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

NCT ID: NCT06203886

Last Updated: 2024-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-11
• Study Completion Date: 2024-07-18

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Test Intervention arm

LumbaCure robotic device

Group Type: EXPERIMENTAL

LumbaCure

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Odix

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

ASBL " Mère Joséphine " - MRS Saint Joseph Blegny

Blégny, Liège, Belgium

Countries

Belgium

Other Identifiers

CIV-23-09-043961

Identifier Type: -

Identifier Source: org_study_id