Myofascial Induction Effects on Stabilometry Versus Sham Laser

Effects of Myofascial Induction Technique in Stabilometry Plantar Fascia Compared to a Placebo Laser

The objective is to determine the effectiveness of myofascial induction effects on stabilometric variables. Forty healthy subjects will be recruited for a single blind clinical trial. All subjects will be randomly distributed into two different groups: control group (simulated laser) and experimental group (myofascial induction). Result measurements will be performed in the center of the pressure area (stabilometry) using a validated platform. Two trials will be recorded for each condition (eyes closed and eyes open)

Study Overview

• Status: Completed
• Conditions: Foot Diseases; Myofascial Pain
• Intervention / Treatment: Other: Sham Laser; Other: Myofascial Induction

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • San Sebastián De Los Reyes, Madrid, Spain, 28702
      • Mayuben Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy individuals without pain.

Exclusion Criteria:

• Previous lower extremities surgery
• History of lower extremities injury with residual symptoms within the last year
• Evidence of a leg-length discrepancy of more than 1 cm
• Evidence of balance deficits

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Sham Laser; Placebo laser application in plantar fascia	Other: Sham Laser; Sham Laser in plantar fascia
Experimental: Experimental group Myofascial Induction; Myofascial Induction technique application in plantar fascia	Other: Myofascial Induction; Myofascial Induction in plantar fascia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stabilometry variable eyes open before Sham Laser or Myofascial Induction	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 from the midline. Stabilometric variables measure the displacement of the center of pressures in X (in millimeters) with the eyes open.	Through study completion, an average of 1 week
Stabilometry variables eyes open before Sham Laser or Myofascial indution	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 30º from the midline. The stabilometry variables measure the displacement of the center of pressures in Y (in millimeters) with the eyes open.	Through study completion, an average of 1 week
Stabilometry variables eyes open before Sham Laser or Myofascial indution	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 Sham Laser or Myofascial indution	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 30º from the midline. Stabilometric variables measure the center of pressure and the velocity displacement of the anteroposterior direction (a-p) (in millimeters / second).	Through study completion, an average of 1 week
Stabilometry variables eyes open before Sham Laser or Myofascial indution	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 30º from the midline. Stabilometric variables measure center of pressure, velocity, and lateral-lateral (lat-lat) direction displacement (in millimeters / second).	Through study completion, an average of 1 week
Stabilometry variables eyes closed before Sham Laser or Myofascial indution	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 from the midline. The stabilometric variables measure the displacement of the center of pressures in X (in millimeters) with the eyes closed.	Through study completion, an average of 1 week
Stabilometry variables eyes closed before Sham Laser or Myofascial indution	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 30º from the midline. The stabilometry variables measure the displacement of the center of pressures in Y (in millimeters) with the eyes closed.	Through study completion, an average of 1 week
Stabilometry variables eyes closed before Sham Laser or Myofascial indution	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 30º from the midline. The stabilometry variables measure the displacement of the area of the center of pressure (COP) (in millimeters²) with the eyes closed.	Through study completion, an average of 1 week
Stabilometry variables eyes closed before Sham Laser or Myofascial indution	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 30º from the midline. Stabilometric variables measure the center of pressure and the velocity displacement of the anteroposterior direction (a-p) (in millimeters / second).	Through study completion, an average of 1 week
Stabilometry variables eyes closed before Sham Laser or Myofascial indution	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 30º from the midline. Stabilometric variables measure center of pressure, velocity, and lateral-lateral (lat-lat) direction displacement (in millimeters / second).	Through study completion, an average of 1 week
Stabilometry variables eyes open after Sham Laser or Myofascial Induction	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 30º from the midline. Stabilometric variables measure the displacement of the center of pressures in X (in millimeters) with the eyes open.	Through study completion, an average of 1 week
Stabilometry variables eyes open after Sham Laser or Myofascial Induction	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 30º from the midline. The stabilometry variables measure the displacement of the center of pressures in Y (in millimeters) with the eyes open.	Through study completion, an average of 1 week
Stabilometry variables eyes open after Sham Laser or Myofascial Induction	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 from the midline. Stabilometric variables measure the displacement of the area of the center of pressure (COP) (in millimeters²) with the eyes open.	Through study completion, an average of 1 week
Stabilometry variables eyes open after Sham Laser or Myofascial Induction	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 30º from the midline. Stabilometric variables measure the center of pressure and the velocity displacement of the anteroposterior direction (a-p) (in millimeters / second).	Through study completion, an average of 1 week
Stabilometry variables eyes open after Sham Laser or Myofascial Induction	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 30º from the midline. Stabilometric variables measure center of pressure, velocity, and lateral-lateral (lat-lat) direction displacement (in millimeters / second).	Through study completion, an average of 1 week
Stabilometry variables eyes closed after Sham Laser or Myofascial Induction	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 30º from the midline. The stabilometric variables measure the displacement of the center of pressures in X (in millimeters) with the eyes closed.	Through study completion, an average of 1 week
Stabilometry variables eyes closed after Sham Laser or Myofascial Induction	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 from the midline. The stabilometry variables measure the displacement of the center of pressures in Y (in millimeters) with the eyes closed.	Through study completion, an average of 1 week
Stabilometry variables eyes closed after Sham Laser or Myofascial Induction	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 30º from the midline. Stabilometric variables measure the displacement of the area of the center of pressure (COP) (in millimeters²) with the eyes closed.	Through study completion, an average of 1 week
Stabilometry variables eyes closed after Sham Laser or Myofascial Induction	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 from the midline. Stabilometry variables measure the center of pressure, the velocity displacement from the anteroposterior direction (a-p) (in millimeters / second).	Through study completion, an average of 1 week
Stabilometry variables eyes closed after Sham Laser or Myofascial Induction	tabilometry 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 30º from the midline. Stabilometric variables measure center of pressure, velocity, and lateral-lateral (lat-lat) direction displacement (in millimeters / second).	Through study completion, an average of 1 week

Collaborators and Investigators

• Sponsor: Mayuben Private Clinic

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2020
• Primary Completion (Actual): November 27, 2020
• Study Completion (Actual): December 2, 2020

Study Registration Dates

• First Submitted: November 7, 2020
• First Submitted That Met QC Criteria: November 7, 2020
• First Posted (Actual): November 13, 2020

Study Record Updates

• Last Update Posted (Actual): December 3, 2020
• Last Update Submitted That Met QC Criteria: December 2, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Musculoskeletal Diseases; Foot Diseases
• Other Study ID Numbers: 2111201814518 C

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No