Low Back Pain, MechanicalNCT03867292
Electrotherapy and Myofascial Therapy in Padel Players
A study testing Myofascial and Electrotherapy in people with Low Back Pain, Mechanical, run by Investigación en Hemofilia y Fisioterapia at 1 site in Spain.
Trial summary
Introduction. The lumbar region is one of the locations with the highest incidence of injuries in the paddle players. The crossed hands myofascial technique is used to release the restrictions of the thoracolumbar fascia, improving its mobility. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Mechanical
- What is being tested?
- Myofascial and Electrotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 10 Mar 2019to 20 Jun 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 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Padel players
- With federal sheet
- Male
- Over 18 years
- Currently participate in regional and / or national competitions
Who cannot join
- Present a medical diagnosis of musculoskeletal pathology
- Not signed the informed consent document.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of a Physiotherapy Intervention by Electrotherapy Combined With Myofascial Therapy for the Improvement of Lumbar Region Mobility in Federated Padel Players. A Pilot Study
Introduction. The lumbar region is one of the locations with the highest incidence of injuries in the paddle players. The crossed hands myofascial technique is used to release the restrictions of the thoracolumbar fascia, improving its mobility. The electrotherapy technique of TENS consists in the application of a low frequency current for the recovery, capitalization and oxygenation of the muscle, thus improving mobility and pain.
Aim. To evaluate the efficacy of an intervention by electrotherapy combined with myofascial therapy, in the lumbar region, for a mobility improvement in older paddle-tennis federated players.
Read more
Study design. Randomized, multicenter, simple blind, clinical trial with follow-up period.
Methods. 30 players paddle will be assigned to the two study groups: experimental (intervention through therapy myofascial and electrotherapy) and control (intervention by electrotherapy). The intervention will have a duration of 4 weeks, with 2 sessions per week, lasting 15 minutes. There will be three evaluations: pre-intervention, post-intervention and follow-up. The variable of study is the mobility of the lumbar spine in the movements of flexion and extension (assessed by the employment of tests of Schober and Fingertip-to-floor). The analysis of normality be performed with the Kolmogorov-Smirnof, and in case of homogeneity of the groups is used in parametric tests: test t-student for paired data (difference between the different assessments) and ANOVA of mean repeated (intra-and intersujeto).
Expected results. Improvement of the mobility of the lumbar spine in the movements of flexion and extension.
- Conditions
- Low Back Pain, Mechanical
- Being tested
- Myofascial, Electrotherapy
- Keywords
- Paddle-tennis, Myofascial release, Electrotherapy, Physiotherapy, Low back, Randomized clinical trial
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyofascialOther
The aim of the application of the crossed hands technique is to produce a deep fascial release, placing the subject in prone position, while the standing physiotherapist will contact with one hand on the spine at the level of the thoracolumbar hinge and with the other hand on the sacrum, so that the hands are crisscrossed. The crossed hands technique will be performed between 90 seconds and 5 minutes.
The application of the TENS, will be performed for 10 minutes by means of a device, model Compex in the lumbar area, subjects will receive a TENS application of low frequency (less than 40Hz). The electrode - (black) in proximal position or on the most painful zone. The electrode + (red) will be placed distally.
ElectrotherapyOther
The application of the TENS, will be performed for 10 minutes by means of a device, model Compex in the lumbar area, subjects will receive a TENS application of low frequency (less than 40Hz). The electrode - (black) in proximal position or on the most painful zone. The electrode + (red) will be placed distally.
| Study group | Role | What they receive |
|---|---|---|
| Myofascial | Experimental | The subjects that include the experimental group will receive an intervention through myofascial therapy of crossed hands and electrotherapy Receives: Other: Myofascial |
| Electrotherapy | Active comparator | The subjects that are included in the experimental group will receive an intervention through electrotherapy Receives: Other: Electrotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline low back flexion after treatment and at a month
Low back flexion will be measured with the Schober test. The subject will remain standing and the evaluator will mark an imaginary line that connects both posterior superior iliac spines (near the Venus pits). A second mark will be placed 10 cm above the first mark and, finally, we will make a third mark 5 cm below the first mark. Next, the subject will be asked to bend to the maximum, keeping the knees extended. When the maximum flexion is reached, the increase in the distance between the skin marks will be measured. The unit of measurement is the centimeter (the greater the distance, the greater the mobility in the flexion of the lumbar spine).
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
Secondary outcomes (2)
Change from baseline low back extension after treatment and at a month
Low back extension will be measured with the Schober test. The subject will remain standing and the evaluator will mark an imaginary line that connects both posterior superior iliac spines (near the Venus pits). A second mark will be placed 10 cm above the first mark and, finally, we will make a third mark 5 cm below the first mark. Next, the subject will be asked to lean back to the maximum, keeping the knees extended. When the maximum extension is reached, the decrease in the distance between the skin marks will be measured. The unit of measurement is the centimeter (at a lower distance, greater mobility in extension of the lumbar spine).
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
Change from baseline low back flexion after treatment and at a month
Low back flexion will be measured with the Fingertip-to-floor test. With the subject standing on a platform 20 cm high (without shoes and with their feet together), you will be asked to lean towards flexion, while keeping your knees, arms and fingers fully extended. The vertical distance between the tip of the middle finger and the platform shall be measured with a flexible measuring tape and expressed in centimeters. The vertical distance (measured in centimeters) between the platform and the tip of the middle finger will be positive when the subject does not reach the platform and negative when it can go further.
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2019
- Study start10 Mar 2019
- Primary completion15 Apr 2019
- Study completion20 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back Pain, MechanicalStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Investigación en Hemofilia y Fisioterapia
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Rubén Cuesta-Barriuso, PhD, Principal investigator, Universidad Europea de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03867292
- Sponsor's protocol ID
- MIOTENS
- Status last verified
- Jan 2020
- First submitted
- 6 Mar 2019
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Physiotherapy Intervention by Electrotherapy Combined With Myofascial Therapy for the Improvement of Lumbar Region Mobility in Federated Padel Players. A Pilot Study
- ClinicalTrials.gov ID
- NCT03867292
- Acronym / sponsor ID
- MIOTENS
- Conditions
- Low Back Pain, Mechanical
- Keywords
- Paddle-tennis, Myofascial release, Electrotherapy, Physiotherapy, Low back, Randomized clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Investigación en Hemofilia y FisioterapiaResearch network
- Study start
- 10 Mar 2019 (actual)
- Primary completion
- 15 Apr 2019 (actual)
- Study completion
- 20 Jun 2019 (actual)
- First posted
- 7 Mar 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.
Introduction. The lumbar region is one of the locations with the highest incidence of injuries in the paddle players. The crossed hands myofascial technique is used to release the restrictions of the thoracolumbar fascia, improving its mobility. The electrotherapy technique of TENS consists in the application of a low frequency current for the recovery, capitalization and oxygenation of the muscle, thus improving mobility and pain.
Aim. To evaluate the efficacy of an intervention by electrotherapy combined with myofascial therapy, in the lumbar region, for a mobility improvement in older paddle-tennis federated players.
Study design. Randomized, multicenter, simple blind, clinical trial with follow-up period.
Methods. 30 players paddle will be assigned to the two study groups: experimental (intervention through therapy myofascial and electrotherapy) and control (intervention by electrotherapy). The intervention will have a duration of 4 weeks, with 2 sessions per week, lasting 15 minutes. There will be three evaluations: pre-intervention, post-intervention and follow-up. The variable of study is the mobility of the lumbar spine in the movements of flexion and extension (assessed by the employment of tests of Schober and Fingertip-to-floor). The analysis of normality be performed with the Kolmogorov-Smirnof, and in case of homogeneity of the groups is used in parametric tests: test t-student for paired data (difference between the different assessments) and ANOVA of mean repeated (intra-and intersujeto).
Expected results. Improvement of the mobility of the lumbar spine in the movements of flexion and extension.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Myofascial | Experimental | Other: MyofascialThe subjects that include the experimental group will receive an intervention through myofascial therapy of crossed hands and electrotherapy |
| Electrotherapy | Active comparator | Other: ElectrotherapyThe subjects that are included in the experimental group will receive an intervention through electrotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Padel players
- With federal sheet
- Male
- Over 18 years
- Currently participate in regional and / or national competitions
Key exclusion criteria (2 listed)
- Present a medical diagnosis of musculoskeletal pathology
- Not signed the informed consent document.
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 |
|---|---|---|
| MyofascialThe aim of the application of the crossed hands technique is to produce a deep fascial release, placing the subject in prone position, while the standing physiotherapist will contact with one hand on the spine at the level of the thoracolumbar hinge and with the other hand on the sacrum, so that the hands are crisscrossed. The crossed hands technique will be performed between 90 seconds and 5 minutes. The application of the TENS, will be performed for 10 minutes by means of a device, model Compex in the lumbar area, subjects will receive a TENS application of low frequency (less than 40Hz). The electrode - (black) in proximal position or on the most painful zone. The electrode + (red) will be placed distally. | Other | Myofascial |
| ElectrotherapyThe application of the TENS, will be performed for 10 minutes by means of a device, model Compex in the lumbar area, subjects will receive a TENS application of low frequency (less than 40Hz). The electrode - (black) in proximal position or on the most painful zone. The electrode + (red) will be placed distally. | Other | Electrotherapy |
Primary outcome
Change from baseline low back flexion after treatment and at a month
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
Low back flexion will be measured with the Schober test. The subject will remain standing and the evaluator will mark an imaginary line that connects both posterior superior iliac spines (near the Venus pits). A second mark will be placed 10 cm above the first mark and, finally, we will make a third mark 5 cm below the first mark. Next, the subject will be asked to bend to the maximum, keeping the knees extended. When the maximum flexion is reached, the increase in the distance between the skin marks will be measured. The unit of measurement is the centimeter (the greater the distance, the greater the mobility in the flexion of the lumbar spine).
2 secondary outcomes
Change from baseline low back extension after treatment and at a month
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
Change from baseline low back flexion after treatment and at a month
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
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 27 Jan 2020.
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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.
Rubén Cuesta-Barriuso, PhD principal investigator
Universidad Europea de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myofascial and Electrotherapy in people with Low Back Pain, Mechanical, run by Investigación en Hemofilia y Fisioterapia 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 2 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 27 Jan 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 from baseline low back flexion after treatment and at a month (time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit). 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 27 Jan 2020.