NCT06499545

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 12, 2024

Completed
12 days until next milestone

Study Start

First participant enrolled

July 24, 2024

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2024

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 3, 2024

Completed
Last Updated

August 6, 2024

Status Verified

August 1, 2024

Enrollment Period

4 days

First QC Date

July 7, 2024

Last Update Submit

August 3, 2024

Conditions

Outcome Measures

Primary Outcomes (8)

  • 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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    Through study completion, an average of 2 days

Study Arms (2)

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.

Other: Pressure release

Non-emision Laser

SHAM COMPARATOR

Application of a non-emitting laser for 5 minutes.

Other: Non emision Laser

Interventions

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

Pressure release

Non emision laser in Flexor digitorum brevis latent trigger point

Non-emision Laser

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayuben Clinic

San Sebastián de los Reyes, Madrid, 28702, Spain

Location

MeSH Terms

Conditions

Myofascial Pain SyndromesFlatfoot

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesTalipesFoot Deformities, AcquiredFoot DeformitiesFoot Deformities, CongenitalLower Extremity Deformities, CongenitalLimb Deformities, CongenitalMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Eva María Martínez-Jiménez, PhD

    Universidad Complutense de Madrid

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist responsible area

Study Record Dates

First Submitted

July 7, 2024

First Posted

July 12, 2024

Study Start

July 24, 2024

Primary Completion

July 28, 2024

Study Completion

August 3, 2024

Last Updated

August 6, 2024

Record last verified: 2024-08

Locations