Myofascial Release in Patients With Plantar Fasciitis

Plantar Fasciitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03506464
• Other study ID #: Sono2018
• Status: Completed
• Phase: N/A
• Start date: May 2, 2018
• Est. completion date: June 16, 2018

Study information

• Verified date: June 2018
• Source: Universidad de Murcia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: June 16, 2018
• Est. primary completion date: May 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Plantar
• Plantar Fasciitis

Intervention

Procedure:
• Myofascial Release Technique
The same described in the arm description

Locations

Country	Name	City	State
Spain	María Elena del Baño Aledo	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Murcia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.