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

NCT06138002 | Terminated

• 1 other identifier: CIV-23-05-043012
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• Disability

  week2 (intervention period); month 1, month 3 and month 6 follow-up period

• Disability responding rate

  week 2, week 4 (intervention period) and at month 1, month 3 and month 6 follow-up period

• Back Pain

  week 1, week 2, week 3 and week 4 (the intervention period)

• Back Pain

  month 1, month 3 and month 6 (follow-up period)

• Back Pain responding rate

  week 2, week 4 (intervention period) and at month 1, month 3 and month 6 (follow-up period)

Other Outcomes (7)

• Patient mobilization

  LumbaCure® session 1 and session 12 : Week 1 (Day 0) and Week 4 (Day 25)

• Measurement in Dynamic/static situation

  Baseline and week 4 (end of intervention period)

• Measurement in Dynamic/static situation

  Baseline and week 4 (end of intervention period)

Study Arms (2)

Test Intervention arm

EXPERIMENTAL

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®

Control Intervention arm

ACTIVE COMPARATOR

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

Interventions

LumbaCure® DEVICE

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

Test Intervention arm

Physical Exercises supervised by the physiotherapist PROCEDURE

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

Control Intervention arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Odix: lead

Study Sites (2)

Jessa Ziekenhuis vzw

Hasselt, 3500, Belgium

Location

Jessa Ziekenhuis vzw

Herk-de-Stad, 3540, Belgium

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2023
• First Posted: November 18, 2023
• Study Start: October 2, 2023
• Primary Completion: March 8, 2024
• Study Completion: September 12, 2024
• Last Updated: October 18, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)