Clinical trial NCT06138002: Clinical Investigation to Assess the Clinical Performance of the LumbaCure® Intervention on Chronic Low Back Pain Patients.
Official title: Randomized Clinical Investigation to Assess Preliminary Clinical Performance, Effectiveness and Safety of the LumbaCure® (prototype C190070.01) Medical Device When Used in Patients Suffering from Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Low Back Pain
Lead sponsor: Odix
Sponsor class: INDUSTRY
First posted: 2023-11-18
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Low Back Pain (LBP) is one of the common causes of morbidity worldwide, with a one-month prevalence of 23.3 %. Number of people with LBP reached 577 million people in 2020. LBP has been the leading cause of years lived with disability from 1990 to 2017. The highest incidence of LBP is in people in their third decade of age. LBP is a complex disease difficult to treat as most of these cases (80 - 90 %) are classified as non-specific meaning that the pain cannot be attributed to any specific injury or pathology.

Until now exercise therapy is commonly used as the treatment of choice in the revalidation program of LBP. The aim of physical treatment is to improve function and prevent disability from getting worse.

LumbaCure® is a robotic system driven by a proprietary movement algorithm to induce a specific and controlled mobilization of the hips and the low back in patient requiring treatment by physical exercises due to orthopedic disorder, especially low back pain.

The investigation include an intervention period of 4 weeks The main objective is to compare the impact on disability (Oswestry disability Index) and movement performance of the interventions (LumbaCure® vs physical exercises supervised by the physiotherapist) in two parallel groups of patients suffering from chronic low back pain.

The investigation includes an intervention period of 4 weeks and a follow-up period of 6 months (post intervention period).


Eligibility criteria: Inclusion Criteria:

* Chronic non-specific LBP (without red flag)
* Patient did not increase, on a long-term basis, his/her regular physical activity in the past 2 months.
* LBP is the principal musculoskeletal condition
* Aged between 18 and 65 years old
* Able to read and understand questionnaires and communicate with the physiotherapist.
* Average Back Pain intensity over the last week above 2, assessed on Numerical Pain Rating Scale from 0 to 10 anchored with "no pain" at 0 and "worst pain imaginable " at 10.
* ODI score \> 20

Exclusion Criteria:

* Suspected or confirmed serious pathology (i.e infection, fracture, cancer, inflammatory arthritis, ....)
* Radicular pain
* Radiculopathy
* Cognitive impairment that precludes participant from consenting, completing investigation questionnaires or complying with recommendations
* Previous spine surgery in the last 3 months
* Pregnant women
* body weight \> 120 kg
* Neurological disease
* Fibromyalgia

Primary outcomes:
measure: Disability
timeFrame: Baseline, week 4 (end of intervention period)
Secondary outcomes:
measure: Disability
timeFrame: week2 (intervention period); month 1, month 3 and month 6 follow-up period
measure: Disability responding rate
timeFrame: week 2, week 4 (intervention period) and at month 1, month 3 and month 6 follow-up period
measure: Back Pain
timeFrame: week 1, week 2, week 3 and week 4 (the intervention period)
measure: Back Pain
timeFrame: month 1, month 3 and month 6 (follow-up period)
measure: Back Pain responding rate
timeFrame: week 2, week 4 (intervention period) and at month 1, month 3 and month 6 (follow-up period)
measure: Function
timeFrame: week 4
measure: Function
timeFrame: Between end of intervention period and month 1, month 3 and 6 post-intervention
measure: Function responding rate
timeFrame: week 4 (intervention period) and at month 1, month 3 and month 6 (follow-up period)
measure: Kinesiophobia
timeFrame: week 4
measure: Kinesiophobia
timeFrame: month 1, month 3 and 6 (follow-up period)
measure: Kinesiophobia responding rate
timeFrame: week 4 (intervention period) and month 1, month 3 and month 6 (follow-up period)
measure: Anxiety and depression
timeFrame: week 4
measure: Anxiety and depression
timeFrame: month 1, month 3 and 6 (follow-up period)
measure: Anxiety and depression responding rate
timeFrame: week 4 (intervention period) and month 1, month 3 and month 6 (follow-up period)
measure: Physiotherapist global satisfaction
timeFrame: week 4
measure: Patient global satisfaction of the therapy
timeFrame: End of intervention period (week 4)
Other outcomes:
measure: Patient mobilization
timeFrame: LumbaCure® session 1 and session 12 : Week 1 (Day 0) and Week 4 (Day 25)
measure: Measurement in Dynamic/static situation
timeFrame: Baseline and week 4 (end of intervention period)
measure: Measurement in Dynamic/static situation
timeFrame: Baseline and week 4 (end of intervention period)
measure: Flexion/extension amplitudes
timeFrame: Baseline and week 4 (end of intervention period)
measure: Force
timeFrame: Baseline and week 4 (end of intervention period)
measure: Distance finger to floor
timeFrame: Baseline and week 4 (end of intervention period)
measure: Adverse events
timeFrame: baseline, week 1, week 2, week 3, week 4
Locations:
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis vzw
city: Herk-de stad
country: Belgium
facility: Jessa Ziekenhuis vzw
Study officials:
References: