Injury;SportsNCT05030896
Ultrasound-guided Percutaneous Electrolysis in Female Soccer With Soleus Injury
A study testing Invasive treatment and exercise therapy in people with Injury;Sports, run by University of Seville at 1 site in Spain.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Injury;Sports
- What is being tested?
- Invasive treatment and exercise therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 2 Sep 2021to 30 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- older than 18 years
- having a soleus muscle injury
- chronic injury (> 3 meses)
- pain at stretch > 3 points measured by NRS
Who cannot join
- belenophobia
- other accuse injury
- lumbar back pathology
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Injury;Sports
- Being tested
- Invasive treatment and exercise therapy
- Medical subject headings
- Athletic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invasive treatment and exercise therapyOther
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
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Participants will receive EPM and they will perform exercise program during 1 month. Receives: Other: Invasive treatment and exercise therapy |
| Control group | Experimental | Participants will receive needling puncture and they will perform exercise program during 1 month. Receives: Other: Invasive treatment and exercise therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain at palpation
measured by numeric rate scale (0 no pain; 10 worst pain)
Measured: From baseline measurement up to one month
Pain at stretch
measured by numeric rate scale (0 no pain; 10 worst pain)
Measured: From baseline measurement up to one month
Secondary outcomes (2)
ankle dorsiflexion
range of motion measured by goniometer (grade)
Measured: From baseline measurement up to one month
muscle fatigue
measured by heel test: raise until muscle fatigue (repetitions)
Measured: From baseline measurement up to one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2021
- Study start2 Sep 2021
- Primary completion1 Nov 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injury;SportsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Blanca de la Cruz Torres, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05030896
- Sponsor's protocol ID
- Female Soccer
- Status last verified
- Nov 2021
- First submitted
- 20 Aug 2021
- Last updated
- 30 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application of Percutaneous Electrolysis in Female Soccer
- ClinicalTrials.gov ID
- NCT05030896
- Acronym / sponsor ID
- Female Soccer
- Conditions
- Injury;Sports
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Study start
- 2 Sep 2021 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 1 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Invasive treatment and exercise therapyParticipants will receive EPM and they will perform exercise program during 1 month. |
| Control group | Experimental | Other: Invasive treatment and exercise therapyParticipants will receive needling puncture and they will perform exercise program during 1 month. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- older than 18 years
- having a soleus muscle injury
- chronic injury (> 3 meses)
- pain at stretch > 3 points measured by NRS
Key exclusion criteria (3 listed)
- belenophobia
- other accuse injury
- lumbar back pathology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Invasive treatment and exercise therapyThe 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 | Other | Control group, Experimental group |
Primary outcome
Pain at palpation
Time frame: From baseline measurement up to one month
measured by numeric rate scale (0 no pain; 10 worst pain)
Pain at stretch
Time frame: From baseline measurement up to one month
measured by numeric rate scale (0 no pain; 10 worst pain)
2 secondary outcomes
ankle dorsiflexion
Time frame: From baseline measurement up to one month
muscle fatigue
Time frame: From baseline measurement up to one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Invasive treatment and exercise therapy in people with Injury;Sports, run by University of Seville at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain at palpation (time frame: From baseline measurement up to one month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2021.