Chronic Low Back Pain (CLBP)LumbaCure2302NCT06662032
Clinical Investigation to Assess the Clinical Effect of the LumbaCure® Intervention on Patients Suffering From Chronic Low Back Pain
A study testing LumbaCure® and Rehab program in people with Chronic Low Back Pain (CLBP), run by Odix at 2 sites in Belgium.
Trial summary
Low Back Pain (LBP) is one of the common causes of morbidity worldwide, with a one-month prevalence of 23.3 %. Number of people with LBP reached 577 million people in 2020. LBP has been the leading cause of years lived with disability from 1990 to 2017. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Low Back Pain (CLBP)
- What is being tested?
- LumbaCure® and Rehab program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesBelgium
- Study dates
- 24 Jun 2024to 26 Jun 2025
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic non-specific LBP (without red flag)
- LBP is the principal musculoskeletal condition
- Aged between 18 and 85 years old
- Able to read and understand questionnaires and communicate with the physiotherapist.
- Average Back Pain intensity over the last week above 2, assessed on Numerical Pain Rating Scale from 0 to 10 anchored with "no pain" at 0 and "worst pain imaginable " at 10.
Who cannot join
- Suspected or confirmed serious pathology (i.e infection, fracture, cancer, inflammatory arthritis, ….)
- Significant sciatica VAS > 7
- Radiculopathy
- Cognitive impairment that precludes participant from consenting, completing investigation questionnaires or complying with recommendations
- Previous spine surgery in the last 3 months
- Pregnant women
Show all 9Show fewer
- body weight > 120 kg
- Neurological disease
- Fibromyalgia
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Randomized Clinical Investigation to Assess Preliminary Clinical Performance, Effectiveness and Safety of the LumbaCure® (Prototype C190070.01) Medical Device When Used in Patients Suffering From Chronic Low Back Pain
Low Back Pain (LBP) is one of the common causes of morbidity worldwide, with a one-month prevalence of 23.3 %. Number of people with LBP reached 577 million people in 2020. LBP has been the leading cause of years lived with disability from 1990 to 2017. The highest incidence of LBP is in people in their third decade of age. LBP is a complex disease difficult to treat as most of these cases (80 - 90 %) are classified as non-specific meaning that the pain cannot be attributed to any specific injury or pathology.
Until now exercise therapy is commonly used as the treatment of choice in the rehab program of LBP. The aim of physical treatment is to improve function and prevent disability from getting worse.
Read more
LumbaCure® is a robotic system driven by a proprietary movement algorithm to induce a specific and controlled mobilization of the low back in patient requiring treatment by physical exercises due to orthopedic disorder, especially low back pain.
In Belgium, the standard back-school programme (rehabilitation programme) includes 35 rehabilitation sessions of 2 h delivered 2x/week at the investigator site (whom the first session is the inclusion visit, no therapy performed) and one session to tackle the psychological component of the condition (information on how to cope with pain). Participants are divided into two groups: the intervention group uses the LumbaCure® device (a seat that mobilizes the lower back for 15 minutes) in addition to the standard sessions (from session 2 to 27), while the control group follows the standard program with an extra 15 minutes of exercises. After session 27 (around 13 weeks), all participants continue their programme without the LumbaCure®, and their progress is assessed before the final 35th session.
Read the detailed description
Low Back Pain (LBP) is one of the most common causes of morbidity worldwide, with a one-month prevalence of 23.3%. In 2020, the number of people suffering from LBP reached 577 million. From 1990 to 2017, LBP remained the leading cause of years lived with disability. The highest incidence of LBP is observed in individuals in their third decade of life. LBP is a complex condition that is often difficult to treat, as 80-90% of cases are classified as non-specific, meaning the pain cannot be attributed to a specific injury or pathology. Exercise therapy is currently the most common treatment for LBP rehabilitation, aiming to improve function and prevent the worsening of disability.
The study involves a standard rehabilitation program in Belgium consisting of 35 multidisciplinary sessions, each lasting 2 hours. Participants are divided into two groups: the intervention group and the control group. The intervention group follows the standard rehabilitation program but also uses the LumbaCure® device, a robotic system driven by a proprietary movement algorithm. The device is designed to induce controlled mobilization of the lower back, which is particularly beneficial for patients requiring physical treatment due to orthopedic disorders like low back pain. During each rehabilitation session, participants in the intervention group perform a 15-minute session on the LumbaCure® device under the supervision of a physiotherapist. Over the intervention period, participants in the intervention group are expected to complete 26 LumbaCure® sessions.
