Chronic Low Back PainNCT06138002
Clinical Investigation to Assess the Clinical Performance of the LumbaCure® Intervention on Chronic Low Back Pain Patients.
A study testing LumbaCure® and Physical Exercises supervised by the physiotherapist in people with Chronic Low Back Pain, 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 65 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- LumbaCure® and Physical Exercises supervised by the physiotherapist
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesBelgium
- Study dates
- 2 Oct 2023to 12 Sep 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic non-specific LBP (without red flag)
- Patient did not increase, on a long-term basis, his/her regular physical activity in the past 2 months.
- LBP is the principal musculoskeletal condition
- Aged between 18 and 65 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.
- ODI score > 20
Who cannot join
- Suspected or confirmed serious pathology (i.e infection, fracture, cancer, inflammatory arthritis, ….)
- Radicular pain
- 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.
Belgium2 sites
Jessa Ziekenhuis vzw
Hasselt, 3500
Jessa Ziekenhuis vzw
Herk-de-Stad, 3540
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 revalidation 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 hips and the low back in patient requiring treatment by physical exercises due to orthopedic disorder, especially low back pain.
The investigation include an intervention period of 4 weeks The main objective is to compare the impact on disability (Oswestry disability Index) and movement performance of the interventions (LumbaCure® vs physical exercises supervised by the physiotherapist) in two parallel groups of patients suffering from chronic low back pain.
The investigation includes an intervention period of 4 weeks and a follow-up period of 6 months (post intervention period).
- Conditions
- Chronic Low Back Pain
- Being tested
- LumbaCure®, Physical Exercises supervised by the physiotherapist
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.
Physical Exercises supervised by the physiotherapistProcedure or surgery
A set of core stability/active qualitative mobilization exercises have been defined, corresponding to standard exercises proposed in center rehabilitation program
| Study group | Role | What they receive |
|---|---|---|
| Test Intervention arm | Experimental | The LumbaCure® is a robotic system which provide active, specific and controlled mobilization of the low back. The device is to be used by the Physiotherapist at the rehabilitation centre. The duration of a session for the patient is 15 minutes.
Patients follow a serie of 12 consecutive LumbaCure® sessions at a frequency of 3 sessions / week for 4 weeks. Receives: Device: LumbaCure® |
| Control Intervention arm | Active comparator | A set of core stability exercises/active qualitative mobilization has been defined with principal investigator according to the standard of care at Investigator site. At each session, 5 exercises will be selected by the investigator depending on the evolution and pathology of the patient. Five minutes of warm-up will be performed before starting the exercises session.
The program will last 15 to 30 min depending on the time required for the patient to complete the prescribed exercises.
Patients follow a serie of 12 consecutive physical exercises sessions at a frequency of 3 sessions / week for 4 weeks. Receives: Procedure: Physical Exercises supervised by the physiotherapist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disability
The change of the Oswestry Disability Index (ODI) between baseline and the end of the intervention period (4 weeks)
Measured: Baseline, week 4 (end of intervention period)
Secondary outcomes (16)
Disability
The change in the ODI score between baseline and follow-up period
Measured: week2 (intervention period); month 1, month 3 and month 6 follow-up period
Disability responding rate
Number and percentage of patients presenting an improvement from baseline of at least 10 points in the ODI
Measured: week 2, week 4 (intervention period) and at month 1, month 3 and month 6 follow-up period
Back Pain
Changes in the average back pain intensity over the last week from baseline, assessed on Numerical Pain Rating Scale from 0 to 10 (0 for no pain and 10 for worst pain imaginable)
Measured: week 1, week 2, week 3 and week 4 (the intervention period)
Back Pain
Changes in average back pain intensity over the last week from end of the intervention period (week 4), assessed on Numerical Rating Scale from 0 to 10 (0 for no pain and 10 for worst pain imaginable) in the follow-up period.
Measured: month 1, month 3 and month 6 (follow-up period)
Back Pain responding rate
Number and percentage of patients presenting an improvement from baseline of at least 1.5 points in the Numerical Pain rating scale
Measured: week 2, week 4 (intervention period) and at month 1, month 3 and month 6 (follow-up period)
Function
Change in function score from baseline, assessed using the Pain Specific Functional Scale. The PSFS requires participants to identify three problematic activities and to rate these activities on a scale from 0 to 10.
Measured: week 4
Function
Change in function score from the end of the intervention period (week 4) in the follow-up period, assessed using the Pain Specific Functional Scale. The PSFS requires participants to identify three problematic activities and to rate these activities on a scale from 0 to 10.
Measured: Between end of intervention period and month 1, month 3 and 6 post-intervention
Function responding rate
Number and percentage of patients presenting an improvement of at least 1.5 points from baseline in the pain specific function scale
Measured: week 4 (intervention period) and at month 1, month 3 and month 6 (follow-up period)
Kinesiophobia
Change in fear of movements and attitudes and behavior from baseline towards pain score, evaluated through the Tampa questionnaire.
Measured: week 4
Kinesiophobia
Change in fear of movements and attitudes and behavior from the end of intervention period (week4), towards pain score, evaluated through the Tampa questionnaire.
Measured: month 1, month 3 and 6 (follow-up period)
Kinesiophobia responding rate
Number and percentage of patients presenting an improvement of at least 6 points from baseline in Tampa scale.
Measured: week 4 (intervention period) and month 1, month 3 and month 6 (follow-up period)
Anxiety and depression
Change in Anxiety and depression score from baseline, assessed by the HAD questionnaire
Measured: week 4
Anxiety and depression
Change in Anxiety and depression score from end of the intervention period (week 4), assessed by the HAD questionnaire.
Measured: month 1, month 3 and 6 (follow-up period)
Anxiety and depression responding rate
Number and percentage of patients presenting an improvement of at least 2 points from baseline for each sub-scale anxiety and depression in the two treatment arms
Measured: week 4 (intervention period) and month 1, month 3 and month 6 (follow-up period)
Physiotherapist global satisfaction
A single score of satisfaction reported by the physiotherapist:
- How satisfied or dissatisfied are you with the ability of the LumbaCure® intervention to improve your patient low back pain condition (7-points scale; 1 = completely dissatisfied; 7 = completely satisfied); ?
- How satisfied or dissatisfied are you with the ability of the Physical exercises intervention to improve your patient low back pain condition (7-points scale; 1 = completely dissatisfied; 7 = completely satisfied)?
Measured: week 4
Patient global satisfaction of the therapy
A single score of satisfaction will be calculated based on a set of two questions:
> How satisfied or dissatisfied are you with the ability of the LumbaCure® / Physical exercises intervention to improve your low back pain condition (7-points scale; 1 = completely dissatisfied; 7 = completely satisfied)? How globally would you rate your experience, on the LumbaCure® device/with physical exercises (7-point Likert scale (1 = very bad; 7 = excellent)) ?
Measured: End of intervention period (week 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start2 Oct 2023
- Primary completion8 Mar 2024
- Study completion12 Sep 2024
Why it stopped: Design change
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06138002
- Sponsor's protocol ID
- CIV-23-05-043012
- Status last verified
- Nov 2023
- First submitted
- 8 Nov 2023
- Last updated
- 18 Oct 2024
- 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 18 Oct 2024. 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
- NCT06138002
- Acronym / sponsor ID
- CIV-23-05-043012
- Conditions
- Chronic Low Back Pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Design change
- Enrolment
- 22 participants (actual)
- Lead sponsor
- OdixIndustry (pharma, biotech, devices)
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- 8 Mar 2024 (actual)
- Study completion
- 12 Sep 2024 (actual)
- First posted
- 18 Nov 2023 (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 revalidation 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 hips and the low back in patient requiring treatment by physical exercises due to orthopedic disorder, especially low back pain.
The investigation include an intervention period of 4 weeks The main objective is to compare the impact on disability (Oswestry disability Index) and movement performance of the interventions (LumbaCure® vs physical exercises supervised by the physiotherapist) in two parallel groups of patients suffering from chronic low back pain.
The investigation includes an intervention period of 4 weeks and a follow-up period of 6 months (post intervention period).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Intervention arm | Experimental | Device: LumbaCure®The LumbaCure® is a robotic system which provide active, specific and controlled mobilization of the low back. The device is to be used by the Physiotherapist at the rehabilitation centre. The duration of a session for the patient is 15 minutes. Patients follow a serie of 12 consecutive LumbaCure® sessions at a frequency of 3 sessions / week for 4 weeks. |
| Control Intervention arm | Active comparator | Procedure: Physical Exercises supervised by the physiotherapistA set of core stability exercises/active qualitative mobilization has been defined with principal investigator according to the standard of care at Investigator site. At each session, 5 exercises will be selected by the investigator depending on the evolution and pathology of the patient. Five minutes of warm-up will be performed before starting the exercises session. The program will last 15 to 30 min depending on the time required for the patient to complete the prescribed exercises. Patients follow a serie of 12 consecutive physical exercises sessions at a frequency of 3 sessions / week for 4 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Chronic non-specific LBP (without red flag)
- Patient did not increase, on a long-term basis, his/her regular physical activity in the past 2 months.
- LBP is the principal musculoskeletal condition
- Aged between 18 and 65 years old
- Able to read and understand questionnaires and communicate with the physiotherapist.
Key exclusion criteria (9 listed)
- Suspected or confirmed serious pathology (i.e infection, fracture, cancer, inflammatory arthritis, ….)
- Radicular pain
- 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 arm |
| Physical Exercises supervised by the physiotherapistA set of core stability/active qualitative mobilization exercises have been defined, corresponding to standard exercises proposed in center rehabilitation program | Procedure or surgery | Control Intervention arm |
Primary outcome
Disability
Time frame: Baseline, week 4 (end of intervention period)
The change of the Oswestry Disability Index (ODI) between baseline and the end of the intervention period (4 weeks)
16 secondary outcomes
Disability
Time frame: week2 (intervention period); month 1, month 3 and month 6 follow-up period
Disability responding rate
Time frame: week 2, week 4 (intervention period) and at month 1, month 3 and month 6 follow-up period
Back Pain
Time frame: week 1, week 2, week 3 and week 4 (the intervention period)
Back Pain
Time frame: month 1, month 3 and month 6 (follow-up period)
Back Pain responding rate
Time frame: week 2, week 4 (intervention period) and at month 1, month 3 and month 6 (follow-up period)
Function
Time frame: week 4
Function
Time frame: Between end of intervention period and month 1, month 3 and 6 post-intervention
Function responding rate
Time frame: week 4 (intervention period) and at month 1, month 3 and month 6 (follow-up period)
Kinesiophobia
Time frame: week 4
Kinesiophobia
Time frame: month 1, month 3 and 6 (follow-up period)
Kinesiophobia responding rate
Time frame: week 4 (intervention period) and month 1, month 3 and month 6 (follow-up period)
Anxiety and depression
Time frame: week 4
Anxiety and depression
Time frame: month 1, month 3 and 6 (follow-up period)
Anxiety and depression responding rate
Time frame: week 4 (intervention period) and month 1, month 3 and month 6 (follow-up period)
Physiotherapist global satisfaction
Time frame: week 4
Patient global satisfaction of the therapy
Time frame: End of intervention period (week 4)
Results and safety
The study was stopped early (reason given: Design change). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Chronic Low Back Pain
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Enrolling by invitation
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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 Physical Exercises supervised by the physiotherapist in people with Chronic Low Back Pain, 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 7 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: stopped early, as of the sponsor's last update on 18 Oct 2024. 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 was stopped early (reason given: Design change). Results are not available in the source record.
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: Baseline, week 4 (end of 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 18 Oct 2024.