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

Back to results

Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Flatfoot focused on measuring Foot, stabilometry, trigger point

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Eva María Martínez-Jimenez

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

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

Arm Description

Bilateral pressure release in Flexor Brevis Digitorum in subjects with latent trigger point

Outcomes

Primary Outcome Measures

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.

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.

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.

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).

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).

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.

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.

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.

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).

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).

Secondary Outcome Measures

Full Information

NCT ID

NCT05873166

First Posted

May 15, 2023

Last Updated

May 31, 2023

Sponsor

Mayuben Private Clinic

1. Study Identification

Unique Protocol Identification Number

NCT05873166

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Completed

Study Start Date

May 25, 2023 (Actual)

Primary Completion Date

May 29, 2023 (Actual)

Study Completion Date

May 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayuben Private Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

Brief 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. The measurements will be made on a pressure platform to record the stabilometry variables.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Flatfoot

Keywords

Foot, stabilometry, trigger point

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bilateral pressure release in Flexor Brevis Digitorum in subjects with latent trigger point

Arm Type

Experimental

Arm Description

Bilateral pressure release in Flexor Brevis Digitorum in subjects with latent trigger point

Arm Title

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

Arm Type

Sham Comparator

Intervention Type

Other

Intervention Name(s)

Bilateral pressure release in Flexor Brevis Digitorum in subjects with latent trigger point

Intervention Description

Bilateral pressure release in Flexor Brevis Digitorum in subjects with latent trigger point

Intervention Type

Other

Intervention Name(s)

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

Intervention Description

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

Primary Outcome Measure Information:

Title

Stabilometry variables eyes open before pressure release (x)

Description

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.

Time Frame