Percutaneous Needle Electrolysis (PNE) in Soleus Injury

Study Overview
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Brief Summary
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This study evaluates if the physiotherapy treatment based on eccentric exercise, ultrasound-guided PNE or a combination of both therapies on chronic soleous injuries may cause changes in pain, functionality, dorsal flexion of the foot, balance and muscle fatigue in dancers.

Official Title
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Effect of the Application of Ultrasound-guided Percutaneous Needle Electrolysis on the Chronic Soleus Injury in Dancers

Conditions
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Soleus Injury

Intervention / Treatment
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* Other: Eccentric exercise
* Other: PNE
* Other: Combined


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Over 16 years. at least 5 years of formal dance training. at least 20 hours of training per week. Pain in the back of the leg diagnosis of chronic soleus injury Exclusion Criteria: Unsurpassed fear of needles History of adverse reactions to needles Immune system disorder Difficulty expressing your feelings properly Epilepsy and / or allergies to metals. Other lower limbs pathology

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 26 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eccentric group<br>The dancers of this group wil perform a soleus eccentric exercise | Other: Eccentric exercise<br>* soleus eccentric exercise<br>|
| Experimental: PNE group<br>The dancers of this group will receive a PNE treatment, consisting of the application of galvanic current, by ultrasound. The approach will be performed with a transverse axis with a needle orientation that will depend on the location of the target tissue. The parameters will be 3 mA, 3 seconds, 3 impacts (3: 3: 3). The periodicity will be 1day/7day/21day | Other: PNE<br>* the application of galvanic current<br>|
| Experimental: Combined group<br>The dancers of this group will receive a combined treatment and will be carried out in the same way as the other two groups. | Other: Combined<br>* soleus eccentric exercise and PNE<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of pain level | Visual Analogue Scale (VAS: 0=no pain; 100= pain as bad as can be | Change from Baseline VAS at 3 months months | 
| Change of Lunge Test | This test measures the ankle range of motion. Less than 9/10 cm, range of motion will be considered restricted | Change from Baseline lunge test at 3 months months | 
| Change of the Releve test | During the unilateral balance test with open eyes, the participant will be asked to hold as much time as possible in the relay position (raised heel of the floor) on one leg | Change from Baseline releve test at 3 months months | 
| Change of the Endurance test | The unilateral raised heel test. The dancer should repeatedly lift the heel from the floor to the maximum range of plantar flexion movement as many times as possible. | Change from Baseline endurance test at 3 months months | 
| Change of the Balance test | The test will be conducted with closed eyes, flat feet and barefoot participants and dancers will perform a retiré position. Participants will maintain the position as long as possible. | Change from Baseline balance test at 3 months months | 
| Changes of the DFOS questionnaire | This questionnaire measures the pain and function (0= bad; 90=well) | Change from Baseline DFOS questionnaire at 3 months months | 
| Change of the Minimal Detectable Change (MCD) | The minimal detectable change is defined as a valid change in score that is not due to chance. Minimally clinically important difference (MCID), in comparison, goes beyond valid change to assess meaningful difference in dance function | Change from after treatment at 3 months months |