Stabilometry and Plantar Pressures Changes After Dry Needling in Flexor Digitoum Brevis.

Sponsor
Mayuben Private Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT04222946
Collaborator
(none)
18
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Study Details

Study Description

Brief Summary

The aim of this clinical trial is to check the effects of dry needling in the Flexor digitorum Brevis .

Condition or Disease Intervention/Treatment Phase
  • Other: Dry needling
N/A

Detailed Description

Fiveteen 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 stabilometry variables and static footprint. The footprint variables will be divided in bilateral rear foot, bilateral midfoot, bilateral fore foot.

Measures. Stabilometry will be measured by displacement of the center of pressures in X and Y with eyes open and closed , center of pressure (COP) with eyes open and closed, COP area with eyes open and closed, COP antero-posterior (a-p) and medio-lateral (m-lat) directions with eyes open and closed, and COP speed. Two trials will be recorded for each condition and the order of the conditions will be randomized across subjects, eyes open and eyes closed. Foot plantar pressure and surface area of two static footprints will be measured during bipedal standing. Static plantar pressure will be evaluated by means of maximum pressure, medium pressure and surface area of each aspect of the foot (rearfoot, midfoot, and fore foot).

Study Design

Study Type:
Interventional
Actual Enrollment :
18 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Pretest posttest of bilateral Flexor digitorum Brevis dry neddling interventionPretest posttest of bilateral Flexor digitorum Brevis dry neddling intervention
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Stabilometry and Plantar Pressures Changes After Bilateral Dry Needling in Flexor Digitoum Brevis.A Pretest Posttest Study.
Actual Study Start Date :
Jan 7, 2020
Actual Primary Completion Date :
Mar 1, 2020
Actual Study Completion Date :
Mar 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental:

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

Other: Dry needling
Bilateral dry needling in latent trigger points of the Flexor digitorum Brevis Muscle

Outcome Measures

Primary Outcome Measures

  1. Static footprint [Through study completion, an average of 1 month]

    Static footprint will measure plantar presures and surface area of rear food, midfoot and fore foot. 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 at 30º away from the midline. During all the examinations, the upper limbs were placed in a relaxed position along the body. The subjects were instructed to stand as still as possible for 30 s, with their eyes open, while concentrating on a point at eye level 2-m away or with their eyes open.

  2. Stabilometry variables eyes open [Through study completion, an average of 1 month]

    Stabilometry assessment was used and 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 at 30º away from the midline. Stabilometry variables measure displacement of the center of pressures in X and Y with open eyes, Center of Pressure (COP) area and anteroposterior(a-p) and mediolateral directions: COP speed.

  3. Stabilometry variables eyes closed [Through study completion, an average of 1 month]

    Stabilometry assessment was used and 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 at 30º away from the midline. Stabilometry variables measure displacement of the center of pressures in X and Y with closed eyes, Center of Pressure (COP) area and anteroposterior(a-p) and mediolateral directions: COP speed.

Secondary Outcome Measures

  1. Static footprint after intervention [Through study completion, an average of 1 month]

    Static footprint will measure plantar presures and surface area of rear food, midfoot and fore foot. 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 at 30º away from the midline. During all the examinations, the upper limbs were placed in a relaxed position along the body. The subjects were instructed to stand as still as possible for 30 s, with their eyes open, while concentrating on a point at eye level 2-m away or with their eyes open.

  2. Stabilometry variables eyes open after intervention [Through study completion, an average of 1 month]

    Stabilometry assessment was used and 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 at 30º away from the midline. Stabilometry variables measure displacement of the center of pressures in X and Y with open eyes, Center of Pressure (COP) area and anteroposterior(a-p) and mediolateral directions: COP speed.

  3. Stabilometry variables eyes closed after intervention [Through study completion, an average of 1 month]

    Stabilometry assessment was used and 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 at 30º away from the midline. Stabilometry variables measure displacement of the center of pressures in X and Y with closed eyes, Center of Pressure (COP) area and anteroposterior(a-p) and mediolateral directions: COP speed.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Healthy individuals

  • 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

  • Balance deficits (determined by oral questionnaire regarding falls)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mayuben Clinic San Sebastián De Los Reyes Madrid Spain 28702

Sponsors and Collaborators

  • Mayuben Private Clinic

Investigators

  • Principal Investigator: Eva María Martínez-Jimenez, Mayuben Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
EVA MARIA MARTÍNEZ JIMENEZ, Head of Podiatry, Principal Investigator, and Physiotherapist, Mayuben Private Clinic
ClinicalTrials.gov Identifier:
NCT04222946
Other Study ID Numbers:
  • 2706201911419
First Posted:
Jan 10, 2020
Last Update Posted:
Mar 3, 2020
Last Verified:
Mar 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by EVA MARIA MARTÍNEZ JIMENEZ, Head of Podiatry, Principal Investigator, and Physiotherapist, Mayuben Private Clinic

Study Results

No Results Posted as of Mar 3, 2020