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Foot Plantar Pressure Changes After Plantar Dry Needling

Primary Purpose

Myofascial Pain Syndrome, Foot Diseases

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Static footprint
Sponsored by
Mayuben Private Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myofascial Pain Syndrome

Eligibility Criteria

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

Inclusion Criteria:

  • Flat foot grade II or II with
  • Must have latent trigger point in Flexor Brevis Digitorum muscles

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

Sites / Locations

  • Mayuben Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bilateral dry needling in Flexor Brevis Digitorum in subjects with latent trigger point

Arm Description

Bilateral dry needling in Flexor Brevis Digitorum in subjects with latent trigger point

Outcomes

Primary Outcome Measures

Variables of plantar pressures with platform before dry puncture
During 30 seconds we will record the plantar pressure variables in grams per square centimeter.
Variable footprint plantar surface with platform before dry puncture
For 30 seconds we will record the area of the footprint in square centimeters.
Variables of plantar pressures with platform after dry puncture
During 30 seconds we will record the plantar pressure variables in grams per square centimeter.
Variable footprint plantar surface with platform after dry puncture
For 30 seconds we will record the area of the footprint in square centimeters.

Secondary Outcome Measures

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
NCT04628312
Brief Title
Foot Plantar Pressure Changes After Plantar Dry Needling
Official Title
Standing Plantar Pressure Changes After Plantar Dry Needling in Flexor Digitorum Brevis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
November 20, 2020 (Actual)
Primary Completion Date
November 27, 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

5. Study Description

Brief Summary
The aim of this clinical trial is to check the effects of dry needling in the Flexor digitorum Brevis. Twenty healthy subjects wil be recruited for a quasi-experimental study. Participants will be from 18 to 40 years old, not obese. Participants will be measured before and after bilateral dry neddling in Flexor digitorum Brevis. The investigators will measure static footprint variables. The footprint variables will be divided in bilateral rear foot, bilateral midfoot, bilateral fore foot.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bilateral dry needling in Flexor Brevis Digitorum in subjects with latent trigger point
Arm Type
Experimental
Arm Description
Bilateral dry needling in Flexor Brevis Digitorum in subjects with latent trigger point
Intervention Type
Other
Intervention Name(s)
Static footprint
Intervention Description
The static footprint will measure the plantar pressures and surface area of the back of the foot, midfoot and forefoot. 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 30 degrees from the midline.
Primary Outcome Measure Information:
Title
Variables of plantar pressures with platform before dry puncture
Description
During 30 seconds we will record the plantar pressure variables in grams per square centimeter.
Time Frame
Through study completion, an average of 1 week
Title
Variable footprint plantar surface with platform before dry puncture
Description
For 30 seconds we will record the area of the footprint in square centimeters.
Time Frame
Through study completion, an average of 1 week
Title
Variables of plantar pressures with platform after dry puncture
Description
During 30 seconds we will record the plantar pressure variables in grams per square centimeter.
Time Frame
Through study completion, an average of 1 week
Title
Variable footprint plantar surface with platform after dry puncture
Description
For 30 seconds we will record the area of the footprint in square centimeters.
Time Frame
Through study completion, an average of 1 week

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: Flat foot grade II or II with Must have latent trigger point in Flexor Brevis Digitorum muscles 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
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

Plan to Share IPD
Undecided

Learn more about this trial

Foot Plantar Pressure Changes After Plantar Dry Needling

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