NCT03756428

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)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2018

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 21, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 28, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

December 1, 2018

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2018

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2018

Completed
Last Updated

December 13, 2018

Status Verified

December 1, 2018

Enrollment Period

4 days

First QC Date

November 21, 2018

Last Update Submit

December 12, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    72 hours

Secondary Outcomes (8)

  • baropodometric measurements: footprint

    72 hours

  • baropodometric measurements: Average footprint pressure

    72 hours

  • baropodometric measurements: forefoot area

    72 hours

  • baropodometric measurements:forefoot load

    72 hours

  • baropodometric measurements: forefoot pressure variation

    72 hours

  • +3 more secondary outcomes

Study Arms (2)

Deep dry needling in tibialis posterior

EXPERIMENTAL

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

Procedure: Deep dry needling in tibialis posterior

Sham technique in tibialis posterior

PLACEBO COMPARATOR

Placebo tibialis dry needling

Procedure: Sham technique in tibialis posterior

Interventions

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.

Deep dry needling in tibialis posterior

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.

Sham technique in tibialis posterior

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • presence of myofascial trigger point in the posterior tibialis
  • Accept participation in the study (signature of informed consent)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad CEU Cardenal Herrera

Valencia, Moncada, 46113, Spain

Location

Related Links

MeSH Terms

Conditions

Movement Disorders

Condition Hierarchy (Ancestors)

Central Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 21, 2018

First Posted

November 28, 2018

Study Start

December 1, 2018

Primary Completion

December 5, 2018

Study Completion

December 11, 2018

Last Updated

December 13, 2018

Record last verified: 2018-12

Locations