- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07421570
The Effect of Capacitive and Resistive Electrical Transfer Therapy on Hamstring Injuries
The Effect of Capacitive and Resistive Electrical Transfer Therapy (CRET) on the Return to Play Time in Elite Soccer Players With Hamstring Strain Injuries
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Hamstring injuries are the most prevalent pathology in professional football, primarily due to the demands of high-speed running. Beyond threatening athlete health, these injuries account for 12-17% of all time-loss injuries, directly impacting a team's seasonal performance. Research has shown that teams with fewer pre-season hamstring injuries achieve greater success, while the annual financial burden on clubs reaches hundreds of millions of pounds. Recent analyses of 21 years of data from the UEFA Elite Club Injury Study reveal that, despite advancements in preventive strategies and training science, hamstring injury rates have not decreased but rather increased by 30% in recent years (5). Given this substantial financial cost, it is evident that current prevention and rehabilitation programs are insufficient, highlighting the need to integrate new therapeutic modalities that optimize tissue healing into clinical practice.
Capacitive and Resistive Electric Transfer (CRET) is a non-invasive electro-physical modality that generates deep endogenous hyperthermia using radiofrequency currents, typically at a stable frequency of 448 kHz. Recent systematic reviews highlight that this method accelerates tissue regeneration not only through its thermal effect but also via biostimulation, which enhances ion mobility by balancing cell membrane potential. By increasing the permeability of ion channels in the cell membrane, it optimizes sodium-potassium (Na/K) pump activity, thereby helping injured and depolarized cells restore their membrane potential. CRET operates through two distinct modes (capacitive and resistive) that focus energy on specific layers based on tissue resistance, allowing it to selectively increase arterial blood perfusion even in deep muscle groups. While these studies recommend Tecar therapy for muscle regeneration, there are no randomized controlled trials investigating its efficacy specifically in hamstring injury rehabilitation. Therefore, this study aims to evaluate the effects of CRET-frequently used in clinics and sports clubs-on professional football players with hamstring injuries. We hypothesized that CRET would have positive effects on tissue healing during the subacute phase
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Irem DUZGUN, PHD
- Phone Number: +90 532 477 40 00
- Email: iremduzgun@hacettepe.edu.tr
Study Contact Backup
- Name: Baran Akay, MD
- Phone Number: +90 535 891 44 03
- Email: baranakay@icloud.com
Study Locations
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Altindag
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Ankara, Altindag, Turkey (Türkiye), 06100
- Recruiting
- Hacettepe University
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Contact:
- Irem Duzgun
- Phone Number: +90 532 477 40 00
- Email: iremduzgun@yahoo.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- History of acute onset hamstring pain.
- Grade I or II hamstring strain injury confirmed by Magnetic Resonance Imaging (MRI) within the first 5 days following the injury.
- No history of anterior cruciate ligament (ACL) reconstruction.
Exclusion Criteria:
- Presence of neurological symptoms.
- Loss of superficial sensation or skin pathologies that may prevent CRET application.
- Refusal to sign the approval form.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: CRET experimental
In addition to the standard rehabilitation program, the experimental group will receive CRET therapy (T-Plus; Wintecare SA, Chiasso, Switzerland) at the end of each session.
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Experimental Group (CRET Therapy): In addition to the standard rehabilitation program, CRET therapy (T-Plus; Wintecare SA, Chiasso, Switzerland) will be applied at the end of each session to the experimental group. Positioning: The athlete will be placed in a prone position, with the passive electrode placed under the quadriceps muscle and the active electrode applied in the direction of the hamstring muscle fibers using classic massage maneuvers. Dosage and Duration: The treatment will last a total of 20 minutes, consisting of 10 minutes in resistive mode followed by 10 minutes in capacitive mode. Intensity: The application will start at 70% intensity. If the thermal sensation reaches a level that disturbs the athlete, the intensity will be gradually reduced by 10% to achieve the maximum tolerable thermal effect.
A standard hamstring rehabilitation program consisting of three phases will be implemented.
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Active Comparator: Control
Participants in the control group will undergo a standard, evidence-based, three-stage hamstring rehabilitation program.
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A standard hamstring rehabilitation program consisting of three phases will be implemented.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Return to Sport Time
Time Frame: 5 weeks
|
The primary outcome measure is the number of days from the time of injury to the time when criteria for full return to sports are met.
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5 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hamstring Flexibility
Time Frame: 5 weeks
|
Passive straight leg raise, passive knee extension at 90° hip flexion, and active knee extension at full hip flexion angles will be measured using a smartphone-based goniometer (Goniometer Plus) with proven validity and reliability.
|
5 weeks
|
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Hamstring strength
Time Frame: 5 weeks
|
Hamstring muscle strength will be assessed using a hand dynamometer (MicroFet 2, Hoggan Health, USA).
Measurements will be taken in the prone position with the knee flexed at 90°, in the form of isometric strength and mid-range eccentric strength tests, and the maximum value of 3 repetitions will be recorded.
|
5 weeks
|
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Muscle Oxygen Saturation (NIRS)
Time Frame: 5 weeks
|
Muscle oxygenation in the injured area will be monitored using a non-invasive near-infrared spectroscopy (NIRS) device (Moxy Monitor, Fortiori Design LLC).
The device will be secured to the injured area with adhesive tape, and the average total hemoglobin and capillary oxygen saturation (SmO2) values obtained during the 10-second measurement period will be recorded.
The Moxy device has previously been shown to be valid and reliable for measuring muscle oxygenation.
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5 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Irem DUZGUN, Hacettepe University
Study record dates
Study Major Dates
Study Start (Actual)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HU-SBE-BA-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
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