ClinicalTrials.gg
CompletedNCT06499545Updated Aug 6, 2024

Plantar Pressures After Pressure Release of the Flexor Digitorum Brevis Muscle Versus a Non-emission Laser.

An interventional study of Pressure release and Non emision Laser in Manual Therapy, Myofascial Pain Syndrome and Foot, sponsored by Mayuben Private Clinic. Completed at 1 site in Spain. Open to participants aged 18 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-06.

Sponsored by Mayuben Private Clinic · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years to 39 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Manual Therapy
  • Myofascial Pain Syndrome
  • Foot
  • Flat Foot
03

In context

Myofascial Pain Syndromes

1,142 studies on the registry are indexed under Myofascial Pain Syndromes; 137 are open to participants now.

This study's enrollment of 36 is below the median of 60 across 937 interventional studies indexed under Myofascial Pain Syndromes.

Browse Myofascial Pain Syndromes studies →

Lead sponsor

Mayuben Private Clinic is the lead sponsor of 22 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 39 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    Pressure release

    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.

    Other: Pressure release

  • Sham comparator
    Non-emision Laser

    Application of a non-emitting laser for 5 minutes.

    Other: Non emision Laser

Interventions

  • OtherPressure release

    Release of pre-pressure at the latent trigger point of flexor digitorum brevis

  • OtherNon emision Laser

    Non emision laser in Flexor digitorum brevis latent trigger point

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Through study completion, an average of 2 days

  2. Variables of plantar pressures with platform before pressure release

    For 30 seconds we will record the plantar pressure variables in grams per square centimetre.

    Time frame: Through study completion, an average of 2 days

  3. Variable footprint planting surface with platform before non-emission laser

    For 30 seconds we will record the area of the footprint in square centimetres.

    Time frame: Through study completion, an average of 2 days

  4. Variable footprint plantar surface with platform before pressure release

    For 30 seconds we will record the plantar pressure variables in grams per square centimetre.

    Time frame: Through study completion, an average of 2 days

  5. 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.

    Time frame: Through study completion, an average of 2 days

  6. Variables of plantar pressures with platform after preassure release

    For 30 seconds we will record the plantar pressure variables in grams per square centimetre.

    Time frame: Through study completion, an average of 2 days

  7. Variable footprint planting surface with platform after non-emission laser

    For 30 seconds we will record the area of the footprint in square centimetres.

    Time frame: Through study completion, an average of 2 days

  8. Variable footprint planting surface with platform after pressure release

    For 30 seconds we will record the area of the footprint in square centimetres.

    Time frame: Through study completion, an average of 2 days

07

Study locations

1 site
  • Mayuben Clinic
    San Sebastián de los Reyes, Madrid 28702, Spain
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2024 to primary completion in Jul 2024, 0 months.

Of 455 non-industry interventional studies with no phase under Myofascial Pain Syndromes, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 20. This study's 0 months is below that.

Counting every sponsor, half of 466 studies reached it within 9 months; a quarter within 3 and three quarters within 20.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 7, 2024
First posted
Jul 12, 2024
StartActual
Jul 24, 2024
Primary completionActual
Jul 28, 2024
CompletionActual
Aug 3, 2024
Last update
Aug 6, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 6, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06499545
Lead sponsor
Mayuben Private Clinic
Responsible party
EVA MARIA MARTÍNEZ JIMENEZ (Physiotherapist responsible area, Mayuben Private Clinic) — Principal investigator
First posted
Jul 12, 2024
Start date
Jul 24, 2024
Primary completion
Jul 28, 2024
Completion
Aug 3, 2024
Last update
Aug 6, 2024

Study contacts

Eva María Martínez-Jiménez, PhD
principal investigator · Universidad Complutense de Madrid

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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