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

NCT ID: NCT06138002

Last Updated: 2024-10-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-02
• Study Completion Date: 2024-09-12

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Test Intervention arm

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.

Group Type: EXPERIMENTAL

LumbaCure®

Intervention Type: DEVICE

LumbaCure®is a robotic system that systematically moves the spine of affected patients with a complex proprietary algorithm.

Control Intervention arm

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.

Group Type: ACTIVE_COMPARATOR

Physical Exercises supervised by the physiotherapist

Intervention Type: PROCEDURE

A set of core stability/active qualitative mobilization exercises have been defined, corresponding to standard exercises proposed in center rehabilitation program

Interventions

LumbaCure®

LumbaCure®is a robotic system that systematically moves the spine of affected patients with a complex proprietary algorithm.

Intervention Type: DEVICE

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Odix

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Jessa Ziekenhuis vzw

Hasselt, , Belgium

Jessa Ziekenhuis vzw

Herk-de-Stad, , Belgium

Countries

Belgium

Other Identifiers

CIV-23-05-043012

Identifier Type: -

Identifier Source: org_study_id