NCT01384071

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. 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. 2.To quantify biomechanical modifications of gait and posture.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2011

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 28, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

February 22, 2012

Status Verified

February 1, 2012

Enrollment Period

8 months

First QC Date

June 15, 2011

Last Update Submit

February 20, 2012

Conditions

Low Back Pain

Keywords

Low back painUnstable shoesGaitBalance

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Secondary Outcomes (8)

  • Change from baseline in gait speed at 6 weeks

    Baseline and 6 weeks

  • Change from baseline in balance performance at 6 weeks

    Baseline and 6 weeks

  • Change from baseline in ankle dorsiflexion during gait at 6 weeks

    Baseline and 6 weeks

  • Change from baseline in pelvis anteversion during gait at 6 weeks

    Baseline and 6 weeks

  • Change from baseline in trunk anteversion during gait at 6 weeks

    Baseline and 6 weeks

  • +3 more secondary outcomes

Study Arms (2)

Unstable shoes (MBT)

EXPERIMENTAL

MBT shoes (Masai Barefoot Technology, Switzerland)

Device: Unstable shoes (MBT)

Stable shoes (Adidas)

SHAM COMPARATOR

Adidas stable shoes (Adidas Bigroar2)

Device: Sham intervention (Adidas shoes)

Interventions

Unstable shoes (MBT)DEVICE

Wearing unstable (MBT) shoes during 6 weeks

Unstable shoes (MBT)
Sham intervention (Adidas shoes)DEVICE

Normal stable shoes (Adidas Bigroar2)

Stable shoes (Adidas)

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals of Geneva

Geneva, 1211, Switzerland

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

June 15, 2011

First Posted

June 28, 2011

Study Start

January 1, 2011

Primary Completion

September 1, 2011

Study Completion

November 1, 2011

Last Updated

February 22, 2012

Record last verified: 2012-02

Locations

CH(1)