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

NCT06203886 | Completed

• 1 other identifier: CIV-23-09-043961
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Functional mobility

  Between baseline and visit 3 (day 28)

• Functional mobility

  Between baseline and visit 2 (Day 14)

• Functional mobility

  Follow-up period : between the end of the investigation period and 1 month post-study (Day 56 - Visit 4)

• Low back pain

  Between baseline and each week through study completion, one month.

• Low back pain

  Before and after each session [12 measures, 3x/week during one month]

Other Outcomes (1)

• Safety of the device

  through study completion, one month

Study Arms (1)

Test Intervention arm

EXPERIMENTAL

LumbaCure robotic device

Device: LumbaCure

Interventions

LumbaCure DEVICE

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.

Test Intervention arm

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Odix: lead

Study Sites (1)

ASBL " Mère Joséphine " - MRS Saint Joseph Blegny

Blégny, Liège, 4670, Belgium

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: January 12, 2024
• Study Start: December 11, 2023
• Primary Completion: June 17, 2024
• Study Completion: July 18, 2024
• Last Updated: August 29, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)