FlatfootNCT05875415
Dynamic Plantar Pressures Changes After Dry Needling in Flexor Digitorum Brevis Versus Non Emission Laser
A study testing Bilateral dry needling in latent trigger points of the Flexor digitorum Brevis Muscle and Bilateral non emission Laser in latent trigger points of the Flexor digitorum Brevis Muscle in people with Flatfoot, run by Mayuben Private Clinic at 1 site in Spain.
Trial summary
Thirty-six subjects randomly distributed between a dry needling intervention group and a control group whose intervention is a non-emission laser. All the subjects will be measured before and after the interventions of each group. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Flatfoot
- What is being tested?
- Bilateral dry needling in latent trigger points of the Flexor digitorum Brevis Muscle and Bilateral non emission Laser in latent trigger points of the Flexor digitorum Brevis Muscle
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteSpain
- Study dates
- 27 May 2023to 2 Jun 2023
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Individuals must have latent trigger point in Flexor Brevis Digitorum muscles with no other pathologies
Who cannot join
- Previous lower extremities surgery.
- History of lower extremities injury with residual symptoms (pain, "giving-away" sensations) within the last year.
- Leg-length discrepancy more than 1 cm
- Balance deficits (determined by oral questionnaire regarding falls)
Trial locations and contacts
1 site in 1 country.
About this study
Thirty-six subjects randomly distributed between a dry needling intervention group and a control group whose intervention is a non-emission laser. All the subjects will be measured before and after the interventions of each group. The measurements will be made on a pressure platform to record the dynamic footprint variables.
Read the detailed description
Thirty-six subjects randomly distributed between a dry needling intervention group and a control group whose intervention is a non-emission laser. All the subjects will be measured before and after the interventions of each group. The measurements will be made on a pressure platform to record the dynamic footprint variables of the first step of both feet.
- Conditions
- Flatfoot
- Being tested
- Bilateral dry needling in latent trigger points of the Flexor digitorum Brevis Muscle, Bilateral non emission Laser in latent trigger points of the Flexor digitorum Brevis Muscle
- Keywords
- Foot, gait, Dry Needling, trigger point
- Medical subject headings
- Flatfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral dry needling in latent trigger points of the Flexor digitorum Brevis MuscleOther
Bilateral dry needling in latent trigger points of the Flexor digitorum Brevis Muscle in flatfoot
Bilateral non emission Laser in latent trigger points of the Flexor digitorum Brevis MuscleOther
Bilateral non emission Laser in latent trigger points of the Flexor digitorum Brevis Muscle in flatfoot
| Study group | Role | What they receive |
|---|---|---|
| Bilateral dry needling in Flexor Brevis Digitorum in subjects with latent trigger point | Experimental | Not described Receives: Other: Bilateral dry needling in latent trigger points of the Flexor digitorum Brevis Muscle |
| Bilateral non emission Laser in latent trigger points of the Flexor digitorum Brevis Muscle | Sham comparator | Not described Receives: Other: Bilateral non emission Laser in latent trigger points of the Flexor digitorum Brevis Muscle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surface before dry needling in right foot at 20% of time of first step
Registration of the surface of the dynamic footprint at 20% of the total duration, measured in square centimeters (cm2)
Measured: Through study completion, an average of 1 week
Surface before dry needling in right foot at 35% of time of first step
Registration of the surface of the dynamic footprint at 35% of the total duration, measured in square centimeters (cm2)
Measured: Through study completion, an average of 1 week
Surface before dry needling in right foot at 92% of time of first step
Registration of the surface of the dynamic footprint at 92% of the total duration, measured in square centimeters (cm2)
Measured: Through study completion, an average of 1 week
Surface before dry needling in right foot at Global of time of first step
Registration of the surface of the global dynamic footprint of the total duration, measured in square centimeters (cm2)
Measured: Through study completion, an average of 1 week
Surface before dry needling in left foot at 20% of time of first step
Registration of the surface of the dynamic footprint at 20% of the total duration, measured in square centimeters (cm2)
Measured: Through study completion, an average of 1 week
Surface before dry needling in left foot at 35% of time of first step
Registration of the surface of the dynamic footprint at 35% of the total duration, measured in square centimeters (cm2)
Measured: Through study completion, an average of 1 week
Surface before dry needling in left foot at 92% of time of first step
Registration of the surface of the dynamic footprint at 92% of the total duration, measured in square centimeters (cm2)
Measured: Through study completion, an average of 1 week
Surface before dry needling in left foot at Global of time of first step
Registration of the surface of the global dynamic footprint of the total duration, measured in square centimeters (cm2)
Measured: Through study completion, an average of 1 week
Surface after dry needling in right foot at 20% of time of first step
Registration of the surface of the dynamic footprint at 20% of the total duration, measured in square centimeters (cm2)
Measured: Through study completion, an average of 1 week
Surface after dry needling in right foot at 35% of time of first step
Registration of the surface of the dynamic footprint at 35% of the total duration, measured in square centimeters (cm2)
Measured: Through study completion, an average of 1 week
Surface after dry needling in right foot at 92% of time of first step
Registration of the surface of the dynamic footprint at 92% of the total duration, measured in square centimeters (cm2)
Measured: Through study completion, an average of 1 week
Surface after dry needling in right foot at Global of time of first step
Registration of the surface of the global dynamic footprint of the total duration, measured in square centimeters (cm2)
Measured: Through study completion, an average of 1 week
Surface after dry needling in left foot at 20% of time of first step
Registration of the surface of the dynamic footprint at 20% of the total duration, measured in square centimeters (cm2)
Measured: Through study completion, an average of 1 week
Surface after dry needling in left foot at 35% of time of first step
Registration of the surface of the dynamic footprint at 35% of the total duration, measured in square centimeters (cm2)
Measured: Through study completion, an average of 1 week
Surface after dry needling in left foot at 92% of time of first step
Registration of the surface of the dynamic footprint at 92% of the total duration, measured in square centimeters (cm2)
Measured: Through study completion, an average of 1 week
Surface after dry needling in left foot at Global of time of first step
Registration of the surface of the global dynamic footprint of the total duration, measured in square centimeters (cm2)
Measured: Through study completion, an average of 1 week
Surface before Laser non-emission in right foot at 20% of time of first step
Registration of the surface of the dynamic footprint at 20% of the total duration, measured in square centimeters (cm2)
Measured: Through study completion, an average of 1 week
Surface before Laser non-emission in right foot at 35% of time of first step
Registration of the surface of the dynamic footprint at 35% of the total duration, measured in square centimeters (cm2).
Measured: Through study completion, an average of 1 week
Surface before Laser non-emission in right foot at 92% of time of first step
Registration of the surface of the dynamic footprint at 92% of the total duration, measured in square centimeters (cm2)
Measured: Through study completion, an average of 1 week
Surface before Laser non-emission in right foot at Global of time of first step
Registration of the surface of the global dynamic footprint of the total duration, measured in square centimeters (cm2)
Measured: Through study completion, an average of 1 week
Surface before Laser non-emission in left foot at 20% of time of first step
Registration of the surface of the dynamic footprint at 20% of the total duration, measured in square centimeters (cm2)
Measured: Through study completion, an average of 1 week
Surface before Laser non-emission in left foot at 35% of time of first step
Registration of the surface of the dynamic footprint at 35% of the total duration, measured in square centimeters (cm2).
Measured: Through study completion, an average of 1 week
Surface before Laser non-emission in left foot at 92% of time of first step
Registration of the surface of the dynamic footprint at 92% of the total duration, measured in square centimeters (cm2)
Measured: Through study completion, an average of 1 week
Surface before Laser non-emission in left foot at Global of time of first step
Registration of the surface of the global dynamic footprint of the total duration, measured in square centimeters (cm2)
Measured: Through study completion, an average of 1 week
Surface after Laser non-emission in right foot at 20% of time of first step
Registration of the surface of the dynamic footprint at 20% of the total duration, measured in square centimeters (cm2)
Measured: Through study completion, an average of 1 week
Surface after Laser non-emission in right foot at 35% of time of first step
Registration of the surface of the dynamic footprint at 35% of the total duration, measured in square centimeters (cm2).
Measured: Through study completion, an average of 1 week
Surface after Laser non-emission in right foot at 92% of time of first step
Registration of the surface of the dynamic footprint at 92% of the total duration, measured in square centimeters (cm2)
Measured: Through study completion, an average of 1 week
Surface after Laser non-emission in right foot at Global of time of first step
Registration of the surface of the global dynamic footprint of the total duration, measured in square centimeters (cm2)
Measured: Through study completion, an average of 1 week
Surface after Laser non-emission in left foot at 20% of time of first step
Registration of the surface of the dynamic footprint at 20% of the total duration, measured in square centimeters (cm2)
Measured: Through study completion, an average of 1 week
Surface after Laser non-emission in left foot at 35% of time of first step
Registration of the surface of the dynamic footprint at 35% of the total duration, measured in square centimeters (cm2).
Measured: Through study completion, an average of 1 week
Surface after Laser non-emission in left foot at 92% of time of first step
Registration of the surface of the dynamic footprint at 92% of the total duration, measured in square centimeters (cm2)
Measured: Through study completion, an average of 1 week
Surface after Laser non-emission in left foot at Global of time of first step
Registration of the surface of the global dynamic footprint of the total duration, measured in square centimeters (cm2)
Measured: Through study completion, an average of 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start27 May 2023
- Primary completion31 May 2023
- Study completion2 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FlatfootStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayuben Private Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, EVA MARIA MARTÍNEZ JIMENEZ, Mayuben Private Clinic
- Investigators
- Eva María MartínezJiménez, Principal investigator, Mayuben Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05875415
- Sponsor's protocol ID
- 1912202200923-B
- Status last verified
- Jun 2023
- First submitted
- 15 May 2023
- Last updated
- 5 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Plantar Pressures Changes After Dry Needling in Flexor Digitorum Brevis Versus Non Emission Laser
- ClinicalTrials.gov ID
- NCT05875415
- Acronym / sponsor ID
- 1912202200923-B
- Conditions
- Flatfoot
- Keywords
- Foot, gait, Dry Needling, trigger point
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Mayuben Private ClinicUniversity, hospital or other
- Study start
- 27 May 2023 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 2 Jun 2023 (actual)
- First posted
- 25 May 2023 (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.
Thirty-six subjects randomly distributed between a dry needling intervention group and a control group whose intervention is a non-emission laser. All the subjects will be measured before and after the interventions of each group. The measurements will be made on a pressure platform to record the dynamic footprint variables.
Detailed description
Thirty-six subjects randomly distributed between a dry needling intervention group and a control group whose intervention is a non-emission laser. All the subjects will be measured before and after the interventions of each group. The measurements will be made on a pressure platform to record the dynamic footprint variables of the first step of both feet.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bilateral dry needling in Flexor Brevis Digitorum in subjects with latent trigger point | Experimental | Other: Bilateral dry needling in latent trigger points of the Flexor digitorum Brevis Muscle |
| Bilateral non emission Laser in latent trigger points of the Flexor digitorum Brevis Muscle | Sham comparator | Other: Bilateral non emission Laser in latent trigger points of the Flexor digitorum Brevis Muscle |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Individuals must have latent trigger point in Flexor Brevis Digitorum muscles with no other pathologies
Key exclusion criteria (4 listed)
- Previous lower extremities surgery.
- History of lower extremities injury with residual symptoms (pain, "giving-away" sensations) within the last year.
- Leg-length discrepancy more than 1 cm
- Balance deficits (determined by oral questionnaire regarding falls)
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 |
|---|---|---|
| Bilateral dry needling in latent trigger points of the Flexor digitorum Brevis MuscleBilateral dry needling in latent trigger points of the Flexor digitorum Brevis Muscle in flatfoot | Other | Bilateral dry needling in Flexor Brevis Digitorum in subjects with latent trigger point |
| Bilateral non emission Laser in latent trigger points of the Flexor digitorum Brevis MuscleBilateral non emission Laser in latent trigger points of the Flexor digitorum Brevis Muscle in flatfoot | Other | Bilateral non emission Laser in latent trigger points of the Flexor digitorum Brevis Muscle |
Primary outcome
Surface before dry needling in right foot at 20% of time of first step
Time frame: Through study completion, an average of 1 week
Registration of the surface of the dynamic footprint at 20% of the total duration, measured in square centimeters (cm2)
Surface before dry needling in right foot at 35% of time of first step
Time frame: Through study completion, an average of 1 week
Registration of the surface of the dynamic footprint at 35% of the total duration, measured in square centimeters (cm2)
Surface before dry needling in right foot at 92% of time of first step
Time frame: Through study completion, an average of 1 week
Registration of the surface of the dynamic footprint at 92% of the total duration, measured in square centimeters (cm2)
Surface before dry needling in right foot at Global of time of first step
Time frame: Through study completion, an average of 1 week
Registration of the surface of the global dynamic footprint of the total duration, measured in square centimeters (cm2)
Surface before dry needling in left foot at 20% of time of first step
Time frame: Through study completion, an average of 1 week
Registration of the surface of the dynamic footprint at 20% of the total duration, measured in square centimeters (cm2)
Surface before dry needling in left foot at 35% of time of first step
Time frame: Through study completion, an average of 1 week
Registration of the surface of the dynamic footprint at 35% of the total duration, measured in square centimeters (cm2)
Surface before dry needling in left foot at 92% of time of first step
Time frame: Through study completion, an average of 1 week
Registration of the surface of the dynamic footprint at 92% of the total duration, measured in square centimeters (cm2)
Surface before dry needling in left foot at Global of time of first step
Time frame: Through study completion, an average of 1 week
Registration of the surface of the global dynamic footprint of the total duration, measured in square centimeters (cm2)
Surface after dry needling in right foot at 20% of time of first step
Time frame: Through study completion, an average of 1 week
Registration of the surface of the dynamic footprint at 20% of the total duration, measured in square centimeters (cm2)
Surface after dry needling in right foot at 35% of time of first step
Time frame: Through study completion, an average of 1 week
Registration of the surface of the dynamic footprint at 35% of the total duration, measured in square centimeters (cm2)
Surface after dry needling in right foot at 92% of time of first step
Time frame: Through study completion, an average of 1 week
Registration of the surface of the dynamic footprint at 92% of the total duration, measured in square centimeters (cm2)
Surface after dry needling in right foot at Global of time of first step
Time frame: Through study completion, an average of 1 week
Registration of the surface of the global dynamic footprint of the total duration, measured in square centimeters (cm2)
Surface after dry needling in left foot at 20% of time of first step
Time frame: Through study completion, an average of 1 week
Registration of the surface of the dynamic footprint at 20% of the total duration, measured in square centimeters (cm2)
Surface after dry needling in left foot at 35% of time of first step
Time frame: Through study completion, an average of 1 week
Registration of the surface of the dynamic footprint at 35% of the total duration, measured in square centimeters (cm2)
Surface after dry needling in left foot at 92% of time of first step
Time frame: Through study completion, an average of 1 week
Registration of the surface of the dynamic footprint at 92% of the total duration, measured in square centimeters (cm2)
Surface after dry needling in left foot at Global of time of first step
Time frame: Through study completion, an average of 1 week
Registration of the surface of the global dynamic footprint of the total duration, measured in square centimeters (cm2)
Surface before Laser non-emission in right foot at 20% of time of first step
Time frame: Through study completion, an average of 1 week
Registration of the surface of the dynamic footprint at 20% of the total duration, measured in square centimeters (cm2)
Surface before Laser non-emission in right foot at 35% of time of first step
Time frame: Through study completion, an average of 1 week
Registration of the surface of the dynamic footprint at 35% of the total duration, measured in square centimeters (cm2).
