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

May 31, 2023 updated by: EVA MARIA MARTÍNEZ JIMENEZ, Mayuben Private Clinic
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. The measurements will be made on a pressure platform to record the stabilometry variables.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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. The measurements will be made on a pressure platform to record the stabilometry variables with eyes closed and open.

Study Type

Interventional

Enrollment (Actual)

36

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

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:

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

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bilateral 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 pressure release in Flexor Brevis Digitorum in subjects with latent trigger point
Sham Comparator: Bilateral 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
Bilateral non emission Laser in latent trigger points of the Flexor digitorum Brevis Muscle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of 1 week
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.
Through study completion, an average of 1 week
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).
Through study completion, an average of 1 week
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).
Through study completion, an average of 1 week
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.
Through study completion, an average of 1 week
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.
Through study completion, an average of 1 week
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).
Through study completion, an average of 1 week
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).
Through study completion, an average of 1 week
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.
Through study completion, an average of 1 week
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.
Through study completion, an average of 1 week

Collaborators and Investigators

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

Sponsor

Mayuben Private Clinic

Investigators

  • Principal Investigator: Eva María Martínez-Jimenez, PhD, 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 25, 2023

Primary Completion (Actual)

May 29, 2023

Study Completion (Actual)

May 30, 2023

Study Registration Dates

First Submitted

May 15, 2023

First Submitted That Met QC Criteria

May 23, 2023

First Posted (Actual)

May 24, 2023

Study Record Updates

Last Update Posted (Actual)

June 1, 2023

Last Update Submitted That Met QC Criteria

May 31, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1912202200923-A

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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