Soleus InjuryNCT04042012
Percutaneous Needle Electrolysis (PNE) in Soleus Injury
A study testing Eccentric exercise, PNE and Combined in people with Soleus Injury, run by University of Seville at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 26 years
- Conditions the study is for
- Soleus Injury
- What is being tested?
- Eccentric exercise, PNE and Combined
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 1 Aug 2019to 31 Dec 2019
- 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 16 to 26 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of the Application of Ultrasound-guided Percutaneous Needle Electrolysis on the Chronic Soleus Injury in Dancers
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.
- Conditions
- Soleus Injury
- Being tested
- Eccentric exercise, PNE, Combined
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eccentric exerciseOther
soleus eccentric exercise
PNEOther
the application of galvanic current
CombinedOther
soleus eccentric exercise and PNE
| Study group | Role | What they receive |
|---|---|---|
| Eccentric group | Experimental | The dancers of this group wil perform a soleus eccentric exercise Receives: Other: Eccentric exercise |
| PNE group | Experimental | 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 Receives: Other: PNE |
| Combined group | Experimental | The dancers of this group will receive a combined treatment and will be carried out in the same way as the other two groups. Receives: Other: Combined |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of pain level
Visual Analogue Scale (VAS: 0=no pain; 100= pain as bad as can be
Measured: Change from Baseline VAS at 3 months months
Change of Lunge Test
This test measures the ankle range of motion. Less than 9/10 cm, range of motion will be considered restricted
Measured: Change from Baseline lunge test at 3 months months
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
Measured: Change from Baseline releve test at 3 months months
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.
Measured: Change from Baseline endurance test at 3 months months
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.
Measured: Change from Baseline balance test at 3 months months
Changes of the DFOS questionnaire
This questionnaire measures the pain and function (0= bad; 90=well)
Measured: Change from Baseline DFOS questionnaire at 3 months months
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
Measured: Change from after treatment at 3 months months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2019
- Study start1 Aug 2019
- Primary completion1 Nov 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Soleus InjuryStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 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
- NCT04042012
- Sponsor's protocol ID
- PNE in soleus
- Status last verified
- Oct 2020
- First submitted
- 27 Jul 2019
- Last updated
- 8 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32908559
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Application of Ultrasound-guided Percutaneous Needle Electrolysis on the Chronic Soleus Injury in Dancers
- ClinicalTrials.gov ID
- NCT04042012
- Acronym / sponsor ID
- PNE in soleus
- Conditions
- Soleus Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 1 Aug 2019 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Eccentric group | Experimental | Other: Eccentric exerciseThe dancers of this group wil perform a soleus eccentric exercise |
| PNE group | Experimental | Other: PNEThe 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 | Experimental | Other: CombinedThe dancers of this group will receive a combined treatment and will be carried out in the same way as the other two groups. |
Who may qualify
- Ages
- 16 to 26 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- Unsurpassed fear of needles
- History of adverse reactions to needles
- Immune system disorder
- Difficulty expressing your feelings properly
- Epilepsy and / or allergies to metals.
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 |
|---|---|---|
| Eccentric exercisesoleus eccentric exercise | Other | Eccentric group |
| PNEthe application of galvanic current | Other | PNE group |
| Combinedsoleus eccentric exercise and PNE | Other | Combined group |
Primary outcome
change of pain level
Time frame: 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
Time frame: 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 Releve test
Time frame: 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 Endurance test
Time frame: 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 Balance test
Time frame: 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.
Changes of the DFOS questionnaire
Time frame: Change from Baseline DFOS questionnaire at 3 months months
This questionnaire measures the pain and function (0= bad; 90=well)
Change of the Minimal Detectable Change (MCD)
Time frame: 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
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 8 Oct 2020.
- Derived from this study: PubMed 32908559De-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.
Related trials for Soleus Injury
Not yet recruiting
Description of Return to Sport in Amateur Athletes Who Underwent Several Functional Tests (K-STARTS, Vertical Jumps and Soleus Muscle Strength) After Initial ACL Reconstruction
ACL - Anterior Cruciate Ligament Rupture
RecruitingObservational study
Do Patients With ACL Tears Demonstrate Weakness of the Soleus Muscle?
ACL Tear, ACL-injury
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 Eccentric exercise, PNE and Combined in people with Soleus Injury, 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 5 inclusion and 6 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 8 Oct 2020. 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?
change of pain level (time frame: Change from Baseline VAS at 3 months months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04042012, which also lists 1 linked publication.
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 8 Oct 2020.