FlatfootNCT05873166

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

A study testing Bilateral pressure release in Flexor Brevis Digitorum in subjects with latent trigger point and Bilateral non emission Laser in latent trigger points of the Flexor digitorum Brevis Muscle in people with Flatfoot, 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

Search all trials

Trial summary

Thirty-six subjects randomly distributed between a pressure release intervention group and a control group whose intervention is a non-emission laser. All the subjects will be measured before and after the interventions of each group. Read more about this study

Who is it for?: Ages 18 to 40 years
Conditions the study is for: Flatfoot
What is being tested?: Bilateral pressure release in Flexor Brevis Digitorum in subjects with latent trigger point and Bilateral non emission Laser in latent trigger points of the Flexor digitorum Brevis Muscle
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 36 participants
Where: 1 siteSpain
Study dates: 25 May 2023to 30 May 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

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-Jimenez
Madrid, 28702

Other trials in Spain

About this study

Read the detailed description

Conditions: Flatfoot
Being tested: Bilateral pressure release in Flexor Brevis Digitorum in subjects with latent trigger point, Bilateral non emission Laser in latent trigger points of the Flexor digitorum Brevis Muscle
Keywords: Foot, stabilometry, trigger point
Medical subject headings: Flatfoot

What participants receive

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

Bilateral pressure release in Flexor Brevis Digitorum in subjects with latent trigger pointOther
Bilateral pressure release in Flexor Brevis Digitorum in subjects with latent trigger point
Bilateral non emission Laser in latent trigger points of the Flexor digitorum Brevis MuscleOther
Bilateral non emission Laser in latent trigger points of the Flexor digitorum Brevis Muscle

Study groups in NCT05873166
Study group	Role	What they receive
Bilateral pressure release in Flexor Brevis Digitorum in subjects with latent trigger point	Experimental	Bilateral pressure release in Flexor Brevis Digitorum in subjects with latent trigger point Receives: Other: Bilateral pressure release in Flexor Brevis Digitorum in subjects with latent trigger point
Bilateral non emission Laser in latent trigger points of the Flexor digitorum Brevis Muscle	Sham comparator	Not described Receives: Other: Bilateral non emission Laser in latent trigger points of the Flexor digitorum Brevis Muscle

What is being measured

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

Stabilometry variables eyes open before pressure release (x)
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
Stabilometry variables eyes open before pressure release (y)
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 millimeters) with open eyes.
Measured: Through study completion, an average of 1 week
Stabilometry variables eyes open before pressure release COP area
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 millimeters2) with eyes open.
Measured: Through study completion, an average of 1 week
Stabilometry variables eyes open before pressure release COP a-p
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 millimeters/second).
Measured: Through study completion, an average of 1 week
Stabilometry variables eyes open before pressure release COP lat-lat
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 millimeters/second).
Measured: Through study completion, an average of 1 week
Stabilometry variables eyes closed after pressure release (x)
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 eyes closed.
Measured: Through study completion, an average of 1 week
Stabilometry variables eyes closed after pressure release (y)
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 millimeters) with closed eyes.
Measured: Through study completion, an average of 1 week
Stabilometry variables eyes closed after pressure release COP area
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 millimeters²) with eyes closed.
Measured: Through study completion, an average of 1 week
Stabilometry variables eyes closed after pressure release COP a-p
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 millimeters/second).
Measured: Through study completion, an average of 1 week
Stabilometry variables eyes closed after pressure release COP lat-lat
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 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.

25 May 202330 May 2023

First posted24 May 2023
Study start25 May 2023
Primary completion29 May 2023
Study completion30 May 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for FlatfootStudies 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: Single blind
Who is masked: Participant
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05873166
Sponsor's protocol ID: 1912202200923-A
Status last verified: May 2023
First submitted: 15 May 2023
Last updated: 1 Jun 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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The Corrective Power of Subtalar Arthrodesis With Mini/Medial Bone Block (SAMBB) in Patients Affected by Progressive Collapsing Foot Deformity (PCFD): Analysis Using Weight-bearing Cone Beam CT.
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All Flatfoot trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Stabilometry After Pressure Release of the Flexor Digitorum Brevis Muscle Versus a Non-emission Laser: Clinical Trial
ClinicalTrials.gov ID: NCT05873166
Acronym / sponsor ID: 1912202200923-A
Conditions: Flatfoot
Keywords: Foot, stabilometry, trigger point
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Mayuben Private ClinicUniversity, hospital or other
Study start: 25 May 2023 (actual)
Primary completion: 29 May 2023 (actual)
Study completion: 30 May 2023 (actual)
First posted: 24 May 2023 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Bilateral pressure release in Flexor Brevis Digitorum in subjects with latent trigger point	Experimental	Other: Bilateral pressure release in Flexor Brevis Digitorum in subjects with latent trigger pointBilateral pressure release in Flexor Brevis Digitorum in subjects with latent trigger point
Bilateral non emission Laser in latent trigger points of the Flexor digitorum Brevis Muscle	Sham comparator	Other: Bilateral non emission Laser in latent trigger points of the Flexor digitorum Brevis Muscle

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Must have latent trigger point in Flexor Brevis Digitorum muscles with no other pathologies

Key exclusion criteria (2 listed)

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)

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
Bilateral pressure release in Flexor Brevis Digitorum in subjects with latent trigger pointBilateral pressure release in Flexor Brevis Digitorum in subjects with latent trigger point	Other	Bilateral pressure release in Flexor Brevis Digitorum in subjects with latent trigger point
Bilateral non emission Laser in latent trigger points of the Flexor digitorum Brevis MuscleBilateral non emission Laser in latent trigger points of the Flexor digitorum Brevis Muscle	Other	Bilateral non emission Laser in latent trigger points of the Flexor digitorum Brevis Muscle

Primary outcome

Stabilometry variables eyes open before pressure release (x)
Time frame: Through study completion, an average of 1 week
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.
Stabilometry variables eyes open before pressure release (y)
Time frame: Through study completion, an average of 1 week
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 millimeters) with open eyes.
Stabilometry variables eyes open before pressure release COP area
Time frame: Through study completion, an average of 1 week
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 millimeters2) with eyes open.
Stabilometry variables eyes open before pressure release COP a-p
Time frame: Through study completion, an average of 1 week
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 millimeters/second).
Stabilometry variables eyes open before pressure release COP lat-lat
Time frame: Through study completion, an average of 1 week
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 millimeters/second).
Stabilometry variables eyes closed after pressure release (x)
Time frame: Through study completion, an average of 1 week
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 eyes closed.
Stabilometry variables eyes closed after pressure release (y)
Time frame: Through study completion, an average of 1 week
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 millimeters) with closed eyes.
Stabilometry variables eyes closed after pressure release COP area
Time frame: Through study completion, an average of 1 week
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 millimeters²) with eyes closed.
Stabilometry variables eyes closed after pressure release COP a-p
Time frame: Through study completion, an average of 1 week
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 millimeters/second).
Stabilometry variables eyes closed after pressure release COP lat-lat
Time frame: Through study completion, an average of 1 week
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 millimeters/second).

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 1 Jun 2023.

Related trials for Flatfoot

Recruiting
Effects of Custom 3D Printed Insoles and Short Foot Exercises in Pes Planus
Pes Planus
Not yet recruiting
Correlation Between Soft Tissue Displacement and Functional Performance in Orthopedic Patients
Hamstring Muscle Strain, Adult Acquired Flatfoot Deformity
Not yet recruiting
The Corrective Power of Subtalar Arthrodesis With Mini/Medial Bone Block (SAMBB) in Patients Affected by Progressive Collapsing Foot Deformity (PCFD): Analysis Using Weight-bearing Cone Beam CT.
Flat Foot
Not yet recruitingObservational study
Tibialis Posterior Muscle Morphology in Flexible Flatfeet Subjects
Flexible Flatfoot
Recruiting
Plantar Stimulation, Whole-Body Vibration, and Baduanjin for Muscle Activation
Flat Feet, Lower-Limb Muscle Activation

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.

Eva María Martínez-Jimenez, PhD principal investigator

Mayuben Private Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 1 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. 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?

Stabilometry variables eyes open before pressure release (x) (time frame: Through study completion, an average of 1 week). The study lists 10 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 NCT05873166.

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 1 Jun 2023.