Percutaneous Electrolysis and Vacuum Myofascial Therapy deviceTrial.

Study Overview
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Brief Summary
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The concept of epicondylitis refers to the manifestation of pain in the area of insertion of the epicondile muscles, and that it is accompanied by limitation functional. A tendinopathy is characterized as a process of degeneration, with fibroblast proliferation and disorganization of the fibers of collagen. This tendon pathology especially affects the epicondyle extensors and especially the first and second radial and short extensor carpal.

Detailed Description
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Experimental group will be treated Therapeutic Percutaneous Electrolysis and Vacuum Myofascial Therapy device once week for four weeks associated with eccentric exercises devices at home and the control group will be included 10 sessions of ultrasound pulsatil therapy (US) and massage associated with eccentric exercises devices at home.

Official Title
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Percutaneous Electrolysis and Vacuum Myofascial Therapy Device in the Treatment of Lateral Epicondylalgia: A Single-Blind Randomized Controlled Trial.

Conditions
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Epicondylitis

Intervention / Treatment
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* Device: Vacuum Myofascial Therapy device
* Other: physical therapy program
* Procedure: Therapeutic Percutaneous Electrolysis
* Procedure: ultrasound pulsatil therapy (US) and massage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of both sexes, aged between 18 and 60 years, in an active state of pain and with a diagnosis of one month of evolution. Exclusion Criteria: Patients who are pregnant, have pacemakers and those surgically operated patients who have been treated with electrolysis and Vacuum Myofascial Therapy Device a month earlier

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A specialist physician will be diagnosed the epicondylitis
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>Therapeutic Percutaneous Electrolysis and Vacuum Myofascial Therapy device once week for four weeks associated with eccentric exercises devices at home. | Device: Vacuum Myofascial Therapy device<br>* Therapeutic Percutaneous Electrolysis and Vacuum Myofascial Therapy device once week for four weeks associated with eccentric exercises devices at home.<br>Procedure: Therapeutic Percutaneous Electrolysis<br>* Therapeutic Percutaneous Electrolysis<br>|
| Experimental: CONTROL GROUP<br>The multimodal physical therapy program includes 10 sessions of ultrasound pulsatil therapy (US) and massage associated with eccentric exercises devices at home. | Other: physical therapy program<br>* The multimodal physical therapy program includes 10 sessions of ultrasound pulsatil therapy (US) and massage associated with eccentric exercises devices at home.<br>Procedure: ultrasound pulsatil therapy (US) and massage<br>* ultrasound pulsatil therapy (US) and massage<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The intensity of pain in epicondylitis | A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) will be used to assess the patients' current level of elbow pain, and the worst and lowest level of pain experienced in the preceding week in the elbow area. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The intensity of pain in epicondylitis | A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) will be used to assess the patients' current level of elbow pain, and the worst and lowest level of pain experienced in the preceding week in the elbow area. | Four and twelve weeks | 
| Active elbow range of motion | Measured by a two branches egoniomter | Baseline,four and twelve weeks | 
| Pressure pain thresholds in epicondylitis trigger points | Pressure pain thresholds (PPTs) will be measured with a pressure algometer (Baseline) | Baseline, four and twelve weeks | 
| Questionnaire SF 12 | The multidimensional health related quality of life | Baseline,four and twelve weeks | 
| Scale PRTEE | PRTEE is designed to evaluate pain and disability in subjects with lateral elbow tendinopathy. A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) will be used to assess the patients' current level of elbow pain, and the worst and lowest level of pain experienced in the preceding week in the elbow area. | Baseline,four weeks and Twelve weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tendinopathy, Electrolysis, Exercise, Dry needing, cupping, vacuum, negative pressure, massage