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| Name | Class |
|---|---|
| University Hospital, Clermont-Ferrand | OTHER |
| Hôpital Cochin | OTHER |
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The JAPET.W+ medical device is a new dynamic distraction support system. It could be considered as a new solution in the therapeutic arsenal for managing common low back pain. This study aims to assess the effectiveness of this device among the two targeted populations during daily use. Each patient will be asked to estimate the intensity of their low back pain several times during the clinical investigation. Our main hypothesis is a reduction in low back pain while wearing the device. The secondary hypothesis is a decrease in activity limitations, an increase in participation, an improvement in quality of life, and a reduction in healthcare product and medication consumption.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Active Comparator | Period 1 (week 1-8): Current care / Washout period (week 9-10) / Period 2 (week 11-18): Current care + Japet.W+ |
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| Group B | Active Comparator | Period 1 (week 1-8): Current care + Japet.W+ / Washout period (week 9-10) / Period 2 (week 11-18): Current care |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Japet.W+ | Device | Current care of low back pain and wearing the Japet.W+ |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale (VAS) | Pain VAS is a unidimensional measure of pain intensity (from 0: no pain to 100: severe pain), used to record the progression of pain in patients or to compare the severity of pain between patients with similar conditions. The VAS has been widely used in various adult populations, for example people suffering from chronic low back pain. | Comparison of the difference Δ1=VASweek8 - VASweek1 and Δ2=VASweek18-VASweek11. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Week 4 day 7, Week 8 day 7, Week 14 day 7 and Week 18 day 7 | |
| Rate of device failure | Group B: Week 4 day 7, Week 8 day 7 / Group A: Week 14 day 7 and Week 18 day 7 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mélissa Moulart, PhD | Contact | +33671307712 | melissa.moulart@japet.eu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Clermont-Ferrand | Recruiting | Clermont-Ferrand | France |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| Control (Standard treatment) | Device | Current care of low back pain |
|
| Functional disability |
Measurement of specific activity limitation using the Roland-Morris score |
| Beginning and end of each period (Week 1 day 1, Week 8 day 7, Week 11 day 1, Week 18 day 7). |
| Quality of life | The SF-12 physical (PCS-12) and mental (MCS-12) component summary scales are scored using norm-based methods. Physical and mental regression weights and a constant for both measures come from the general U.S. population. Both the PCS-12 and MCS-12 scales are transformed to have a mean of 50 and a standard deviation of 10 in the general U.S. population. The minimum possible PCS score (standard version of the SF-12) is 9.9 points and the maximum is 76.0 points. For the MCS, the minimum is 3.2 and the maximum is 77.9. In both cases, the higher the score, the better the patient's health status. | Beginning and end of each period (Week 1 day 1, Week 8 day 7, Week 11 day 1, Week 18 day 7). |
| Adherence to Japet.W+ | Recovery of Japet.W+ usage time. | Recovery of Japet.W+ usage time after 28 days and 56 days of use. Group A (using the device during the second period): Week 14, day 7, and Week 18, day 7. Group B (using the device during the first period): Week 4, day 7, and Week 8, day 7. |
| Number of healthcare products consumed (drugs, medical appointments, physiotherapy sessions, etc.) | Information retrieved 3 times per period (D+7, D+28, D+56). Period 1: Week 1 day 7, Week 4 day 7, Week 8 day 7. Period 2: Week 11 day 7, Week 14 day 7, and Week 18 day 7. |
| Hôpital de Cochin, APHP | Recruiting | Paris | 75014 | France |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |