The Effects of Unstable Shoes on Chronic Low Back Pain

NCT ID: NCT01384071

Last Updated: 2012-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-11-30

Brief Summary

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Some physicians, physiotherapists and nurses use or even suggest unstable shoes in cases of low back pain. No studies on the real effects of these shoes on low back pain in health care professions have been carried out and therefore as yet there is no real evidence of their effectiveness. Thus the investigators assume that wearing unstable shoes over a period of six weeks could reduce low back pain and functional disability due to the changes of the gait and posture and may increase the quality of life.

The purposes of this study are:

1. To evaluate the modifications of pain level, functional capacity and quality of life among individuals with moderate level of non-specific chronic low back pain after wearing unstable shoes.
2. To quantify biomechanical modifications of gait and posture.

Detailed Description

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Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Unstable shoes (MBT)

MBT shoes (Masai Barefoot Technology, Switzerland)

Group Type EXPERIMENTAL

Unstable shoes (MBT)

Intervention Type DEVICE

Wearing unstable (MBT) shoes during 6 weeks

Stable shoes (Adidas)

Adidas stable shoes (Adidas Bigroar2)

Group Type SHAM_COMPARATOR

Sham intervention (Adidas shoes)

Intervention Type DEVICE

Normal stable shoes (Adidas Bigroar2)

Interventions

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Unstable shoes (MBT)

Wearing unstable (MBT) shoes during 6 weeks

Intervention Type DEVICE

Sham intervention (Adidas shoes)

Normal stable shoes (Adidas Bigroar2)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* employees of Geneva University Hospital
* working in a standing position for at least 50% of their working day
* aged between 30 and 65
* having chronic low back pain that has been defined at least 3 out of 10 on a visual analogue scale during the last 3 months or the need to take regular pain medication for this reason

Exclusion Criteria

* having severe pain in other body parts
* undergone back surgery, neurological or balance problems
* inability to walk a distance of 100 meters
* already worn unstable shoes and being off of work because of low back pain
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Geneva

OTHER

Sponsor Role lead

Responsible Party

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Armand Staphane

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Hospitals of Geneva

Geneva, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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LBP-2011

Identifier Type: -

Identifier Source: org_study_id

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