Manual TherapyNCT06499545
Plantar Pressures After Pressure Release of the Flexor Digitorum Brevis Muscle Versus a Non-emission Laser.
A study testing Pressure release and Non emision Laser in people with Manual Therapy and Myofascial Pain Syndrome, run by Mayuben Private Clinic at 1 site in Spain.
Trial summary
In this study we will test the effects of pressure release on the Flexor digitorum brevis muscle on the plantar pressures variables using a pressure platform. Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Manual Therapy, Myofascial Pain Syndrome, Foot
- What is being tested?
- Pressure release and Non emision Laser
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteSpain
- Study dates
- 24 Jul 2024to 3 Aug 2024
- 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 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants who came to the clinic presenting with pain in both heels and who were diagnosed with active or latent myofascial trigger point in bilateral flexor digitorum brevis muscles.
- Myofascila trigger points of flexor digitorum brevis were the only ones diagnosed in the foot.
- All participants with normal body mass, without obesity.
Who cannot join
- Diagnosis of lower limb injury, such as plantar fasciitis, tendinopathy, bursitis, ligamentous injuries.
- History of previous lower limb surgery.
- Participants will not be subjected to ankle stretching or any other treatment.
- Diabetes due to possible elevation of plantar pressure.
- Toe deformities such as hammertoes and hallux valgus due to possible alteration of plantar pressure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Plantar Pressures After Pressure Release of the Flexor Digitorum Brevis Muscle Versus a Non-emission Laser: Clinical Trial.
In this study we will test the effects of pressure release on the Flexor digitorum brevis muscle on the plantar pressures variables using a pressure platform.
- Conditions
- Manual Therapy, Myofascial Pain Syndrome, Foot, Flat Foot
- Being tested
- Pressure release, Non emision Laser
- Medical subject headings
- Myofascial Pain Syndromes, Flatfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pressure releaseOther
Release of pre-pressure at the latent trigger point of flexor digitorum brevis
Non emision LaserOther
Non emision laser in Flexor digitorum brevis latent trigger point
| Study group | Role | What they receive |
|---|---|---|
| Pressure release | Experimental | Application of pressure release as a trigger point treatment of the flexor digitorum brevis muscle. Performing 3 pressure cycles until the disappearance of the referred pain for a minimum of 90 seconds. Receives: Other: Pressure release |
| Non-emision Laser | Sham comparator | Application of a non-emitting laser for 5 minutes. Receives: Other: Non emision Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variables of plantar pressures with platform before non-emission laser
For 30 seconds we will record the plantar pressure variables in grams per square centimetre.
Measured: Through study completion, an average of 2 days
Variables of plantar pressures with platform before pressure release
For 30 seconds we will record the plantar pressure variables in grams per square centimetre.
Measured: Through study completion, an average of 2 days
Variable footprint planting surface with platform before non-emission laser
For 30 seconds we will record the area of the footprint in square centimetres.
Measured: Through study completion, an average of 2 days
Variable footprint plantar surface with platform before pressure release
For 30 seconds we will record the plantar pressure variables in grams per square centimetre.
Measured: Through study completion, an average of 2 days
Variables of plantar pressures with platform after non-emission laser
For 30 seconds we will record the plantar pressure variables in grams per square centimetre.
Measured: Through study completion, an average of 2 days
Variables of plantar pressures with platform after preassure release
For 30 seconds we will record the plantar pressure variables in grams per square centimetre.
Measured: Through study completion, an average of 2 days
Variable footprint planting surface with platform after non-emission laser
For 30 seconds we will record the area of the footprint in square centimetres.
Measured: Through study completion, an average of 2 days
Variable footprint planting surface with platform after pressure release
For 30 seconds we will record the area of the footprint in square centimetres.
Measured: Through study completion, an average of 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start24 Jul 2024
- Primary completion28 Jul 2024
- Study completion3 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Manual TherapyStudies 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
- Other
- 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 Martínez-Jiménez, PhD, Principal investigator, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06499545
- Sponsor's protocol ID
- 1912202200923 B
- Status last verified
- Aug 2024
- First submitted
- 7 Jul 2024
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plantar Pressures After Pressure Release of the Flexor Digitorum Brevis Muscle Versus a Non-emission Laser: Clinical Trial.
- ClinicalTrials.gov ID
- NCT06499545
- Acronym / sponsor ID
- 1912202200923 B
- Conditions
- Manual Therapy, Myofascial Pain Syndrome, Foot, Flat Foot
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Mayuben Private ClinicUniversity, hospital or other
- Study start
- 24 Jul 2024 (actual)
- Primary completion
- 28 Jul 2024 (actual)
- Study completion
- 3 Aug 2024 (actual)
- First posted
- 12 Jul 2024 (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.
In this study we will test the effects of pressure release on the Flexor digitorum brevis muscle on the plantar pressures variables using a pressure platform.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pressure release | Experimental | Other: Pressure releaseApplication of pressure release as a trigger point treatment of the flexor digitorum brevis muscle. Performing 3 pressure cycles until the disappearance of the referred pain for a minimum of 90 seconds. |
| Non-emision Laser | Sham comparator | Other: Non emision LaserApplication of a non-emitting laser for 5 minutes. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Participants who came to the clinic presenting with pain in both heels and who were diagnosed with active or latent myofascial trigger point in bilateral flexor digitorum brevis muscles.
- Myofascila trigger points of flexor digitorum brevis were the only ones diagnosed in the foot.
- All participants with normal body mass, without obesity.
Key exclusion criteria (5 listed)
- Diagnosis of lower limb injury, such as plantar fasciitis, tendinopathy, bursitis, ligamentous injuries.
- History of previous lower limb surgery.
- Participants will not be subjected to ankle stretching or any other treatment.
- Diabetes due to possible elevation of plantar pressure.
- Toe deformities such as hammertoes and hallux valgus due to possible alteration of plantar pressure.
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 |
|---|---|---|
| Pressure releaseRelease of pre-pressure at the latent trigger point of flexor digitorum brevis | Other | Pressure release |
| Non emision LaserNon emision laser in Flexor digitorum brevis latent trigger point | Other | Non-emision Laser |
Primary outcome
Variables of plantar pressures with platform before non-emission laser
Time frame: Through study completion, an average of 2 days
For 30 seconds we will record the plantar pressure variables in grams per square centimetre.
Variables of plantar pressures with platform before pressure release
Time frame: Through study completion, an average of 2 days
For 30 seconds we will record the plantar pressure variables in grams per square centimetre.
Variable footprint planting surface with platform before non-emission laser
Time frame: Through study completion, an average of 2 days
For 30 seconds we will record the area of the footprint in square centimetres.
Variable footprint plantar surface with platform before pressure release
Time frame: Through study completion, an average of 2 days
For 30 seconds we will record the plantar pressure variables in grams per square centimetre.
Variables of plantar pressures with platform after non-emission laser
Time frame: Through study completion, an average of 2 days
For 30 seconds we will record the plantar pressure variables in grams per square centimetre.
Variables of plantar pressures with platform after preassure release
Time frame: Through study completion, an average of 2 days
For 30 seconds we will record the plantar pressure variables in grams per square centimetre.
Variable footprint planting surface with platform after non-emission laser
Time frame: Through study completion, an average of 2 days
For 30 seconds we will record the area of the footprint in square centimetres.
Variable footprint planting surface with platform after pressure release
Time frame: Through study completion, an average of 2 days
For 30 seconds we will record the area of the footprint in square centimetres.
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 6 Aug 2024.
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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 Martínez-Jiménez, PhD principal investigator
Universidad Complutense de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pressure release and Non emision Laser in people with Manual Therapy and Myofascial Pain Syndrome, 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 3 inclusion and 5 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 6 Aug 2024. 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?
Variables of plantar pressures with platform before non-emission laser (time frame: Through study completion, an average of 2 days). The study lists 8 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 6 Aug 2024.