The Effects of Unstable Shoes on Chronic Low Back Pain

Not Applicable

Completed

• Conditions: Low Back Pain
• Interventions: Device: Unstable shoes (MBT); Device: Sham intervention (Adidas shoes)

• Registration Number: NCT01384071
• Lead Sponsor: University Hospital, Geneva

Brief Summary

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

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-06-15
• Study First Submitted QC: 2011-06-27
• Study First Posted: 2011-06-28
• Primary Completion: 2011-09
• Study Completion: 2011-11
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-20
• Last Update Posted: 2012-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Unstable shoes (MBT)	Unstable shoes (MBT)	MBT shoes (Masai Barefoot Technology, Switzerland)
Stable shoes (Adidas)	Sham intervention (Adidas shoes)	Adidas stable shoes (Adidas Bigroar2)

Primary Outcome Measures

Name	Time	Method
Change from baseline in low back pain at 6 weeks	Baseline and 6 weeks	Low back pain level with the visual analogue scale (VAS) from 0 to 10;
Change from baseline in the Roland-Morris disability questionnaire at 6 weeks	Baseline and 6 weeks	functional disability with the Roland-Morris disability questionnaire (this questionnaire has been validated in French as the Functional Disability Scale for the Assessment of Low Back Pain - Eifel)
Change from baseline in the EQ-5D quality of life questionnaire at 6 weeks	Baseline and 6 weeks	Quality of life with the EQ-5D.

Secondary Outcome Measures

Name	Time	Method
Change from baseline in gait speed at 6 weeks	Baseline and 6 weeks	Seft-selected gait speed
Change from baseline in balance performance at 6 weeks	Baseline and 6 weeks	center of pressure speed in conditions : * eyes opened and eyes closed; * stable and unstable surface
Change from baseline in ankle dorsiflexion during gait at 6 weeks	Baseline and 6 weeks	Ankle dorsiflexion at initial contact during gait
Change from baseline in pelvis anteversion during gait at 6 weeks	Baseline and 6 weeks	Mean pelvis anteversion during gait
Change from baseline in trunk anteversion during gait at 6 weeks	Baseline and 6 weeks	Mean trunk anteversion during gait
Change from baseline in activation period of lower-limb muscles during gait at 6 weeks	Baseline and 6 weeks	Activation period of lower-limb muscles (gasctrocnemius, peroneus, tibialis anterior, rectus femoris and semi-tendinosus) during gait
Change from baseline in activation period of erector spinae during gait at 6 weeks	Baseline and 6 weeks	Activation period of erector spinae during gait
Change from baseline in maximum knee extension during gait stance phase at 6 weeks	Baseline and 6 weeks	Maximum knee extension during stance phase

Trial Locations

Locations (1)

University Hospitals of Geneva; 🇨🇭 Geneva, Switzerland