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Energy Transfer Therapy in Treatment of Medial Gastrocnemius

Primary Purpose

Strain of Gastrocnemius Muscle (Diagnosis), Diathermy Plate Burn, Thermography

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
TECAR Therapy
Placebo
Sponsored by
Fundación Universidad Católica de Valencia San Vicente Mártir
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Strain of Gastrocnemius Muscle (Diagnosis)

Eligibility Criteria

16 Years - 39 Years (Child, Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Male players
  • Semi-professional players who are currently active
  • Not have suffered a lower limb injury in the last 6 months before the study
  • Not having suffered a rupture of the triceps surae
  • Contain a latent trigger point in the medial gastrocnemius

Exclusion Criteria:

  • Players suffering from any disease that could alter the study or be contradictory

Sites / Locations

  • Universidad Católica de Valencia San Vicente Mártir

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control

TECAR THERAPY

Arm Description

The simulated mode technique is applied (machine off)

The intervention will be performed with the T-Care TECAR® therapy machine at the latent trigger points of both gastrocnemius. The professional will apply the therapy with the generator that emits radio frequency signals of 0.5 MHz at a variable power with a maximum of 300W. The frequency to be used will be 500MHz with an intensity of 40% and with direct current.

Outcomes

Primary Outcome Measures

Pain intensity
Visual analogue scale (VAS) of pain

Secondary Outcome Measures

Back flexion
LUNGE Test
Thermographic evaluation
Ymiko Wifi Digital Weather Station with FLIR E60 camera and interpreted with FLIR tools software.

Full Information

First Posted
March 23, 2020
Last Updated
September 28, 2020
Sponsor
Fundación Universidad Católica de Valencia San Vicente Mártir
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1. Study Identification

Unique Protocol Identification Number
NCT04325750
Brief Title
Energy Transfer Therapy in Treatment of Medial Gastrocnemius
Official Title
Effects of Capacitive and Resistive Energy Transfer Therapy in Pre and Post-treatment Medial Gastrocnemius in National Level Basketball Players
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
August 28, 2020 (Actual)
Study Completion Date
August 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundación Universidad Católica de Valencia San Vicente Mártir

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study develops the effects of Capacitive and Resistive Energy Transfer Therapy (TECAR) on medial gastrocnemius using thermographic cameras, algometry and lunge tests, in a pre-post study with basketball players using a control group to which placebo is applied. (simulated technique) and an intervention group to which the technique is performed. The main objective of the study is to establish whether the TECAR produces physiological and mechanical changes in the subjects that improve muscle recovery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Strain of Gastrocnemius Muscle (Diagnosis), Diathermy Plate Burn, Thermography, Sports Physical Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
The simulated mode technique is applied (machine off)
Arm Title
TECAR THERAPY
Arm Type
Experimental
Arm Description
The intervention will be performed with the T-Care TECAR® therapy machine at the latent trigger points of both gastrocnemius. The professional will apply the therapy with the generator that emits radio frequency signals of 0.5 MHz at a variable power with a maximum of 300W. The frequency to be used will be 500MHz with an intensity of 40% and with direct current.
Intervention Type
Procedure
Intervention Name(s)
TECAR Therapy
Intervention Description
The intervention will be performed with the T-Care TECAR® therapy machine at the latent trigger points of both gastrocnemius. The professional will apply the therapy with the generator that emits radio frequency signals of 0.5 MHz at a variable power with a maximum of 300W. The frequency to be used will be 500MHz with an intensity of 40% and with direct current.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
simulated TECAR Therapy (machine off)
Primary Outcome Measure Information:
Title
Pain intensity
Description
Visual analogue scale (VAS) of pain
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Back flexion
Description
LUNGE Test
Time Frame
30 minutes
Title
Thermographic evaluation
Description
Ymiko Wifi Digital Weather Station with FLIR E60 camera and interpreted with FLIR tools software.
Time Frame
30 minutes

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male players Semi-professional players who are currently active Not have suffered a lower limb injury in the last 6 months before the study Not having suffered a rupture of the triceps surae Contain a latent trigger point in the medial gastrocnemius Exclusion Criteria: Players suffering from any disease that could alter the study or be contradictory
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos Barrios, PhD
Organizational Affiliation
Universidad Católica de Valencia San Vicente Mártir
Official's Role
Study Director
Facility Information:
Facility Name
Universidad Católica de Valencia San Vicente Mártir
City
Valencia
ZIP/Postal Code
46001
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Energy Transfer Therapy in Treatment of Medial Gastrocnemius

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