Assessing the Japet.W+ Lumbar Traction Device in Rehabilitation for Patients With Non-specific Mechanical Low Back Pain

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGrand Hôpital de Charleroi

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Use of the Exoskeleton JAPET.W

    Other intervention

    Phsysiotherapy sessions with the support of the Exoskeleton JAPET.W

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Group CTRLNo intervention 0 interventions
Group B: Group EXPExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Up to six months
2

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

Time frame
Up to six months
3

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.

Time frame
Up to six months
4

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

Time frame
Up to six months

Secondary outcomes

1

Assessment of the safety of the JAPET.W

Rate of patients who had at least one device related adverse event during the clinical investigation.

Time frame
Up to six months

Other outcomes

Sponsors and contacts

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