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Ultrasound-guided Percutaneous Electrolysis in Female Soccer With Soleus Injury

Primary Purpose

Injury;Sports

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Invasive treatment and exercise therapy
Sponsored by
University of Seville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Injury;Sports

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • older than 18 years
  • having a soleus muscle injury
  • chronic injury (> 3 meses)
  • pain at stretch > 3 points measured by NRS

Exclusion Criteria:

  • belenophobia
  • other accuse injury
  • lumbar back pathology

Sites / Locations

  • University of Seville

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Experimental group

Control group

Arm Description

Participants will receive EPM and they will perform exercise program during 1 month.

Participants will receive needling puncture and they will perform exercise program during 1 month.

Outcomes

Primary Outcome Measures

Pain at palpation
measured by numeric rate scale (0 no pain; 10 worst pain)
Pain at stretch
measured by numeric rate scale (0 no pain; 10 worst pain)

Secondary Outcome Measures

ankle dorsiflexion
range of motion measured by goniometer (grade)
muscle fatigue
measured by heel test: raise until muscle fatigue (repetitions)

Full Information

First Posted
August 20, 2021
Last Updated
November 29, 2021
Sponsor
University of Seville
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1. Study Identification

Unique Protocol Identification Number
NCT05030896
Brief Title
Ultrasound-guided Percutaneous Electrolysis in Female Soccer With Soleus Injury
Official Title
Clinical Application of Percutaneous Electrolysis in Female Soccer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
September 2, 2021 (Actual)
Primary Completion Date
November 1, 2021 (Actual)
Study Completion Date
November 30, 2021 (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
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study evaluates if the physiotherapy treatment based on combination of therapeutic exercise program and ultrasound-guided PNE on chronic soleous injuries may cause changes in pain, dorsal flexion of the ankle and muscle fatigue in female dance

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Participants will receive EPM and they will perform exercise program during 1 month.
Arm Title
Control group
Arm Type
Experimental
Arm Description
Participants will receive needling puncture and they will perform exercise program during 1 month.
Intervention Type
Other
Intervention Name(s)
Invasive treatment and exercise therapy
Intervention Description
The subjects of experimental group will perform therapeutic exercise program and they will be receive Percutaneous Electrolysis therapy and the subjects of experimental group will perform the same exercise program and they will be receive only needling puncture
Primary Outcome Measure Information:
Title
Pain at palpation
Description
measured by numeric rate scale (0 no pain; 10 worst pain)
Time Frame
From baseline measurement up to one month
Title
Pain at stretch
Description
measured by numeric rate scale (0 no pain; 10 worst pain)
Time Frame
From baseline measurement up to one month
Secondary Outcome Measure Information:
Title
ankle dorsiflexion
Description
range of motion measured by goniometer (grade)
Time Frame
From baseline measurement up to one month
Title
muscle fatigue
Description
measured by heel test: raise until muscle fatigue (repetitions)
Time Frame
From baseline measurement up to one month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: older than 18 years having a soleus muscle injury chronic injury (> 3 meses) pain at stretch > 3 points measured by NRS Exclusion Criteria: belenophobia other accuse injury lumbar back pathology
Facility Information:
Facility Name
University of Seville
City
Seville
Country
Spain

12. IPD Sharing Statement

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Ultrasound-guided Percutaneous Electrolysis in Female Soccer With Soleus Injury

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