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| ID | Type | Description | Link |
|---|---|---|---|
| CIV-23-05-043012 | Other Identifier | AFMPS |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Intervention | Experimental | In the intervention arm, participants will follow the standard rehabilitation programme at a frequency of ideally 2 times a week. LumbaCure® device will be used in addition to the standard programme. A session of 15 min will be performed at each rehabilitation session. The device is to be used by the Physiotherapist at the rehabilitation centre. In total, the participant should perform 26 LumbaCure® sessions during the intervention period, this corresponds to the number of rehabilitation sessions considered in the intervention period. |
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| Control Intervention | Active Comparator | Participants in the control arm will follow the standard rehabilitation programme at a frequency of ideally 2 times a week. To align with the duration of the intervention arm, participants in the control arm will also perform an additional 15 minutes of exercises (following standard care of the site). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LumbaCure® | Device | LumbaCure® is a robotic system that systematically moves the spine of affected patients with a complex proprietary algorithm. |
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| Measure | Description | Time Frame |
|---|---|---|
| Disability | Comparison of the Oswestry Disability Index (ODI) evolution from baseline to session 26 (visit 4, end of intervention) between the two treatment arms. | Around week 13 (intervention period) |
| Measure | Description | Time Frame |
|---|---|---|
| Disability | - Comparison of the difference in the ODI evolution from baseline to session 8 (visit2) session 18 (visit 3) and during the follow-up period (visit 5), between the two treatment arms. | Around week 4, 9 (intervention period) and week 18 (follow-up) |
| Back pain |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction | For both arms, a single score of satisfaction will be calculated at the end of the intervention period based on a set of two questions: > How satisfied or dissatisfied are you with the ability of the programme to improve your low back pain condition (7-points scale)? Number and percentage of patients with a satisfaction score > 4 in the two treatment arms. Only for the intervention arm: > How globally would you rate your experience, on the LumbaCure® device (7-points scale)? Number and percentage of patients with a score > 4 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jessa Ziekenhuis | Hasselt | Belgium | ||||
| Jessa Ziekenhuis |
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| Rehab program | Other | Standard rehabilitation program |
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| Around week 4, 9, 13, 18 |
| Function |
| Around week 4, 9, 13, 18 |
| Kinesiophobia |
| Around week 4, 9, 13, 18 |
| Pain catastrophizing | Change in pain catastrophizing score, evaluated through the Pain catastrophizing scale (PCS), between baseline to the different timepoints (visits 2 to 4 and during follow-up : V5). The total score is calculated by adding up 13 sub-questions assessed using a 5-point Likert scale (from 0 to 4), with high score indicating a greater degree of pain catastrophising. | Around week 4, 9, 13, 18 |
| Flexibility | The ability of the patient to flex the lower back via fingertips to floor distance. It will be performed at each visit for both groups. | Around week 4, 9, 13, 18 |
| Disability | - Disability Responding rate: Number and percentage of patients presenting a clinically significant improvement in the ODI at the different timepoints versus baseline in the two treatment arms | Around week 4, 9 (intervention period) and week 18 (follow-up) |
| Back pain | - Pain responding rate : Number and percentage of patients presenting a clinically significant improvement in the NPRS at the different timepoints versus baseline in the two treatment arms | Around week 4, 9, 13, 18 |
| Function | Function responding rate : Number and percentage of patients presenting a clinically significant improvement in the pain specific function scale at the different timepoints versus baseline in the two treatment arms. | Around week 4, 9, 13, 18 |
| Kinesiophobia | Responding Rate kinesiophobia : Number and percentage of patients presenting a clinically significant improvement in Tampa scale (TSK-17) at the different timepoints versus baseline in the two treatment arms. | Around week 4, 9, 13, 18 |
| Pain catastrophizing | Responding Rate pain catastrophization : Number and percentage of patients presenting a clinically significant improvement in Pain catastrophizing scale (PCS) at the different timepoints versus baseline, in the two-treatment arms. | Around week 4, 9, 13, 18 |
| Around week 13 |
| Flexion/extension amplitudes and forces | Flexion/extension amplitudes and forces measured using the Tergumed or DavidBack device. It will be performed at baseline (V1), mid-intervention (V3) and at the end of rehabilitation programme (V5) for both groups. | Around week 0, 9, 13 |
| Herk-de-Stad |
| Belgium |