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BalanceNCT06509347

Stabilometry After Pressure Release of the Flexor Digitorum Brevis Muscle Versus a Non-emission Laser.

A study testing Preassure release and Non-emision laser in people with Balance and Manual Therapy, run by Mayuben Private Clinic at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In this study we will test the effects of pressure release on the Flexor digitorum brevis muscle on stabilometric variables that support static equilibrium. Read more about this study

Who is it for?
Ages 18 to 39 years
Conditions the study is for
Balance, Manual Therapy, Foot
What is being tested?
Preassure release and Non-emision laser
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
34 participants
Where
1 siteSpain
Study dates
22 Jul 2024to 28 Jul 2024
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 39 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Healthy individuals
  • Must have latent trigger point in Flexor Brevis Digitorum muscles with no other pathologies.

Who cannot join

  • Previous lower extremities surgery.
  • History of lower extremities injury with residual symptoms (pain, "giving-away" sensations) within the last year.
  • Leg-length discrepancy more than 1 cm
  • Balance deficits (determined by oral questionnaire regarding falls)

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Eva María Martínez-Jiménez In Mayuben CLinic

    Madrid, 28702

Other trials in Spain

About this study

Official title: Stabilometry After Pressure Release of the Flexor Digitorum Brevis Muscle Versus a Non-emission Laser: Clinical Trial

In this study we will test the effects of pressure release on the Flexor digitorum brevis muscle on stabilometric variables that support static equilibrium.

Read the detailed description

In this study we will test the effects of pressure release on the Flexor digitorum brevis muscle on the stabilometric variables that support static balance. To test the effects on balance.

Being tested
Preassure release, Non-emision laser
Keywords
balance, myofascial trigger point, foot
Medical subject headings
Myofascial Pain Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Preassure releaseOther

    Preassure release in Flexor digitorum brevis trigger point muscle.

  • Non-emision laserOther

    Bilateral non emission Laser in latent trigger points of the Flexor digitorum Brevis Muscle

Study groups in NCT06509347
Study groupRoleWhat they receive
Pressure releaseExperimentalApplication of pressure on the trigger point of the flexor digitorum brevis until remission of referred pain for a minimum of 90 seconds, at least 3 cycles.
Receives: Other: Preassure release
Non-emision LaserSham comparatorApplication of a non-emitting laser for 5 minutes on the trigger point of the flexor digitorum brevis muscle.
Receives: Other: Non-emision laser

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 1.Stabilometric variable x displacement open eyes before pressure release.

    Stabilometry assessment was used and subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. Stabilometry variables measure displacement of the center of pressures in X (in millimeters) with open eyes.

    Measured: Through study completion, an average of 1 week.

  2. 2.Stabilometric variable x displacement open eyes before non emission Laser

    Stabilometry assessment was used and subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. Stabilometric variables measure displacement of the center of pressures in Y (in millimeters) with open eyes.

    Measured: Through study completion, an average of 1 week.

  3. 3.Stabilometric variable center of pressure area open eyes before pressure release.

    Stabilometric assessment was used and subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. Stabilometric variables measure displacement of the center of Pressure (COP) area (in millimeters²) with eyes open.

    Measured: Through study completion, an average of 1 week.

  4. 4.Stabilometric variable center of pressure area open eyes before non emission laser.

    Stabilometric assessment was used and subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. Stabilometric variables measure displacement of the center of Pressure (COP) area (in millimeters²) with eyes open.

    Measured: Through study completion, an average of 1 week.

  5. 5.Stabilometric variable center of pressure speed displacement of the anteroposterior(a-p) direction open eyes before pressure release.

    Stabilometric assessment was used and subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. Stabilometric variables measure center of pressure speed displacement of the anteroposterior(a-p) direction (in millimeters/second).

    Measured: Through study completion, an average of 1 week.

  6. 6.Stabilometric variable center of pressure speed displacement of the anteroposterior(a-p) direction open eyes before pressure non-emission Laser.

    Stabilometric assessment was used and subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. Stabilometric variables measure center of pressure speed displacement of the anteroposterior(a-p) direction (in millimeters/second).

    Measured: Through study completion, an average of 1 week.

  7. 7.Stabilometric variable y displacement open eyes before pressure release

    Stabilometric assessment was used and subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. Stabilometric variables measure displacement of the center of pressures in Y (in millimeters) with open eyes.

    Measured: Through study completion, an average of 1 week.

  8. 8.Stabilometric variable x displacement open eyes before non emission Laser

    Stabilometric assessment was used and subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. Stabilometry variables measure displacement of the center of pressures in Y (in millimeters) with open eyes.

    Measured: Through study completion, an average of 1 week.

  9. 9.Stabilometric variable center of pressure speed displacement of the latero-lateral(lat-lat) direction open eyes before pressure release

    Stabilometric assessment was used and subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. Stabilometry variables measure center of pressure speed displacement of the latero-lateral(lat-lat) direction (in millimeters/second).

