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Percutaneous Needle Electrolysis (PNE) in Soleus Injury

Primary Purpose

Soleus Injury

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Eccentric exercise

PNE

Combined

About this trial

This is an interventional treatment trial for Soleus Injury

Eligibility Criteria

16 Years - 26 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Seville

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Eccentric group

PNE group

Combined group

Arm Description

The dancers of this group wil perform a soleus eccentric exercise

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

The dancers of this group will receive a combined treatment and will be carried out in the same way as the other two groups.

Outcomes

Primary Outcome Measures

change of pain level

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

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 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 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 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.

Changes of the DFOS questionnaire

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

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04042012

First Posted

July 27, 2019

Last Updated

October 7, 2020

Sponsor

University of Seville

1. Study Identification

Unique Protocol Identification Number

NCT04042012

Brief Title

Percutaneous Needle Electrolysis (PNE) in Soleus Injury

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Completed

Study Start Date

August 1, 2019 (Actual)

Primary Completion Date

November 1, 2019 (Actual)

Study Completion Date

December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Seville

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Soleus Injury

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Eccentric group

Arm Type

Experimental

Arm Description

The dancers of this group wil perform a soleus eccentric exercise

Arm Title

PNE group

Arm Type

Experimental

Arm Description

Arm Title

Combined group

Arm Type

Experimental

Arm Description

The dancers of this group will receive a combined treatment and will be carried out in the same way as the other two groups.

Intervention Type

Other

Intervention Name(s)

Eccentric exercise

Intervention Description

soleus eccentric exercise

Intervention Type

Other

Intervention Name(s)

PNE

Intervention Description

the application of galvanic current

Intervention Type

Other

Intervention Name(s)

Combined

Intervention Description

soleus eccentric exercise and PNE

Primary Outcome Measure Information:

Title

change of pain level

Description

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

Time Frame

Change from Baseline VAS at 3 months months

Title

Change of Lunge Test

Description

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

Time Frame

Change from Baseline lunge test at 3 months months

Title

Change of the Releve test

Description

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

Time Frame

Change from Baseline releve test at 3 months months

Title

Change of the Endurance test

Description

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.

Time Frame

Change from Baseline endurance test at 3 months months

Title

Change of the Balance test

Description

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.

Time Frame

Change from Baseline balance test at 3 months months

Title

Changes of the DFOS questionnaire

Description

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

Time Frame

Change from Baseline DFOS questionnaire at 3 months months

Title

Change of the Minimal Detectable Change (MCD)

Description

Time Frame

Change from after treatment at 3 months months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

26 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

University of Seville

City

Seville

ZIP/Postal Code

41009

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

32908559

Citation

De-la-Cruz-Torres B, Barrera-Garcia-Martin I, Valera-Garrido F, Minaya-Munoz F, Romero-Morales C. Ultrasound-Guided Percutaneous Needle Electrolysis in Dancers with Chronic Soleus Injury: A Randomized Clinical Trial. Evid Based Complement Alternat Med. 2020 Aug 27;2020:4156258. doi: 10.1155/2020/4156258. eCollection 2020.

Results Reference

derived

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Percutaneous Needle Electrolysis (PNE) in Soleus Injury

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