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

Study Overview
=================
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.

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

Conditions
-----------------
Flatfoot

Intervention / Treatment
-----------------
* 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


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention 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<br>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<br>* Bilateral pressure release in Flexor Brevis Digitorum in subjects with latent trigger point<br>|
| Sham Comparator: Bilateral non emission Laser in latent trigger points of the Flexor digitorum Brevis Muscle<br> | Other: Bilateral non emission Laser in latent trigger points of the Flexor digitorum Brevis Muscle<br>* Bilateral non emission Laser in latent trigger points of the Flexor digitorum Brevis Muscle<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Foot, stabilometry, trigger point