The Effects of Unstable Shoes on Chronic Low Back Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Armand Staphane, University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT01384071
First received: June 15, 2011
Last updated: February 20, 2012
Last verified: February 2012
  Purpose

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.

Condition Intervention
Low Back Pain
Device: Unstable shoes (MBT)
Device: Sham intervention (Adidas shoes)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • Change from baseline in low back pain at 6 weeks [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
    Quality of life with the EQ-5D.


Secondary Outcome Measures:
  • Change from baseline in gait speed at 6 weeks [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
    Seft-selected gait speed

  • Change from baseline in balance performance at 6 weeks [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]

    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 [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
    Ankle dorsiflexion at initial contact during gait

  • Change from baseline in pelvis anteversion during gait at 6 weeks [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
    Mean pelvis anteversion during gait

  • Change from baseline in trunk anteversion during gait at 6 weeks [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
    Mean trunk anteversion during gait

  • Change from baseline in activation period of lower-limb muscles during gait at 6 weeks [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
    Activation period of erector spinae during gait

  • Change from baseline in maximum knee extension during gait stance phase at 6 weeks [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
    Maximum knee extension during stance phase


Enrollment: 40
Study Start Date: January 2011
Study Completion Date: November 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01384071

Locations
Switzerland
University Hospitals of Geneva
Geneva, Switzerland, 1211
Sponsors and Collaborators
University Hospital, Geneva
  More Information

No publications provided

Responsible Party: Armand Staphane, PhD, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT01384071     History of Changes
Other Study ID Numbers: LBP-2011
Study First Received: June 15, 2011
Last Updated: February 20, 2012
Health Authority: Switzerland: Federal Office of Public Health

Keywords provided by University Hospital, Geneva:
Low back pain
Unstable shoes
Gait
Balance

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 31, 2014