Effect of the LumbaCure® Intervention on Elderly Patients Suffering From cLBP. (LumbaCure2303)

Exploratory Clinical Investigation of the LumbaCure® Medical Device Used in Elderly People Suffering From Chronic Low Back Pain.

The goal of this investigation is to evaluate the safety and efficacy of the LumbaCure® device in elderly people suffering from low back pain. The study is being carried out at several sites, in nursing homes, in order to reach the elderly patients most at risk of a sedentary lifestyle.

Study Overview

• Status: Recruiting
• Conditions: Low Back Pain
• Intervention / Treatment: Device: LumbaCure

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Valérie Gordenne; Phone Number: +32 496673585; Email: valerie.gordenne@odixmedical.com

Study Locations

• Belgium
  • Liège
    • Blégny, Liège, Belgium, 4670
      • Recruiting
      • ASBL " Mère Joséphine " - MRS Saint Joseph Blegny
      • Contact: Sophie Dugard; Email: r.soins@merejosephine.be
      • Principal Investigator: Dimitri Heyne

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Chronic or sub-acute low back pain (without "red flag")
• The subject, a resident or worker at the investigation site (nursing home), over 60 years of age
• Ability to communicate with the physiotherapist.
• Ability to remain in a sitting position for at least 10 minutes.
• A level of back pain > 2 on the numerical pain rating scale

Exclusion Criteria:

• Suspected or confirmed serious pathology (infection, fracture, cancer, inflammatory arthritis, ....) related to the back/spine.
• Body weight > 120 kg
• Subject is non-ambulatory or has severely reduced mobility.
• Dominant component of radicular pain (common lumbago with distal radiation below the knee)
• Radiculopathy
• Severe cardiorespiratory disease
• Dementia or significant cognitive impairment that prevents the participant from giving consent, completing study questionnaires or complying with recommendations.
• Fracture or operation less than 3 months old of the spine, pelvis, hip or leg bones.
• Known vertebral pathology other than osteoarthritis.
• Major neurological disease, movement or motor neuron disorders
• Fibromyalgia or other systemic rheumatic disease
• Recent history of stroke or heart failure, unstable heart condition
• Uncontrolled substance abuse disorders
• Invasive procedures to relieve pain in the last 3 months
• Acute or terminal illness
• Any other medical condition considered by the study team to be a contraindication to the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test Intervention arm; LumbaCure robotic device	Device: LumbaCure; LumbaCure® is a device developed to induce specific mobilization of the lower back in patients requiring physical rehabilitation for orthopaedic disorders, particularly chronic low back pain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Low back pain	Mean intensity of low back pain during the last week, assessed on a numerical pain rating scale from 0 to 10	Change between baseline and Visit 3 (Day 28)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional mobility	Change in the time taken to complete the time up and go (TUG) test. The TUG consists of measuring the time it takes a person to get up from a chair, walk 3 metres at their usual pace, turn around, return to the chair and sit down. Two attempts are made and the best time is recorded	Between baseline and visit 3 (day 28)
Functional mobility	Change in the time taken to complete the time up and go (TUG) test. The TUG consists of measuring the time it takes a person to get up from a chair, walk 3 metres at their usual pace, turn around, return to the chair and sit down. Two attempts are made and the best time is recorded	Between baseline and visit 2 (Day 14)
Functional mobility	Change in the time taken to complete the time up and go (TUG) test. The TUG consists of measuring the time it takes a person to get up from a chair, walk 3 metres at their usual pace, turn around, return to the chair and sit down. Two attempts are made and the best time is recorded	Follow-up period : between the end of the investigation period and 1 month post-study (Day 56 - Visit 4)
Low back pain	Weekly changes from baseline in mean intensity of low back pain during the last week, assessed on a numerical pain rating scale from 0 to 10.	Between baseline and each week through study completion, one month.
Low back pain	Current back pain intensity before and after each session, assessed on a numerical pain rating scale from 0 to 10.	Before and after each session [12 measures, 3x/week during one month]
Low back pain	Changes in mean intensity of low back pain in the last week, assessed on a numerical rating scale from 0 to 10, during the follow-up period between the end of the investigation period and 1 month post-study.	Follow-up : Between end of the investigation period [Day 28] and 1 month post-study.
Overall satisfaction of the physiotherapist with the LumbaCure® intervention	A single satisfaction score will be reported at the end of the intervention period by the physiotherapist: How satisfied or dissatisfied are you with the ability of the LumbaCure® device intervention to improve your patient's low back pain condition (7 point scale)?; To what extent are you satisfied or dissatisfied with the ability of the LumbaCure® device to improve your patient's mobilisation (7-point scale)?	End of intervention period [Day 28]
Overall patient satisfaction with the LumbaCure® intervention	A single satisfaction score will be calculated at the end of the intervention period based on a series of three questions : How satisfied or dissatisfied are you with the ability of the LumbaCure® procedure to improve your lower back pain (7 point scale)?; How satisfied or dissatisfied are you with the ability of the LumbaCure® procedure to improve your mobility?; How would you rate your overall experience with the LumbaCure® device (7-point scale)?	End of intervention period [Day 28]
Risk of falling	Change in the risk of falling between baseline and the end of the intervention period, visit 3 (day 28), assessed by the Tinetti test. This test is a comprehensive assessment of both balance and gait. It assesses the patient's ability to change position, maintain balance in different situations and walk.	Between baseline and the end of the investigation,visit 3 [Day 28]
Risk of falling	Changes in the risk of falling during the follow-up period assessed by the Tinetti test. This test is a comprehensive assessment of both balance and gait. It assesses the patient's ability to change position, maintain balance in different situations and walk.	Between the end of the investigation,visit 3 [Day 28] and one month follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of the device	The number, intensity and severity of adverse events are reported before each LumbaCure session.	through study completion, one month

Collaborators and Investigators

• Sponsor: Odix

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2023
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: December 13, 2023
• First Submitted That Met QC Criteria: January 2, 2024
• First Posted (Actual): January 12, 2024

Study Record Updates

• Last Update Posted (Actual): January 12, 2024
• Last Update Submitted That Met QC Criteria: January 2, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: CIV-23-09-043961

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