- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03756428
Effects on Plantar Support After Deep Dry Needling in Posterior Tibial Muscle
December 12, 2018 updated by: SERGIO MONTERO NAVARRO, Cardenal Herrera University
Effects on Plantar Support After Deep Dry Needling in Posterior Tibial Muscle: Baropodometric Study
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)
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Moncada
-
Valencia, Moncada, Spain, 46113
- Universidad CEU Cardenal Herrera
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Deep dry needling in tibialis posterior
Deep dry needling will be applied in the tibialis posterior myofascial trigger point
|
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
72 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
baropodometric measurements: footprint
Time Frame: 72 hours
|
The investigator will be collected maximum pressure point in the footprint (g / cm)
|
72 hours
|
baropodometric measurements: Average footprint pressure
Time Frame: 72 hours
|
The investigator will be collected the average footprint pressure (g/cm)
|
72 hours
|
baropodometric measurements: forefoot area
Time Frame: 72 hours
|
The investigator will be collected the forefoot area (cm)
|
72 hours
|
baropodometric measurements:forefoot load
Time Frame: 72 hours
|
The investigator will be collected the forefoot load (%)
|
72 hours
|
baropodometric measurements: forefoot pressure variation
Time Frame: 72 hours
|
The investigator will be collected the forefoot pressure variation (%)
|
72 hours
|
baropodometric measurements: rearfoot support surface
Time Frame: 72 hours
|
The investigator will be collected the rearfoot support surface (cm)
|
72 hours
|
baropodometric measurements: hindfoot load
Time Frame: 72 hours
|
The investigator will be collected the hindfoot load ( %)
|
72 hours
|
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)
|
72 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2018
Primary Completion (Actual)
December 5, 2018
Study Completion (Actual)
December 11, 2018
Study Registration Dates
First Submitted
November 21, 2018
First Submitted That Met QC Criteria
November 26, 2018
First Posted (Actual)
November 28, 2018
Study Record Updates
Last Update Posted (Actual)
December 13, 2018
Last Update Submitted That Met QC Criteria
December 12, 2018
Last Verified
December 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEU UCH 210
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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