Efficacy of Unstable Shoes for Instability and Lumbopelvic Pain

NCT ID: NCT03065270

Last Updated: 2017-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2015-05-31

Brief 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. 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.

Conditions

Lumbopelvic Postpartum Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

A group

Group Type: EXPERIMENTAL

Use unstable shoes Masai Barefoot Technology (MBT)

Intervention Type: OTHER

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

B group

Group Type: EXPERIMENTAL

Use conventional sport shoes

Intervention Type: OTHER

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

Interventions

Use unstable shoes Masai Barefoot Technology (MBT)

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

Intervention Type: OTHER

Use conventional sport shoes

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Universidad Europea de Madrid

OTHER

Sponsor Role: lead

Responsible Party

Raquel Díaz-Meco Conde

Principal Investigador

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Raquel Diaz-Meco Conde, Doctor

Role: PRINCIPAL_INVESTIGATOR

Universidad Europea

Other Identifiers

UEM-DOL-2011-01

Identifier Type: -

Identifier Source: org_study_id