Action of the Actiflux Magnetic Belt on chronic low back pain

Authors of the magnetic study: Dr JF Marc, Rheumatologist, rue Élisée Reclus, Roanne 42300 Dr JL Renevier, Rheumatologist, Centre Medicosocial du Lac, 1 rue René Duguay Trouin, Mantes la Jolie 78200

INTRODUCTION: According to an estimate by the World Health Organization, based on its study on the global burden of disease (1), low back pain is the leading cause of disability in the world... In France, spinal pathologies are among the most frequent ailments following load handling (INRS website, "prevention of risks related to manual handling", 2011) and nearly 10% are likely to evolve into chronic or recurrent low back pain(2). This minority of cases is also responsible for 75 to 90% of the total costs of low back pain, depending on the study, and these costs are considerable due to the handicap of the situation that they create and the repercussions on employment that they cause (3). In fact, they represent the second most common cause of disability (23.1%) for employees under the general social security system, after psychiatric disorders (28.1%) (4).
Definition of chronic low back pain

In 2000, the Agence Nationale d'Accréditation et d'Evaluation en Santé defined low back pain as unusual pain in the lumbar region. This pain may radiate to the buttock, the iliac crest, or even the thigh, and only exceptionally extends beyond the knee (5). In this context, these recommendations do not cover the diagnosis and management of low back pain secondary (so-called "symptomatic") to an inflammatory, traumatic, tumoral or infectious cause. The recommendations of this same agency in 2005 (6) on the massokinesitherapy management of common low back pain distinguish according to their duration: acute low back pain with a duration of 4 weeks or less, subacute low back pain with a duration of between 4 and 12 weeks, and chronic low back pain marked by its duration of more than 3 months. Recurrent low back pain is distinguished from chronic low back pain by the existence of periods of remission of the painful symptom(s).

There are currently "magneto-active" orthoses on the market that provide a slight restraint without being immobilizing but that provide a local analgesic effect linked to a reduction in the conduction of certain pain fibers of the peripheral nerves and a stimulation of the secretion of endogenous opioids (powerful natural painkillers). This effect would be due to the presence of powerful Neodymium Iron Boron medical magnets (3000 Gauss in contact with the skin) but there are no controlled studies on the effectiveness of such belts (15, 16).

Even if the precise origin of low back pain is mostly unknown in the current state of knowledge, we propose to test the impact of the ACTIFLUX Auris magneto-active belt on chronic low back pain patients in a study.

MATERIALS AND METHODS: This is a multicenter, observational, prospective study with a 3-month follow-up.

MAIN OBJECTIVE: To evaluate the impact of the ACTIFLUX Auris magneto-active belt in chronic low back pain patients using the VAS scale and the Dallas Self-Assessment Device (DRAD) spine pain scale.

The DRAD scale has good metrological qualities in chronic low back pain patients.

The DALLAS self-questionnaire is divided into 16 questions, which are subdivided into 4 groups:

    Questions 1 through 7 concern the percentage rate (ranging from 0 to 100%) of impact on daily activities.
    Questions 8-10 are about the percentage of impact on the work/leisure ratio.
    Questions 11-13 are an estimate of the percentage of impact on the anxiety/depression ratio.
    Questions 14-16 are a percentage of impact on sociability. The primary objective will be met if the improvement on VAS is > or = 2 points and there is an improvement in the DRAD score.

SECONDARY OBJECTIVE: to evaluate the decrease in analgesics and/or NSAIDs.

Inclusion Criteria:

    Patients aged 18 years and older.
    Patients who gave written consent to participate after receiving oral and written information about the study.
    Patients with a proven diagnosis of chronic low back pain with a radiological workup of less than 6 months, an inflammatory biological workup of less than 3 months, a pain VAS > or = 6 out of 10.
    Patients who have been receiving analgesic or NSAID treatment for more than 15 days.
    Patients able to understand and answer the DALLAS self-questionnaire.

Exclusion criteria:

    Patients with a Pace-Maker. - Patients with medical conditions that, in the opinion of the investigator, would limit their ability to participate fully in the study or to meet all study requirements.
    Pregnant women.
    Patients under 18 years of age.
    Patients who cannot understand or respond to the DALLAS self-questionnaire.
    Patients with work-related injuries.
    Patients who have undergone lumbar spine surgery or are awaiting surgery within 3 months.
    Patients treated with morphine, corticosteroid infiltration for less than 3 months, AASAL for less than 3 months.
    Patients with a waist circumference > 130 cm

CENTER: 2 centers with liberal rheumatologists: Dr JF MARC in Roanne (42), Dr JL RENEVIER in Mantes-La-Jolie (78).

