Clinical Investigation to Assess the Clinical Effect of the LumbaCure® Intervention on Patients Suffering From Chronic Low Back Pain
CompletedNot applicableNCT06662032
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- 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
- Conditions
- Interventions
- Device: LumbaCure®
- Other: Rehab program
- Sponsor
- Odix
- Start date
- 2024-06-24
- Primary completion
- 2025-06-26
- Sex
- All
- Age range
- from 18 Years to 85 Years
- Results posted
- No results posted in this snapshot
- Countries
- Belgium
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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. Exclusion Criteria: * 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 * body weight \> 120 kg * Neurological disease * Fibromyalgia
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06662032