Clinical Investigation to Assess the Clinical Effect of the LumbaCure® Intervention on Patients Suffering From Chronic Low Back Pain

NCT06662032 | Completed

• 2 other identifiers: LumbaCure2302_2.0CIV-23-05-043012
• Study Type: interventional
• Target: 50
• 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 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.

Conditions

Chronic Low Back Pain (CLBP)

Keywords

LBP; rehab; nCLPB

Outcome Measures

Primary Outcomes (1)

• Disability

  Comparison of the Oswestry Disability Index (ODI) evolution from baseline to session 26 (visit 4, end of intervention) between the two treatment arms.

  Around week 13 (intervention period)

Secondary Outcomes (11)

• Disability

  Around week 4, 9 (intervention period) and week 18 (follow-up)

• Back pain

  Around week 4, 9, 13, 18

• Function

  Around week 4, 9, 13, 18

• Kinesiophobia

  Around week 4, 9, 13, 18

• Pain catastrophizing

  Around week 4, 9, 13, 18

Other Outcomes (2)

• Patient satisfaction

  Around week 13

• Flexion/extension amplitudes and forces

  Around week 0, 9, 13

Study Arms (2)

Test Intervention

EXPERIMENTAL

In the intervention arm, participants will follow the standard rehabilitation programme at a frequency of ideally 2 times a week. LumbaCure® device will be used in addition to the standard programme. A session of 15 min will be performed at each rehabilitation session. The device is to be used by the Physiotherapist at the rehabilitation centre. In total, the participant should perform 26 LumbaCure® sessions during the intervention period, this corresponds to the number of rehabilitation sessions considered in the intervention period.

Device: LumbaCure®; Other: Rehab program

Control Intervention

ACTIVE COMPARATOR

Participants in the control arm will follow the standard rehabilitation programme at a frequency of ideally 2 times a week. To align with the duration of the intervention arm, participants in the control arm will also perform an additional 15 minutes of exercises (following standard care of the site).

Other: Rehab program

Interventions

LumbaCure® DEVICE

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

Test Intervention

Rehab program OTHER

Standard rehabilitation program

Control Intervention; Test Intervention

Eligibility Criteria

• Age: 18 Years - 85 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)
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Odix: lead

Study Sites (2)

Jessa Ziekenhuis

Hasselt, Belgium

Location

Jessa Ziekenhuis

Herk-de-Stad, Belgium

Location

Study Design

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

Study Record Dates

• First Submitted: October 16, 2024
• First Posted: October 28, 2024
• Study Start: June 24, 2024
• Primary Completion: June 26, 2025
• Study Completion: June 26, 2025
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)