Low Back PainLOMBACTNCT04701073
Lumbar Belt Benefit Compared to the Usual Care in the Treatment of Non-specific Low Back Pain
A study testing LombaStab belt in people with Low Back Pain, run by Thuasne at 3 sites in France.
Trial summary
Lumbar belt benefit compared to the usual care in the treatment of non-specific low back pain -an interventional, prospective, multicenter, randomized, open and controlled.study Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- LombaStab belt
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 3 sitesFrance
- Study dates
- 1 Feb 2021to 20 Jun 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female, aged from 18 to 55 years old
- Patient suffering from non-specific low back pain with current episode has progressed for 1 to 6 months
- At least one lumbar mean pain at rest or at effort of the last 72 hours collected on inclusion ≥ 40/100 on an NRS scale.
- Ability of the patient or legally authorized representative to provide a signed and dated i informed consent form before any procedure or data collection.
- Patient covered by the French Social security system.
Who cannot join
- Patient wearing a lumbar belt the day of the inclusion visit
- Patient who has had surgical intervention on dorso-lumbar spine or lower limb the past 5 years or who has planned surgery during the study
- MODIC diagnosis (disc degeneration) known or confirmed by MRI
- On sick leave for more than 3 consecutive months due to low back pain at the time of inclusion
- Low back pain related to an accident at work
- Low back pain due to secondary origin: tumor, inflammatory, infectious cause, related to a fracture or a vertebral compression
Show all 18Show fewer
- Patient with fibromyalgia
- Patient with lumbar radicular syndrome (radicular conflict like disc herniation, spinal stenosis...)
- Pregnant woman or trying to become pregnant during the study
- Patient with confirmed depression
- Patient with cognitive or mental disorders
- Morphology with measurements not allowing to match with the sizes of belts available
- Patient presenting chronic pathology with disabling functional consequences
- Patient who received an infiltration less than one month before inclusion visit or planned during the study
- Patient with known allergy to any of the materials (see product composition in the Description section of user instruction)
- Patient with contraindicated to belt wearing: hiatus hernia, deficient respiratory functions
- Anticipated poor compliance of subject with study procedures
- Current participation in an interventional investigation drug or device treatment study with an impact on evaluation criteria
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHU Grenoble Alpes
Grenoble
Hôpital Cochin
Paris
CHU de St Etienne
Saint-Etienne
About this study
Official title: Lumbar Belt Benefit Compared to the Usual Care in the Treatment of Non-specific Low Back Pain -an Interventional, Prospective, Multicenter, Randomized, Open and Controlled Study
Lumbar belt benefit compared to the usual care in the treatment of non-specific low back pain -an interventional, prospective, multicenter, randomized, open and controlled.study
Read the detailed description
This is a controlled study, with randomization of the patients, which aims at evaluating the benefit and interest of wearing a new generation lumbar belt, in patients suffering from non-specific low back pain. This trial is also designed to provide quality of life data and to assess the medico-economic interest of wearing such a lumbar belt.
This is an interventional study with low risks and constraints that does not deviate from the local standard of care for enrolled patients. No invasive examination or procedure is performed; as such, there will be no additional risks for participating patients.
203 patients will be followed during 12 weeks in up to 20 investigational sites Patients meeting all eligibility criteria will be included in the study and randomized into one of the two following groups on a 1: 1 ratio.
- Control group "usual care": promotion of physical activity and taking usual medicines for pain relief
- Intervention group: wearing the LombaStab belt in addition to usual care (promotion of physical activity and taking usual medicines for pain relief).
Three visits will be performed:
- Inclusion visit - baseline D0 - V0
- Follow-up visit at week 4 (+/- 5 days) - V1
- Follow-up visit at week 12 (+/- 5 days) - V2
At inclusion visit, after verification of the eligibility criteria, data regarding patients will be collected: demographic data, low back pain history, medical and surgical history, concomitant medications.
At each visit will be performed:
- physical examinations and score assessment by the investigator: ODI score, finger-to-floor distance test, Schober Mac Rae test
- medical interview with patient in order to collect the following information: description of pain, drug consumption, duration of sick leave and resumption of activity at work, use of medical resources (consultations and complementary).
- reporting of all AEs and device deficiencies
Patients will be asked to complete on-line questionnaires, following visits and each week.
- Conditions
- Low Back Pain
- Being tested
- LombaStab belt
- Keywords
- Low back pain, Lumbar belt, Functional capacity, Medicoeconomic, Compliance
- Medical subject headings
- Low Back Pain, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LombaStab beltDevice
Instruction given to the patient will be to wear the LombaStab belt from 4 to 8 hours per days, over the whole duration of the study (12 weeks). The investigator will explain to the patient how to adjust it.
The LombaStab belt will be equiped with thermosensor to evaluate the belt wearing time at the end of the study.
| Study group | Role | What they receive |
|---|---|---|
| Control group "usual care" | No intervention | Promotion of physical activity and taking usual medicines for pain relief |
| Intervention group : lumbar belt | Experimental | wearing the LombaStab belt during 3 months in addition to usual care (promotion of physical activity and taking usual medicines for pain relief). Receives: Device: LombaStab belt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline ODI score (Oswestry Disability Index) at 12 weeks
The functional capacity is measured by ODI score.The ODI questionnaire consists in 10 questions and 6 answers modalities.The ODI score results are expressed in percentage.The higher the percentage is, the more the functional capacity is impaired.
Measured: Week: 0 and 12
Secondary outcomes (15)
Evolution of functional capacity
The functional capacity is measured by ODI score.The ODI questionnaire consists in 10 questions and 6 answers modalities.The ODI score results are expressed in percentage.The higher the percentage is, the more the functional capacity is impaired.
Measured: Week: 0 and 4
Evolution of pain level
Pain level is measured by NRS scale completed by the patient : minimum, maximum, mean at effort and at rest : 0 corresponds to no pain (better outcome) and 10 to maximum pain (worst outcome)
Measured: Week: 0, 4 and 12
Evolution of pain characteristics
Characteristics of pain are evaluated by specific questions regarding the description of pain
Measured: Week: 0, 4 and 12
Evolution of Quality of Life
Quality of life is measured by the EQ5D questionnaire completed by the patient. The EQ-5D questionnaire has two components: health state description and evaluation.
In the description part, health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Mobility dimension asks about the person's walking ability. Self-care dimension asks about the ability to wash or dress by oneself, and usual activities dimension measures performance in "work, study, housework, family or leisure activities". In pain/discomfort dimension, it asks how much pain or discomfort they have, and in anxiety/depression dimension, it asks how anxious or depressed they are. The respondents self-rate their level of severity for each dimension using five-level (EQ-5D-5L) scale.
In the evaluation part, the respondents evaluate their overall health status using the visual analogue scale (EQ-VAS).
Measured: Week: 0 and 12
Assessment of doctors' opinion on improving the patient's health condition caused by low back pain and severity
Improvement and severity are measured by the CGI-I and CGI-S questionnaires respectively.
Doctors' opinion on the change of patient's health condition due to low back pain is measured by the Clinical Global Impression - Improvement questionnaire. The scale has 7 levels of answer from "very strongly improved" which is the better outcome (= 1 point) to "very strongly aggravated" which is the worst outcome (= 7 points) .Intermediate levels are: " Significantly improved "(= 2 points) ; " Slightly improved " (= 3 points) ; " No improvement " (=4 points) ; " Slightly worsen " (=5 points) ; " Seriously worsen" ( = 6 points).
The highest score corresponds to the most impairment in quality of life.
Measured: Week 0, 4 and 12
Assessment of patient's opinion on Global Impression of Change about his general condition
Improvement is measured by the PGI-C questionnaire. Patient's opinion on Global Impression of Change about her general condition is measured by the modified PGI-C questionnaire (Patient's opinion on Global Impression of Change). The scale has 7 levels from "no change or condition has got worsed"(worse outcome) to "a great deal better, and a considerable improvement that has made all the difference ( better outcome)". Intermediate levels are: "almost the same, hardly any change at all"; "a little better, but no noticeable change", "somewhat better, but the change has not made any real difference"; "moderately better, and a slight but noticeable change"; "better, and a definite improvement that has made a real and worthwhile difference.
Measured: Week: 4 and 12
Evolution of spinal mobility vie Finger to floor distance test
Spinal mobility is measured by finger-to-floor distance test. The subject stands erect on a platform 20-cm high He's asked to bend forward as far as possible, while maintaining the knees, arms, and fingers fully extended. The vertical distance between the tip of the middle finger and the platform is measured with a suppletape measure in centimeters. The vertical distance between the platform and tip of the middle finger is positive when the subject do not reach the platform and negative when he can go further.
Measured: Week: 0, 4 and 12
Evolution of spinal mobility via Schober Mac Rae test
Spinal mobility is measured by Schober Mac Rae test. The Patient is standing, examiner marks both posterior superior iliac spine and then draws a horizontal line at the centre of both marks. A second line is marked 5 cm below the first line.
A third line is marked 10 cm above the first line. Patient is then instructed to flex forward as if attempting to touch his/her toes, examiner remeasures distance between the top and bottom line.
Measured: Week: 0, 4 and 12
Evolution of physical activity
Physical activity is measured by IPAQ questionnaire completed by the patient The IPAQ questionnaire measures the time associated to intensive activity, moderate activity, walking and sitting in the last week.
Measured: Week: 0, 4 and 12
Evolution of drug consumption
Drug consumption (analgesics, anti-inflammatories, etc), is recorded by the patient each week in ePRO (name of the drug, frequency of taking the medication)
Measured: Week: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12
Medical and paramedical consultations
Number of consultations (physiotherapy / doctors / osteopathy…) or hospitalization and complementary examinations carried out are measured by patient's interview
Measured: Week: 0, 4 and 12
Duration of Sick leave
Global duration of sick leave (number of days, Saturday and Sunday included) is measured by patient's interview
Measured: Week: 0, 4 and 12
Assessment of tolerance
Tolerance is measured by adverse events reported. Number and type of serious and non-serious Adverse Device Effects (ADE) are reported..
Measured: Week: 4 and 12
Assessment of time of belt's wearing
Compliance is measured by a thermosensor specific device fixed to the belt
Measured: through study completion, an average of 12 weeks
Assessment of patient's satisfaction about the lumbar belt comfort and design
Satisfaction is measured by a specific questionnaire completed by the patient. Questions are about comfort, easy to use, performance on pain, aesthetic...
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start1 Feb 2021
- Primary completion20 Jun 2024
- Study completion20 Jun 2024
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
- Model description
- An interventional, prospective, multicenter, randomized, open and controlled study
- Masking
- None (open label)
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thuasne
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- RCTs
- Responsible party
- Sponsor
- Investigators
- Laurent GRANGE, MD, PH, Principal investigator, CHU de Grenoble Alpes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04701073
- Sponsor's protocol ID
- EC33
- Other IDs
- 2020-003201-54
- Acronym
- LOMBACT
- Status last verified
- Sep 2024
- First submitted
- 17 Dec 2020
- Last updated
- 5 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Grange L, Calmels P, Pers YM, Laustriat G, Wieczorek V, Saih N, De-Seze M, Nguyen C, Daste C, Fayolle-Minon I, Coudeyre E, Rannou F. Lumbar Belt for Nonspecific Low Back Pain: A Randomized Clinical Trial. JAMA Netw Open. 2026 Aug 3;9(8):e2629793. doi: 10.1001/jamanetworkopen.2026.29793.
PubMed 42616499
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lumbar Belt Benefit Compared to the Usual Care in the Treatment of Non-specific Low Back Pain -an Interventional, Prospective, Multicenter, Randomized, Open and Controlled Study
- ClinicalTrials.gov ID
- NCT04701073
- Acronym / sponsor ID
- LOMBACT / EC33
- Conditions
- Low Back Pain
- Keywords
- Low back pain, Lumbar belt, Functional capacity, Medicoeconomic, Compliance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- ThuasneIndustry (pharma, biotech, devices)
- Collaborators
- RCTs
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 20 Jun 2024 (actual)
- Study completion
- 20 Jun 2024 (actual)
- First posted
- 8 Jan 2021 (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.
Lumbar belt benefit compared to the usual care in the treatment of non-specific low back pain -an interventional, prospective, multicenter, randomized, open and controlled.study
Detailed description
This is a controlled study, with randomization of the patients, which aims at evaluating the benefit and interest of wearing a new generation lumbar belt, in patients suffering from non-specific low back pain. This trial is also designed to provide quality of life data and to assess the medico-economic interest of wearing such a lumbar belt.
This is an interventional study with low risks and constraints that does not deviate from the local standard of care for enrolled patients. No invasive examination or procedure is performed; as such, there will be no additional risks for participating patients.
203 patients will be followed during 12 weeks in up to 20 investigational sites Patients meeting all eligibility criteria will be included in the study and randomized into one of the two following groups on a 1: 1 ratio.
- Control group "usual care": promotion of physical activity and taking usual medicines for pain relief
- Intervention group: wearing the LombaStab belt in addition to usual care (promotion of physical activity and taking usual medicines for pain relief).
Three visits will be performed:
- Inclusion visit - baseline D0 - V0
- Follow-up visit at week 4 (+/- 5 days) - V1
- Follow-up visit at week 12 (+/- 5 days) - V2
At inclusion visit, after verification of the eligibility criteria, data regarding patients will be collected: demographic data, low back pain history, medical and surgical history, concomitant medications.
At each visit will be performed:
- physical examinations and score assessment by the investigator: ODI score, finger-to-floor distance test, Schober Mac Rae test
- medical interview with patient in order to collect the following information: description of pain, drug consumption, duration of sick leave and resumption of activity at work, use of medical resources (consultations and complementary).
- reporting of all AEs and device deficiencies
Patients will be asked to complete on-line questionnaires, following visits and each week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- An interventional, prospective, multicenter, randomized, open and controlled study
| Arm | Type | Receives |
|---|---|---|
| Control group "usual care" | No intervention | –Promotion of physical activity and taking usual medicines for pain relief |
| Intervention group : lumbar belt | Experimental | Device: LombaStab beltwearing the LombaStab belt during 3 months in addition to usual care (promotion of physical activity and taking usual medicines for pain relief). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or female, aged from 18 to 55 years old
- Patient suffering from non-specific low back pain with current episode has progressed for 1 to 6 months
- At least one lumbar mean pain at rest or at effort of the last 72 hours collected on inclusion ≥ 40/100 on an NRS scale.
- Ability of the patient or legally authorized representative to provide a signed and dated i informed consent form before any procedure or data collection.
- Patient covered by the French Social security system.
Key exclusion criteria (18 listed)
- Patient wearing a lumbar belt the day of the inclusion visit
- Patient who has had surgical intervention on dorso-lumbar spine or lower limb the past 5 years or who has planned surgery during the study
- MODIC diagnosis (disc degeneration) known or confirmed by MRI
- On sick leave for more than 3 consecutive months due to low back pain at the time of inclusion
- Low back pain related to an accident at work
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 |
|---|---|---|
| LombaStab beltInstruction given to the patient will be to wear the LombaStab belt from 4 to 8 hours per days, over the whole duration of the study (12 weeks). The investigator will explain to the patient how to adjust it. The LombaStab belt will be equiped with thermosensor to evaluate the belt wearing time at the end of the study. | Device | Intervention group : lumbar belt |
Primary outcome
Change from baseline ODI score (Oswestry Disability Index) at 12 weeks
Time frame: Week: 0 and 12
The functional capacity is measured by ODI score.The ODI questionnaire consists in 10 questions and 6 answers modalities.The ODI score results are expressed in percentage.The higher the percentage is, the more the functional capacity is impaired.
15 secondary outcomes
Evolution of functional capacity
Time frame: Week: 0 and 4
Evolution of pain level
Time frame: Week: 0, 4 and 12
Evolution of pain characteristics
Time frame: Week: 0, 4 and 12
Evolution of Quality of Life
Time frame: Week: 0 and 12
Assessment of doctors' opinion on improving the patient's health condition caused by low back pain and severity
Time frame: Week 0, 4 and 12
Assessment of patient's opinion on Global Impression of Change about his general condition
Time frame: Week: 4 and 12
Evolution of spinal mobility vie Finger to floor distance test
Time frame: Week: 0, 4 and 12
Evolution of spinal mobility via Schober Mac Rae test
Time frame: Week: 0, 4 and 12
Evolution of physical activity
Time frame: Week: 0, 4 and 12
Evolution of drug consumption
Time frame: Week: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12
Medical and paramedical consultations
Time frame: Week: 0, 4 and 12
Duration of Sick leave
Time frame: Week: 0, 4 and 12
Assessment of tolerance
Time frame: Week: 4 and 12
Assessment of time of belt's wearing
Time frame: through study completion, an average of 12 weeks
Assessment of patient's satisfaction about the lumbar belt comfort and design
Time frame: Week 12
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 5 Sep 2024.
- Derived from this study: PubMed 42616499Grange L, Calmels P, Pers YM, Laustriat G, Wieczorek V, Saih N, De-Seze M, Nguyen C, Daste C, Fayolle-Minon I, Coudeyre E, Rannou F. Lumbar Belt for Nonspecific Low Back Pain: A Randomized Clinical Trial. JAMA Netw Open. 2026 Aug 3;9(8):e2629793. doi: 10.1001/jamanetworkopen.2026.29793.
- 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.
Laurent GRANGE, MD, PH principal investigator
CHU de Grenoble Alpes
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LombaStab belt in people with Low Back Pain, run by Thuasne at 3 sites 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 5 inclusion and 18 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 5 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Change from baseline ODI score (Oswestry Disability Index) at 12 weeks (time frame: Week: 0 and 12). 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 NCT04701073, 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 5 Sep 2024; AzTrials last refreshed its copy on 6 Nov 2026.