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Bilateral Latent Myofascial Trigger Points of Flexor Digitorum BrevisNCT05836142

Stabilometry and Plantar Pressures Changes After Progressive Pressure Release in Flexor Digitoum Brevis in Latent Trigger Points

A study testing progressive pressure release in people with Bilateral Latent Myofascial Trigger Points of Flexor Digitorum Brevis, 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

The aim of this clinical trial is to check the effects of progressive pressure release in the Flexor digitorum Brevis Read more about this study

Who is it for?
Ages 18 to 40 years
What is being tested?
progressive pressure release
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteSpain
Study dates
27 May 2023to 2 Jun 2023
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 40 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Asyntomatic subjects with flat foot

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

The aim of this clinical trial is to check the effects of progressive pressure release in the Flexor digitorum Brevis

Read the detailed description

Eighteen subjects with bilatereal lantent myofascial trigger points wil be recruited for a pre- test post-test study. Participants will be from 18 to 40 years old, not obese. Participants will be measured before and after bilateral dry needling in Flexor digitorum Brevis. The investigators will measure stabilometry variables and static footprint. The footprint variables will be divided in bilateral rear foot, bilateral midfoot, bilateral fore foot.

Stabilometry will be measured by displacement of the center of pressures in X and Y with eyes open and closed , center of pressure (COP) with eyes open and closed, COP area with eyes open and closed, COP antero-posterior (a-p) and medio-lateral (m-lat) directions with eyes open and closed, and COP speed. Two trials will be recorded for each condition and the order of the conditions will be randomized across subjects, eyes open and eyes closed. Foot plantar pressure and surface area of two static footprints will be measured during bipedal standing. Static plantar pressure will be evaluated by means of maximum pressure, medium pressure and surface area of each aspect of the foot (rearfoot, midfoot, and fore foot).

Being tested
progressive pressure release
Keywords
Foot, Stabilometry, Platform, therapeutics, trigger point

What participants receive

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

  • progressive pressure releaseProcedure or surgery

    Bilateral progressive pressure release in latent trigger points of the Flexor digitorum Brevis Muscle

Study groups in NCT05836142
Study groupRoleWhat they receive
Experimental: progressive pressure releaseExperimentalBilateral progressive pressure release in latent trigger points of the Flexor digitorum Brevis Muscle
Receives: Procedure: progressive pressure release

What is being measured

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

  1. Static footprint

    Static footprint will measure plantar presures and surface area of rear food, midfoot and fore foot. 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. During all the examinations, the upper limbs were placed in a relaxed position along the body. The subjects were instructed to stand as still as possible for 30 s, with their eyes open, while concentrating on a point at eye level 2-m away or with their eyes open.

    Measured: Through study completion, an average of 3 days

  2. Stabilometry variable x displacement open eyes before progressive 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 milimeters) with open eyes.

    Measured: Through study completion, an average of 3 days

  3. Stabilometry variable y displacement open eyes before progressive 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 Y (in milimeters) with open eyes.

    Measured: Through study completion, an average of 3 days

  4. Stabilometry variable center of pressure area open eyes before progressive 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 Pressure (COP) area (in milimeters²) with eyes open.

    Measured: Through study completion, an average of 3 days

  5. Stabilometry variable center of pressure speed displacement of the anteroposterior(a-p) direction open eyes before progressive 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 center of pressure speed displacement of the anteroposterior(a-p) direction (in milimeters/second).

    Measured: Through study completion, an average of 3 days

  6. Stabilometry variable center of pressure speed displacement of the latero-lateral(lat-lat) direction open eyes before progressive 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 center of pressure speed displacement of the latero-lateral(lat-lat) direction (in milimeters/second).

    Measured: Through study completion, an average of 3 days

  7. Stabilometry variable x displacement before progressive pressure release with closed eyes

    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 milimeters) with eyes closed.

    Measured: Through study completion, an average of 3 days

  8. Stabilometry variable y displacement before progressive pressure release with closed eyes

    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 Y (in milimeters) with closed eyes.

    Measured: Through study completion, an average of 3 days

  9. Stabilometry variable center of pressure area before progressive pressure release with closed eyes

    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 Pressure (COP) area (in milimeters²) with eyes closed.

    Measured: Through study completion, an average of 3 days

  10. Stabilometry variable center of pressure speed displacement of the anteroposterior(a-p) direction before progressive pressure release with closed eyes

    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 center of pressure speed displacement of the anteroposterior(a-p) direction (in milimeters/second).

    Measured: Through study completion, an average of 3 days

  11. Stabilometry variable center of pressure speed displacement of the latero-lateral(lat-lat) direction before progressive pressure release with closed eyes

    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 center of pressure speed displacement of the latero-lateral(lat-lat) direction (in milimeters/second).

    Measured: Through study completion, an average of 3 days

  12. Stabilometry variable x displacement open eyes after intervention

    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 milimeters) with open eyes.

    Measured: Through study completion, an average of 3 days

  13. Stabilometry variable y displacement open eyes after intervention

    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 Y (in milimeters) with open eyes.

    Measured: Through study completion, an average of 3 days

  14. Stabilometry variable center of pressure area open eyes after intervention

    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 Pressure (COP) area (in milimeters²) with eyes open.

    Measured: Through study completion, an average of 3 days

  15. Stabilometry variable center of pressure speed displacement of the anteroposterior(a-p) direction with open eyes after intervention

    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 center of pressure speed displacement of the anteroposterior(a-p) direction (in milimeters/second).

    Measured: Through study completion, an average of 3 days

  16. Stabilometry variable center of pressure speed displacement of the latero-lateral(lat-lat) direction with open eyes after intervention

    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 center of pressure speed displacement of the latero-lateral(lat-lat) direction (in milimeters/second).

    Measured: Through study completion, an average of 3 days

  17. Stabilometry variable x displacement with closed eyes after intervention

    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 milimeters) with eyes closed.

    Measured: Through study completion, an average of 3 days

  18. Stabilometry variable y displacement with closed eyes after intervention

    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 Y (in milimeters) with closed eyes.

    Measured: Through study completion, an average of 3 days

  19. Stabilometry variable center of pressure area with closed eyes after intervention

    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 Pressure (COP) area (in milimeters²) with eyes closed.

    Measured: Through study completion, an average of 3 days

  20. Stabilometry variable center of pressure speed displacement of the anteroposterior(a-p) direction with closed eyes after intervention

    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 center of pressure speed displacement of the anteroposterior(a-p) direction (in milimeters/second).

    Measured: Through study completion, an average of 3 days

  21. Stabilometry variable center of pressure speed displacement of the latero-lateral(lat-lat) direction with closed eyes after intervention

    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 center of pressure speed displacement of the latero-lateral(lat-lat) direction (in milimeters/second).

    Measured: Through study completion, an average of 3 days

Timeline

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

  1. First posted1 May 2023
  2. Study start27 May 2023
  3. Primary completion31 May 2023
  4. Study completion2 Jun 2023

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
Not applicable
Intervention model
Single group
Model description
Pretest posttest of bilateral Flexor digitorum Brevis progressive pressure release intervention
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05836142
Sponsor's protocol ID
1912202200923
Status last verified
Jun 2023
First submitted
18 Apr 2023
Last updated
5 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing progressive pressure release in people with Bilateral Latent Myofascial Trigger Points of Flexor Digitorum Brevis, 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 1 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 5 Jun 2023. 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?

Static footprint (time frame: Through study completion, an average of 3 days). The study lists 21 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 5 Jun 2023.

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