post-intervention (recovery).
|
|
Participant Satisfaction and Perceived Recovery
Time Frame: 5 minutes after each recovery intervention.
|
Measured using a Visual Analog Scale (VAS) and a customized survey (Likert scale 1-5).
Participants rate which recovery modality felt better and their perceived level of muscle readiness for a new effort.
|
5 minutes after each recovery intervention.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Musculoskeletal Diseases
- Nervous System Diseases
- Muscular Diseases
- Wounds and Injuries
- Neuromuscular Diseases
- Musculoskeletal Pain
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Athletic Injuries
- Myalgia
- Therapeutics
- Complementary Therapies
- Physical Therapy Modalities
- Rehabilitation
- Ultrasonic Therapy
- Diathermy
- Hyperthermia, Induced
- Therapy, Soft Tissue
- Musculoskeletal Manipulations
- Massage
- Drainage
- Extracorporeal Shockwave Therapy
- Manual Lymphatic Drainage
- Cupping Therapy
Other Study ID Numbers
- 22
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Athletic Injuries
-
Gulf Medical UniversityAlva's College of PhysiotherapyCompletedAthletic Injuries/Prevention and ControlUnited Arab Emirates
-
INTI International UniversityEnrolling by invitationSports Injuries | Athletic Performance and Injury RiskMalaysia
-
Fundación Universidad Católica de Valencia San...CompletedAthletic Performance | Postural Balance | Sports Injuries | Foot PostureSpain
-
Health Education Research Foundation (HERF)CompletedAthletic Injuries | Athletic Performance | Hamstring TightnessPakistan
-
Fu Jen Catholic University HospitalActive, not recruitingAnterior Cruciate Ligament Injuries | Athletic Performance | Biomechanical Phenomena | Sports Injuries | Female AthletesTaiwan
-
Emory UniversityNational Collegiate Athletic Association - NCAARecruiting
-
Halic UniversityCompleted
-
Istanbul Medipol University HospitalCompletedAthletic InjuriesTurkey
-
Riphah International UniversityCompleted
-
National Taiwan Sport UniversityTerminated
Clinical Trials on Extracorporeal Shockwave Therapy (ESWT)
-
Loewenstein HospitalUniversity of Melbourne; James Cook University, Queensland, Australia; MedispecCompleted
-
Unfallkrankenhaus BerlinCompletedBurn Wound and Skin Graft HealingGermany
-
AUVA Trauma Center MeidlingUnknownSpinal Cord InjuriesAustria
-
Krishnadevaraya College of Dental Sciences & HospitalCompleted
-
National Taiwan University HospitalNot yet recruitingNeuropathic Pain | Plantar Fasciitis
-
Odense University HospitalUnknownErectile Dysfunction | Radical Prostatectomy | Extracorporeal Shockwave TherapyDenmark
-
Gazi UniversityNot yet recruitingLymphedema, Lower Limb | Edema Leg | Placebo Control Design | Extracorporeal Shock Wave Therapy | Sham-controlledTurkey (Türkiye)
-
European University CyprusCompletedMyofascial Pain Syndrome | Myofascial Trigger Point Pain | Upper Trapezius Trigger PointsCyprus
-
Northeast College of Health SciencesWithdrawnAcute Lower Back PainUnited States
-
KTO Karatay UniversityCompletedPain | Foot Diseases | Plantar FasciitisTurkey