Assessing the Japet.W+ Lumbar Traction Device in Rehabilitation for Patients With Non-specific Mechanical Low Back Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Use of the Exoskeleton JAPET.W.
- Who it may be relevant to
- Registry conditions: Low Back Pain, Mechanical. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Other Use of the Exoskeleton JAPET.W
Phsysiotherapy sessions with the support of the Exoskeleton JAPET.W
Primary outcome measures
- Assessment of the efficacy of the JAPET.W - measurement of pain [Time frame: Up to six months]
- Assessment of the efficacy of the JAPET.W - consumption of analgesic [Time frame: Up to six months]
- Assessment of the efficacy of the JAPET.W - functional assessment [Time frame: Up to six months]
- Assessment of the efficacy of the JAPET.W - Assessment of the kinesiophobia [Time frame: Up to six months]
- Assessment of the efficacy of the JAPET.W - Assessment in quality of life [Time frame: Up to six months]
- Assessment of the efficacy of the JAPET.W - Assessment of the Anxiety level [Time frame: Up to six months]
Secondary outcome measures (1)
- Assessment of the safety of the JAPET.W [Time frame: Up to six months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Belgium · 1 center
- Grand Hôpital de Charleroi — Charleroi
Identifiers
NCT: NCT06718348 · EXO-Exoskeleton Japet.W