Back to resultsDynamic Plantar Pressures Changes After Dry Needling in Flexor Digitorum Brevis Versus Non Emission Laser
Primary Purpose
Flatfoot
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Bilateral dry needling in latent trigger points of the Flexor digitorum Brevis Muscle
Bilateral non emission Laser in latent trigger points of the Flexor digitorum Brevis Muscle
Sponsored by
About this trial
This is an interventional treatment trial for Flatfoot focused on measuring Foot, gait, Dry Needling, trigger point
Eligibility Criteria
Inclusion Criteria: Individuals 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)
Sites / Locations
- Eva María Martínez-Jimenez
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Bilateral dry needling in Flexor Brevis Digitorum in subjects with latent trigger point
Bilateral non emission Laser in latent trigger points of the Flexor digitorum Brevis Muscle
Arm Description
Outcomes
Primary Outcome Measures
Surface before dry needling in right foot at 20% of time of first step
Registration of the surface of the dynamic footprint at 20% of the total duration, measured in square centimeters (cm2)
Surface before dry needling in right foot at 35% of time of first step
Registration of the surface of the dynamic footprint at 35% of the total duration, measured in square centimeters (cm2)
Surface before dry needling in right foot at 92% of time of first step
Registration of the surface of the dynamic footprint at 92% of the total duration, measured in square centimeters (cm2)
Surface before dry needling in right foot at Global of time of first step
Registration of the surface of the global dynamic footprint of the total duration, measured in square centimeters (cm2)
Surface before dry needling in left foot at 20% of time of first step
Registration of the surface of the dynamic footprint at 20% of the total duration, measured in square centimeters (cm2)
Surface before dry needling in left foot at 35% of time of first step
Registration of the surface of the dynamic footprint at 35% of the total duration, measured in square centimeters (cm2)
Surface before dry needling in left foot at 92% of time of first step
Registration of the surface of the dynamic footprint at 92% of the total duration, measured in square centimeters (cm2)
Surface before dry needling in left foot at Global of time of first step
Registration of the surface of the global dynamic footprint of the total duration, measured in square centimeters (cm2)
Surface after dry needling in right foot at 20% of time of first step
Registration of the surface of the dynamic footprint at 20% of the total duration, measured in square centimeters (cm2)
Surface after dry needling in right foot at 35% of time of first step
Registration of the surface of the dynamic footprint at 35% of the total duration, measured in square centimeters (cm2)
Surface after dry needling in right foot at 92% of time of first step
Registration of the surface of the dynamic footprint at 92% of the total duration, measured in square centimeters (cm2)
Surface after dry needling in right foot at Global of time of first step
Registration of the surface of the global dynamic footprint of the total duration, measured in square centimeters (cm2)
Surface after dry needling in left foot at 20% of time of first step
Registration of the surface of the dynamic footprint at 20% of the total duration, measured in square centimeters (cm2)
Surface after dry needling in left foot at 35% of time of first step
Registration of the surface of the dynamic footprint at 35% of the total duration, measured in square centimeters (cm2)
Surface after dry needling in left foot at 92% of time of first step
Registration of the surface of the dynamic footprint at 92% of the total duration, measured in square centimeters (cm2)
Surface after dry needling in left foot at Global of time of first step
Registration of the surface of the global dynamic footprint of the total duration, measured in square centimeters (cm2)
Surface before Laser non-emission in right foot at 20% of time of first step
Registration of the surface of the dynamic footprint at 20% of the total duration, measured in square centimeters (cm2)
Surface before Laser non-emission in right foot at 35% of time of first step
Registration of the surface of the dynamic footprint at 35% of the total duration, measured in square centimeters (cm2).
Surface before Laser non-emission in right foot at 92% of time of first step
Registration of the surface of the dynamic footprint at 92% of the total duration, measured in square centimeters (cm2)
Surface before Laser non-emission in right foot at Global of time of first step
Registration of the surface of the global dynamic footprint of the total duration, measured in square centimeters (cm2)
Surface before Laser non-emission in left foot at 20% of time of first step
Registration of the surface of the dynamic footprint at 20% of the total duration, measured in square centimeters (cm2)
Surface before Laser non-emission in left foot at 35% of time of first step
Registration of the surface of the dynamic footprint at 35% of the total duration, measured in square centimeters (cm2).
Surface before Laser non-emission in left foot at 92% of time of first step
Registration of the surface of the dynamic footprint at 92% of the total duration, measured in square centimeters (cm2)
Surface before Laser non-emission in left foot at Global of time of first step
Registration of the surface of the global dynamic footprint of the total duration, measured in square centimeters (cm2)
Surface after Laser non-emission in right foot at 20% of time of first step
Registration of the surface of the dynamic footprint at 20% of the total duration, measured in square centimeters (cm2)
Surface after Laser non-emission in right foot at 35% of time of first step
Registration of the surface of the dynamic footprint at 35% of the total duration, measured in square centimeters (cm2).
