Evaluation of the Japet.W+ Medical Device for Low Back Pain Management

N/ANot Yet RecruitingNCT07195422

Japet Medical Devices102 enrolled

Overview

The JAPET.W+ medical device is a new dynamic distraction support system. It could be considered as a new solution in the therapeutic arsenal for managing common low back pain. This study aims to assess the effectiveness of this device among the two targeted populations during daily use. Each patient will be asked to estimate the intensity of their low back pain several times during the clinical investigation. Our main hypothesis is a reduction in low back pain while wearing the device. The secondary hypothesis is a decrease in activity limitations, an increase in participation, an improvement in quality of life, and a reduction in healthcare product and medication consumption.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

102

Conditions

Low Back Pain

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Non-specific chronic low back pain with active discopathy OR Non-specific chronic low back pain without active discopathy, * 18 years ≤ Age \< 80 years, * Average pain intensity (VAS) over the last week ≥ 40/100, * 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 in origin). * Motor neurological deficits (peripheral or central). * Extrapyramidal syndrome. * Treatment with implanted neurostimulation. * Severe heart or circulatory disease or respiratory problems. * Arthrodesis or disc replacement. * Surgery for herniated disc (\<3 months). * Spinal fracture or floating ribs (\<3 months). * Skin lesions on the trunk, history of contusions or skin lesions following traction of the trunk. * Pregnancy. * Patients who cannot tolerate the JAPET.W+ device during an initial trial. * Patients under guardianship, curatorship, or legal protection. * Participation in another clinical trial. * Patients who have worn a device designed to reduce lower back pain regularly during the 2 weeks prior to inclusion (lumbar belt, corset, exoskeleton).

Outcomes

Primary Outcomes

Visual Analogue Scale (VAS)

Pain VAS is a unidimensional measure of pain intensity (from 0: no pain to 100: severe pain), used to record the progression of pain in patients or to compare the severity of pain between patients with similar conditions. The VAS has been widely used in various adult populations, for example people suffering from chronic low back pain.

Time frame: Comparison of the difference Δ1=VASweek8 - VASweek1 and Δ2=VASweek18-VASweek11.

Secondary Outcomes

Adverse events

Time frame: Week 4 day 7, Week 8 day 7, Week 14 day 7 and Week 18 day 7

Rate of device failure

Time frame: Group B: Week 4 day 7, Week 8 day 7 / Group A: Week 14 day 7 and Week 18 day 7

Functional disability

Measurement of specific activity limitation using the Roland-Morris score

Time frame: Beginning and end of each period (Week 1 day 1, Week 8 day 7, Week 11 day 1, Week 18 day 7).

Quality of life

The SF-12 physical (PCS-12) and mental (MCS-12) component summary scales are scored using norm-based methods. Physical and mental regression weights and a constant for both measures come from the general U.S. population. Both the PCS-12 and MCS-12 scales are transformed to have a mean of 50 and a standard deviation of 10 in the general U.S. population. The minimum possible PCS score (standard version of the SF-12) is 9.9 points and the maximum is 76.0 points. For the MCS, the minimum is 3.2 and the maximum is 77.9. In both cases, the higher the score, the better the patient's health status.

Time frame: Beginning and end of each period (Week 1 day 1, Week 8 day 7, Week 11 day 1, Week 18 day 7).

Adherence to Japet.W+

Recovery of Japet.W+ usage time.

Time frame: Recovery of Japet.W+ usage time after 28 days and 56 days of use. Group A (using the device during the second period): Week 14, day 7, and Week 18, day 7. Group B (using the device during the first period): Week 4, day 7, and Week 8, day 7.

Number of healthcare products consumed (drugs, medical appointments, physiotherapy sessions, etc.)

Time frame: Information retrieved 3 times per period (D+7, D+28, D+56). Period 1: Week 1 day 7, Week 4 day 7, Week 8 day 7. Period 2: Week 11 day 7, Week 14 day 7, and Week 18 day 7.