NCT06509347

Brief Summary

In this study we will test the effects of pressure release on the Flexor digitorum brevis muscle on stabilometric variables that support static equilibrium.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 19, 2024

Completed
3 days until next milestone

Study Start

First participant enrolled

July 22, 2024

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 24, 2024

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2024

Completed
Last Updated

July 30, 2024

Status Verified

July 1, 2024

Enrollment Period

2 days

First QC Date

July 7, 2024

Last Update Submit

July 28, 2024

Conditions

Keywords

balancemyofascial trigger pointfoot

Outcome Measures

Primary Outcomes (20)

  • 1.Stabilometric variable x displacement open eyes before pressure release.

    Stabilometry assessment was used and 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 at 30º away from the midline. Stabilometry variables measure displacement of the center of pressures in X (in millimeters) with open eyes.

    Through study completion, an average of 1 week.

  • 2.Stabilometric variable x displacement open eyes before non emission Laser

    Stabilometry assessment was used and 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 at 30º away from the midline. Stabilometric variables measure displacement of the center of pressures in Y (in millimeters) with open eyes.

    Through study completion, an average of 1 week.

  • 3.Stabilometric variable center of pressure area open eyes before pressure release.

    Stabilometric assessment was used and 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 at 30º away from the midline. Stabilometric variables measure displacement of the center of Pressure (COP) area (in millimeters²) with eyes open.

    Through study completion, an average of 1 week.

  • 4.Stabilometric variable center of pressure area open eyes before non emission laser.

    Stabilometric assessment was used and 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 at 30º away from the midline. Stabilometric variables measure displacement of the center of Pressure (COP) area (in millimeters²) with eyes open.

    Through study completion, an average of 1 week.

  • 5.Stabilometric variable center of pressure speed displacement of the anteroposterior(a-p) direction open eyes before pressure release.

    Stabilometric assessment was used and 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 at 30º away from the midline. Stabilometric variables measure center of pressure speed displacement of the anteroposterior(a-p) direction (in millimeters/second).

    Through study completion, an average of 1 week.

  • 6.Stabilometric variable center of pressure speed displacement of the anteroposterior(a-p) direction open eyes before pressure non-emission Laser.

    Stabilometric assessment was used and 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 at 30º away from the midline. Stabilometric variables measure center of pressure speed displacement of the anteroposterior(a-p) direction (in millimeters/second).

    Through study completion, an average of 1 week.

  • 7.Stabilometric variable y displacement open eyes before pressure release

    Stabilometric assessment was used and 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 at 30º away from the midline. Stabilometric variables measure displacement of the center of pressures in Y (in millimeters) with open eyes.

    Through study completion, an average of 1 week.

  • 8.Stabilometric variable x displacement open eyes before non emission Laser

    Stabilometric assessment was used and 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 at 30º away from the midline. Stabilometry variables measure displacement of the center of pressures in Y (in millimeters) with open eyes.

    Through study completion, an average of 1 week.

  • 9.Stabilometric variable center of pressure speed displacement of the latero-lateral(lat-lat) direction open eyes before pressure release

    Stabilometric assessment was used and 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 at 30º away from the midline. Stabilometry variables measure center of pressure speed displacement of the latero-lateral(lat-lat) direction (in millimeters/second).

    Through study completion, an average of 1 week.

  • 10.Stabilometric variable center of pressure speed displacement of the latero-lateral(lat-lat) direction open eyes non emision Laser.

    Stabilometric assessment was used and 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 at 30º away from the midline. Stabilometry variables measure center of pressure speed displacement of the latero-lateral(lat-lat) direction (in millimeters/second).

    Through study completion, an average of 1 week.

  • 11.Stabilometric variable x displacement closed eyes before pressure release

    Stabilometric assessment was used and 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 at 30º away from the midline. Stabilometric variables measure displacement of the center of pressures in X (in millimeters) with closed eyes.

    Through study completion, an average of 1 week.

  • 12.Stabilometric variable x displacement closed eyes before non emission Laser

    Stabilometric assessment was used and 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 at 30º away from the midline. Stabilometric variables measure displacement of the center of pressures in X (in millimeters) with closed eyes.

    Through study completion, an average of 1 week.

  • 13.Stabilometric variable center of pressure area closed eyes before pressure release.

