Low Back Pain, Mechanical
Conditions
Brief summary
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
Detailed description
The study will include patients suffering from nonspecific mechanical low back pain for more than 6 weeks. The study will consist of two groups: a control group (Group CTRL) and an experimental group (Group EXP). Participants will be categorized into two categories: "workers," patients on temporary work leave due to low back pain, and "non-workers," patients unable to work due to this condition after exhausting all available therapeutic solutions. Monitoring period (30 physiotherapy sessions): evaluations will be conducted at sessions 1, 15 and 30, on the two groups. Evaluation session 3 months after the end of the physiotherapy sessions.
Interventions
OTHERUse of the Exoskeleton JAPET.W
Phsysiotherapy sessions with the support of the Exoskeleton JAPET.W
Sponsors
Grand Hôpital de Charleroi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Specific low back pain (infectious, inflammatory, tumorous, or traumatic origin), * Motor neurological deficits (peripheral or central), * Extrapyramidal syndrome, * Treatment with implanted neurostimulation, * Cardiac or circulatory diseases or serious respiratory problems, * Previous recent arthrodesis or recent lumbar prosthesis surgery, * Surgery for herniated disc (\<3 months), * Fracture of the dorsolumbar spine or rib (\<3 months), * Skin lesions, contusions and stretching injuries of the trunk, * Pregnancy, * Individuals not tolerating the JAPET.W+ device during an initial trial, * Under guardianship, curatorship or legal protection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of the efficacy of the JAPET.W - measurement of pain | Up to six months | 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 | Up to six months | Assessment of analgesic use in the two groups at the first and last session |
| Assessment of the efficacy of the JAPET.W - functional assessment | Up to six months | 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 | Up to six months | Comparison of the difference in TAMPA scale. This scale goes to 1-strongly disagree to 4-strongly agree with the proposal |
| Assessment of the efficacy of the JAPET.W - Assessment in quality of life | Up to six months | Assessment in quality of life with EQ-5D-5L. The scale goes to 1-totally able to carry out the activity up to 5-totally unable to do so. |
| Assessment of the efficacy of the JAPET.W - Assessment of the Anxiety level | Up to six months | Assessment of the Anxiety level with Hospital Anxiety Depression Scale. This scale ranges from 0-no anxiety to 3-totally anxious. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of the safety of the JAPET.W | Up to six months | Rate of patients who had at least one device related adverse event during the clinical investigation. |
Countries
Belgium
Contacts
CONTACTSerge TROUSSEL, MD
PRINCIPAL_INVESTIGATORSerge TROUSSEL, MD
Grand Hôpital de Charleroi
Outcome results
None listed