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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
22
LumbaCure®is a robotic system that systematically moves the spine of affected patients with a complex proprietary algorithm.
A set of core stability/active qualitative mobilization exercises have been defined, corresponding to standard exercises proposed in center rehabilitation program
Jessa Ziekenhuis vzw
Hasselt, Belgium
Jessa Ziekenhuis vzw
Herk-de-Stad, Belgium
Disability
The change of the Oswestry Disability Index (ODI) between baseline and the end of the intervention period (4 weeks)
Time frame: Baseline, week 4 (end of intervention period)
Disability
The change in the ODI score between baseline and follow-up period
Time frame: week2 (intervention period); month 1, month 3 and month 6 follow-up period
Disability responding rate
Number and percentage of patients presenting an improvement from baseline of at least 10 points in the ODI
Time frame: week 2, week 4 (intervention period) and at month 1, month 3 and month 6 follow-up period
Back Pain
Changes in the average back pain intensity over the last week from baseline, assessed on Numerical Pain Rating Scale from 0 to 10 (0 for no pain and 10 for worst pain imaginable)
Time frame: week 1, week 2, week 3 and week 4 (the intervention period)
Back Pain
Changes in average back pain intensity over the last week from end of the intervention period (week 4), assessed on Numerical Rating Scale from 0 to 10 (0 for no pain and 10 for worst pain imaginable) in the follow-up period.
Time frame: month 1, month 3 and month 6 (follow-up period)
Back Pain responding rate
Number and percentage of patients presenting an improvement from baseline of at least 1.5 points in the Numerical Pain rating scale
Time frame: week 2, week 4 (intervention period) and at month 1, month 3 and month 6 (follow-up period)
Function
Change in function score from baseline, assessed using the Pain Specific Functional Scale. The PSFS requires participants to identify three problematic activities and to rate these activities on a scale from 0 to 10.
Time frame: week 4
Function
Change in function score from the end of the intervention period (week 4) in the follow-up period, assessed using the Pain Specific Functional Scale. The PSFS requires participants to identify three problematic activities and to rate these activities on a scale from 0 to 10.
Time frame: Between end of intervention period and month 1, month 3 and 6 post-intervention
Function responding rate
Number and percentage of patients presenting an improvement of at least 1.5 points from baseline in the pain specific function scale
Time frame: week 4 (intervention period) and at month 1, month 3 and month 6 (follow-up period)
Kinesiophobia
Change in fear of movements and attitudes and behavior from baseline towards pain score, evaluated through the Tampa questionnaire.
Time frame: week 4
Kinesiophobia
Change in fear of movements and attitudes and behavior from the end of intervention period (week4), towards pain score, evaluated through the Tampa questionnaire.
Time frame: month 1, month 3 and 6 (follow-up period)
Kinesiophobia responding rate
Number and percentage of patients presenting an improvement of at least 6 points from baseline in Tampa scale.
Time frame: week 4 (intervention period) and month 1, month 3 and month 6 (follow-up period)
Anxiety and depression
Change in Anxiety and depression score from baseline, assessed by the HAD questionnaire
Time frame: week 4
Anxiety and depression
Change in Anxiety and depression score from end of the intervention period (week 4), assessed by the HAD questionnaire.
Time frame: month 1, month 3 and 6 (follow-up period)
Anxiety and depression responding rate
Number and percentage of patients presenting an improvement of at least 2 points from baseline for each sub-scale anxiety and depression in the two treatment arms
Time frame: week 4 (intervention period) and month 1, month 3 and month 6 (follow-up period)
Physiotherapist global satisfaction
A single score of satisfaction reported by the physiotherapist: * How satisfied or dissatisfied are you with the ability of the LumbaCure® intervention to improve your patient low back pain condition (7-points scale; 1 = completely dissatisfied; 7 = completely satisfied); ? * How satisfied or dissatisfied are you with the ability of the Physical exercises intervention to improve your patient low back pain condition (7-points scale; 1 = completely dissatisfied; 7 = completely satisfied)?
Time frame: week 4
Patient global satisfaction of the therapy
A single score of satisfaction will be calculated based on a set of two questions: \> How satisfied or dissatisfied are you with the ability of the LumbaCure® / Physical exercises intervention to improve your low back pain condition (7-points scale; 1 = completely dissatisfied; 7 = completely satisfied)? How globally would you rate your experience, on the LumbaCure® device/with physical exercises (7-point Likert scale (1 = very bad; 7 = excellent)) ?
Time frame: End of intervention period (week 4)
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