Clinical trial NCT03506464: 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
Overall status: COMPLETED
Phase: NA
Conditions: Plantar Fasciitis
Keywords: Plantar Fasciitis
physical therapy
sonoelastography
Lead sponsor: Universidad de Murcia
Sponsor class: OTHER
First posted: 2018-04-24
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Changes in thickness of the plantar fascia
timeFrame: Measured twice. pre and post treatment. Post treatment examination will be carried out 10 minutes after the intervention concludes.
measure: Changes in echointensity
timeFrame: Measured twice. pre and post treatment. Post treatment examination will be carried out 10 minutes after the intervention concludes.
measure: Changes in Echovariation
timeFrame: Measured twice. pre and post treatment. Post treatment examination will be carried out 10 minutes after the intervention concludes.
Secondary outcomes:
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: María Elena del Baño Aledo
Study officials:
affiliation: Universidad de Murcia
name: Maria Elena del Baño-Aledo, Dr
role: PRINCIPAL_INVESTIGATOR
References: