Movement DisordersNCT03756428
Effects on Plantar Support After Deep Dry Needling in Posterior Tibial Muscle
A study testing Deep dry needling in tibialis posterior in people with Movement Disorders, run by Cardenal Herrera University at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Movement Disorders
- What is being tested?
- Deep dry needling in tibialis posterior
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2018to 11 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- presence of myofascial trigger point in the posterior tibialis
- Accept participation in the study (signature of informed consent)
- Do not present any exclusion criteria
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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)
- Conditions
- Movement Disorders
- Being tested
- Deep dry needling in tibialis posterior, Sham technique in tibialis posterior
- Medical subject headings
- Movement Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep dry needling in tibialis posteriorProcedure or surgery
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 posteriorProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Deep dry needling in tibialis posterior | Experimental | Deep dry needling will be applied in the tibialis posterior myofascial trigger point Receives: Procedure: Deep dry needling in tibialis posterior |
| Sham technique in tibialis posterior | Placebo comparator | Placebo tibialis dry needling Receives: Procedure: Sham technique in tibialis posterior |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 72 hours
Secondary outcomes (8)
baropodometric measurements: footprint
The investigator will be collected maximum pressure point in the footprint (g / cm)
Measured: 72 hours
baropodometric measurements: Average footprint pressure
The investigator will be collected the average footprint pressure (g/cm)
Measured: 72 hours
baropodometric measurements: forefoot area
The investigator will be collected the forefoot area (cm)
Measured: 72 hours
baropodometric measurements:forefoot load
The investigator will be collected the forefoot load (%)
Measured: 72 hours
baropodometric measurements: forefoot pressure variation
The investigator will be collected the forefoot pressure variation (%)
Measured: 72 hours
baropodometric measurements: rearfoot support surface
The investigator will be collected the rearfoot support surface (cm)
Measured: 72 hours
baropodometric measurements: hindfoot load
The investigator will be collected the hindfoot load ( %)
Measured: 72 hours
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)
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study start1 Dec 2018
- Primary completion5 Dec 2018
- Study completion11 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Movement DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardenal Herrera University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SERGIO MONTERO NAVARRO, Cardenal Herrera University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03756428
- Sponsor's protocol ID
- CEU UCH 210
- Status last verified
- Dec 2018
- First submitted
- 21 Nov 2018
- Last updated
- 13 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Martinez-Gonzalez MC, Del-Rio-Medina S, Montero-Navarro S, Sanchez-Mas J, Rocha-Ortiz MI, Molina-Paya FJ, Orts-Ruiz C, Salar-Andreu C, Calderon-Santos LE, Botella-Rico JM, Morera-Balaguer J. Effects on deep dry needling of the TIBIALIS posterior muscle on plantar pressure distribution: A single-blinded randomized controlled baropodometric trial. PLoS One. 2026 Sep 22;21(9):e0357010. doi: 10.1371/journal.pone.0357010. eCollection 2026.
PubMed 42771642
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects on Plantar Support After Deep Dry Needling in Posterior Tibial Muscle: Baropodometric Study
- ClinicalTrials.gov ID
- NCT03756428
- Acronym / sponsor ID
- CEU UCH 210
- Conditions
- Movement Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Cardenal Herrera UniversityUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 5 Dec 2018 (actual)
- Study completion
- 11 Dec 2018 (actual)
- First posted
- 28 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deep dry needling in tibialis posterior | Experimental | Procedure: Deep dry needling in tibialis posteriorDeep dry needling will be applied in the tibialis posterior myofascial trigger point |
| Sham technique in tibialis posterior | Placebo comparator | Procedure: Sham technique in tibialis posteriorPlacebo tibialis dry needling |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- presence of myofascial trigger point in the posterior tibialis
- Accept participation in the study (signature of informed consent)
- Do not present any exclusion criteria
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep dry needling in tibialis posteriorThe 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. | Procedure or surgery | Deep dry needling in tibialis posterior |
| Sham technique in tibialis posteriorThe 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. | Procedure or surgery | Sham technique in tibialis posterior |
Primary outcome
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
8 secondary outcomes
baropodometric measurements: footprint
Time frame: 72 hours
baropodometric measurements: Average footprint pressure
Time frame: 72 hours
baropodometric measurements: forefoot area
Time frame: 72 hours
baropodometric measurements:forefoot load
Time frame: 72 hours
baropodometric measurements: forefoot pressure variation
Time frame: 72 hours
baropodometric measurements: rearfoot support surface
Time frame: 72 hours
baropodometric measurements: hindfoot load
Time frame: 72 hours
baropodometric measurements: areas of maximum pressure between the foot lines
Time frame: 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2018.
- Derived from this study: PubMed 42771642Martinez-Gonzalez MC, Del-Rio-Medina S, Montero-Navarro S, Sanchez-Mas J, Rocha-Ortiz MI, Molina-Paya FJ, Orts-Ruiz C, Salar-Andreu C, Calderon-Santos LE, Botella-Rico JM, Morera-Balaguer J. Effects on deep dry needling of the TIBIALIS posterior muscle on plantar pressure distribution: A single-blinded randomized controlled baropodometric trial. PLoS One. 2026 Sep 22;21(9):e0357010. doi: 10.1371/journal.pone.0357010. eCollection 2026.
- 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 SpainLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep dry needling in tibialis posterior in people with Movement Disorders, run by Cardenal Herrera University at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain pressure threshold (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03756428, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2018; AzTrials last refreshed its copy on 3 Nov 2026.