The Effects of Unstable Shoes on Chronic Low Back Pain

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Device: Unstable shoes (MBT); Device: Sham intervention (Adidas shoes)

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Geneva, Switzerland, 1211
    • University Hospitals of Geneva

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Geneva

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: June 15, 2011
• First Submitted That Met QC Criteria: June 27, 2011
• First Posted (Estimate): June 28, 2011

Study Record Updates

• Last Update Posted (Estimate): February 22, 2012
• Last Update Submitted That Met QC Criteria: February 20, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: Balance; Low back pain; Unstable shoes; Gait
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: LBP-2011

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No