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The Effects of Unstable Shoes on Chronic Low Back Pain

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Unstable shoes (MBT)
Sham intervention (Adidas shoes)
Sponsored by
University Hospital, Geneva
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Low back pain, Unstable shoes, Gait, Balance

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospitals of Geneva

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Unstable shoes (MBT)

Stable shoes (Adidas)

Arm Description

MBT shoes (Masai Barefoot Technology, Switzerland)

Adidas stable shoes (Adidas Bigroar2)

Outcomes

Primary Outcome Measures

Change from baseline in low back pain at 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
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
Quality of life with the EQ-5D.

Secondary Outcome Measures

Change from baseline in gait speed at 6 weeks
Seft-selected gait speed
Change from baseline in balance performance at 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
Ankle dorsiflexion at initial contact during gait
Change from baseline in pelvis anteversion during gait at 6 weeks
Mean pelvis anteversion during gait
Change from baseline in trunk anteversion during gait at 6 weeks
Mean trunk anteversion during gait
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
Change from baseline in activation period of erector spinae during gait at 6 weeks
Activation period of erector spinae during gait
Change from baseline in maximum knee extension during gait stance phase at 6 weeks
Maximum knee extension during stance phase

Full Information

First Posted
June 15, 2011
Last Updated
February 20, 2012
Sponsor
University Hospital, Geneva
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1. Study Identification

Unique Protocol Identification Number
NCT01384071
Brief Title
The Effects of Unstable Shoes on Chronic Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Geneva

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Low back pain, Unstable shoes, Gait, Balance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Unstable shoes (MBT)
Arm Type
Experimental
Arm Description
MBT shoes (Masai Barefoot Technology, Switzerland)
Arm Title
Stable shoes (Adidas)
Arm Type
Sham Comparator
Arm Description
Adidas stable shoes (Adidas Bigroar2)
Intervention Type
Device
Intervention Name(s)
Unstable shoes (MBT)
Intervention Description
Wearing unstable (MBT) shoes during 6 weeks
Intervention Type
Device
Intervention Name(s)
Sham intervention (Adidas shoes)
Intervention Description
Normal stable shoes (Adidas Bigroar2)
Primary Outcome Measure Information:
Title
Change from baseline in low back pain at 6 weeks
Description
Low back pain level with the visual analogue scale (VAS) from 0 to 10;
Time Frame
Baseline and 6 weeks
Title
Change from baseline in the Roland-Morris disability questionnaire at 6 weeks
Description
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)
Time Frame
Baseline and 6 weeks
Title
Change from baseline in the EQ-5D quality of life questionnaire at 6 weeks
Description
Quality of life with the EQ-5D.
Time Frame
Baseline and 6 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in gait speed at 6 weeks
Description
Seft-selected gait speed
Time Frame
Baseline and 6 weeks
Title
Change from baseline in balance performance at 6 weeks
Description
center of pressure speed in conditions : eyes opened and eyes closed stable and unstable surface
Time Frame
Baseline and 6 weeks
Title
Change from baseline in ankle dorsiflexion during gait at 6 weeks
Description
Ankle dorsiflexion at initial contact during gait
Time Frame
Baseline and 6 weeks
Title
Change from baseline in pelvis anteversion during gait at 6 weeks
Description
Mean pelvis anteversion during gait
Time Frame
Baseline and 6 weeks
Title
Change from baseline in trunk anteversion during gait at 6 weeks
Description
Mean trunk anteversion during gait
Time Frame
Baseline and 6 weeks
Title
Change from baseline in activation period of lower-limb muscles during gait at 6 weeks
Description
Activation period of lower-limb muscles (gasctrocnemius, peroneus, tibialis anterior, rectus femoris and semi-tendinosus) during gait
Time Frame
Baseline and 6 weeks
Title
Change from baseline in activation period of erector spinae during gait at 6 weeks
Description
Activation period of erector spinae during gait
Time Frame
Baseline and 6 weeks
Title
Change from baseline in maximum knee extension during gait stance phase at 6 weeks
Description
Maximum knee extension during stance phase
Time Frame
Baseline and 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University Hospitals of Geneva
City
Geneva
ZIP/Postal Code
1211
Country
Switzerland

12. IPD Sharing Statement

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The Effects of Unstable Shoes on Chronic Low Back Pain

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