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OpenTrials
Completed

NCT Number: NCT03065270

Efficacy of Unstable Shoes for Instability and 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.

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.

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Key information

Conditions

Lumbopelvic Postpartum Pain

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

  • Presence of vaginal prolapses.
  • Be receiving another treatment for the alteration that concerns us, pharmacological or any other type of therapy.
  • Neuromuscular alterations.

Treatment and study plan

Use unstable shoes Masai Barefoot Technology (MBT)

Other

Use of unstable shoes during 9 weeks, at least four hours per day.

Use conventional sport shoes

Other

Use of conventional sport shoes during 9 weeks, at least four hours per day.

Primary outcomes

  1. Pain

    Time frame: 9th week

    Sacroiliac pain provocation test.

Secondary outcomes

  1. Pelvic Stability

    Time frame: 9th week

    Podiatric Stabilometry.

Sponsors and collaborators

Lead sponsor

Universidad Europea de Madrid

Other

Registry information

Official study title

Efficacy of Masai Barefoot Technology (MBT) for Decreasing Pain and Improvement of Lumbopelvic Pain

Important dates

Study start
2011
Primary completion
2013
Study completion
2015
First posted
Feb 27, 2017
Registry last updated
Feb 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.