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).

Study Overview

• Status: Terminated
• Conditions: Chronic Low Back Pain
• Intervention / Treatment: Device: LumbaCure®; Procedure: Physical Exercises supervised by the physiotherapist

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Hasselt, Belgium, 3500
    • Jessa Ziekenhuis VZW
  • Herk-de stad, Belgium, 3540
    • Jessa Ziekenhuis VZW

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: LumbaCure®; LumbaCure®is a robotic system that systematically moves the spine of affected patients with a complex proprietary algorithm.
Active Comparator: 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disability	The change in the ODI score between baseline and follow-up period	week2 (intervention period); month 1, month 3 and month 6 follow-up period
Disability responding rate	Number and percentage of patients presenting an improvement from baseline of at least 10 points in the ODI	week 2, week 4 (intervention period) and at month 1, month 3 and month 6 follow-up period
Back Pain	Changes in the average back pain intensity over the last week from baseline, assessed on Numerical Pain Rating Scale from 0 to 10 (0 for no pain and 10 for worst pain imaginable)	week 1, week 2, week 3 and week 4 (the intervention period)
Back Pain	Changes in average back pain intensity over the last week from end of the intervention period (week 4), assessed on Numerical Rating Scale from 0 to 10 (0 for no pain and 10 for worst pain imaginable) in the follow-up period.	month 1, month 3 and month 6 (follow-up period)
Back Pain responding rate	Number and percentage of patients presenting an improvement from baseline of at least 1.5 points in the Numerical Pain rating scale	week 2, week 4 (intervention period) and at month 1, month 3 and month 6 (follow-up period)
Function	Change in function score from baseline, assessed using the Pain Specific Functional Scale. The PSFS requires participants to identify three problematic activities and to rate these activities on a scale from 0 to 10.	week 4
Function	Change in function score from the end of the intervention period (week 4) in the follow-up period, assessed using the Pain Specific Functional Scale. The PSFS requires participants to identify three problematic activities and to rate these activities on a scale from 0 to 10.	Between end of intervention period and month 1, month 3 and 6 post-intervention
Function responding rate	Number and percentage of patients presenting an improvement of at least 1.5 points from baseline in the pain specific function scale	week 4 (intervention period) and at month 1, month 3 and month 6 (follow-up period)
Kinesiophobia	Change in fear of movements and attitudes and behavior from baseline towards pain score, evaluated through the Tampa questionnaire.	week 4
Kinesiophobia	Change in fear of movements and attitudes and behavior from the end of intervention period (week4), towards pain score, evaluated through the Tampa questionnaire.	month 1, month 3 and 6 (follow-up period)
Kinesiophobia responding rate	Number and percentage of patients presenting an improvement of at least 6 points from baseline in Tampa scale.	week 4 (intervention period) and month 1, month 3 and month 6 (follow-up period)
Anxiety and depression	Change in Anxiety and depression score from baseline, assessed by the HAD questionnaire	week 4
Anxiety and depression	Change in Anxiety and depression score from end of the intervention period (week 4), assessed by the HAD questionnaire.	month 1, month 3 and 6 (follow-up period)
Anxiety and depression responding rate	Number and percentage of patients presenting an improvement of at least 2 points from baseline for each sub-scale anxiety and depression in the two treatment arms	week 4 (intervention period) and month 1, month 3 and month 6 (follow-up period)
Physiotherapist global satisfaction	A single score of satisfaction reported by the physiotherapist: How satisfied or dissatisfied are you with the ability of the LumbaCure® intervention to improve your patient low back pain condition (7-points scale; 1 = completely dissatisfied; 7 = completely satisfied); ?; How satisfied or dissatisfied are you with the ability of the Physical exercises intervention to improve your patient low back pain condition (7-points scale; 1 = completely dissatisfied; 7 = completely satisfied)?	week 4
Patient global satisfaction of the therapy	A single score of satisfaction will be calculated based on a set of two questions: > How satisfied or dissatisfied are you with the ability of the LumbaCure® / Physical exercises intervention to improve your low back pain condition (7-points scale; 1 = completely dissatisfied; 7 = completely satisfied)? How globally would you rate your experience, on the LumbaCure® device/with physical exercises (7-point Likert scale (1 = very bad; 7 = excellent)) ?	End of intervention period (week 4)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient mobilization	o Pressure distribution using a pressure mat	LumbaCure® session 1 and session 12 : Week 1 (Day 0) and Week 4 (Day 25)
Measurement in Dynamic/static situation	During standardized everyday dynamic/static movements (5x) : "sit-to-stand", 5 repetitions; climbing stairs", 5 repetitions; and "bending task", 30 sec position maintenance: - Patient muscular activation of the back muscles is measured by surface EMG (sEMG). Targeted muscles: Iliocostalis, longissimus, multifidus, obliques.	Baseline and week 4 (end of intervention period)
Measurement in Dynamic/static situation	During standardized everyday dynamic/static movements (5x) : "sit-to-stand", 5 repetitions; climbing stairs", 5 repetitions; and "bending task", 30 sec position maintenance: - Patient Trunk acceleration, measured by IMU.	Baseline and week 4 (end of intervention period)
Flexion/extension amplitudes	Flexion/extension amplitudes measured using the Tergumed or DavidBack device.	Baseline and week 4 (end of intervention period)
Force	Force measured using the Tergumed or DavidBack device.	Baseline and week 4 (end of intervention period)
Distance finger to floor	The ability of the patient to flex the lower back via fingertips to floor distance.	Baseline and week 4 (end of intervention period)
Adverse events	The occurrence, intensity and severity of adverse events will be monitored on both arm	baseline, week 1, week 2, week 3, week 4

Collaborators and Investigators

• Sponsor: Odix

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2023
• Primary Completion (Actual): March 8, 2024
• Study Completion (Actual): September 12, 2024

Study Registration Dates

• First Submitted: November 8, 2023
• First Submitted That Met QC Criteria: November 16, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Actual): October 18, 2024
• Last Update Submitted That Met QC Criteria: October 16, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: CIV-23-05-043012 (Other Identifier: AFMPS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No