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Myofascial Release in Patients With Plantar Fasciitis

Primary Purpose

Plantar Fasciitis

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Myofascial Release Technique
Sponsored by
Universidad de Murcia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plantar Fasciitis focused on measuring Plantar Fasciitis, physical therapy, sonoelastography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • María Elena del Baño Aledo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

plantar fasciitis group

control group

Arm Description

Myofascial release technique

None of the control group received the treatment

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 19, 2018
Last Updated
June 19, 2018
Sponsor
Universidad de Murcia
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1. Study Identification

Unique Protocol Identification Number
NCT03506464
Brief Title
Myofascial Release in Patients With Plantar Fasciitis
Official Title
Short-term Effects of a Myofascial Release on Elasticity in Patients With Plantar Fasciitis: A Pre-post Evaluation With Sonoelastography
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
May 2, 2018 (Actual)
Primary Completion Date
May 30, 2018 (Actual)
Study Completion Date
June 16, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Murcia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plantar Fasciitis
Keywords
Plantar Fasciitis, physical therapy, sonoelastography

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
plantar fasciitis group
Arm Type
Experimental
Arm Description
Myofascial release technique
Arm Title
control group
Arm Type
No Intervention
Arm Description
None of the control group received the treatment
Intervention Type
Procedure
Intervention Name(s)
Myofascial Release Technique
Intervention Description
The same described in the arm description
Primary Outcome Measure Information:
Title
Changes in thickness of the plantar fascia
Description
Measured from the anterior edge of the inferior calcaneal border vertically to the inferior border 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.
Title
Changes in echointensity
Description
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
Time Frame
Measured twice. pre and post treatment. Post treatment examination will be carried out 10 minutes after the intervention concludes.
Title
Changes in Echovariation
Description
Determined as the relation between standard deviation and mean of pixel intensity obtained from the histogram
Time Frame
Measured twice. pre and post treatment. Post treatment examination will be carried out 10 minutes after the intervention concludes.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Elena del Baño-Aledo, Dr
Organizational Affiliation
Universidad de Murcia
Official's Role
Principal Investigator
Facility Information:
Facility Name
María Elena del Baño Aledo
City
Murcia
ZIP/Postal Code
30107
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Myofascial Release in Patients With Plantar Fasciitis

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