Surface before Laser non-emission in right foot at 92% of time of first step
Time frame: Through study completion, an average of 1 week
Registration of the surface of the dynamic footprint at 92% of the total duration, measured in square centimeters (cm2)
Surface before Laser non-emission in right foot at Global of time of first step
Time frame: Through study completion, an average of 1 week
Registration of the surface of the global dynamic footprint of the total duration, measured in square centimeters (cm2)
Surface before Laser non-emission in left foot at 20% of time of first step
Time frame: Through study completion, an average of 1 week
Registration of the surface of the dynamic footprint at 20% of the total duration, measured in square centimeters (cm2)
Surface before Laser non-emission in left foot at 35% of time of first step
Time frame: Through study completion, an average of 1 week
Registration of the surface of the dynamic footprint at 35% of the total duration, measured in square centimeters (cm2).
Surface before Laser non-emission in left foot at 92% of time of first step
Time frame: Through study completion, an average of 1 week
Registration of the surface of the dynamic footprint at 92% of the total duration, measured in square centimeters (cm2)
Surface before Laser non-emission in left foot at Global of time of first step
Time frame: Through study completion, an average of 1 week
Registration of the surface of the global dynamic footprint of the total duration, measured in square centimeters (cm2)
Surface after Laser non-emission in right foot at 20% of time of first step
Time frame: Through study completion, an average of 1 week
Registration of the surface of the dynamic footprint at 20% of the total duration, measured in square centimeters (cm2)
Surface after Laser non-emission in right foot at 35% of time of first step
Time frame: Through study completion, an average of 1 week
Registration of the surface of the dynamic footprint at 35% of the total duration, measured in square centimeters (cm2).
Surface after Laser non-emission in right foot at 92% of time of first step
Time frame: Through study completion, an average of 1 week
Registration of the surface of the dynamic footprint at 92% of the total duration, measured in square centimeters (cm2)
Surface after Laser non-emission in right foot at Global of time of first step
Time frame: Through study completion, an average of 1 week
Registration of the surface of the global dynamic footprint of the total duration, measured in square centimeters (cm2)
Surface after Laser non-emission in left foot at 20% of time of first step
Time frame: Through study completion, an average of 1 week
Registration of the surface of the dynamic footprint at 20% of the total duration, measured in square centimeters (cm2)
Surface after Laser non-emission in left foot at 35% of time of first step
Time frame: Through study completion, an average of 1 week
Registration of the surface of the dynamic footprint at 35% of the total duration, measured in square centimeters (cm2).
Surface after Laser non-emission in left foot at 92% of time of first step
Time frame: Through study completion, an average of 1 week
Registration of the surface of the dynamic footprint at 92% of the total duration, measured in square centimeters (cm2)
Surface after Laser non-emission in left foot at Global of time of first step
Time frame: Through study completion, an average of 1 week
Registration of the surface of the global dynamic footprint of the total duration, measured in square centimeters (cm2)
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 5 Jun 2023.
- Individual participant dataSharing planned: No
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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.
Eva María MartínezJiménez principal investigator
Mayuben Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral dry needling in latent trigger points of the Flexor digitorum Brevis Muscle and Bilateral non emission Laser in latent trigger points of the Flexor digitorum Brevis Muscle in people with Flatfoot, run by Mayuben Private Clinic 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 1 inclusion and 4 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 5 Jun 2023. 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?
Surface before dry needling in right foot at 20% of time of first step (time frame: Through study completion, an average of 1 week). The study lists 32 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jun 2023.