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

Primary Purpose

Movement Disorders

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Deep dry needling in tibialis posterior
Sham technique in tibialis posterior
Sponsored by
Cardenal Herrera University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Movement Disorders

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Universidad CEU Cardenal Herrera

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Deep dry needling in tibialis posterior

Sham technique in tibialis posterior

Arm Description

Deep dry needling will be applied in the tibialis posterior myofascial trigger point

Placebo tibialis dry needling

Outcomes

Primary Outcome Measures

Pain pressure threshold
Amount of pressure (Kg/cm2) applied at the tibialis posterior myofascial trigger point site that elicit pain for the patient will be reported

Secondary Outcome Measures

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

Full Information

First Posted
November 21, 2018
Last Updated
December 12, 2018
Sponsor
Cardenal Herrera University
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1. Study Identification

Unique Protocol Identification Number
NCT03756428
Brief Title
Effects on Plantar Support After Deep Dry Needling in Posterior Tibial Muscle
Official Title
Effects on Plantar Support After Deep Dry Needling in Posterior Tibial Muscle: Baropodometric Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
December 5, 2018 (Actual)
Study Completion Date
December 11, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cardenal Herrera University

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
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Movement Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Deep dry needling in tibialis posterior
Arm Type
Experimental
Arm Description
Deep dry needling will be applied in the tibialis posterior myofascial trigger point
Arm Title
Sham technique in tibialis posterior
Arm Type
Placebo Comparator
Arm Description
Placebo tibialis dry needling
Intervention Type
Procedure
Intervention Name(s)
Deep dry needling in tibialis posterior
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Sham technique in tibialis posterior
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain pressure threshold
Description
Amount of pressure (Kg/cm2) applied at the tibialis posterior myofascial trigger point site that elicit pain for the patient will be reported
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
baropodometric measurements: footprint
Description
The investigator will be collected maximum pressure point in the footprint (g / cm)
Time Frame
72 hours
Title
baropodometric measurements: Average footprint pressure
Description
The investigator will be collected the average footprint pressure (g/cm)
Time Frame
72 hours
Title
baropodometric measurements: forefoot area
Description
The investigator will be collected the forefoot area (cm)
Time Frame
72 hours
Title
baropodometric measurements:forefoot load
Description
The investigator will be collected the forefoot load (%)
Time Frame
72 hours
Title
baropodometric measurements: forefoot pressure variation
Description
The investigator will be collected the forefoot pressure variation (%)
Time Frame
72 hours
Title
baropodometric measurements: rearfoot support surface
Description
The investigator will be collected the rearfoot support surface (cm)
Time Frame
72 hours
Title
baropodometric measurements: hindfoot load
Description
The investigator will be collected the hindfoot load ( %)
Time Frame
72 hours
Title
baropodometric measurements: areas of maximum pressure between the foot lines
Description
The investigator will be collected the areas of maximum pressure between the foot lines (g/cm)
Time Frame
72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Universidad CEU Cardenal Herrera
City
Valencia
State/Province
Moncada
ZIP/Postal Code
46113
Country
Spain

12. IPD Sharing Statement

Links:
URL
http://www.uchceu.es
Description
The University CEU-Cardenal Herrera is th first private university in the Valencian Community. It belongs to the Foundation San Pablo - CEU and is the leading educational organization in Spain with three Universities all over Spain

Learn more about this trial

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

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