Clinical trial NCT01384071: The Effects of Unstable Shoes on Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Low back pain
Unstable shoes
Gait
Balance
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2011-06-28
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change from baseline in low back pain at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change from baseline in the Roland-Morris disability questionnaire at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change from baseline in the EQ-5D quality of life questionnaire at 6 weeks
timeFrame: Baseline and 6 weeks
Secondary outcomes:
measure: Change from baseline in gait speed at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change from baseline in balance performance at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change from baseline in ankle dorsiflexion during gait at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change from baseline in pelvis anteversion during gait at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change from baseline in trunk anteversion during gait at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change from baseline in activation period of lower-limb muscles during gait at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change from baseline in activation period of erector spinae during gait at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change from baseline in maximum knee extension during gait stance phase at 6 weeks
timeFrame: Baseline and 6 weeks
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: University Hospitals of Geneva
Study officials:
References: