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

Not Applicable

Completed

• Conditions: Flatfoot
• Interventions: Other: Bilateral pressure release in Flexor Brevis Digitorum in subjects with latent trigger point; Other: Bilateral non emission Laser in latent trigger points of the Flexor digitorum Brevis Muscle

• Registration Number: NCT05873166
• Lead Sponsor: Mayuben Private Clinic

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.

Study Timeline

• Status Verified: 2023-05
• Study First Submitted: 2023-05-15
• Study First Submitted QC: 2023-05-23
• Study First Posted: 2023-05-24
• Study Start: 2023-05-25
• Primary Completion: 2023-05-29
• Study Completion: 2023-05-30
• Last Update Submitted: 2023-05-31
• Last Update Posted: 2023-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
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	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	Bilateral non emission Laser in latent trigger points of the Flexor digitorum Brevis Muscle	-

Primary Outcome Measures

Name	Time	Method
Stabilometry variables eyes open before pressure release (y)	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 (x)	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 COP area	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	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 a-p	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 (y)	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	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 lat-lat	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 open before pressure release COP lat-lat	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)	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.

Trial Locations

Locations (1)

Eva María Martínez-Jimenez; 🇪🇸 Madrid, Spain