Status:
COMPLETED
Effect of the LumbaCure® Intervention on Elderly Patients Suffering From cLBP.
Lead Sponsor:
Odix
Conditions:
Low Back Pain
Eligibility:
All Genders
60+ years
Phase:
NA
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 nursi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 11 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 18 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06203886
Start Date
December 11 2023
End Date
July 18 2024
Last Update
August 29 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
ASBL " Mère Joséphine " - MRS Saint Joseph Blegny
Blégny, Liège, Belgium, 4670