Evaluation of the Japet.W+ Medical Device for Low Back Pain Management
ConditionLow Back Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorJapet Medical Devices
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Non-specific chronic low back pain with active discopathy OR Non-specific chronic low back pain without active discopathy,
18 years ≤ Age < 80 years,
Average pain intensity (VAS) over the last week ≥ 40/100,
Patient affiliated to the health social security system,
Disqualifiers
Specific low back pain (infectious, inflammatory, tumorous, or traumatic in origin).
Motor neurological deficits (peripheral or central).
Extrapyramidal syndrome.
Treatment with implanted neurostimulation.
Trial design
Design model
Crossover
Treatments tested in this trial
Japet.W+
DeviceCurrent care of low back pain and wearing the Japet.W+
Control (Standard treatment)
DeviceCurrent care of low back pain
Treatment groups
102 Participants
are divided into 2 treatment groupsGroup A: Group AActive comparator 2 interventions
Group B: Group BActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Comparison of the difference Δ1=VASweek8 - VASweek1 and Δ2=VASweek18-VASweek11.Secondary outcomes
1
Adverse events
Time frame
Week 4 day 7, Week 8 day 7, Week 14 day 7 and Week 18 day 72
Rate of device failure
Time frame
Group B: Week 4 day 7, Week 8 day 7 / Group A: Week 14 day 7 and Week 18 day 73
Functional disability
Measurement of specific activity limitation using the Roland-Morris score
Time frame
Beginning and end of each period (Week 1 day 1, Week 8 day 7, Week 11 day 1, Week 18 day 7).4
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.
Time frame
Beginning and end of each period (Week 1 day 1, Week 8 day 7, Week 11 day 1, Week 18 day 7).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Japet Medical Devices
Lead sponsor
University Hospital, Clermont-Ferrand
Collaborator
Hôpital Cochin
Collaborator
Source ClinicalTrials.gov