Low Back PainLombaMobNCT05600543
Evaluation of the Effect of Lumbar Belt on Spinal Mobility in Subjects With and Without Low Back Pain
A study testing Lumbar belt and Lombaskin lumbar belt and the Lyne Up percko postural T-shirt. in people with Low Back Pain, run by Thuasne at 1 site in France.
Trial summary
Low back pain (LBP) is a common condition worldwide as the lifetime prevalence is up to 80%. It is defined as pain in the lumbosacral region in which the etiological causes are most often mechanical, and it is therefore defined as "non-specific LBP". Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Lumbar belt and Lombaskin lumbar belt and the Lyne Up percko postural T-shirt.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteFrance
- Study dates
- 30 Sep 2022to 29 Mar 2024
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female,
- Aged between 18 and 70 years,
- With a waist circumference between 75 cm and 110 cm,
- With a 18.5 < BMI < 30 kg/m2,
- Suffering from a current episode of non-specific low back pain (symptomatic subjects),
- At least one average low back pain at rest or during exercise in the last 72 hours collected at inclusion (≥ 4/10 on an EN scale),
Show all 17Show fewer
- Followed by a primary care physician or specialist for this clinical condition,
- Having received or scheduled to receive an EOS type radiological workup in less than 6 months
- Affiliated or entitled to a social security system,
- Having signed the written consent.
- Male or female,
- Aged 18 to 70 years,
- With a waist circumference between 75 cm and 110 cm,
- With a 18.5 < BMI < 30 kg/m2,
- Never having suffered from LBP or any other type of lumbar disorder,
- Affiliated or entitled to a social security system,
- Having signed the written consent.
Who cannot join
- Subjects suffering from LBP of inflammatory, tumoral or infectious cause.
- Pregnant women.
- Subjects with cognitive or mental disorders or confirmed depression;
- Subjects who received an infiltration less than one month prior to the inclusion visit or planned during the study;
- Subjects with a known allergy to any of the materials;
- Subjects complaining of chronic, unstabilized or symptomatic cardiac or respiratory problems;
Show all 9Show fewer
- Subjects with current participation in an interventional investigational drug or device therapy study that impacts the endpoints.
- Subjects under legal protection or unable to express their consent;
- Subject presenting a lumbar radicular syndrome (hiatal hernia, spinal stenosis...).
Trial locations and contacts
1 site in 1 country.
About this study
Low back pain (LBP) is a common condition worldwide as the lifetime prevalence is up to 80%. It is defined as pain in the lumbosacral region in which the etiological causes are most often mechanical, and it is therefore defined as "non-specific LBP".
Lumbar belts are used in the treatment and secondary prevention of LBP. They are supposed to reduce the intensity of pain by improving the functional capacities of daily activities and thus preventing the risk of chronicity related to immobility (HAS).
Read more
Despite some proof of their efficiency in the literature, it is still not clear how the pressure applied by the belt and the immobilization constraints on the trunk improve the patient mobility.
Considering that LBP causes movement limitation, and that the lumbar belt contributes to initially decrease the pain intensity, as well as to improve the mobility and the functional capacities of the patient, we propose to evaluate the clinical and biomechanical effects of the lumbar belt during different trunk movements in subjects with and without LBP.
This is a clinical investigation on a CE marked medical device, used in accordance with its intended purpose, in the context of a post-marketing clinical follow-up with additional non-invasive procedures (IC SCAC: case 4.1 of the medical device regulation 2017/745).This is a prospective, monocentric, comparative and open clinical investigation.
The objective is to evaluate the clinical and functional effects related to spinal movements in 2 conditions, with and without the wearing of a lumbar belt. The study will be carried out with two groups of subjects: one group of subjects presenting an episode of LBP (NS>4) (subjects considered to have subacute or chronic nonspecific LBP according to the classification of LBP) and another group of control subjects with no spinal symptoms and no pain that could limit movement (healthy subjects).
Each group will undergo 2 visits on 2 separate days with a 30-day delay for the LBP subjects and a 7-day delay for the healthy subjects
- a first visit (V1) for inclusion, familiarization with a clinical and functional test, and an external measurement of spinal mobility during movements;
- a second visit (V2) for a clinical and functional evaluation, external measurements of spinal mobility and biomechanical measurements.
A third visit (V3) will be offered to healthy subjects for the measurement of spinal segment kinematics with the LombaSkin belt and Percko postural T-shirt.
- Conditions
- Low Back Pain
- Being tested
- Lumbar belt, Lombaskin lumbar belt and the Lyne Up percko postural T-shirt.
- Keywords
- Low Back Pain, Lumbar belt, Movement, Kinematics
- 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.
Lumbar beltDevice
All subjects (LBP group and healthy group) wear the belt during the two visits to perform differents tests.
The invistigator will ask the LBP patients to wear the lumbar belt between the two visits (for 4 weeks, for 4 to 8 hours per day)
Lombaskin lumbar belt and the Lyne Up percko postural T-shirt.Device
Lombaskin lumbar belt and the Lyne Up percko postural T-shirt could be worn during the third addtional visit proposed to the healthy subject.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Lumbar belt Lombastab® (Thuasne, Levallois Perret, France) | Experimental | Low back pain patients wear Lumbar belt Lombastab® during 4 weeks according to the instructions given by the investigator of the study. Receives: Device: Lumbar belt |
| Optional arm: Healthy subjects who will done the third additional visit | Experimental | For the healthy subjects, they will be offered to do a third additional visit during which they will be able to test the Lombaskin lumbar belt and the Lyne Up percko postural T-shirt. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spinal Mobility assessed by the fingertip to floor distance test (FTF)
The effect of wearing a lumbar belt on spinal mobility during anterior flexion of the trunk (sagittal plane) in subjects with LBP using the fingertip to floor (FTF) distance test.
Measured: Immediately with and without wearing the lumbar belt (Day 0)
Spinal Mobility assessed by the fingertip to floor distance test (FTF)
The effect of wearing a lumbar belt (for 4 weeks) on spinal mobility during anterior flexion of the trunk (sagittal plane) in subjects with LBP using the fingertip to floor (FTF) distance test.
Measured: After 4 weeks with and without wearing the lumbar belt (Day 30)
Secondary outcomes (7)
Spinal Mobility assessed by the fingertip to floor distance test (FTF)
Spinal mobility (using the FTF test in forward flexion, the FTF test in lateral flexion and the sternum to wall test in extension):
a.1) In subjects with LBP at Day 0 and Day 30
a.2) In healthy subjects (at Day 0)
a.3) Between healthy subjects and LBP subjects (at Day 0)
Measured: During the Day 0 (for both groups) and Day 30 (for LBP patients) with and without wearing the belt
Pain level assessed by Numerical Scale (NS)
Pain in LBP subjects (Day 0 vs Day 30) using Numerical Scale (NS) from 0 to 10 (0: no pain and 10: worst pain)
Measured: During the Day 0 and Day 30 immediately before and after wearing the belt, and after each movement with and without the belt (for LBP patients)
Functional capacities assessed by Oswestry Disability Index (ODI)
Functional capacities of LBP subjects (Day 0 and Day 30) using Oswestry Disability Index (ODI)
Measured: During the beginning of Day 0 and Day 30 (for LBP patients)
Kinematics of the spinal segments assessed by Inertial Measurement Units sensors
Kinematics of the spinal segments using 3 IMUs (Inertial Measurement Units) sensors:
d.1) In LBP subjects (Day 0 vs Day 30) d.2) In healthy subjects (at Day 0 and at the third visit only on LombaSkin belt and Percko postural T-shirt) d.3) Between healthy subjects and LBP subjects (at Day 0)
Measured: During Day 0 (for both groups), third visit (for healthy subjects) and Day 30 (for LBP patients) with and without wearing the belt
Trunk posture measured by 8-camera image stereo correlation system
Trunk posture using 8-camera image stereo-correlation system (Alternative to motion capture) e.1) In subjects with LBP (Day 30) e.2) In healthy subjects (at Day 7) e.3) Between healthy subjects and subjects with LBP (Day 7 vs Day 30)
Measured: During Day 7 (for healthy subjects) and Day 30 (for LBP patients)
The pressure applied by the belt on the trunk assessed by piezo-resistive sensors
The pressure applied by the belt on the trunk using piezo-resistive sensors f.1) In subjects with LBP (Day 30) f.2) In healthy subjects (at Day 7) f.3) Between healthy subjects and LBP subjects (Day 7 vs Day 30)
Measured: During Day 7 (for healthy subjects) and Day 30 (for LBP patients)
Deformation of the lumbar belt assessed by 8-camera image stereo-correlation system
To evaluate, during spinal movements, the deformation of the lumbar belt considered as a mechanism of action using 8-camera image stereo-correlation system:
g.1) In LBP subjects (Day 30) g.2) In healthy subjects (Day 7) g.3) Between healthy subjects and LBP subjects (Day 7 vs Day 30)
Measured: During Day 7 (for healthy subjects) and Day 30 (for LBP patients)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study start30 Sep 2022
- Primary completion29 Mar 2024
- Study completion29 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thuasne
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul CALMELS, MD PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05600543
- Sponsor's protocol ID
- 2022-A01060-43
- Other IDs
- ANSM
- Acronym
- LombaMob
- Status last verified
- Sep 2024
- First submitted
- 21 Oct 2022
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Oshikawa T, Kaneoka K, Morimoto Y, Akuzawa H. Comparison of Lumbar Kinematics with a History of Low Back Pain During Baseball Hitting. Int J Sports Med. 2020 Feb;41(2):119-127. doi: 10.1055/a-1014-3041. Epub 2020 Jan 7.
PubMed 31910447Masharawi Y, Haj A, Weisman A. Lumbar Axial Rotation Kinematics in an Upright Sitting and With Forward Bending Positions in Men With Nonspecific Chronic Low Back Pain. Spine (Phila Pa 1976). 2020 Mar 1;45(5):E244-E251. doi: 10.1097/BRS.0000000000003265.
PubMed 32032339Christe G, Rochat V, Jolles BM, Favre J. Lumbar and thoracic kinematics during step-up: Comparison of three-dimensional angles between patients with chronic low back pain and asymptomatic individuals. J Orthop Res. 2020 Jun;38(6):1248-1256. doi: 10.1002/jor.24575. Epub 2020 Jan 7.
PubMed 31879969Marich AV, Hwang CT, Sorensen CJ, van Dillen LR. Examination of the Lumbar Movement Pattern during a Clinical Test and a Functional Activity Test in People with and without Low Back Pain. PM R. 2020 Feb;12(2):140-146. doi: 10.1002/pmrj.12197. Epub 2019 Sep 3.
PubMed 31140705Haj A, Weisman A, Masharawi Y. Lumbar axial rotation kinematics in men with non-specific chronic low back pain. Clin Biomech (Bristol). 2019 Jan;61:192-198. doi: 10.1016/j.clinbiomech.2018.12.022. Epub 2018 Dec 22.
PubMed 30594767Hernandez A, Gross K, Gombatto S. Differences in lumbar spine and lower extremity kinematics during a step down functional task in people with and people without low back pain. Clin Biomech (Bristol). 2017 Aug;47:46-52. doi: 10.1016/j.clinbiomech.2017.05.012. Epub 2017 May 27.
PubMed 28600994Mitchell K, Porter M, Anderson L, Phillips C, Arceo G, Montz B, Levy S, Gombatto SP. Differences in lumbar spine and lower extremity kinematics in people with and without low back pain during a step-up task: a cross-sectional study. BMC Musculoskelet Disord. 2017 Aug 25;18(1):369. doi: 10.1186/s12891-017-1721-z.
PubMed 28841866Shojaei I, Salt EG, Hooker Q, Van Dillen LR, Bazrgari B. Comparison of lumbo-pelvic kinematics during trunk forward bending and backward return between patients with acute low back pain and asymptomatic controls. Clin Biomech (Bristol). 2017 Jan;41:66-71. doi: 10.1016/j.clinbiomech.2016.12.005. Epub 2016 Dec 10.
PubMed 27992778Gombatto SP, D'Arpa N, Landerholm S, Mateo C, O'Connor R, Tokunaga J, Tuttle LJ. Differences in kinematics of the lumbar spine and lower extremities between people with and without low back pain during the down phase of a pick up task, an observational study. Musculoskelet Sci Pract. 2017 Apr;28:25-31. doi: 10.1016/j.msksp.2016.12.017. Epub 2017 Jan 5.
PubMed 28171775Marich AV, Hwang CT, Salsich GB, Lang CE, Van Dillen LR. Consistency of a lumbar movement pattern across functional activities in people with low back pain. Clin Biomech (Bristol). 2017 May;44:45-51. doi: 10.1016/j.clinbiomech.2017.03.004. Epub 2017 Mar 7.
PubMed 28324797Vaisy M, Gizzi L, Petzke F, Consmuller T, Pfingsten M, Falla D. Measurement of Lumbar Spine Functional Movement in Low Back Pain. Clin J Pain. 2015 Oct;31(10):876-85. doi: 10.1097/AJP.0000000000000190.
PubMed 25503596Gombatto SP, Brock T, DeLork A, Jones G, Madden E, Rinere C. Lumbar spine kinematics during walking in people with and people without low back pain. Gait Posture. 2015 Oct;42(4):539-44. doi: 10.1016/j.gaitpost.2015.08.010. Epub 2015 Sep 3.
PubMed 26380913Van Hoof W, Volkaerts K, O'Sullivan K, Verschueren S, Dankaerts W. Comparing lower lumbar kinematics in cyclists with low back pain (flexion pattern) versus asymptomatic controls--field study using a wireless posture monitoring system. Man Ther. 2012 Aug;17(4):312-7. doi: 10.1016/j.math.2012.02.012. Epub 2012 Mar 20.
PubMed 22436688
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Lumbar Belt on Spinal Mobility in Subjects With and Without Low Back Pain
- ClinicalTrials.gov ID
- NCT05600543
- Acronym / sponsor ID
- LombaMob / 2022-A01060-43
- Conditions
- Low Back Pain
- Keywords
- Low Back Pain, Lumbar belt, Movement, Kinematics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- ThuasneIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2022 (actual)
- Primary completion
- 29 Mar 2024 (actual)
- Study completion
- 29 Mar 2024 (actual)
- First posted
- 31 Oct 2022 (actual)
- 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.
Low back pain (LBP) is a common condition worldwide as the lifetime prevalence is up to 80%. It is defined as pain in the lumbosacral region in which the etiological causes are most often mechanical, and it is therefore defined as "non-specific LBP".
Lumbar belts are used in the treatment and secondary prevention of LBP. They are supposed to reduce the intensity of pain by improving the functional capacities of daily activities and thus preventing the risk of chronicity related to immobility (HAS).
Despite some proof of their efficiency in the literature, it is still not clear how the pressure applied by the belt and the immobilization constraints on the trunk improve the patient mobility.
Considering that LBP causes movement limitation, and that the lumbar belt contributes to initially decrease the pain intensity, as well as to improve the mobility and the functional capacities of the patient, we propose to evaluate the clinical and biomechanical effects of the lumbar belt during different trunk movements in subjects with and without LBP.
This is a clinical investigation on a CE marked medical device, used in accordance with its intended purpose, in the context of a post-marketing clinical follow-up with additional non-invasive procedures (IC SCAC: case 4.1 of the medical device regulation 2017/745).This is a prospective, monocentric, comparative and open clinical investigation.
The objective is to evaluate the clinical and functional effects related to spinal movements in 2 conditions, with and without the wearing of a lumbar belt. The study will be carried out with two groups of subjects: one group of subjects presenting an episode of LBP (NS>4) (subjects considered to have subacute or chronic nonspecific LBP according to the classification of LBP) and another group of control subjects with no spinal symptoms and no pain that could limit movement (healthy subjects).
Each group will undergo 2 visits on 2 separate days with a 30-day delay for the LBP subjects and a 7-day delay for the healthy subjects
- a first visit (V1) for inclusion, familiarization with a clinical and functional test, and an external measurement of spinal mobility during movements;
- a second visit (V2) for a clinical and functional evaluation, external measurements of spinal mobility and biomechanical measurements.
A third visit (V3) will be offered to healthy subjects for the measurement of spinal segment kinematics with the LombaSkin belt and Percko postural T-shirt.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Lumbar belt Lombastab® (Thuasne, Levallois Perret, France) | Experimental | Device: Lumbar beltLow back pain patients wear Lumbar belt Lombastab® during 4 weeks according to the instructions given by the investigator of the study. |
| Optional arm: Healthy subjects who will done the third additional visit | Experimental | –For the healthy subjects, they will be offered to do a third additional visit during which they will be able to test the Lombaskin lumbar belt and the Lyne Up percko postural T-shirt. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Male or female,
- Aged between 18 and 70 years,
- With a waist circumference between 75 cm and 110 cm,
- With a 18.5 < BMI < 30 kg/m2,
- Suffering from a current episode of non-specific low back pain (symptomatic subjects),
Key exclusion criteria (9 listed)
- Subjects suffering from LBP of inflammatory, tumoral or infectious cause.
- Pregnant women.
- Subjects with cognitive or mental disorders or confirmed depression;
- Subjects who received an infiltration less than one month prior to the inclusion visit or planned during the study;
- Subjects with a known allergy to any of the materials;
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 |
|---|---|---|
| Lumbar beltAll subjects (LBP group and healthy group) wear the belt during the two visits to perform differents tests. The invistigator will ask the LBP patients to wear the lumbar belt between the two visits (for 4 weeks, for 4 to 8 hours per day) | Device | Arm 1: Lumbar belt Lombastab® (Thuasne, Levallois Perret, France) |
| Lombaskin lumbar belt and the Lyne Up percko postural T-shirt.Lombaskin lumbar belt and the Lyne Up percko postural T-shirt could be worn during the third addtional visit proposed to the healthy subject. | Device | – |
Primary outcome
Spinal Mobility assessed by the fingertip to floor distance test (FTF)
Time frame: Immediately with and without wearing the lumbar belt (Day 0)
The effect of wearing a lumbar belt on spinal mobility during anterior flexion of the trunk (sagittal plane) in subjects with LBP using the fingertip to floor (FTF) distance test.
Spinal Mobility assessed by the fingertip to floor distance test (FTF)
Time frame: After 4 weeks with and without wearing the lumbar belt (Day 30)
The effect of wearing a lumbar belt (for 4 weeks) on spinal mobility during anterior flexion of the trunk (sagittal plane) in subjects with LBP using the fingertip to floor (FTF) distance test.
7 secondary outcomes
Spinal Mobility assessed by the fingertip to floor distance test (FTF)
Time frame: During the Day 0 (for both groups) and Day 30 (for LBP patients) with and without wearing the belt
Pain level assessed by Numerical Scale (NS)
Time frame: During the Day 0 and Day 30 immediately before and after wearing the belt, and after each movement with and without the belt (for LBP patients)
Functional capacities assessed by Oswestry Disability Index (ODI)
Time frame: During the beginning of Day 0 and Day 30 (for LBP patients)
Kinematics of the spinal segments assessed by Inertial Measurement Units sensors
Time frame: During Day 0 (for both groups), third visit (for healthy subjects) and Day 30 (for LBP patients) with and without wearing the belt
Trunk posture measured by 8-camera image stereo correlation system
Time frame: During Day 7 (for healthy subjects) and Day 30 (for LBP patients)
The pressure applied by the belt on the trunk assessed by piezo-resistive sensors
Time frame: During Day 7 (for healthy subjects) and Day 30 (for LBP patients)
Deformation of the lumbar belt assessed by 8-camera image stereo-correlation system
Time frame: During Day 7 (for healthy subjects) and Day 30 (for LBP patients)
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 10 Apr 2025.
- Background: PubMed 31910447Oshikawa T, Kaneoka K, Morimoto Y, Akuzawa H. Comparison of Lumbar Kinematics with a History of Low Back Pain During Baseball Hitting. Int J Sports Med. 2020 Feb;41(2):119-127. doi: 10.1055/a-1014-3041. Epub 2020 Jan 7.
- Background: PubMed 32032339Masharawi Y, Haj A, Weisman A. Lumbar Axial Rotation Kinematics in an Upright Sitting and With Forward Bending Positions in Men With Nonspecific Chronic Low Back Pain. Spine (Phila Pa 1976). 2020 Mar 1;45(5):E244-E251. doi: 10.1097/BRS.0000000000003265.
