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

Odix

Status: Completed

Conditions: Low Back Pain

Treatments: Device: LumbaCure

Study type: Interventional

Funder types: Industry

Identifiers

NCT06203886

CIV-23-09-043961

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Test Intervention arm

Experimental group

Description:

LumbaCure robotic device

Treatment:

Device: LumbaCure