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
About this trial
This is an interventional treatment trial for Myofascial Pain Syndrome
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
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
NCT ID
NCT04628312
First Posted
November 7, 2020
Last Updated
December 2, 2020
Sponsor
Mayuben Private Clinic
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
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Foot Plantar Pressure Changes After Plantar Dry Needling
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