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

Grand Hôpital de Charleroi60 enrolled

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Low Back Pain, Mechanical

Interventions

Use of the Exoskeleton JAPET.WOTHER

Phsysiotherapy sessions with the support of the Exoskeleton JAPET.W

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Grand Hôpital de Charleroi

Charleroi, Hainaut, Belgium

RECRUITING

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

Time frame: Up to six months

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

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

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

Assessment of the efficacy of the JAPET.W - Assessment in quality of life

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.

Time frame: Up to six months

Assessment of the efficacy of the JAPET.W - Assessment of the Anxiety level

Assessment of the Anxiety level with Hospital Anxiety Depression Scale. This scale ranges from 0-no anxiety to 3-totally anxious.

Time frame: Up to six months

Secondary Outcomes

Assessment of the safety of the JAPET.W

Central Contacts

Serge TROUSSEL, MD

CONTACT

0032 71 10 Serge.TROUSSEL@ghdc.be

Data from ClinicalTrials.gov

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