    Stabilometric assessment was used and 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 at 30º away from the midline. Stabilometric variables measure displacement of the center of Pressure (COP) area (in millimeters²) with closed eyes.

    Through study completion, an average of 1 week.

  • 14.Stabilometric variable center of pressure area closed eyes before non emission laser.

    Stabilometric assessment was used and 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 at 30º away from the midline. Stabilometric variables measure displacement of the center of Pressure (COP) area (in millimeters²) with closed eyes.

    Through study completion, an average of 1 week.

  • 15.5.Stabilometric variable center of pressure speed displacement of the anteroposterior(a-p) direction closed eyes before pressure release.

    Stabilometric assessment was used and 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 at 30º away from the midline. Stabilometric variables measure center of pressure speed displacement of the anteroposterior(a-p) direction (in millimeters/second).

    Through study completion, an average of 1 week.

  • .Stabilometric variable center of pressure speed displacement of the anteroposterior(a-p) direction closed eyes before pressure non-emission Laser.

    Stabilometric assessment was used and 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 at 30º away from the midline. Stabilometric variables measure center of pressure speed displacement of the anteroposterior(a-p) direction (in millimeters/second).

    Through study completion, an average of 1 week.

  • 17.Stabilometric variable y displacement closed eyes before pressure release

    Stabilometric assessment was used and 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 at 30º away from the midline. Stabilometric variables measure displacement of the center of pressures in Y (in millimeters) with closed eyes.

    Through study completion, an average of 1 week.

  • 18.Stabilometric variable x displacement closed eyes before non emission Laser

    Stabilometric assessment was used and 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 at 30º away from the midline. Stabilometric variables measure displacement of the center of pressures in Y (in millimeters) with closed eyes.

    Through study completion, an average of 1 week.

  • 9.Stabilometric variable center of pressure speed displacement of the latero-lateral(lat-lat) direction closed eyes before pressure release.

    Stabilometric assessment was used and 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 at 30º away from the midline. Stabilometric variables measure center of pressure speed displacement of the latero-lateral(lat-lat) direction (in millimeters/second).

    Through study completion, an average of 1 week.

  • 20. Stabilometric variable center of pressure speed displacement of the latero-lateral(lat-lat) direction closed eyes non emission Laser.

    Stabilometric assessment was used and 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 at 30º away from the midline. Stabilometric variables measure center of pressure speed displacement of the latero-lateral(lat-lat) direction (in millimeters/second).

    Through study completion, an average of 1 week.

Study Arms (2)

Pressure release

EXPERIMENTAL

Application of pressure on the trigger point of the flexor digitorum brevis until remission of referred pain for a minimum of 90 seconds, at least 3 cycles.

Other: Preassure release

Non-emision Laser

SHAM COMPARATOR

Application of a non-emitting laser for 5 minutes on the trigger point of the flexor digitorum brevis muscle.

Other: Non-emision laser

Interventions

Preassure release in Flexor digitorum brevis trigger point muscle.

Pressure release

Bilateral non emission Laser in latent trigger points of the Flexor digitorum Brevis Muscle

Non-emision Laser

Eligibility Criteria

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

You may qualify if:

  • Healthy individuals
  • Must have latent trigger point in Flexor Brevis Digitorum muscles with no other pathologies.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eva María Martínez-Jiménez In Mayuben CLinic

Madrid, 28702, Spain

Location

Related Publications (1)

  • Martinez-Jimenez EM, Becerro-de-Bengoa-Vallejo R, Losa-Iglesias ME, Perez-Boal E, Posada-Ordax J, Sanchez-Serena A, Trevisson-Redondo B, Benito-de-Pedro M, Martinez-Corcoles V, Casado-Hernandez I. Plantar pressures and stabilometry effects of ischemic compression in Flexor digitorum brevis muscle Myofascial Trigger Point: A prepost study. PLoS One. 2025 Aug 14;20(8):e0329734. doi: 10.1371/journal.pone.0329734. eCollection 2025.

MeSH Terms

Conditions

Myofascial Pain Syndromes

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Laser is a non-emission Laser
Purpose
TREATMENT
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 19, 2024

Study Start

July 22, 2024

Primary Completion

July 24, 2024

Study Completion

July 28, 2024

Last Updated

July 30, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations