Clinical trial NCT06718348: Assessing the Japet.W+ Lumbar Traction Device in Rehabilitation for Patients With Non-specific Mechanical Low Back Pain
Official title: Assessing the Japet.W+ Lumbar Traction Device in Rehabilitation for Patients With Non-specific Mechanical Low Back Pain
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Low Back Pain, Mechanical
Lead sponsor: Grand Hôpital de Charleroi
Sponsor class: OTHER
First posted: 2024-12-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of the efficacy of the JAPET.W - measurement of pain
timeFrame: Up to six months
measure: Assessment of the efficacy of the JAPET.W - consumption of analgesic
timeFrame: Up to six months
measure: Assessment of the efficacy of the JAPET.W - functional assessment
timeFrame: Up to six months
measure: Assessment of the efficacy of the JAPET.W - Assessment of the kinesiophobia
timeFrame: Up to six months
measure: Assessment of the efficacy of the JAPET.W - Assessment in quality of life
timeFrame: Up to six months
measure: Assessment of the efficacy of the JAPET.W - Assessment of the Anxiety level
timeFrame: Up to six months
Secondary outcomes:
measure: Assessment of the safety of the JAPET.W
timeFrame: Up to six months
Other outcomes:
Locations:
city: Charleroi
country: Belgium
facility: Grand Hôpital de Charleroi
state: Hainaut
Study officials:
affiliation: Grand Hôpital de Charleroi
name: Serge TROUSSEL, MD
role: PRINCIPAL_INVESTIGATOR
References: