Low Back PainNCT01384071
The Effects of Unstable Shoes on Chronic Low Back Pain
A study testing Unstable shoes (MBT) in people with Low Back Pain, run by University Hospital, Geneva at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Unstable shoes (MBT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2011to Nov 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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:
- 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.
- To quantify biomechanical modifications of gait and posture.
- Conditions
- Low Back Pain
- Being tested
- Unstable shoes (MBT), Sham intervention (Adidas shoes)
- Keywords
- Low back pain, Unstable shoes, Gait, Balance
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unstable shoes (MBT)Device
Wearing unstable (MBT) shoes during 6 weeks
Sham intervention (Adidas shoes)Device
Normal stable shoes (Adidas Bigroar2)
| Study group | Role | What they receive |
|---|---|---|
| Unstable shoes (MBT) | Experimental | MBT shoes (Masai Barefoot Technology, Switzerland) Receives: Device: Unstable shoes (MBT) |
| Stable shoes (Adidas) | Sham comparator | Adidas stable shoes (Adidas Bigroar2) Receives: Device: Sham intervention (Adidas shoes) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in low back pain at 6 weeks
Low back pain level with the visual analogue scale (VAS) from 0 to 10;
Measured: 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)
Measured: 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.
Measured: Baseline and 6 weeks
Secondary outcomes (8)
Change from baseline in gait speed at 6 weeks
Seft-selected gait speed
Measured: Baseline and 6 weeks
Change from baseline in balance performance at 6 weeks
center of pressure speed in conditions :
- eyes opened and eyes closed
- stable and unstable surface
Measured: Baseline and 6 weeks
Change from baseline in ankle dorsiflexion during gait at 6 weeks
Ankle dorsiflexion at initial contact during gait
Measured: Baseline and 6 weeks
Change from baseline in pelvis anteversion during gait at 6 weeks
Mean pelvis anteversion during gait
Measured: Baseline and 6 weeks
Change from baseline in trunk anteversion during gait at 6 weeks
Mean trunk anteversion during gait
Measured: Baseline and 6 weeks
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
Measured: Baseline and 6 weeks
Change from baseline in activation period of erector spinae during gait at 6 weeks
Activation period of erector spinae during gait
Measured: Baseline and 6 weeks
Change from baseline in maximum knee extension during gait stance phase at 6 weeks
Maximum knee extension during stance phase
Measured: Baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2011 (estimated)
- Study startJan 2011
- Primary completionSep 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Armand Staphane, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01384071
- Sponsor's protocol ID
- LBP-2011
- Status last verified
- Feb 2012
- First submitted
- 15 Jun 2011
- Last updated
- 22 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Unstable Shoes on Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT01384071
- Acronym / sponsor ID
- LBP-2011
- Conditions
- Low Back Pain
- Keywords
- Low back pain, Unstable shoes, Gait, Balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 28 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- To quantify biomechanical modifications of gait and posture.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unstable shoes (MBT) | Experimental | Device: Unstable shoes (MBT)MBT shoes (Masai Barefoot Technology, Switzerland) |
| Stable shoes (Adidas) | Sham comparator | Device: Sham intervention (Adidas shoes)Adidas stable shoes (Adidas Bigroar2) |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unstable shoes (MBT)Wearing unstable (MBT) shoes during 6 weeks | Device | Unstable shoes (MBT) |
| Sham intervention (Adidas shoes)Normal stable shoes (Adidas Bigroar2) | Device | Stable shoes (Adidas) |
Primary outcome
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;
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)
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.
8 secondary outcomes
Change from baseline in gait speed at 6 weeks
Time frame: Baseline and 6 weeks
Change from baseline in balance performance at 6 weeks
Time frame: Baseline and 6 weeks
Change from baseline in ankle dorsiflexion during gait at 6 weeks
Time frame: Baseline and 6 weeks
Change from baseline in pelvis anteversion during gait at 6 weeks
Time frame: Baseline and 6 weeks
Change from baseline in trunk anteversion during gait at 6 weeks
Time frame: Baseline and 6 weeks
Change from baseline in activation period of lower-limb muscles during gait at 6 weeks
Time frame: Baseline and 6 weeks
Change from baseline in activation period of erector spinae during gait at 6 weeks
Time frame: Baseline and 6 weeks
Change from baseline in maximum knee extension during gait stance phase at 6 weeks
Time frame: Baseline and 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unstable shoes (MBT) in people with Low Back Pain, run by University Hospital, Geneva at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in low back pain at 6 weeks (time frame: Baseline and 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2012; AzTrials last refreshed its copy on 7 Nov 2026.