NCT03506464

Brief Summary

Background: Plantar fasciitis is the most common cause of heel pain in runners. No studies have described the short-term effects of myofascial release on plantar fasciitis using ultrasound. Objectives: To describe the immediate sonoelastographic changes in the plantar fascia of amateur runners with fasciitis after applying a myofascial release technique. Design: A single-centre, experimental and controlled study. Method: Patients with plantar fasciitis and a group of healthy subjects will be examined using B-mode and real time sonoelastography scanning. Fascia thickness, echointensity and echovariation of the color histogram will be analyzed pre- and post intervention. A two-way (Group × Time) repeated measures ANOVA will be performed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2018

Shorter than P25 for not_applicable

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

February 19, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 24, 2018

Completed
8 days until next milestone

Study Start

First participant enrolled

May 2, 2018

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2018

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2018

Completed
Last Updated

June 21, 2018

Status Verified

June 1, 2018

Enrollment Period

28 days

First QC Date

February 19, 2018

Last Update Submit

June 19, 2018

Conditions

Keywords

Plantar Fasciitisphysical therapysonoelastography

Outcome Measures

Primary Outcomes (3)

  • Changes in thickness of the plantar fascia

    Measured from the anterior edge of the inferior calcaneal border vertically to the inferior border of the plantar fascia

    Measured twice. pre and post treatment. Post treatment examination will be carried out 10 minutes after the intervention concludes.

  • Changes in echointensity

    The EI of the color histogram computed the mean value of intensity of red, green and blue channels (color intensity range, 0-255) within a given area

    Measured twice. pre and post treatment. Post treatment examination will be carried out 10 minutes after the intervention concludes.

  • Changes in Echovariation

    Determined as the relation between standard deviation and mean of pixel intensity obtained from the histogram

    Measured twice. pre and post treatment. Post treatment examination will be carried out 10 minutes after the intervention concludes.

Study Arms (2)

plantar fasciitis group

EXPERIMENTAL

Myofascial release technique

Procedure: Myofascial Release Technique

control group

NO INTERVENTION

None of the control group received the treatment

Interventions

The same described in the arm description

plantar fasciitis group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • heel pain at the proximal fascia insertion
  • worse pain when waking up in the morning or after a period of rest
  • a visual analog score (VAS) of more than 4 on a scale of 10

You may not qualify if:

  • Patients who had undergone surgery or steroid injections to the heel will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

María Elena del Baño Aledo

Murcia, 30107, Spain

Location

MeSH Terms

Conditions

Fasciitis, Plantar

Interventions

Myofascial Release Therapy

Condition Hierarchy (Ancestors)

FasciitisMusculoskeletal DiseasesFoot Diseases

Intervention Hierarchy (Ancestors)

MassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Maria Elena del Baño-Aledo, Dr

    Universidad de Murcia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 19, 2018

First Posted

April 24, 2018

Study Start

May 2, 2018

Primary Completion

May 30, 2018

Study Completion

June 16, 2018

Last Updated

June 21, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations