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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03756428
Recruitment Status : Completed
First Posted : November 28, 2018
Last Update Posted : December 13, 2018
Sponsor:
Information provided by (Responsible Party):
SERGIO MONTERO NAVARRO, Cardenal Herrera University

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : December 1, 2018
Actual Primary Completion Date : December 5, 2018
Actual Study Completion Date : December 11, 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. baropodometric measurements: footprint [ Time Frame: 72 hours ]
    The investigator will be collected maximum pressure point in the footprint (g / cm)

  2. baropodometric measurements: Average footprint pressure [ Time Frame: 72 hours ]
    The investigator will be collected the average footprint pressure (g/cm)

  3. baropodometric measurements: forefoot area [ Time Frame: 72 hours ]
    The investigator will be collected the forefoot area (cm)

  4. baropodometric measurements:forefoot load [ Time Frame: 72 hours ]
    The investigator will be collected the forefoot load (%)

  5. baropodometric measurements: forefoot pressure variation [ Time Frame: 72 hours ]
    The investigator will be collected the forefoot pressure variation (%)

  6. baropodometric measurements: rearfoot support surface [ Time Frame: 72 hours ]
    The investigator will be collected the rearfoot support surface (cm)

  7. baropodometric measurements: hindfoot load [ Time Frame: 72 hours ]
    The investigator will be collected the hindfoot load ( %)

  8. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03756428


Locations
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Spain
Universidad CEU Cardenal Herrera
Valencia, Moncada, Spain, 46113
Sponsors and Collaborators
Cardenal Herrera University
  Study Documents (Full-Text)

Documents provided by SERGIO MONTERO NAVARRO, Cardenal Herrera University:
Additional Information:
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Responsible Party: SERGIO MONTERO NAVARRO, Principal Investigator, Cardenal Herrera University
ClinicalTrials.gov Identifier: NCT03756428    
Other Study ID Numbers: CEU UCH 210
First Posted: November 28, 2018    Key Record Dates
Last Update Posted: December 13, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Movement Disorders
Central Nervous System Diseases
Nervous System Diseases