The Effects of Unstable Shoes on Chronic Low Back Pain

Study Overview
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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: 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. To quantify biomechanical modifications of gait and posture.

Conditions
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Low Back Pain

Intervention / Treatment
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* Device: Unstable shoes (MBT)
* Device: Sham intervention (Adidas shoes)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Unstable shoes (MBT)<br>MBT shoes (Masai Barefoot Technology, Switzerland) | Device: Unstable shoes (MBT)<br>* Wearing unstable (MBT) shoes during 6 weeks<br>|
| Sham Comparator: Stable shoes (Adidas)<br>Adidas stable shoes (Adidas Bigroar2) | Device: Sham intervention (Adidas shoes)<br>* Normal stable shoes (Adidas Bigroar2)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in low back pain at 6 weeks | Low back pain level with the visual analogue scale (VAS) from 0 to 10; | Baseline and 6 weeks | 
| Change from baseline in the Roland-Morris disability questionnaire at 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) | Baseline and 6 weeks | 
| Change from baseline in the EQ-5D quality of life questionnaire at 6 weeks | Quality of life with the EQ-5D. | Baseline and 6 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low back pain, Unstable shoes, Gait, Balance