The Effects of Unstable Shoes on Chronic Low Back Pain

Low Back Pain Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01384071
• Other study ID #: LBP-2011
• Status: Completed
• Phase: N/A
• First received: June 15, 2011
• Last updated: February 20, 2012
• Start date: January 2011
• Est. completion date: November 2011

Study information

• Verified date: February 2012
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Federal Office of Public Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Device:
• Unstable shoes (MBT)
Wearing unstable (MBT) shoes during 6 weeks
• Sham intervention (Adidas shoes)
Normal stable shoes (Adidas Bigroar2)

Locations

Country	Name	City	State
Switzerland	University Hospitals of Geneva	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in low back pain at 6 weeks	Low back pain level with the visual analogue scale (VAS) from 0 to 10;	Baseline and 6 weeks	No
Primary	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)	Baseline and 6 weeks	No
Primary	Change from baseline in the EQ-5D quality of life questionnaire at 6 weeks	Quality of life with the EQ-5D.	Baseline and 6 weeks	No
Secondary	Change from baseline in gait speed at 6 weeks	Seft-selected gait speed	Baseline and 6 weeks	No
Secondary	Change from baseline in balance performance at 6 weeks	center of pressure speed in conditions : eyes opened and eyes closed; stable and unstable surface	Baseline and 6 weeks	No
Secondary	Change from baseline in ankle dorsiflexion during gait at 6 weeks	Ankle dorsiflexion at initial contact during gait	Baseline and 6 weeks	No
Secondary	Change from baseline in pelvis anteversion during gait at 6 weeks	Mean pelvis anteversion during gait	Baseline and 6 weeks	No
Secondary	Change from baseline in trunk anteversion during gait at 6 weeks	Mean trunk anteversion during gait	Baseline and 6 weeks	No
Secondary	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	Baseline and 6 weeks	No
Secondary	Change from baseline in activation period of erector spinae during gait at 6 weeks	Activation period of erector spinae during gait	Baseline and 6 weeks	No
Secondary	Change from baseline in maximum knee extension during gait stance phase at 6 weeks	Maximum knee extension during stance phase	Baseline and 6 weeks	No