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The Effects of Unstable Shoes on Chronic Low Back Pain

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01384071
Enrollment
40
Registered
2011-06-28
Start date
2011-01-31
Completion date
2011-11-30
Last updated
2012-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain

Keywords

Low back pain, Unstable shoes, Gait, Balance

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: 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.

Interventions

DEVICEUnstable shoes (MBT)

Wearing unstable (MBT) shoes during 6 weeks

DEVICESham intervention (Adidas shoes)

Normal stable shoes (Adidas Bigroar2)

Sponsors

University Hospital, Geneva
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline in low back pain at 6 weeksBaseline and 6 weeksLow back pain level with the visual analogue scale (VAS) from 0 to 10;
Change from baseline in the Roland-Morris disability questionnaire at 6 weeksBaseline and 6 weeksfunctional 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 weeksBaseline and 6 weeksQuality of life with the EQ-5D.

Secondary

MeasureTime frameDescription
Change from baseline in pelvis anteversion during gait at 6 weeksBaseline and 6 weeksMean pelvis anteversion during gait
Change from baseline in trunk anteversion during gait at 6 weeksBaseline and 6 weeksMean trunk anteversion during gait
Change from baseline in gait speed at 6 weeksBaseline and 6 weeksSeft-selected gait speed
Change from baseline in activation period of erector spinae during gait at 6 weeksBaseline and 6 weeksActivation period of erector spinae during gait
Change from baseline in maximum knee extension during gait stance phase at 6 weeksBaseline and 6 weeksMaximum knee extension during stance phase
Change from baseline in activation period of lower-limb muscles during gait at 6 weeksBaseline and 6 weeksActivation period of lower-limb muscles (gasctrocnemius, peroneus, tibialis anterior, rectus femoris and semi-tendinosus) during gait
Change from baseline in balance performance at 6 weeksBaseline and 6 weekscenter of pressure speed in conditions : * eyes opened and eyes closed * stable and unstable surface
Change from baseline in ankle dorsiflexion during gait at 6 weeksBaseline and 6 weeksAnkle dorsiflexion at initial contact during gait

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026