Clinical Investigation to Assess the Clinical Performance of the LumbaCure® Intervention on Chronic Low Back Pain Patients.

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Chronic Low Back Pain

Intervention / Treatment
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* Device: LumbaCure®
* Procedure: Physical Exercises supervised by the physiotherapist


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 body weight > 120 kg Neurological disease Fibromyalgia

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Intervention arm<br>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. | Device: LumbaCure®<br>* LumbaCure®is a robotic system that systematically moves the spine of affected patients with a complex proprietary algorithm.<br>|
| Active Comparator: Control Intervention arm<br>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. | Procedure: Physical Exercises supervised by the physiotherapist<br>* A set of core stability/active qualitative mobilization exercises have been defined, corresponding to standard exercises proposed in center rehabilitation program<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disability | The change of the Oswestry Disability Index (ODI) between baseline and the end of the intervention period (4 weeks) | Baseline, week 4 (end of intervention period) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disability | The change in the ODI score between baseline and follow-up period | 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 | 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) | 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. | 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 | 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. | 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. | 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 | 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. | 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. | 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. | 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 | week 4 | 
| Anxiety and depression | Change in Anxiety and depression score from end of the intervention period (week 4), assessed by the HAD questionnaire. | 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 | 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)? | 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)) ? | End of intervention period (week 4) |