In the control group, participants follow the same standard rehabilitation program with a frequency of ideally twice a week. To match the duration of the intervention group's additional LumbaCure® sessions, participants in the control group perform 15 minutes of additional exercises based on the standard care practices of their respective rehabilitation center.
After session 27, which ideally take place over a period of 13 weeks, all participants continue with the remaining 8 sessions of the standard rehabilitation program. However, during this final phase, no LumbaCure® sessions are included for the intervention group. Participants' progress is monitored throughout the study, with a final evaluation taking place before the completion of the 35th session. This follow-up allows researchers to assess the overall effectiveness of the rehabilitation program, including the impact of the LumbaCure® device on patient outcomes compared to the standard care protocol.
- Conditions
- Chronic Low Back Pain (CLBP)
- Being tested
- LumbaCure®, Rehab program
- Keywords
- LBP, rehab, nCLPB
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LumbaCure®Device
LumbaCure® is a robotic system that systematically moves the spine of affected patients with a complex proprietary algorithm.
Rehab programOther
Standard rehabilitation program
| Study group | Role | What they receive |
|---|---|---|
| Test Intervention | Experimental | In the intervention arm, participants will follow the standard rehabilitation programme at a frequency of ideally 2 times a week. LumbaCure® device will be used in addition to the standard programme. A session of 15 min will be performed at each rehabilitation session. The device is to be used by the Physiotherapist at the rehabilitation centre. In total, the participant should perform 26 LumbaCure® sessions during the intervention period, this corresponds to the number of rehabilitation sessions considered in the intervention period. Receives: Device: LumbaCure®; Other: Rehab program |
| Control Intervention | Active comparator | Participants in the control arm will follow the standard rehabilitation programme at a frequency of ideally 2 times a week. To align with the duration of the intervention arm, participants in the control arm will also perform an additional 15 minutes of exercises (following standard care of the site). Receives: Other: Rehab program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disability
Comparison of the Oswestry Disability Index (ODI) evolution from baseline to session 26 (visit 4, end of intervention) between the two treatment arms.
Measured: Around week 13 (intervention period)
Secondary outcomes (11)
Disability
- Comparison of the difference in the ODI evolution from baseline to session 8 (visit2) session 18 (visit 3) and during the follow-up period (visit 5), between the two treatment arms.
Measured: Around week 4, 9 (intervention period) and week 18 (follow-up)
Back pain
- Changes from baseline, in average back pain intensity over the last week, assessed on Numerical Pain Rating Scale (NPRS) from 0 to 10. Assessed at the different timepoints (visits 2 to 4).
- Changes in average back pain intensity over the last week, assessed on Numerical Rating Scale from 0 to 10, during the follow-up period (V5).
Measured: Around week 4, 9, 13, 18
Function
- Change in function score, assessed using the Patient Specific Functional Scale, between baseline, and the different time points (visits 2 to 4). The PSFS requires participants to identify three problematic activities and to rate these activities on a scale from 0 to 10. A high score indicates a greater ability to accomplish the task.
- Change in function score during the follow-up period, assessed using the Pain Specific Functional Scale.
Measured: Around week 4, 9, 13, 18
Kinesiophobia
- Change in fear of movements and attitudes and behaviour towards pain score, evaluated through the Tampa questionnaire (TSK-17) between baseline to the different timepoints (visits 2 to 4). The total score is calculated by adding up 17 sub-questions assessed using a 4-point Likert scale (from 1 to 4), with high scores indicating a greater degree of kinesiophobia.
- Change in fear of movements and attitudes and behaviour towards pain score, evaluated through the Tampa questionnaire,during the follow-up period (V5)
Measured: Around week 4, 9, 13, 18
Pain catastrophizing
Change in pain catastrophizing score, evaluated through the Pain catastrophizing scale (PCS), between baseline to the different timepoints (visits 2 to 4 and during follow-up : V5). The total score is calculated by adding up 13 sub-questions assessed using a 5-point Likert scale (from 0 to 4), with high score indicating a greater degree of pain catastrophising.
Measured: Around week 4, 9, 13, 18
Flexibility
The ability of the patient to flex the lower back via fingertips to floor distance.
It will be performed at each visit for both groups.
Measured: Around week 4, 9, 13, 18
Disability
- Disability Responding rate: Number and percentage of patients presenting a clinically significant improvement in the ODI at the different timepoints versus baseline in the two treatment arms
Measured: Around week 4, 9 (intervention period) and week 18 (follow-up)
Back pain
- Pain responding rate : Number and percentage of patients presenting a clinically significant improvement in the NPRS at the different timepoints versus baseline in the two treatment arms
Measured: Around week 4, 9, 13, 18
Function
Function responding rate : Number and percentage of patients presenting a clinically significant improvement in the pain specific function scale at the different timepoints versus baseline in the two treatment arms.
Measured: Around week 4, 9, 13, 18
Kinesiophobia
Responding Rate kinesiophobia : Number and percentage of patients presenting a clinically significant improvement in Tampa scale (TSK-17) at the different timepoints versus baseline in the two treatment arms.
Measured: Around week 4, 9, 13, 18
Pain catastrophizing
Responding Rate pain catastrophization : Number and percentage of patients presenting a clinically significant improvement in Pain catastrophizing scale (PCS) at the different timepoints versus baseline, in the two-treatment arms.
Measured: Around week 4, 9, 13, 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start24 Jun 2024
- Primary completion26 Jun 2025
- Study completion26 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back Pain (CLBP)Studies 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
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06662032
- Sponsor's protocol ID
- LumbaCure2302_2.0
- Other IDs
- CIV-23-05-043012
- Acronym
- LumbaCure2302
- Status last verified
- Jan 2026
- First submitted
- 16 Oct 2024
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Investigation to Assess Preliminary Clinical Performance, Effectiveness and Safety of the LumbaCure® (Prototype C190070.01) Medical Device When Used in Patients Suffering From Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT06662032
- Acronym / sponsor ID
- LumbaCure2302 / LumbaCure2302_2.0
- Conditions
- Chronic Low Back Pain (CLBP)
- Keywords
- LBP, rehab, nCLPB
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- OdixIndustry (pharma, biotech, devices)
- Study start
- 24 Jun 2024 (actual)
- Primary completion
- 26 Jun 2025 (actual)
- Study completion
- 26 Jun 2025 (actual)
- First posted
- 28 Oct 2024 (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 one of the common causes of morbidity worldwide, with a one-month prevalence of 23.3 %. Number of people with LBP reached 577 million people in 2020. LBP has been the leading cause of years lived with disability from 1990 to 2017. The highest incidence of LBP is in people in their third decade of age. LBP is a complex disease difficult to treat as most of these cases (80 - 90 %) are classified as non-specific meaning that the pain cannot be attributed to any specific injury or pathology.
Until now exercise therapy is commonly used as the treatment of choice in the rehab program of LBP. The aim of physical treatment is to improve function and prevent disability from getting worse.
LumbaCure® is a robotic system driven by a proprietary movement algorithm to induce a specific and controlled mobilization of the low back in patient requiring treatment by physical exercises due to orthopedic disorder, especially low back pain.
In Belgium, the standard back-school programme (rehabilitation programme) includes 35 rehabilitation sessions of 2 h delivered 2x/week at the investigator site (whom the first session is the inclusion visit, no therapy performed) and one session to tackle the psychological component of the condition (information on how to cope with pain). Participants are divided into two groups: the intervention group uses the LumbaCure® device (a seat that mobilizes the lower back for 15 minutes) in addition to the standard sessions (from session 2 to 27), while the control group follows the standard program with an extra 15 minutes of exercises. After session 27 (around 13 weeks), all participants continue their programme without the LumbaCure®, and their progress is assessed before the final 35th session.
Detailed description
Low Back Pain (LBP) is one of the most common causes of morbidity worldwide, with a one-month prevalence of 23.3%. In 2020, the number of people suffering from LBP reached 577 million. From 1990 to 2017, LBP remained the leading cause of years lived with disability. The highest incidence of LBP is observed in individuals in their third decade of life. LBP is a complex condition that is often difficult to treat, as 80-90% of cases are classified as non-specific, meaning the pain cannot be attributed to a specific injury or pathology. Exercise therapy is currently the most common treatment for LBP rehabilitation, aiming to improve function and prevent the worsening of disability.
The study involves a standard rehabilitation program in Belgium consisting of 35 multidisciplinary sessions, each lasting 2 hours. Participants are divided into two groups: the intervention group and the control group. The intervention group follows the standard rehabilitation program but also uses the LumbaCure® device, a robotic system driven by a proprietary movement algorithm. The device is designed to induce controlled mobilization of the lower back, which is particularly beneficial for patients requiring physical treatment due to orthopedic disorders like low back pain. During each rehabilitation session, participants in the intervention group perform a 15-minute session on the LumbaCure® device under the supervision of a physiotherapist. Over the intervention period, participants in the intervention group are expected to complete 26 LumbaCure® sessions.
In the control group, participants follow the same standard rehabilitation program with a frequency of ideally twice a week. To match the duration of the intervention group's additional LumbaCure® sessions, participants in the control group perform 15 minutes of additional exercises based on the standard care practices of their respective rehabilitation center.
After session 27, which ideally take place over a period of 13 weeks, all participants continue with the remaining 8 sessions of the standard rehabilitation program. However, during this final phase, no LumbaCure® sessions are included for the intervention group. Participants' progress is monitored throughout the study, with a final evaluation taking place before the completion of the 35th session. This follow-up allows researchers to assess the overall effectiveness of the rehabilitation program, including the impact of the LumbaCure® device on patient outcomes compared to the standard care protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Intervention | Experimental | Device: LumbaCure®, Other: Rehab programIn the intervention arm, participants will follow the standard rehabilitation programme at a frequency of ideally 2 times a week. LumbaCure® device will be used in addition to the standard programme. A session of 15 min will be performed at each rehabilitation session. The device is to be used by the Physiotherapist at the rehabilitation centre. In total, the participant should perform 26 LumbaCure® sessions during the intervention period, this corresponds to the number of rehabilitation sessions considered in the intervention period. |
| Control Intervention | Active comparator | Other: Rehab programParticipants in the control arm will follow the standard rehabilitation programme at a frequency of ideally 2 times a week. To align with the duration of the intervention arm, participants in the control arm will also perform an additional 15 minutes of exercises (following standard care of the site). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Chronic non-specific LBP (without red flag)
- LBP is the principal musculoskeletal condition
- Aged between 18 and 85 years old
- Able to read and understand questionnaires and communicate with the physiotherapist.
- Average Back Pain intensity over the last week above 2, assessed on Numerical Pain Rating Scale from 0 to 10 anchored with "no pain" at 0 and "worst pain imaginable " at 10.
Key exclusion criteria (9 listed)
- Suspected or confirmed serious pathology (i.e infection, fracture, cancer, inflammatory arthritis, ….)
- Significant sciatica VAS > 7
- Radiculopathy
- Cognitive impairment that precludes participant from consenting, completing investigation questionnaires or complying with recommendations
- Previous spine surgery in the last 3 months
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 |
|---|---|---|
| LumbaCure®LumbaCure® is a robotic system that systematically moves the spine of affected patients with a complex proprietary algorithm. | Device | Test Intervention |
| Rehab programStandard rehabilitation program | Other | Control Intervention, Test Intervention |
Primary outcome
Disability
Time frame: Around week 13 (intervention period)
Comparison of the Oswestry Disability Index (ODI) evolution from baseline to session 26 (visit 4, end of intervention) between the two treatment arms.
11 secondary outcomes
Disability
Time frame: Around week 4, 9 (intervention period) and week 18 (follow-up)
Back pain
Time frame: Around week 4, 9, 13, 18
Function
Time frame: Around week 4, 9, 13, 18
Kinesiophobia
Time frame: Around week 4, 9, 13, 18
Pain catastrophizing
Time frame: Around week 4, 9, 13, 18
Flexibility
Time frame: Around week 4, 9, 13, 18
Disability
Time frame: Around week 4, 9 (intervention period) and week 18 (follow-up)
Back pain
Time frame: Around week 4, 9, 13, 18
Function
Time frame: Around week 4, 9, 13, 18
Kinesiophobia
Time frame: Around week 4, 9, 13, 18
Pain catastrophizing
Time frame: Around week 4, 9, 13, 18
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 15 Jan 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LumbaCure® and Rehab program in people with Chronic Low Back Pain (CLBP), run by Odix at 2 sites in Belgium.
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 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 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. 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 (time frame: Around week 13 (intervention period)). 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 15 Jan 2026.