Foot DiseasesNCT03997955
Myofascial Induction Effects on Plantar Pressures and Stabilometry
A study testing Myofascial induction in people with Foot Diseases and Myofascial Pain, run by Universidad de León at 1 site in Spain.
Trial summary
The objective is to determine the effectiveness of myofascial Induction effects on plantar pressures and stabilometry variables. Forty healthy subjects (28 females and 12 males) will be recruited for a simple blind clinical trial. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Foot Diseases, Myofascial Pain
- What is being tested?
- Myofascial induction
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 25 Jun 2019to 10 Sep 2019
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy individuals without pain.
Who cannot join
- Previous lower extremities surgery
- History of lower extremities injury with residual symptoms within the last year
- Evidence of a leg-length discrepancy of more than 1 cm
- Evidence of balance deficits
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Myofascial Induction Effects on Plantar Pressures and Stabilometry Variables. A Clinical Trial
The objective is to determine the effectiveness of myofascial Induction effects on plantar pressures and stabilometry variables. Forty healthy subjects (28 females and 12 males) will be recruited for a simple blind clinical trial. All subjects will be randomly distributed in two different groups: control group (sham treatment of myofascial Induction) and experimental group (myofascial Induction). Outcome measurements will be foot plantar pressure area (footprint) and center of pressure area (stabilometry) by the Balance Evaluation Systems test. Two trials will be recorded for each condition.
- Conditions
- Foot Diseases, Myofascial Pain
- Being tested
- Myofascial induction, Sham myofascial induction
- Medical subject headings
- Foot Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myofascial inductionOther
Myofascial induction in plantar fascia
Sham myofascial inductionOther
Sham myofascial induction in plantar fascia
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Myofascial induction Receives: Other: Myofascial induction |
| Control group | Sham comparator | Sham myofascial induction Receives: Other: Sham myofascial induction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Foot plantar pressure area
Foot plantar pressure area measured by the Balance Evaluation Systems test (squared centimeters)
Measured: Change from foot plantar pressure area at 2 minutes
Secondary outcomes (1)
Center of pressure area
Center of pressure area measured by the Balance Evaluation Systems test (squared centimeters)
Measured: Change from center of pressure area at 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2019
- Study start25 Jun 2019
- Primary completion5 Sep 2019
- Study completion10 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Foot DiseasesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de León
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, César Calvo Lobo, Universidad de León
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03997955
- Sponsor's protocol ID
- Myofascial-Induction_CT
- Status last verified
- Sep 2019
- First submitted
- 23 Jun 2019
- Last updated
- 11 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Martinez-Jimenez EM, Becerro-de-Bengoa-Vallejo R, Losa-Iglesias ME, Diaz-Velazquez JI, Palomo-Lopez P, Rodriguez-Sanz D, Calvo-Lobo C, Lopez-Lopez D. Pressure and Traction Technique Improves Postural Control More Than Tactile Stimulation in Foot Plantar Fascia: A Randomized Single-Blind Trial. Arch Phys Med Rehabil. 2020 Jun;101(6):978-984. doi: 10.1016/j.apmr.2020.01.017. Epub 2020 Feb 28.
PubMed 32113972
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myofascial Induction Effects on Plantar Pressures and Stabilometry Variables. A Clinical Trial
- ClinicalTrials.gov ID
- NCT03997955
- Acronym / sponsor ID
- Myofascial-Induction_CT
- Conditions
- Foot Diseases, Myofascial Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universidad de LeónUniversity, hospital or other
- Study start
- 25 Jun 2019 (actual)
- Primary completion
- 5 Sep 2019 (actual)
- Study completion
- 10 Sep 2019 (actual)
- First posted
- 25 Jun 2019 (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.
The objective is to determine the effectiveness of myofascial Induction effects on plantar pressures and stabilometry variables. Forty healthy subjects (28 females and 12 males) will be recruited for a simple blind clinical trial. All subjects will be randomly distributed in two different groups: control group (sham treatment of myofascial Induction) and experimental group (myofascial Induction). Outcome measurements will be foot plantar pressure area (footprint) and center of pressure area (stabilometry) by the Balance Evaluation Systems test. Two trials will be recorded for each condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Myofascial inductionMyofascial induction |
| Control group | Sham comparator | Other: Sham myofascial inductionSham myofascial induction |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy individuals without pain.
Key exclusion criteria (4 listed)
- Previous lower extremities surgery
- History of lower extremities injury with residual symptoms within the last year
- Evidence of a leg-length discrepancy of more than 1 cm
- Evidence of balance deficits
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 inductionMyofascial induction in plantar fascia | Other | Experimental group |
| Sham myofascial inductionSham myofascial induction in plantar fascia | Other | Control group |
Primary outcome
Foot plantar pressure area
Time frame: Change from foot plantar pressure area at 2 minutes
Foot plantar pressure area measured by the Balance Evaluation Systems test (squared centimeters)
1 secondary outcome
Center of pressure area
Time frame: Change from center of pressure area at 2 minutes
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 11 Sep 2019.
- Derived from this study: PubMed 32113972Martinez-Jimenez EM, Becerro-de-Bengoa-Vallejo R, Losa-Iglesias ME, Diaz-Velazquez JI, Palomo-Lopez P, Rodriguez-Sanz D, Calvo-Lobo C, Lopez-Lopez D. Pressure and Traction Technique Improves Postural Control More Than Tactile Stimulation in Foot Plantar Fascia: A Randomized Single-Blind Trial. Arch Phys Med Rehabil. 2020 Jun;101(6):978-984. doi: 10.1016/j.apmr.2020.01.017. Epub 2020 Feb 28.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 induction in people with Foot Diseases and Myofascial Pain, run by Universidad de León 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 1 inclusion and 4 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 11 Sep 2019. 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. Some participants in this study may receive a placebo. 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?
Foot plantar pressure area (time frame: Change from foot plantar pressure area at 2 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03997955, which also lists 1 linked publication.
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 11 Sep 2019.