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OpenTrials
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NCT Number: NCT03506464

Myofascial Release in Patients With Plantar Fasciitis

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.

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Key information

Conditions

Plantar Fasciitis Fasciitis Fasciitis, Plantar Foot Diseases Musculoskeletal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

María Elena del Baño Aledo

Murcia, 30107, Spain

About this study

Participants

Subjects of the plantar fasciitis group (PFG) will be recruited in May2018 to apply to them a myofascial release technique.

Healthy volunteers without a history of plantar fascia disease will be recruited as control group (CG).

The examination will be included B-mode scanning and real time sonoelastography using an US scanner with linear array transducer (ML6-15). All examinations will be conducted by a sonographer with more than 10 years' experience in musculoskeletal imaging.

Using a standardized protocol three images of every pre-post intervention video will be stored uncompressed and with no losses in bitmap format (bmp), and the mean value of the histogram components will be used for statistical analysis. The examination protocol shows good reliability, and has been reported previously.

ImageJ 1.45 software will be used to perform quantitative analysis of gray-scale images and the color histogram of the elastogram.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Myofascial release technique

Procedure

The same described in the arm description

Primary outcomes

  1. Changes in thickness of the plantar fascia

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

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

  2. Changes in echointensity

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

    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

  3. Changes in Echovariation

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

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

Sponsors and collaborators

Lead sponsor

Universidad de Murcia

Other

Registry information

Official study title

Short-term Effects of a Myofascial Release on Elasticity in Patients With Plantar Fasciitis: A Pre-post Evaluation With Sonoelastography

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 24, 2018
Registry last updated
Jun 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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