Skip to main content
OpenTrials
Completed

NCT Number: NCT01384071

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals of Geneva

Geneva, 1211, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Unstable shoes (MBT)

Device

Wearing unstable (MBT) shoes during 6 weeks

Sham intervention (Adidas shoes)

Device

Normal stable shoes (Adidas Bigroar2)

Primary outcomes

  1. Change from baseline in low back pain at 6 weeks

    Time frame: Baseline and 6 weeks

    Low back pain level with the visual analogue scale (VAS) from 0 to 10;

  2. Change from baseline in the Roland-Morris disability questionnaire at 6 weeks

    Time frame: 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)

  3. Change from baseline in the EQ-5D quality of life questionnaire at 6 weeks

    Time frame: Baseline and 6 weeks

    Quality of life with the EQ-5D.

Secondary outcomes

  1. Change from baseline in gait speed at 6 weeks

    Time frame: Baseline and 6 weeks

    Seft-selected gait speed

  2. Change from baseline in balance performance at 6 weeks

    Time frame: Baseline and 6 weeks

    center of pressure speed in conditions :

    • eyes opened and eyes closed
    • stable and unstable surface

  3. Change from baseline in ankle dorsiflexion during gait at 6 weeks

    Time frame: Baseline and 6 weeks

    Ankle dorsiflexion at initial contact during gait

  4. Change from baseline in pelvis anteversion during gait at 6 weeks

    Time frame: Baseline and 6 weeks

    Mean pelvis anteversion during gait

  5. Change from baseline in trunk anteversion during gait at 6 weeks

    Time frame: Baseline and 6 weeks

    Mean trunk anteversion during gait

  6. Change from baseline in activation period of lower-limb muscles during gait at 6 weeks

    Time frame: Baseline and 6 weeks

    Activation period of lower-limb muscles (gasctrocnemius, peroneus, tibialis anterior, rectus femoris and semi-tendinosus) during gait

  7. Change from baseline in activation period of erector spinae during gait at 6 weeks

    Time frame: Baseline and 6 weeks

    Activation period of erector spinae during gait

  8. Change from baseline in maximum knee extension during gait stance phase at 6 weeks

    Time frame: Baseline and 6 weeks

    Maximum knee extension during stance phase

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jun 28, 2011
Registry last updated
Feb 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.