Dynamic Plantar Pressures Changes After Dry Needling in Flexor Digitorum Brevis Versus Non Emission Laser

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.

Study Overview

• Status: Completed
• Conditions: Flatfoot
• Intervention / Treatment: Other: Bilateral dry needling in latent trigger points of the Flexor digitorum Brevis Muscle; Other: Bilateral non emission Laser in latent trigger points of the Flexor digitorum Brevis Muscle

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28040
    • Eva María Martínez-Jimenez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Bilateral non emission Laser in latent trigger points of the Flexor digitorum Brevis Muscle	Other: Bilateral non emission Laser in latent trigger points of the Flexor digitorum Brevis Muscle; Bilateral non emission Laser in latent trigger points of the Flexor digitorum Brevis Muscle in flatfoot
Experimental: Bilateral dry needling in Flexor Brevis Digitorum in subjects with latent trigger point	Other: Bilateral dry needling in latent trigger points of the Flexor digitorum Brevis Muscle; Bilateral dry needling in latent trigger points of the Flexor digitorum Brevis Muscle in flatfoot

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Through study completion, an average of 1 week
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)	Through study completion, an average of 1 week
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)	Through study completion, an average of 1 week
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)	Through study completion, an average of 1 week
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)	Through study completion, an average of 1 week
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)	Through study completion, an average of 1 week
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)	Through study completion, an average of 1 week
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)	Through study completion, an average of 1 week
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)	Through study completion, an average of 1 week
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)	Through study completion, an average of 1 week
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)	Through study completion, an average of 1 week
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)	Through study completion, an average of 1 week
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)	Through study completion, an average of 1 week
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)	Through study completion, an average of 1 week
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)	Through study completion, an average of 1 week
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).	Through study completion, an average of 1 week
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)	Through study completion, an average of 1 week
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)	Through study completion, an average of 1 week
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)	Through study completion, an average of 1 week
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).	Through study completion, an average of 1 week
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)	Through study completion, an average of 1 week
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)	Through study completion, an average of 1 week
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)	Through study completion, an average of 1 week
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).	Through study completion, an average of 1 week
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)	Through study completion, an average of 1 week
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)	Through study completion, an average of 1 week
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)	Through study completion, an average of 1 week
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).	Through study completion, an average of 1 week
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)	Through study completion, an average of 1 week
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)	Through study completion, an average of 1 week
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)	Through study completion, an average of 1 week
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)	Through study completion, an average of 1 week

Collaborators and Investigators

• Sponsor: Mayuben Private Clinic
• Investigators: Principal Investigator: Eva María MartínezJiménez, Mayuben Clinic

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2023
• Primary Completion (Actual): May 31, 2023
• Study Completion (Actual): June 2, 2023

Study Registration Dates

• First Submitted: May 15, 2023
• First Submitted That Met QC Criteria: May 16, 2023
• First Posted (Actual): May 25, 2023

Study Record Updates

• Last Update Posted (Actual): June 5, 2023
• Last Update Submitted That Met QC Criteria: June 2, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: gait; Dry Needling; trigger point; Foot
• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Limb Deformities, Congenital; Foot Deformities; Foot Deformities, Acquired; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Talipes; Flatfoot
• Other Study ID Numbers: 1912202200923-B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No