NCT04628312

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 7, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 13, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

November 20, 2020

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2020

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2020

Completed
Last Updated

December 3, 2020

Status Verified

November 1, 2020

Enrollment Period

7 days

First QC Date

November 7, 2020

Last Update Submit

December 2, 2020

Conditions

Outcome Measures

Primary Outcomes (4)

  • Variables of plantar pressures with platform before dry puncture

    During 30 seconds we will record the plantar pressure variables in grams per square centimeter.

    Through study completion, an average of 1 week

  • Variable footprint plantar surface with platform before dry puncture

    For 30 seconds we will record the area of the footprint in square centimeters.

    Through study completion, an average of 1 week

  • Variables of plantar pressures with platform after dry puncture

    During 30 seconds we will record the plantar pressure variables in grams per square centimeter.

    Through study completion, an average of 1 week

  • Variable footprint plantar surface with platform after dry puncture

    For 30 seconds we will record the area of the footprint in square centimeters.

    Through study completion, an average of 1 week

Study Arms (1)

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

EXPERIMENTAL

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

Other: Static footprint

Interventions

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.

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

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayuben Clinic

San Sebastián de los Reyes, Madrid, 28702, Spain

Location

MeSH Terms

Conditions

Myofascial Pain SyndromesFoot Diseases

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Podiatry, Principal Investigator, and Physiotherapist

Study Record Dates

First Submitted

November 7, 2020

First Posted

November 13, 2020

Study Start

November 20, 2020

Primary Completion

November 27, 2020

Study Completion

December 2, 2020

Last Updated

December 3, 2020

Record last verified: 2020-11

Locations