Surface after Laser non-emission in right foot at 92% of time of first step
Registration of the surface of the dynamic footprint at 92% of the total duration, measured in square centimeters (cm2)
Surface after Laser non-emission in right foot at Global of time of first step
Registration of the surface of the global dynamic footprint of the total duration, measured in square centimeters (cm2)
Surface after Laser non-emission in left foot at 20% of time of first step
Registration of the surface of the dynamic footprint at 20% of the total duration, measured in square centimeters (cm2)
Surface after Laser non-emission in left foot at 35% of time of first step
Registration of the surface of the dynamic footprint at 35% of the total duration, measured in square centimeters (cm2).
Surface after Laser non-emission in left foot at 92% of time of first step
Registration of the surface of the dynamic footprint at 92% of the total duration, measured in square centimeters (cm2)
Surface after Laser non-emission in left foot at Global of time of first step
Registration of the surface of the global dynamic footprint of the total duration, measured in square centimeters (cm2)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05875415
Brief Title
Dynamic Plantar Pressures Changes After Dry Needling in Flexor Digitorum Brevis Versus Non Emission Laser
Official Title
Dynamic Plantar Pressures Changes After Dry Needling in Flexor Digitorum Brevis Versus Non Emission Laser
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
May 27, 2023 (Actual)
Primary Completion Date
May 31, 2023 (Actual)
Study Completion Date
June 2, 2023 (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
Thirty-six subjects randomly distributed between a dry needling 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 dynamic footprint variables.
Detailed Description
Thirty-six subjects randomly distributed between a dry needling 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 dynamic footprint variables of the first step of both feet.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Flatfoot
Keywords
Foot, gait, Dry Needling, trigger point
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
Bilateral dry needling in Flexor Brevis Digitorum in subjects with latent trigger point
Arm Type
Experimental
Arm Title
Bilateral non emission Laser in latent trigger points of the Flexor digitorum Brevis Muscle
Arm Type
Sham Comparator
Intervention Type
Other
Intervention Name(s)
Bilateral dry needling in latent trigger points of the Flexor digitorum Brevis Muscle
Intervention Description
Bilateral dry needling in latent trigger points of the Flexor digitorum Brevis Muscle in flatfoot
Intervention Type
Other
Intervention Name(s)
Bilateral non emission Laser in latent trigger points of the Flexor digitorum Brevis Muscle
Intervention Description
Bilateral non emission Laser in latent trigger points of the Flexor digitorum Brevis Muscle in flatfoot
Primary Outcome Measure Information:
Title
Surface before dry needling in right foot at 20% of time of first step
Description
Registration of the surface of the dynamic footprint at 20% of the total duration, measured in square centimeters (cm2)
Time Frame
Through study completion, an average of 1 week
Title
Surface before dry needling in right foot at 35% of time of first step
Description
Registration of the surface of the dynamic footprint at 35% of the total duration, measured in square centimeters (cm2)
Time Frame
Through study completion, an average of 1 week
Title
Surface before dry needling in right foot at 92% of time of first step
Description
Registration of the surface of the dynamic footprint at 92% of the total duration, measured in square centimeters (cm2)
Time Frame
Through study completion, an average of 1 week
Title
Surface before dry needling in right foot at Global of time of first step
Description
Registration of the surface of the global dynamic footprint of the total duration, measured in square centimeters (cm2)
Time Frame
Through study completion, an average of 1 week
Title
Surface before dry needling in left foot at 20% of time of first step
Description
Registration of the surface of the dynamic footprint at 20% of the total duration, measured in square centimeters (cm2)
Time Frame
Through study completion, an average of 1 week
Title
Surface before dry needling in left foot at 35% of time of first step
Description
Registration of the surface of the dynamic footprint at 35% of the total duration, measured in square centimeters (cm2)
Time Frame
Through study completion, an average of 1 week
Title
Surface before dry needling in left foot at 92% of time of first step
Description
Registration of the surface of the dynamic footprint at 92% of the total duration, measured in square centimeters (cm2)
Time Frame
Through study completion, an average of 1 week
Title
Surface before dry needling in left foot at Global of time of first step
Description
Registration of the surface of the global dynamic footprint of the total duration, measured in square centimeters (cm2)
Time Frame
Through study completion, an average of 1 week
Title
Surface after dry needling in right foot at 20% of time of first step
Description
Registration of the surface of the dynamic footprint at 20% of the total duration, measured in square centimeters (cm2)
Time Frame
Through study completion, an average of 1 week
Title
Surface after dry needling in right foot at 35% of time of first step
Description
Registration of the surface of the dynamic footprint at 35% of the total duration, measured in square centimeters (cm2)
Time Frame
Through study completion, an average of 1 week
Title
Surface after dry needling in right foot at 92% of time of first step
Description
Registration of the surface of the dynamic footprint at 92% of the total duration, measured in square centimeters (cm2)
Time Frame
Through study completion, an average of 1 week
Title
Surface after dry needling in right foot at Global of time of first step
Description
Registration of the surface of the global dynamic footprint of the total duration, measured in square centimeters (cm2)
Time Frame
Through study completion, an average of 1 week
Title
Surface after dry needling in left foot at 20% of time of first step
Description
Registration of the surface of the dynamic footprint at 20% of the total duration, measured in square centimeters (cm2)
Time Frame
Through study completion, an average of 1 week
Title
Surface after dry needling in left foot at 35% of time of first step
Description
Registration of the surface of the dynamic footprint at 35% of the total duration, measured in square centimeters (cm2)
Time Frame
Through study completion, an average of 1 week
Title
Surface after dry needling in left foot at 92% of time of first step
Description
Registration of the surface of the dynamic footprint at 92% of the total duration, measured in square centimeters (cm2)
Time Frame
Through study completion, an average of 1 week
Title
Surface after dry needling in left foot at Global of time of first step
Description
Registration of the surface of the global dynamic footprint of the total duration, measured in square centimeters (cm2)
Time Frame
Through study completion, an average of 1 week
Title
Surface before Laser non-emission in right foot at 20% of time of first step
Description
Registration of the surface of the dynamic footprint at 20% of the total duration, measured in square centimeters (cm2)
Time Frame
Through study completion, an average of 1 week
Title
Surface before Laser non-emission in right foot at 35% of time of first step
Description
Registration of the surface of the dynamic footprint at 35% of the total duration, measured in square centimeters (cm2).
Time Frame
Through study completion, an average of 1 week
Title
Surface before Laser non-emission in right foot at 92% of time of first step
Description
Registration of the surface of the dynamic footprint at 92% of the total duration, measured in square centimeters (cm2)
Time Frame
Through study completion, an average of 1 week
Title
Surface before Laser non-emission in right foot at Global of time of first step
Description
Registration of the surface of the global dynamic footprint of the total duration, measured in square centimeters (cm2)
Time Frame
Through study completion, an average of 1 week
Title
Surface before Laser non-emission in left foot at 20% of time of first step
Description
Registration of the surface of the dynamic footprint at 20% of the total duration, measured in square centimeters (cm2)
Time Frame
Through study completion, an average of 1 week
Title
Surface before Laser non-emission in left foot at 35% of time of first step
Description
Registration of the surface of the dynamic footprint at 35% of the total duration, measured in square centimeters (cm2).
Time Frame
Through study completion, an average of 1 week
Title
Surface before Laser non-emission in left foot at 92% of time of first step
Description
Registration of the surface of the dynamic footprint at 92% of the total duration, measured in square centimeters (cm2)
Time Frame
Through study completion, an average of 1 week
Title
Surface before Laser non-emission in left foot at Global of time of first step
Description
Registration of the surface of the global dynamic footprint of the total duration, measured in square centimeters (cm2)
Time Frame
Through study completion, an average of 1 week
Title
Surface after Laser non-emission in right foot at 20% of time of first step
Description
Registration of the surface of the dynamic footprint at 20% of the total duration, measured in square centimeters (cm2)
Time Frame
Through study completion, an average of 1 week
Title
Surface after Laser non-emission in right foot at 35% of time of first step
Description
Registration of the surface of the dynamic footprint at 35% of the total duration, measured in square centimeters (cm2).
Time Frame
Through study completion, an average of 1 week
Title
Surface after Laser non-emission in right foot at 92% of time of first step
Description
Registration of the surface of the dynamic footprint at 92% of the total duration, measured in square centimeters (cm2)
Time Frame
Through study completion, an average of 1 week
Title
Surface after Laser non-emission in right foot at Global of time of first step
Description
Registration of the surface of the global dynamic footprint of the total duration, measured in square centimeters (cm2)
Time Frame
Through study completion, an average of 1 week
Title
Surface after Laser non-emission in left foot at 20% of time of first step
Description
Registration of the surface of the dynamic footprint at 20% of the total duration, measured in square centimeters (cm2)
Time Frame
Through study completion, an average of 1 week
Title
Surface after Laser non-emission in left foot at 35% of time of first step
Description
Registration of the surface of the dynamic footprint at 35% of the total duration, measured in square centimeters (cm2).
Time Frame
Through study completion, an average of 1 week
Title
Surface after Laser non-emission in left foot at 92% of time of first step
Description
Registration of the surface of the dynamic footprint at 92% of the total duration, measured in square centimeters (cm2)
Time Frame
Through study completion, an average of 1 week
Title
Surface after Laser non-emission in left foot at Global of time of first step
Description
Registration of the surface of the global dynamic footprint of the total duration, measured in square centimeters (cm2)
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
No
Eligibility Criteria
Inclusion Criteria:
Individuals 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva María MartínezJiménez
Organizational Affiliation
Mayuben Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eva María Martínez-Jimenez
City
Madrid
ZIP/Postal Code
28040
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Dynamic Plantar Pressures Changes After Dry Needling in Flexor Digitorum Brevis Versus Non Emission Laser
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