Plantar FasciitisNCT03506464
Myofascial Release in Patients With Plantar Fasciitis
A study testing Myofascial Release Technique in people with Plantar Fasciitis, run by Universidad de Murcia at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Plantar Fasciitis
- What is being tested?
- Myofascial Release Technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteSpain
- Study dates
- 2 May 2018to 16 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients who had undergone surgery or steroid injections to the heel will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Plantar Fasciitis
- Being tested
- Myofascial Release Technique
- Keywords
- Plantar Fasciitis, physical therapy, sonoelastography
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myofascial Release TechniqueProcedure or surgery
The same described in the arm description
| Study group | Role | What they receive |
|---|---|---|
| plantar fasciitis group | Experimental | Myofascial release technique Receives: Procedure: Myofascial Release Technique |
| control group | No intervention | None of the control group received the treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured twice. pre and post treatment. Post treatment examination will be carried out 10 minutes after the intervention concludes.
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: Measured twice. pre and post treatment. Post treatment examination will be carried out 10 minutes after the intervention concludes.
Changes in Echovariation
Determined as the relation between standard deviation and mean of pixel intensity obtained from the histogram
Measured: Measured twice. pre and post treatment. Post treatment examination will be carried out 10 minutes after the intervention concludes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2018
- Study start2 May 2018
- Primary completion30 May 2018
- Study completion16 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar FasciitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María Elena del Baño-Aledo, Universidad de Murcia
- Investigators
- Maria Elena del Baño-Aledo, Dr, Principal investigator, Universidad de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03506464
- Sponsor's protocol ID
- Sono2018
- Status last verified
- Jun 2018
- First submitted
- 19 Feb 2018
- Last updated
- 21 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Effects of a Myofascial Release on Elasticity in Patients With Plantar Fasciitis: A Pre-post Evaluation With Sonoelastography
- ClinicalTrials.gov ID
- NCT03506464
- Acronym / sponsor ID
- Sono2018
- Conditions
- Plantar Fasciitis
- Keywords
- Plantar Fasciitis, physical therapy, sonoelastography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Universidad de MurciaUniversity, hospital or other
- Study start
- 2 May 2018 (actual)
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 16 Jun 2018 (actual)
- First posted
- 24 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| plantar fasciitis group | Experimental | Procedure: Myofascial Release TechniqueMyofascial release technique |
| control group | No intervention | –None of the control group received the treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Patients who had undergone surgery or steroid injections to the heel will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Myofascial Release TechniqueThe same described in the arm description | Procedure or surgery | plantar fasciitis group |
Primary outcome
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2018.
- Individual participant dataSharing planned: No
Related trials for Plantar Fasciitis
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Active Release Technique vs. Dynamic Soft Tissue Mobilization for Plantar Pain
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Hip Muscle Strengthening and Calf Myofascial Release in Females With Chronic Plantar Fasciitis
Chronic Planter Fascitis
Recruiting
F-18 Sodium Fluoride PET/CT-Guided Pain Palliation in Chronic Plantar Fasciitis: A Comparative Study of ¹⁷⁷Lutetium-Corticosteroid-Local Anaesthetic Injection vs Corticosteroid-Local Anaesthetic Injection
Plantar Fascitis, Chronic Heel Pain
Not yet recruiting
Radial vs Focused Shockwave Therapy for Plantar Fasciitis
Plantar Fasciitis, Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Elena del Baño-Aledo, Dr principal investigator
Universidad de Murcia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myofascial Release Technique in people with Plantar Fasciitis, run by Universidad de Murcia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2018.