- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05030896
Ultrasound-guided Percutaneous Electrolysis in Female Soccer With Soleus Injury
November 29, 2021 updated by: Blanca de la Cruz Torres, University of Seville
Clinical Application of Percutaneous Electrolysis in Female Soccer
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seville, Spain
- University of Seville
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental group
Participants will receive EPM and they will perform exercise program during 1 month.
|
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
|
|
Experimental: Control group
Participants will receive needling puncture and they will perform exercise program during 1 month.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain at palpation
Time Frame: From baseline measurement up to one month
|
measured by numeric rate scale (0 no pain; 10 worst pain)
|
From baseline measurement up to one month
|
|
Pain at stretch
Time Frame: From baseline measurement up to one month
|
measured by numeric rate scale (0 no pain; 10 worst pain)
|
From baseline measurement up to one month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ankle dorsiflexion
Time Frame: From baseline measurement up to one month
|
range of motion measured by goniometer (grade)
|
From baseline measurement up to one month
|
|
muscle fatigue
Time Frame: From baseline measurement up to one month
|
measured by heel test: raise until muscle fatigue (repetitions)
|
From baseline measurement up to one month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 2, 2021
Primary Completion (Actual)
November 1, 2021
Study Completion (Actual)
November 30, 2021
Study Registration Dates
First Submitted
August 20, 2021
First Submitted That Met QC Criteria
August 26, 2021
First Posted (Actual)
September 1, 2021
Study Record Updates
Last Update Posted (Actual)
November 30, 2021
Last Update Submitted That Met QC Criteria
November 29, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Female Soccer
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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