Clinical trial NCT06662032: Clinical Investigation to Assess the Clinical Effect of the LumbaCure® Intervention on Patients Suffering From Chronic Low Back Pain
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: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Low Back Pain (CLBP)
Keywords: LBP
rehab
nCLPB
Lead sponsor: Odix
Sponsor class: INDUSTRY
First posted: 2024-10-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 rehab 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 low back in patient requiring treatment by physical exercises due to orthopedic disorder, especially low back pain.

In Belgium, the standard back-school programme (rehabilitation programme) includes 35 rehabilitation sessions of 2 h delivered 2x/week at the investigator site (whom the first session is the inclusion visit, no therapy performed) and one session to tackle the psychological component of the condition (information on how to cope with pain). Participants are divided into two groups: the intervention group uses the LumbaCure® device (a seat that mobilizes the lower back for 15 minutes) in addition to the standard sessions (from session 2 to 27), while the control group follows the standard program with an extra 15 minutes of exercises. After session 27 (around 13 weeks), all participants continue their programme without the LumbaCure®, and their progress is assessed before the final 35th session.

Detailed description: Low Back Pain (LBP) is one of the most common causes of morbidity worldwide, with a one-month prevalence of 23.3%. In 2020, the number of people suffering from LBP reached 577 million. From 1990 to 2017, LBP remained the leading cause of years lived with disability. The highest incidence of LBP is observed in individuals in their third decade of life. LBP is a complex condition that is often difficult to treat, as 80-90% of cases are classified as non-specific, meaning the pain cannot be attributed to a specific injury or pathology. Exercise therapy is currently the most common treatment for LBP rehabilitation, aiming to improve function and prevent the worsening of disability.

The study involves a standard rehabilitation program in Belgium consisting of 35 multidisciplinary sessions, each lasting 2 hours. Participants are divided into two groups: the intervention group and the control group. The intervention group follows the standard rehabilitation program but also uses the LumbaCure® device, a robotic system driven by a proprietary movement algorithm. The device is designed to induce controlled mobilization of the lower back, which is particularly beneficial for patients requiring physical treatment due to orthopedic disorders like low back pain. During each rehabilitation session, participants in the intervention group perform a 15-minute session on the LumbaCure® device under the supervision of a physiotherapist. Over the intervention period, participants in the intervention group are expected to complete 26 LumbaCure® sessions.

In the control group, participants follow the same standard rehabilitation program with a frequency of ideally twice a week. To match the duration of the intervention group's additional LumbaCure® sessions, participants in the control group perform 15 minutes of additional exercises based on the standard care practices of their respective rehabilitation center.

After session 27, which ideally take place over a period of 13 weeks, all participants continue with the remaining 8 sessions of the standard rehabilitation program. However, during this final phase, no LumbaCure® sessions are included for the intervention group. Participants' progress is monitored throughout the study, with a final evaluation taking place before the completion of the 35th session. This follow-up allows researchers to assess the overall effectiveness of the rehabilitation program, including the impact of the LumbaCure® device on patient outcomes compared to the standard care protocol.

Eligibility criteria: Inclusion Criteria:

* Chronic non-specific LBP (without red flag)
* LBP is the principal musculoskeletal condition
* Aged between 18 and 85 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.

Exclusion Criteria:

* Suspected or confirmed serious pathology (i.e infection, fracture, cancer, inflammatory arthritis, ....)
* Significant sciatica VAS \> 7
* 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: Around week 13 (intervention period)
Secondary outcomes:
measure: Disability
timeFrame: Around week 4, 9 (intervention period) and week 18 (follow-up)
measure: Back pain
timeFrame: Around week 4, 9, 13, 18
measure: Function
timeFrame: Around week 4, 9, 13, 18
measure: Kinesiophobia
timeFrame: Around week 4, 9, 13, 18
measure: Flexibility
timeFrame: Around week 4, 9, 13, 18
measure: Disability
timeFrame: Around week 4, 9 (intervention period) and week 18 (follow-up)
measure: Back pain
timeFrame: Around week 4, 9, 13, 18
measure: Function
timeFrame: Around week 4, 9, 13, 18
measure: Kinesiophobia
timeFrame: Around week 4, 9, 13, 18
Other outcomes:
measure: Patient satisfaction
timeFrame: Around week 13
measure: Flexion/extension amplitudes and forces
timeFrame: Around week 0, 9, 13
Locations:
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis
city: Herk-De-Stad
country: Belgium
facility: Jessa Ziekenhuis
Study officials:
References: