NCT06138002

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Odix · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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. 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).

Conditions

• Chronic Low Back Pain

Interventions

Type	Name	Description
DEVICE	LumbaCure®	LumbaCure®is a robotic system that systematically moves the spine of affected patients with a complex proprietary algorithm.
PROCEDURE	Physical Exercises supervised by the physiotherapist	A set of core stability/active qualitative mobilization exercises have been defined, corresponding to standard exercises proposed in center rehabilitation program

Timeline

• Start date: 2023-10-02
• Primary completion: 2024-03-08
• Completion: 2024-09-12
• First posted: 2023-11-18
• Last updated: 2024-10-18

Locations

2 sites across 1 country: Belgium