- Background: PubMed 31879969Christe G, Rochat V, Jolles BM, Favre J. Lumbar and thoracic kinematics during step-up: Comparison of three-dimensional angles between patients with chronic low back pain and asymptomatic individuals. J Orthop Res. 2020 Jun;38(6):1248-1256. doi: 10.1002/jor.24575. Epub 2020 Jan 7.
- Background: PubMed 31140705Marich AV, Hwang CT, Sorensen CJ, van Dillen LR. Examination of the Lumbar Movement Pattern during a Clinical Test and a Functional Activity Test in People with and without Low Back Pain. PM R. 2020 Feb;12(2):140-146. doi: 10.1002/pmrj.12197. Epub 2019 Sep 3.
- Background: PubMed 30594767Haj A, Weisman A, Masharawi Y. Lumbar axial rotation kinematics in men with non-specific chronic low back pain. Clin Biomech (Bristol). 2019 Jan;61:192-198. doi: 10.1016/j.clinbiomech.2018.12.022. Epub 2018 Dec 22.
- Background: PubMed 28600994Hernandez A, Gross K, Gombatto S. Differences in lumbar spine and lower extremity kinematics during a step down functional task in people with and people without low back pain. Clin Biomech (Bristol). 2017 Aug;47:46-52. doi: 10.1016/j.clinbiomech.2017.05.012. Epub 2017 May 27.
- Background: PubMed 28841866Mitchell K, Porter M, Anderson L, Phillips C, Arceo G, Montz B, Levy S, Gombatto SP. Differences in lumbar spine and lower extremity kinematics in people with and without low back pain during a step-up task: a cross-sectional study. BMC Musculoskelet Disord. 2017 Aug 25;18(1):369. doi: 10.1186/s12891-017-1721-z.
- Background: PubMed 27992778Shojaei I, Salt EG, Hooker Q, Van Dillen LR, Bazrgari B. Comparison of lumbo-pelvic kinematics during trunk forward bending and backward return between patients with acute low back pain and asymptomatic controls. Clin Biomech (Bristol). 2017 Jan;41:66-71. doi: 10.1016/j.clinbiomech.2016.12.005. Epub 2016 Dec 10.
- Background: PubMed 28171775Gombatto SP, D'Arpa N, Landerholm S, Mateo C, O'Connor R, Tokunaga J, Tuttle LJ. Differences in kinematics of the lumbar spine and lower extremities between people with and without low back pain during the down phase of a pick up task, an observational study. Musculoskelet Sci Pract. 2017 Apr;28:25-31. doi: 10.1016/j.msksp.2016.12.017. Epub 2017 Jan 5.
- Background: PubMed 28324797Marich AV, Hwang CT, Salsich GB, Lang CE, Van Dillen LR. Consistency of a lumbar movement pattern across functional activities in people with low back pain. Clin Biomech (Bristol). 2017 May;44:45-51. doi: 10.1016/j.clinbiomech.2017.03.004. Epub 2017 Mar 7.
- Background: PubMed 25503596Vaisy M, Gizzi L, Petzke F, Consmuller T, Pfingsten M, Falla D. Measurement of Lumbar Spine Functional Movement in Low Back Pain. Clin J Pain. 2015 Oct;31(10):876-85. doi: 10.1097/AJP.0000000000000190.
- Background: PubMed 26380913Gombatto SP, Brock T, DeLork A, Jones G, Madden E, Rinere C. Lumbar spine kinematics during walking in people with and people without low back pain. Gait Posture. 2015 Oct;42(4):539-44. doi: 10.1016/j.gaitpost.2015.08.010. Epub 2015 Sep 3.
- Individual participant dataSharing planned: No
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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.
Paul CALMELS, MD PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumbar belt and Lombaskin lumbar belt and the Lyne Up percko postural T-shirt. in people with Low Back Pain, run by Thuasne at 1 site in France.
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 17 inclusion and 9 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 10 Apr 2025. 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 France. 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?
Spinal Mobility assessed by the fingertip to floor distance test (FTF) (time frame: Immediately with and without wearing the lumbar belt (Day 0)). The study lists 2 primary outcomes in all. 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 NCT05600543, which also lists 13 linked publications.
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 10 Apr 2025.