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Myofascial Release in Patients With Plantar Fasciitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03506464
Recruitment Status : Completed
First Posted : April 24, 2018
Last Update Posted : June 21, 2018
Sponsor:
Information provided by (Responsible Party):
María Elena del Baño-Aledo, Universidad de Murcia

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.


Condition or disease Intervention/treatment Phase
Plantar Fasciitis Procedure: Myofascial Release Technique Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Short-term Effects of a Myofascial Release on Elasticity in Patients With Plantar Fasciitis: A Pre-post Evaluation With Sonoelastography
Actual Study Start Date : May 2, 2018
Actual Primary Completion Date : May 30, 2018
Actual Study Completion Date : June 16, 2018

Arm Intervention/treatment
Experimental: plantar fasciitis group
Myofascial release technique
Procedure: Myofascial Release Technique
The same described in the arm description

No Intervention: control group
None of the control group received the treatment



Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03506464


Locations
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Spain
María Elena del Baño Aledo
Murcia, Spain, 30107
Sponsors and Collaborators
Universidad de Murcia
Investigators
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Principal Investigator: Maria Elena del Baño-Aledo, Dr Universidad de Murcia
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Responsible Party: María Elena del Baño-Aledo, Principal Investigator, Universidad de Murcia
ClinicalTrials.gov Identifier: NCT03506464    
Other Study ID Numbers: Sono2018
First Posted: April 24, 2018    Key Record Dates
Last Update Posted: June 21, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by María Elena del Baño-Aledo, Universidad de Murcia:
Plantar Fasciitis
physical therapy
sonoelastography
Additional relevant MeSH terms:
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Fasciitis
Fasciitis, Plantar
Musculoskeletal Diseases
Foot Diseases