Low Back PainNCT02606370
Effects of Unstable Shoes on Trunk Muscle Activity, Lumbar Spine Kinematics and Pain in Patients With Low Back Pain
A study testing Unstable shoe in people with Low Back Pain, run by Cardenal Herrera University at 1 site in Spain.
Trial summary
Aim: To compare trunk muscle activity, lumbar spine range of motion (ROM) and LBP during gait using an unstable shoe (Intervention group) and a conventional stable control shoe (Control Group). Design: Randomized Controlled Trial. Setting: A Biomechanics laboratory. Population: Patients with Low Back Pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Unstable shoe
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2016to May 2016
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Chronic LBP
- BMI < 30
Who cannot join
- Hernia
- Lower limb pathologies
- Previous experience with unstable shoes
Trial locations and contacts
1 site in 1 country.
About this study
Aim: To compare trunk muscle activity, lumbar spine range of motion (ROM) and LBP during gait using an unstable shoe (Intervention group) and a conventional stable control shoe (Control Group).
Design: Randomized Controlled Trial. Setting: A Biomechanics laboratory. Population: Patients with Low Back Pain.
Read the detailed description
Background: An unstable shoe was developed as a walking device to strengthen the lower extremity muscles and reduce joint loading. A large number of studies have reported increased electromyographic (EMG) activity throughout the gait cycle in most of the lower limb muscles, and significant kinematic changes in the lower extremity. However, no studies have investigated the effects of wearing (1 month) unstable shoes on 1) spine kinematics, 2) trunk muscle activity and 3) Low Back Pain (LBP) during gait in Patients with chronic LBP.
Aim: To compare trunk muscle activity, lumbar spine range of motion (ROM) and LBP during gait using an unstable shoe (Intervention group) and a conventional stable control shoe (Control Group).
Design: Randomized Controlled Trial. Setting: A Biomechanics laboratory. Population: Patients with Low Back Pain.
- Conditions
- Low Back Pain
- Being tested
- Unstable shoe
- Keywords
- Unstable Shoes;Trunk muscles;Lumbar lordosis;Low Back Pain
- 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 shoeOther
Wearing Unstable shoes during 1 month
| Study group | Role | What they receive |
|---|---|---|
| Unstable shoes | Experimental | Wearing unstable shoes during 1 month Receives: Other: Unstable shoe |
| Control Group | No intervention | Not Wearing unstable shoes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disability (assessed by Roland Morris Questionaire)
Measured: At 1 month
Secondary outcomes (2)
EMG activity of trunk muscles
Measured: At baseline and at 1 month follow-up
Lumbar spine range of movement (sagittal plane)
Measured: At baseline and at 1 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2015 (estimated)
- Study startJan 2016
- Primary completionApr 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardenal Herrera University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan F. Lisón Párraga, Dr, Cardenal Herrera University
- Investigators
- JF Lisón, Dr., Study director, Cardenal Herrera UniversityPablo Salvador-Coloma, Principal investigator, Cardenal Herrera University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02606370
- Sponsor's protocol ID
- UNIVERSITY CARDENAL HERRERA
- Status last verified
- Sep 2017
- First submitted
- 11 Nov 2015
- Last updated
- 25 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lison JF, Perez-Soriano P, Llana-Belloch S, Sanchez-Zuriaga D, Salvador-Coloma P. Effects of unstable shoes on trunk muscle activity and lumbar spine kinematics. Eur J Phys Rehabil Med. 2016 Aug;52(4):440-6. Epub 2015 Apr 9.
PubMed 25854301
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Unstable Shoes on Trunk Muscle Activity, Lumbar Spine Kinematics and Pain in Patients With Low Back Pain
- ClinicalTrials.gov ID
- NCT02606370
- Acronym / sponsor ID
- UNIVERSITY CARDENAL HERRERA
- Conditions
- Low Back Pain
- Keywords
- Unstable Shoes;Trunk muscles;Lumbar lordosis;Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cardenal Herrera UniversityUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Apr 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 17 Nov 2015 (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.
Aim: To compare trunk muscle activity, lumbar spine range of motion (ROM) and LBP during gait using an unstable shoe (Intervention group) and a conventional stable control shoe (Control Group).
Design: Randomized Controlled Trial. Setting: A Biomechanics laboratory. Population: Patients with Low Back Pain.
Detailed description
Background: An unstable shoe was developed as a walking device to strengthen the lower extremity muscles and reduce joint loading. A large number of studies have reported increased electromyographic (EMG) activity throughout the gait cycle in most of the lower limb muscles, and significant kinematic changes in the lower extremity. However, no studies have investigated the effects of wearing (1 month) unstable shoes on 1) spine kinematics, 2) trunk muscle activity and 3) Low Back Pain (LBP) during gait in Patients with chronic LBP.
Aim: To compare trunk muscle activity, lumbar spine range of motion (ROM) and LBP during gait using an unstable shoe (Intervention group) and a conventional stable control shoe (Control Group).
Design: Randomized Controlled Trial. Setting: A Biomechanics laboratory. Population: Patients with Low Back Pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unstable shoes | Experimental | Other: Unstable shoeWearing unstable shoes during 1 month |
| Control Group | No intervention | –Not Wearing unstable shoes |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with Chronic LBP
- BMI < 30
Key exclusion criteria (3 listed)
- Hernia
- Lower limb pathologies
- Previous experience with unstable shoes
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 shoeWearing Unstable shoes during 1 month | Other | Unstable shoes |
Primary outcome
Disability (assessed by Roland Morris Questionaire)
Time frame: At 1 month
2 secondary outcomes
EMG activity of trunk muscles
Time frame: At baseline and at 1 month follow-up
Lumbar spine range of movement (sagittal plane)
Time frame: At baseline and at 1 month follow-up
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 25 Sep 2017.
- Results publication: PubMed 25854301Lison JF, Perez-Soriano P, Llana-Belloch S, Sanchez-Zuriaga D, Salvador-Coloma P. Effects of unstable shoes on trunk muscle activity and lumbar spine kinematics. Eur J Phys Rehabil Med. 2016 Aug;52(4):440-6. Epub 2015 Apr 9.
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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.
JF Lisón, Dr. study director
Cardenal Herrera University
Pablo Salvador-Coloma principal investigator
Cardenal Herrera University
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 shoe in people with Low Back Pain, run by Cardenal Herrera University at 1 site in Spain.
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 2 inclusion and 3 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 25 Sep 2017. 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 Spain. 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. 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?
Disability (assessed by Roland Morris Questionaire) (time frame: At 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02606370, which also lists 1 linked publication.
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 25 Sep 2017.