Lumbopelvic Postpartum PainNCT03065270
Efficacy of Unstable Shoes for Instability and Lumbopelvic Pain
A study testing Use unstable shoes Masai Barefoot Technology (MBT) and Use conventional sport shoes in people with Lumbopelvic Postpartum Pain, run by Universidad Europea de Madrid.
Trial summary
During pregnancy, pregnant women adopt an atypical pattern position with the intention to maintain stability and balance.These postural changes can cause instability at the level of the sacroiliac joint with painful condition during pregnancy and postpartum. 40 % of women have postpartum lumbopelvic instability. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Lumbopelvic Postpartum Pain
- What is being tested?
- Use unstable shoes Masai Barefoot Technology (MBT) and Use conventional sport shoes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Sep 2011to May 2015
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Primparous women.
- Postpartum, between 8-12 weeks after the date of delivery.
- With lumbopelvic pain and positive diagnostic tests of sacroiliac pain
- Women with ambulation ability.
Who cannot join
- Presence of vaginal prolapses.
- Be receiving another treatment for the alteration that concerns us, pharmacological or any other type of therapy.
- Neuromuscular alterations.
About this study
Official title: Efficacy of Masai Barefoot Technology (MBT) for Decreasing Pain and Improvement of Lumbopelvic Pain
During pregnancy, pregnant women adopt an atypical pattern position with the intention to maintain stability and balance.These postural changes can cause instability at the level of the sacroiliac joint with painful condition during pregnancy and postpartum.
40 % of women have postpartum lumbopelvic instability. In 17 % of cases the lumbopelvic pain is perpetuated.
Read more
Another alteration influenced by the gestational status and progress of labor is urinary incontinence (UI).
The mechanism developed by Masai Barefoot Technology (MBT) provides an unstable base. Some studies reviewed, indicate that this shoe increases muscle activity, contributes to the decrease of joint overload and thereby, decreases pain.
Objective To compare the efficacy of shoes with unstable sole MBT®, over the use of conventional sports shoes, in primiparous women with lumbopelvic postpartum pain.
Material and Methods Randomized clinical trial. 24 postpartum women from the Gynecology Service of the Hospital Universitario Madrid Chiron were included in the study.
The subjects were randomly divided into experimental and control group.
- Conditions
- Lumbopelvic Postpartum Pain
- Being tested
- Use unstable shoes Masai Barefoot Technology (MBT), Use conventional sport shoes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use unstable shoes Masai Barefoot Technology (MBT)Other
Use of unstable shoes during 9 weeks, at least four hours per day.
Use conventional sport shoesOther
Use of conventional sport shoes during 9 weeks, at least four hours per day.
| Study group | Role | What they receive |
|---|---|---|
| A group | Experimental | Not described Receives: Other: Use unstable shoes Masai Barefoot Technology (MBT) |
| B group | Experimental | Not described Receives: Other: Use conventional sport shoes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Sacroiliac pain provocation test.
Measured: 9th week
Secondary outcomes (1)
Pelvic Stability
Podiatric Stabilometry.
Measured: 9th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2017
- Study startSep 2011
- Primary completionOct 2013
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbopelvic Postpartum PainStudies 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
- Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Europea de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raquel Díaz-Meco Conde, Universidad Europea de Madrid
- Investigators
- Raquel Diaz-Meco Conde, Doctor, Principal investigator, Universidad Europea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03065270
- Sponsor's protocol ID
- UEM-DOL-2011-01
- Status last verified
- Feb 2017
- First submitted
- 10 Feb 2017
- Last updated
- 27 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- 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 27 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Masai Barefoot Technology (MBT) for Decreasing Pain and Improvement of Lumbopelvic Pain
- ClinicalTrials.gov ID
- NCT03065270
- Acronym / sponsor ID
- UEM-DOL-2011-01
- Conditions
- Lumbopelvic Postpartum Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Universidad Europea de MadridUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 27 Feb 2017 (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.
During pregnancy, pregnant women adopt an atypical pattern position with the intention to maintain stability and balance.These postural changes can cause instability at the level of the sacroiliac joint with painful condition during pregnancy and postpartum.
40 % of women have postpartum lumbopelvic instability. In 17 % of cases the lumbopelvic pain is perpetuated.
Another alteration influenced by the gestational status and progress of labor is urinary incontinence (UI).
The mechanism developed by Masai Barefoot Technology (MBT) provides an unstable base. Some studies reviewed, indicate that this shoe increases muscle activity, contributes to the decrease of joint overload and thereby, decreases pain.
Objective To compare the efficacy of shoes with unstable sole MBT®, over the use of conventional sports shoes, in primiparous women with lumbopelvic postpartum pain.
Material and Methods Randomized clinical trial. 24 postpartum women from the Gynecology Service of the Hospital Universitario Madrid Chiron were included in the study.
The subjects were randomly divided into experimental and control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A group | Experimental | Other: Use unstable shoes Masai Barefoot Technology (MBT) |
| B group | Experimental | Other: Use conventional sport shoes |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Primparous women.
- Postpartum, between 8-12 weeks after the date of delivery.
- With lumbopelvic pain and positive diagnostic tests of sacroiliac pain
- Women with ambulation ability.
Key exclusion criteria (3 listed)
- Presence of vaginal prolapses.
- Be receiving another treatment for the alteration that concerns us, pharmacological or any other type of therapy.
- Neuromuscular alterations.
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 |
|---|---|---|
| Use unstable shoes Masai Barefoot Technology (MBT)Use of unstable shoes during 9 weeks, at least four hours per day. | Other | A group |
| Use conventional sport shoesUse of conventional sport shoes during 9 weeks, at least four hours per day. | Other | B group |
Primary outcome
Pain
Time frame: 9th week
Sacroiliac pain provocation test.
1 secondary outcome
Pelvic Stability
Time frame: 9th week
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 27 Feb 2017.
- Individual participant dataSharing planned: No
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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.
Raquel Diaz-Meco Conde, Doctor principal investigator
Universidad Europea
Questions about this trial
What is this clinical trial studying?
A study testing Use unstable shoes Masai Barefoot Technology (MBT) and Use conventional sport shoes in people with Lumbopelvic Postpartum Pain, run by Universidad Europea de Madrid.
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 4 inclusion and 3 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 27 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Pain (time frame: 9th week). 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 27 Feb 2017.