About this trial
The study will include patients suffering from nonspecific mechanical low back pain for more than 6 weeks. Two groups will be compared. A Control group and an Experimental group with the exoskeleton JAPET.W
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Nonspecific mechanical low back pain for more than 6 weeks,
18 years ≤ Age < 80 years,
Patient affiliated to the health social security system,
Patient able to understand the information relating to the study and to sign the informed consent form
Disqualifiers
Specific low back pain (infectious, inflammatory, tumorous, or traumatic origin),
Motor neurological deficits (peripheral or central),
Extrapyramidal syndrome,
Treatment with implanted neurostimulation,
Trial design
Parallel
Treatments tested in this trial
Use of the Exoskeleton JAPET.W
Other interventionPhsysiotherapy sessions with the support of the Exoskeleton JAPET.W
Treatment groups
Trial outcomes
Primary outcomes
Assessment of the efficacy of the JAPET.W - measurement of pain
VAS scale for pain (o -no pain to 10 - pain as bad as it could possibly be) : rate of the patients who had at least -20 points/100 on the VAS for pain
Assessment of the efficacy of the JAPET.W - consumption of analgesic
Assessment of analgesic use in the two groups at the first and last session
Assessment of the efficacy of the JAPET.W - functional assessment
Mobility assessment with the french version of Oswestry Disablility Index. The scale goes from 0 - no pain to 5 - worse.
Assessment of the efficacy of the JAPET.W - Assessment of the kinesiophobia
Comparison of the difference in TAMPA scale. This scale goes to 1-strongly disagree to 4-strongly agree with the proposal
Secondary outcomes
Assessment of the safety of the JAPET.W
Rate of patients who had at least one device related adverse event during the clinical investigation.
Sponsors and contacts
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