Efficacy of Unstable Shoes for Instability and Lumbopelvic Pain

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.

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 Overview

• Status: Completed
• Conditions: Lumbopelvic Postpartum Pain
• Intervention / Treatment: Other: Use unstable shoes Masai Barefoot Technology (MBT); Other: Use conventional sport shoes

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: A group	Other: Use unstable shoes Masai Barefoot Technology (MBT); Use of unstable shoes during 9 weeks, at least four hours per day.
EXPERIMENTAL: B group	Other: Use conventional sport shoes; Use of conventional sport shoes during 9 weeks, at least four hours per day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain	Sacroiliac pain provocation test.	9th week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pelvic Stability	Podiatric Stabilometry.	9th week

Collaborators and Investigators

• Sponsor: Universidad Europea de Madrid
• Investigators: Principal Investigator: Raquel Diaz-Meco Conde, Doctor, Universidad Europea

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (ACTUAL): October 1, 2013
• Study Completion (ACTUAL): May 1, 2015

Study Registration Dates

• First Submitted: February 10, 2017
• First Submitted That Met QC Criteria: February 24, 2017
• First Posted (ACTUAL): February 27, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 27, 2017
• Last Update Submitted That Met QC Criteria: February 24, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: UEM-DOL-2011-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No