Effects on Plantar Support After Deep Dry Needling in Posterior Tibial Muscle

December 12, 2018 updated by: SERGIO MONTERO NAVARRO, Cardenal Herrera University

Effects on Plantar Support After Deep Dry Needling in Posterior Tibial Muscle: Baropodometric Study

This study aims to analyze the changes in plantar support after the technique of deep dry puncture in the posterior tibial. The data will be analyzed by a baropodometer which will record the possible changes in the footprint. The investigator will perform a pre-intervention measurement and 3 post-intervention measurements (immediately after the intervention, at 24 hours and at 72 hours)

Study Overview

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Moncada
      • Valencia, Moncada, Spain, 46113
        • Universidad CEU Cardenal Herrera

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • presence of myofascial trigger point in the posterior tibialis
  • Accept participation in the study (signature of informed consent)
  • Do not present any exclusion criteria

Exclusion Criteria:

  • Do not present myofascial trigger point in the tibialis posterior.
  • Suffering and / or having suffered from lower limb pathologies, deformities or orthopedic injuries that could alter the static and biomechanics.
  • Not clearly identify the Myofascial trigger point in the tibialis posterior.
  • Have been diagnosed with fibromyalgia, myelopathy or radiculopathy.
  • Having contraindicated the technique of dry needling for suffering, for example, coagulation problems.
  • Be pregnant.
  • Have used analgesics 24 hours before participating in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Deep dry needling in tibialis posterior
Deep dry needling will be applied in the tibialis posterior myofascial trigger point
The inspector, with gloves, disinfects the area to be treated with 70º alcohol. Once the alcohol is applied, the intervenor locates and takes the myofascial trigger point and places the needle with the guide tube resting on the skin of the patient. The inspector holds the guide tube between the index and middle fingers lightly touch the needle with the index finger of the other hand to insert the needle perpendicularly into the skin, directing it towards the inspector's thumb. Once the needle is inserted subcutaneously, the guide tube is removed. The controller deepens the needle to myofascial trigger point, and makes fast inputs and outputs into it. The rapid exit is made to the subcutaneous cellular tissue, outside the muscle, but not outside the skin. Next, hemostasis is performed in the area. Once this hemostasis is completed, the patient is incorporated and dressed.
Placebo Comparator: Sham technique in tibialis posterior
Placebo tibialis dry needling
The patient lies on the stretcher without the trousers. The interventor, with the guide tube, simulates the technique of puncture in the right twin of the subject. The comptroller cleans the area with 70º alcohol. Once the alcohol is applied, he performs the simulated dry needling technique in a plane with his index and middle fingers with the guide tube. It is important that the subject has his head stuck in the hollow of the head of the stretcher throughout the technique to make a correct masking.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain pressure threshold
Time Frame: 72 hours
Amount of pressure (Kg/cm2) applied at the tibialis posterior myofascial trigger point site that elicit pain for the patient will be reported
72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
baropodometric measurements: footprint
Time Frame: 72 hours
The investigator will be collected maximum pressure point in the footprint (g / cm)
72 hours
baropodometric measurements: Average footprint pressure
Time Frame: 72 hours
The investigator will be collected the average footprint pressure (g/cm)
72 hours
baropodometric measurements: forefoot area
Time Frame: 72 hours
The investigator will be collected the forefoot area (cm)
72 hours
baropodometric measurements:forefoot load
Time Frame: 72 hours
The investigator will be collected the forefoot load (%)
72 hours
baropodometric measurements: forefoot pressure variation
Time Frame: 72 hours
The investigator will be collected the forefoot pressure variation (%)
72 hours
baropodometric measurements: rearfoot support surface
Time Frame: 72 hours
The investigator will be collected the rearfoot support surface (cm)
72 hours
baropodometric measurements: hindfoot load
Time Frame: 72 hours
The investigator will be collected the hindfoot load ( %)
72 hours
baropodometric measurements: areas of maximum pressure between the foot lines
Time Frame: 72 hours
The investigator will be collected the areas of maximum pressure between the foot lines (g/cm)
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2018

Primary Completion (Actual)

December 5, 2018

Study Completion (Actual)

December 11, 2018

Study Registration Dates

First Submitted

November 21, 2018

First Submitted That Met QC Criteria

November 26, 2018

First Posted (Actual)

November 28, 2018

Study Record Updates

Last Update Posted (Actual)

December 13, 2018

Last Update Submitted That Met QC Criteria

December 12, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • CEU UCH 210

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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