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OpenTrials
Completed

NCT Number: NCT04042012

Percutaneous Needle Electrolysis (PNE) in Soleus Injury

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.

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Key information

Conditions

Soleus Injury

Age range

16 year–26 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Seville

Seville, 41009, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Eccentric exercise

Other

soleus eccentric exercise

PNE

Other

the application of galvanic current

Combined

Other

soleus eccentric exercise and PNE

Primary outcomes

  1. change of pain level

    Time frame: Change from Baseline VAS at 3 months months

    Visual Analogue Scale (VAS: 0=no pain; 100= pain as bad as can be

  2. Change of Lunge Test

    Time frame: Change from Baseline lunge test at 3 months months

    This test measures the ankle range of motion. Less than 9/10 cm, range of motion will be considered restricted

  3. Change of the Releve test

    Time frame: Change from Baseline releve test at 3 months months

    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

  4. Change of the Endurance test

    Time frame: Change from Baseline endurance test at 3 months months

    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.

  5. Change of the Balance test

    Time frame: Change from Baseline balance test at 3 months months

    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.

  6. Changes of the DFOS questionnaire

    Time frame: Change from Baseline DFOS questionnaire at 3 months months

    This questionnaire measures the pain and function (0= bad; 90=well)

  7. Change of the Minimal Detectable Change (MCD)

    Time frame: Change from after treatment at 3 months months

    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

Sponsors and collaborators

Lead sponsor

University of Seville

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Aug 1, 2019
Registry last updated
Oct 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.