Myofascial Pain SyndromeNCT04628312
Foot Plantar Pressure Changes After Plantar Dry Needling
A study testing Static footprint in people with Myofascial Pain Syndrome and Foot Diseases, run by Mayuben Private Clinic at 1 site in Spain.
Trial summary
The aim of this clinical trial is to check the effects of dry needling in the Flexor digitorum Brevis. Twenty healthy subjects wil be recruited for a quasi-experimental study. Participants will be from 18 to 40 years old, not obese. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Myofascial Pain Syndrome, Foot Diseases
- What is being tested?
- Static footprint
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSpain
- Study dates
- 20 Nov 2020to 2 Dec 2020
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Flat foot grade II or II with
- Must have latent trigger point in Flexor Brevis Digitorum muscles
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Standing Plantar Pressure Changes After Plantar Dry Needling in Flexor Digitorum Brevis
The aim of this clinical trial is to check the effects of dry needling in the Flexor digitorum Brevis.
Twenty healthy subjects wil be recruited for a quasi-experimental study. Participants will be from 18 to 40 years old, not obese. Participants will be measured before and after bilateral dry neddling in Flexor digitorum Brevis. The investigators will measure static footprint variables. The footprint variables will be divided in bilateral rear foot, bilateral midfoot, bilateral fore foot.
- Conditions
- Myofascial Pain Syndrome, Foot Diseases
- Being tested
- Static footprint
- Medical subject headings
- Myofascial Pain Syndromes, Foot Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Static footprintOther
The static footprint will measure the plantar pressures and surface area of the back of the foot, midfoot and forefoot. Subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned 30 degrees from the midline.
| Study group | Role | What they receive |
|---|---|---|
| Bilateral dry needling in Flexor Brevis Digitorum in subjects with latent trigger point | Experimental | Bilateral dry needling in Flexor Brevis Digitorum in subjects with latent trigger point Receives: Other: Static footprint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variables of plantar pressures with platform before dry puncture
During 30 seconds we will record the plantar pressure variables in grams per square centimeter.
Measured: Through study completion, an average of 1 week
Variable footprint plantar surface with platform before dry puncture
For 30 seconds we will record the area of the footprint in square centimeters.
Measured: Through study completion, an average of 1 week
Variables of plantar pressures with platform after dry puncture
During 30 seconds we will record the plantar pressure variables in grams per square centimeter.
Measured: Through study completion, an average of 1 week
Variable footprint plantar surface with platform after dry puncture
For 30 seconds we will record the area of the footprint in square centimeters.
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 posted13 Nov 2020
- Study start20 Nov 2020
- Primary completion27 Nov 2020
- Study completion2 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial Pain SyndromeStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04628312
- Sponsor's protocol ID
- 2706201911419 C
- Status last verified
- Nov 2020
- First submitted
- 7 Nov 2020
- Last updated
- 3 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standing Plantar Pressure Changes After Plantar Dry Needling in Flexor Digitorum Brevis
- ClinicalTrials.gov ID
- NCT04628312
- Acronym / sponsor ID
- 2706201911419 C
- Conditions
- Myofascial Pain Syndrome, Foot Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Mayuben Private ClinicUniversity, hospital or other
- Study start
- 20 Nov 2020 (actual)
- Primary completion
- 27 Nov 2020 (actual)
- Study completion
- 2 Dec 2020 (actual)
- First posted
- 13 Nov 2020 (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.
The aim of this clinical trial is to check the effects of dry needling in the Flexor digitorum Brevis.
Twenty healthy subjects wil be recruited for a quasi-experimental study. Participants will be from 18 to 40 years old, not obese. Participants will be measured before and after bilateral dry neddling in Flexor digitorum Brevis. The investigators will measure static footprint variables. The footprint variables will be divided in bilateral rear foot, bilateral midfoot, bilateral fore foot.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bilateral dry needling in Flexor Brevis Digitorum in subjects with latent trigger point | Experimental | Other: Static footprintBilateral dry needling in Flexor Brevis Digitorum in subjects with latent trigger point |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Flat foot grade II or II with
- Must have latent trigger point in Flexor Brevis Digitorum muscles
Key exclusion criteria (3 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
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 |
|---|---|---|
| Static footprintThe static footprint will measure the plantar pressures and surface area of the back of the foot, midfoot and forefoot. Subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned 30 degrees from the midline. | Other | Bilateral dry needling in Flexor Brevis Digitorum in subjects with latent trigger point |
Primary outcome
Variables of plantar pressures with platform before dry puncture
Time frame: Through study completion, an average of 1 week
During 30 seconds we will record the plantar pressure variables in grams per square centimeter.
Variable footprint plantar surface with platform before dry puncture
Time frame: Through study completion, an average of 1 week
For 30 seconds we will record the area of the footprint in square centimeters.
Variables of plantar pressures with platform after dry puncture
Time frame: Through study completion, an average of 1 week
During 30 seconds we will record the plantar pressure variables in grams per square centimeter.
Variable footprint plantar surface with platform after dry puncture
Time frame: Through study completion, an average of 1 week
For 30 seconds we will record the area of the footprint in square centimeters.
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 3 Dec 2020.
- Individual participant dataSharing planned: Undecided
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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 Static footprint in people with Myofascial Pain Syndrome and Foot Diseases, 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 2 inclusion and 3 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 3 Dec 2020. 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. 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?
Variables of plantar pressures with platform before dry puncture (time frame: Through study completion, an average of 1 week). The study lists 4 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 3 Dec 2020.