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

Sponsor

Cardenal Herrera University (Other)

Overall Status

Completed

CT.gov ID

NCT03756428

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Days)

243.5

Patients Per Site Per Month

Study Details

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)

Condition or Disease	Intervention/Treatment	Phase
Movement Disorders	Procedure: Deep dry needling in tibialis posterior Procedure: Sham technique in tibialis posterior	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 1, 2018

Actual Primary Completion Date :

Dec 5, 2018

Actual Study Completion Date :

Dec 11, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Deep dry needling in tibialis posterior Deep dry needling will be applied in the tibialis posterior myofascial trigger point	Procedure: Deep dry needling in tibialis posterior 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	Procedure: Sham technique 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.

Arm

Intervention/Treatment

Experimental: Deep dry needling in tibialis posterior

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

Procedure: Deep dry needling in tibialis posterior

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

Procedure: Sham technique 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.

Outcome Measures

Primary Outcome Measures

Pain pressure threshold [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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universidad CEU Cardenal Herrera	Valencia	Moncada	Spain	46113

Sponsors and Collaborators

Cardenal Herrera University

Investigators

None specified.

Study Documents (Full-Text)

Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Mar 18, 2013

More Information

Additional Information:

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

Publications

None provided.

Responsible Party:

SERGIO MONTERO NAVARRO, Principal Investigator, Cardenal Herrera University

ClinicalTrials.gov Identifier:

NCT03756428

Other Study ID Numbers:

CEU UCH 210

First Posted:

Nov 28, 2018

Last Update Posted:

Dec 13, 2018

Last Verified:

Dec 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Movement Disorders

Study Results

No Results Posted as of Dec 13, 2018