Percutaneous Needle Electrolysis (PNE) in Soleus Injury

Soleus Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04042012
• Other study ID #: PNE in soleus
• Status: Completed
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: October 2020
• Source: University of Seville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 31, 2019
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 26 Years

Eligibility

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

Related Conditions & MeSH terms

• Soleus Injury
• Wounds and Injuries

Intervention

Other:
• Eccentric exercise
soleus eccentric exercise
• PNE
the application of galvanic current
• Combined
soleus eccentric exercise and PNE

Locations

Country	Name	City	State
Spain	University of Seville	Seville

Sponsors (1)

Lead Sponsor	Collaborator
University of Seville

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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