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

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.

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).

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