    Measured: Through study completion, an average of 1 week.

  10. 10.Stabilometric variable center of pressure speed displacement of the latero-lateral(lat-lat) direction open eyes non emision Laser.

    Stabilometric assessment was used and subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. Stabilometry variables measure center of pressure speed displacement of the latero-lateral(lat-lat) direction (in millimeters/second).

    Measured: Through study completion, an average of 1 week.

  11. 11.Stabilometric variable x displacement closed eyes before pressure release

    Stabilometric assessment was used and subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. Stabilometric variables measure displacement of the center of pressures in X (in millimeters) with closed eyes.

    Measured: Through study completion, an average of 1 week.

  12. 12.Stabilometric variable x displacement closed eyes before non emission Laser

    Stabilometric assessment was used and subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. Stabilometric variables measure displacement of the center of pressures in X (in millimeters) with closed eyes.

    Measured: Through study completion, an average of 1 week.

  13. 13.Stabilometric variable center of pressure area closed eyes before pressure release.

    Stabilometric assessment was used and subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. Stabilometric variables measure displacement of the center of Pressure (COP) area (in millimeters²) with closed eyes.

    Measured: Through study completion, an average of 1 week.

  14. 14.Stabilometric variable center of pressure area closed eyes before non emission laser.

    Stabilometric assessment was used and subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. Stabilometric variables measure displacement of the center of Pressure (COP) area (in millimeters²) with closed eyes.

    Measured: Through study completion, an average of 1 week.

  15. 15.5.Stabilometric variable center of pressure speed displacement of the anteroposterior(a-p) direction closed eyes before pressure release.

    Stabilometric assessment was used and subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. Stabilometric variables measure center of pressure speed displacement of the anteroposterior(a-p) direction (in millimeters/second).

    Measured: Through study completion, an average of 1 week.

  16. .Stabilometric variable center of pressure speed displacement of the anteroposterior(a-p) direction closed eyes before pressure non-emission Laser.

    Stabilometric assessment was used and subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. Stabilometric variables measure center of pressure speed displacement of the anteroposterior(a-p) direction (in millimeters/second).

    Measured: Through study completion, an average of 1 week.

  17. 17.Stabilometric variable y displacement closed eyes before pressure release

    Stabilometric assessment was used and subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. Stabilometric variables measure displacement of the center of pressures in Y (in millimeters) with closed eyes.

    Measured: Through study completion, an average of 1 week.

  18. 18.Stabilometric variable x displacement closed eyes before non emission Laser

    Stabilometric assessment was used and subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. Stabilometric variables measure displacement of the center of pressures in Y (in millimeters) with closed eyes.

    Measured: Through study completion, an average of 1 week.

  19. 9.Stabilometric variable center of pressure speed displacement of the latero-lateral(lat-lat) direction closed eyes before pressure release.

    Stabilometric assessment was used and subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. Stabilometric variables measure center of pressure speed displacement of the latero-lateral(lat-lat) direction (in millimeters/second).

    Measured: Through study completion, an average of 1 week.

  20. 20. Stabilometric variable center of pressure speed displacement of the latero-lateral(lat-lat) direction closed eyes non emission Laser.

    Stabilometric assessment was used and subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. Stabilometric variables measure center of pressure speed displacement of the latero-lateral(lat-lat) direction (in millimeters/second).

    Measured: Through study completion, an average of 1 week.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2024
  2. Study start22 Jul 2024
  3. Primary completion24 Jul 2024
  4. Study completion28 Jul 2024

Resources

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
Single blind
Who is masked
Participant
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06509347
Sponsor's protocol ID
1912202200923A
Status last verified
Jul 2024
First submitted
7 Jul 2024
Last updated
30 Jul 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Martinez-Jimenez EM, Becerro-de-Bengoa-Vallejo R, Losa-Iglesias ME, Perez-Boal E, Posada-Ordax J, Sanchez-Serena A, Trevisson-Redondo B, Benito-de-Pedro M, Martinez-Corcoles V, Casado-Hernandez I. Plantar pressures and stabilometry effects of ischemic compression in Flexor digitorum brevis muscle Myofascial Trigger Point: A prepost study. PLoS One. 2025 Aug 14;20(8):e0329734. doi: 10.1371/journal.pone.0329734. eCollection 2025.

    PubMed 40811690

Questions about this trial

What is this clinical trial studying?

A study testing Preassure release and Non-emision laser in people with Balance and Manual Therapy, run by Mayuben Private Clinic 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 2 inclusion and 4 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 Jul 2024. 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. Some participants in this study may receive a placebo. 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?

1.Stabilometric variable x displacement open eyes before pressure release. (time frame: Through study completion, an average of 1 week.). The study lists 20 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 NCT06509347, 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 30 Jul 2024.

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