Percutaneous Needle Electrolysis (PNE) in Soleus Injury

Not Applicable

Completed

• Conditions: Soleus Injury
• Interventions: Other: Eccentric exercise; Other: PNE; Other: Combined

• Registration Number: NCT04042012
• Lead Sponsor: University of Seville

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-27
• Study First Submitted QC: 2019-07-30
• Study Start: 2019-08-01
• Study First Posted: 2019-08-01
• Primary Completion: 2019-11-01
• Study Completion: 2019-12-31
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-07
• Last Update Posted: 2020-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Eccentric group	Eccentric exercise	The dancers of this group wil perform a soleus eccentric exercise
PNE group	PNE	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
Combined group	Combined	The dancers of this group will receive a combined treatment and will be carried out in the same way as the other two groups.

Primary Outcome Measures

Name	Time	Method
Changes of the DFOS questionnaire	Change from Baseline DFOS questionnaire at 3 months months	This questionnaire measures the pain and function (0= bad; 90=well)
change of pain level	Change from Baseline VAS at 3 months months	Visual Analogue Scale (VAS: 0=no pain; 100= pain as bad as can be
Change of Lunge Test	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
Change of the Endurance test	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.
Change of the Releve test	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
Change of the Balance test	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.
Change of the Minimal Detectable Change (MCD)	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

Trial Locations

Locations (1)

University of Seville; 🇪🇸 Seville, Spain