- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03506464
Myofascial Release in Patients With Plantar Fasciitis
Short-term Effects of a Myofascial Release on Elasticity in Patients With Plantar Fasciitis: A Pre-post Evaluation With Sonoelastography
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
-
Murcia, Spain, 30107
- María Elena del Baño Aledo
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: plantar fasciitis group
Myofascial release technique
|
The same described in the arm description
|
|
No Intervention: control group
None of the control group received the treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Measured twice. pre and post treatment. Post treatment examination will be carried out 10 minutes after the intervention concludes.
|
|
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
|
Measured twice. pre and post treatment. Post treatment examination will be carried out 10 minutes after the intervention concludes.
|
|
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
|
Measured twice. pre and post treatment. Post treatment examination will be carried out 10 minutes after the intervention concludes.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Maria Elena del Baño-Aledo, Dr, Universidad de Murcia
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Sono2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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