Clinical trial NCT06203886: Effect of the LumbaCure® Intervention on Elderly Patients Suffering From cLBP.
Official title: Exploratory Clinical Investigation of the LumbaCure® Medical Device Used in Elderly People Suffering From Chronic Low Back Pain.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Odix
Sponsor class: INDUSTRY
First posted: 2024-01-12
Enrollment: 10
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Low back pain
timeFrame: Change between baseline and Visit 3 (Day 28)
Secondary outcomes:
measure: Functional mobility
timeFrame: Between baseline and visit 3 (day 28)
measure: Functional mobility
timeFrame: Between baseline and visit 2 (Day 14)
measure: Functional mobility
timeFrame: Follow-up period : between the end of the investigation period and 1 month post-study (Day 56 - Visit 4)
measure: Low back pain
timeFrame: Between baseline and each week through study completion, one month.
measure: Low back pain
timeFrame: Before and after each session [12 measures, 3x/week during one month]
measure: Low back pain
timeFrame: Follow-up : Between end of the investigation period [Day 28] and 1 month post-study.
measure: Overall satisfaction of the physiotherapist with the LumbaCure® intervention
timeFrame: End of intervention period [Day 28]
measure: Overall patient satisfaction with the LumbaCure® intervention
timeFrame: End of intervention period [Day 28]
measure: Risk of falling
timeFrame: Between baseline and the end of the investigation,visit 3 [Day 28]
measure: Risk of falling
timeFrame: Between the end of the investigation,visit 3 [Day 28] and one month follow-up
Other outcomes:
measure: Safety of the device
timeFrame: through study completion, one month
Locations:
city: Blégny
country: Belgium
facility: ASBL " Mère Joséphine " - MRS Saint Joseph Blegny
state: Liège
Study officials:
References: