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Effects of the Myofascial Induction Technique Versus a Control Laser

Primary Purpose

Foot Diseases, Myofascial Pain

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Sham Laser
Myofascial Induction
Sponsored by
Mayuben Private Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Foot Diseases

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Mayuben Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Sham Laser

Experimental group Myofascial Induction

Arm Description

A non-emission laser will be applied in plantar fascia

Myofascial Induction in plantar fascia

Outcomes

Primary Outcome Measures

Plantar pressure measure
Plantar pressure measure by validated footprint platform in grams / square centimeter

Secondary Outcome Measures

Plantar surface measure
Area of plantar footprint measure by aa validated footprint platform in square centimeters

Full Information

First Posted
November 7, 2020
Last Updated
December 2, 2020
Sponsor
Mayuben Private Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT04628299
Brief Title
Effects of the Myofascial Induction Technique Versus a Control Laser
Official Title
Effects of the Myofascial Induction Technique Versus a Control Laser
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
November 16, 2020 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
December 2, 2020 (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
The objective is to determine the effectiveness of myofascial Induction effects on plantar pressures variables. Forty healthy subjects will be recruited for a simple blind clinical trial. All subjects will be randomly distributed in two different groups: control group (sham Laser) and experimental group (myofascial Induction). Outcome measurements will be foot plantar pressure area (footprint) by a validated platform. Two trials will be recorded before and after intervention in standing position.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Foot Diseases, Myofascial Pain

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
Sham Laser
Arm Type
Placebo Comparator
Arm Description
A non-emission laser will be applied in plantar fascia
Arm Title
Experimental group Myofascial Induction
Arm Type
Experimental
Arm Description
Myofascial Induction in plantar fascia
Intervention Type
Other
Intervention Name(s)
Sham Laser
Intervention Description
Sham Laser in plantar fascia
Intervention Type
Other
Intervention Name(s)
Myofascial Induction
Intervention Description
Myofascial Induction in plantar fascia
Primary Outcome Measure Information:
Title
Plantar pressure measure
Description
Plantar pressure measure by validated footprint platform in grams / square centimeter
Time Frame
Register a plantar pressures of foot print in standing position of 30 seconds
Secondary Outcome Measure Information:
Title
Plantar surface measure
Description
Area of plantar footprint measure by aa validated footprint platform in square centimeters
Time Frame
Register a plantar surface area of foot print in standing position of 30 seconds

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Mayuben Clinic
City
San Sebastián De Los Reyes
State/Province
Madrid
ZIP/Postal Code
28702
Country
Spain

12. IPD Sharing Statement

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Effects of the Myofascial Induction Technique Versus a Control Laser

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