NCT06499441

Brief Summary

The aim of the study is to test the effect of myofascial induction and pre-pressure release of the grastrocnemius muscle on the proximal musculature: biceps femoris, flexor digitorum brevis and extensor digitorum grandus on the pain pre-pressure threshold variable and range of motion of ankle with knee bend and flexed

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 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
10 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
10 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

2 days

First QC Date

July 7, 2024

Last Update Submit

August 3, 2024

Conditions

Keywords

Fasciamyofascial trigger pointlower limb

Outcome Measures

Primary Outcomes (10)

  • 1.Threshold of pain on pressure on biceps femoris before.

    The pressure at which the patient starts to feel pain with pressure is measured 3 times with an algometer. It is measured in newtons

    Immediately before the intervention.

  • 2.Pain threshold to pressure in the extensor digitorum longus muscle before.

    The pressure at which the patient starts to feel pain with pressure is measured 3 times with an algometer. It is measured in newtons

    Immediately before the intervention.

  • 3.Pain threshold to pressure on flexor digitorum brevis muscle before.

    The pressure at which the patient starts to feel pain with pressure is measured 3 times with an algometer. It is measured in newtons

    Immediately before the intervention.

  • 4.Pain threshold on biceps femoris pressure after.

    The pressure at which the patient starts to feel pain with pressure is measured 3 times with an algometer. It is measured in newtons

    Immediately before the intervention.

  • 5.Pain threshold to pressure in the extensor digitorum longus muscle after.

    The pressure at which the patient starts to feel pain with pressure is measured 3 times with an algometer. It is measured in newtons

    Immediately before the intervention.

  • 6.Pain threshold on pressure in the flexor digitorum brevis muscle tras.

    The pressure at which the patient starts to feel pain with pressure is measured 3 times with an algometer. It is measured in newtons

    Immediately before the intervention.

  • 7. Ankle range of motion with knee extended before intervention

    The joint amplitude is measured in dorsiflexion of the ankle joint with the knee extended under load and is measured with an inclinometer in degrees. measured in degrees.

    Immediately before the intervention.

  • 8. Ankle range of motion with knee flexed before intervention

    The joint amplitude is measured in dorsiflexion of the ankle joint with the knee flexed under load and is measured with an inclinometer in degrees. measured in degrees.

    Immediately before the intervention.

  • 9. Ankle range of motion with knee extended after intervention

    The joint amplitude is measured in dorsiflexion of the ankle joint with the knee extended under load and is measured with an inclinometer in degrees. measured in degrees.

    Immediately after the intervention.

  • 10. Ankle range of motion with knee flexed after intervention

    The joint amplitude is measured in dorsiflexion of the ankle joint with the knee flexed under load and is measured with an inclinometer in degrees. measured in degrees.

    Immediately after the intervention.

Study Arms (2)

Myofascial induction in the gastrocnemius muscle

EXPERIMENTAL

A 3-pass shallow leg gliding technique was applied first, followed by 5 minutes of the deep myofascial calf induction technique described by Pilat.

Other: Myofascial induction in gastrocnemius

Preassure release in gastrocnemius muscle

ACTIVE COMPARATOR

Also called ischaemic pressure. Three cycles of pressure are applied to the trigger point of the gastrocnemius muscle until the pain disappears on pressure.

Other: Preassure release

Interventions

A 3-pass shallow leg gliding technique was applied first, followed by 5 minutes of the deep myofascial calf induction technique described by Pilat.

Myofascial induction in the gastrocnemius muscle

Also called ischaemic pressure. Three cycles of pressure are applied to the trigger point of the gastrocnemius muscle until the pain disappears on pressure.

Preassure release in gastrocnemius muscle

Eligibility Criteria

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

You may qualify if:

  • Subjects from 18 to 39 years old.
  • Healthy subjects with trigger point 1 of the gastrocnemius muscle in both lower limbs

You may not qualify if:

  • Diagnosis of lower limb injury, including any tendinopathy, bursitis, ligamentous involvement, and/or fasciitis
  • History of lower limb surgery or history of lower-extremity injury with residual symptoms (pain or feeling of sensations) within the last year.
  • Participants could not have undergone ankle stretching or any other treatment.
  • Diabetes due to possible alteration of arterial distal circulation.
  • Foot deformity, cavus, and flat feet.
  • Foot deformities, such as hammer toes and hallux valgus,
  • Plantar corns and calluses.
  • Lower limb dysfunction or chronic injury.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayuben Clinic

San Sebastián de los Reyes, Madrid, 28702, Spain

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
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 22, 2024

Primary Completion

July 24, 2024

Study Completion

August 3, 2024

Last Updated

August 6, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations