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

June 2, 2023 updated by: EVA MARIA MARTÍNEZ JIMENEZ, Mayuben Private Clinic
The aim of this clinical trial is to check the effects of progressive pressure release in the Flexor digitorum Brevis

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28702
        • Eva María Martínez-Jiménez In Mayuben CLinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Asyntomatic subjects with flat foot

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: progressive pressure release
Bilateral progressive pressure release in latent trigger points of the Flexor digitorum Brevis Muscle
Procedure: progressive pressure release
Bilateral progressive pressure release in latent trigger points of the Flexor digitorum Brevis Muscle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Static footprint
Time Frame: Through study completion, an average of 3 days
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.
Through study completion, an average of 3 days
Stabilometry variable x displacement open eyes before progressive pressure release
Time Frame: Through study completion, an average of 3 days
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.
Through study completion, an average of 3 days
Stabilometry variable y displacement open eyes before progressive pressure release
Time Frame: Through study completion, an average of 3 days
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.
Through study completion, an average of 3 days
Stabilometry variable center of pressure area open eyes before progressive pressure release
Time Frame: Through study completion, an average of 3 days
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.
Through study completion, an average of 3 days
Stabilometry variable center of pressure speed displacement of the anteroposterior(a-p) direction open eyes before progressive pressure release
Time Frame: Through study completion, an average of 3 days
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).
Through study completion, an average of 3 days
Stabilometry variable center of pressure speed displacement of the latero-lateral(lat-lat) direction open eyes before progressive pressure release
Time Frame: Through study completion, an average of 3 days
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).
Through study completion, an average of 3 days
Stabilometry variable x displacement before progressive pressure release with closed eyes
Time Frame: Through study completion, an average of 3 days
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.
Through study completion, an average of 3 days
Stabilometry variable y displacement before progressive pressure release with closed eyes
Time Frame: Through study completion, an average of 3 days
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.
Through study completion, an average of 3 days
Stabilometry variable center of pressure area before progressive pressure release with closed eyes
Time Frame: Through study completion, an average of 3 days
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.
Through study completion, an average of 3 days
Stabilometry variable center of pressure speed displacement of the anteroposterior(a-p) direction before progressive pressure release with closed eyes
Time Frame: Through study completion, an average of 3 days
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).
Through study completion, an average of 3 days
Stabilometry variable center of pressure speed displacement of the latero-lateral(lat-lat) direction before progressive pressure release with closed eyes
Time Frame: Through study completion, an average of 3 days
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).
Through study completion, an average of 3 days
Stabilometry variable x displacement open eyes after intervention
Time Frame: Through study completion, an average of 3 days
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.
Through study completion, an average of 3 days
Stabilometry variable y displacement open eyes after intervention
Time Frame: Through study completion, an average of 3 days
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.
Through study completion, an average of 3 days
Stabilometry variable center of pressure area open eyes after intervention
Time Frame: Through study completion, an average of 3 days
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.
Through study completion, an average of 3 days
Stabilometry variable center of pressure speed displacement of the anteroposterior(a-p) direction with open eyes after intervention
Time Frame: Through study completion, an average of 3 days
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).
Through study completion, an average of 3 days
Stabilometry variable center of pressure speed displacement of the latero-lateral(lat-lat) direction with open eyes after intervention
Time Frame: Through study completion, an average of 3 days
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).
Through study completion, an average of 3 days
Stabilometry variable x displacement with closed eyes after intervention
Time Frame: Through study completion, an average of 3 days
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.
Through study completion, an average of 3 days
Stabilometry variable y displacement with closed eyes after intervention
Time Frame: Through study completion, an average of 3 days
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.
Through study completion, an average of 3 days
Stabilometry variable center of pressure area with closed eyes after intervention
Time Frame: Through study completion, an average of 3 days
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.
Through study completion, an average of 3 days
Stabilometry variable center of pressure speed displacement of the anteroposterior(a-p) direction with closed eyes after intervention
Time Frame: Through study completion, an average of 3 days
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).
Through study completion, an average of 3 days
Stabilometry variable center of pressure speed displacement of the latero-lateral(lat-lat) direction with closed eyes after intervention
Time Frame: Through study completion, an average of 3 days
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).
Through study completion, an average of 3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayuben Private Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 27, 2023

Primary Completion (Actual)

May 31, 2023

Study Completion (Actual)

June 2, 2023

Study Registration Dates

First Submitted

April 18, 2023

First Submitted That Met QC Criteria

April 28, 2023

First Posted (Actual)

May 1, 2023

Study Record Updates

Last Update Posted (Actual)

June 5, 2023

Last Update Submitted That Met QC Criteria

June 2, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1912202200923

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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