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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03756428
Other study ID # CEU UCH 210
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2018
Est. completion date December 11, 2018

Study information

Verified date December 2018
Source Cardenal Herrera University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date December 11, 2018
Est. primary completion date December 5, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Spain Universidad CEU Cardenal Herrera Valencia Moncada

Sponsors (1)

Lead Sponsor Collaborator
Cardenal Herrera University

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 baropodometric measurements: footprint The investigator will be collected maximum pressure point in the footprint (g / cm) 72 hours
Secondary baropodometric measurements: Average footprint pressure The investigator will be collected the average footprint pressure (g/cm) 72 hours
Secondary baropodometric measurements: forefoot area The investigator will be collected the forefoot area (cm) 72 hours
Secondary baropodometric measurements:forefoot load The investigator will be collected the forefoot load (%) 72 hours
Secondary baropodometric measurements: forefoot pressure variation The investigator will be collected the forefoot pressure variation (%) 72 hours
Secondary baropodometric measurements: rearfoot support surface The investigator will be collected the rearfoot support surface (cm) 72 hours
Secondary baropodometric measurements: hindfoot load The investigator will be collected the hindfoot load ( %) 72 hours
Secondary 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) 72 hours
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