PATIENTS: 20 patients will be included in the study (10 per center)

DATA COLLECTION: Physicians will report study data in an observation book at inclusion and then every month for 3 months.

D0 inclusion: VAS scale + DRAD and traceability of analgesic drugs: the patient is asked to put on the lumbar support belt permanently day and night for 7 days, then all day for 12 hours over 7 days, then at least 6 hours a day for 14 days.

M1 : EVA control : If rapid response (improvement of EVA > or equal to 3 points) the patient is authorized to put on the belt on demand. If slow responder or non-responder, wear the belt for a minimum of 6 consecutive hours each day until M2

M2: idem

M3: EVA + DRAD control and traceability of analgesic drugs.

Clinical examination: weight, height, BMI, waist circumference, Schoeber index (normal > or = 5 cm), DDS (finger-to-ground distance).


    Study set up from November 01, 2016.
    Inclusions of patients from November 2016 to January 2017
    Patient follow-up from November 2016 to April 2017


Sex ratio of 8 females and 12 males with a mean age of 60.8 years.

No subjects lost to follow-up.

The average BMI was 26.37 kg/m2, i.e. overweight which is expected in a low back pain population over 60 years old.

In the case of the biological workup, no inflammatory syndrome was accepted, which was confirmed by the samples taken.

The radiological workup could include either an X-ray, a CT scan, or an MRI, with no time limit.

VAS: Initially close in both centers (7.02 average in center 1, Dr. Renevier, 6.91 average in center 2, Dr. Marc), i.e., overall, VAS at inclusion = 6.97. The improvement was significant with a monthly progression to reach an average of 3.2 for patients in center 1 and 2.15 for patients in center 2, i.e. overall, VAS = 2.68

The results show a progression largely superior to the 2 points expected as the main objective: 3.82 for center 1 and 4.76 for center 2, i.e. an overall average of 4.29 improvement.

Of course, pain always has a personal and subjective dimension, particularly in the case of chronic pain, but the improvement observed in sub-pelvic stiffness (DDS index), which is less related to kinesiophobia than lumbar stiffness (measured by Schoeber's index), confirms the definite effectiveness of wearing the magneto-active belt on pain.

Concerning the second element of the main objective, i.e. an improvement of the DRAD score

score at admission:

    Average percentage of impact on daily activities = 62.75
    Average percentage of impact on work/leisure = 47%.
    Average percentage of impact on anxiety/depression = 42.5
    Average percentage of impact on sociability =46.5

and at 3 months:

    Mean percent impact on daily activities = 47.38%
    Average percentage of impact on work/leisure = 26%.
    Average percentage of impact on anxiety/depression = 28.38
    Average percentage of impact on sociability = 32.75%.

There is therefore a significant improvement in the Dallas Self-Report Score.

For each item of the Dallas score the magneto-active belt allows a significant improvement testifying to a functional gain besides the analgesic effect but also a positive impact on the mood and on the socio-familial environment of the patients.

What about lumbar orthoses?

Lumbar orthoses include belts and corsets and can be classified according to their rigidity (soft, semi-rigid and rigid) and according to their manufacturing methods (mass-produced or custom-made). A lumbar belt generally refers to a soft, mass-produced brace, while a corset refers to a rigid, custom-made brace.

Belts" are widely prescribed for low back pain, to relieve pain but also as a means of individual prevention in the workplace. Whatever the type of support, the biomechanical principle is the same: on the one hand, the increase in intra-abdominal pressure and the resulting reduction in compression forces on the intervertebral disc, and on the other hand, the reduction in mobility of the lumbar spine.

During lifting efforts, the contractions of the abdominal wall muscles, the diaphragm and the perineum, by leaning on the abdominal viscera, increase the intra-abdominal pressure and make it more rigid. It then plays a role of guardian in front of the lumbar spine and participates in the transfer of forces between the upper body and the pelvis, which decreases the pressures in the intervertebral discs (7, 8). These muscular mechanisms and their biomechanical consequences would be potentiated by the wearing of a lumbar brace that increases the rigidity of the abdominal cavity.

Since the year 2000, we have known, thanks to the work of Van Poppel (9) and Wassel (10), that wearing a lumbar brace reduces spinal mobility, without prejudging the clinical relevance of this data, particularly with regard to their analgesic effect. This limitation is especially convincing at the upper lumbar levels and the ideal support should include the thighs and the abdomen to divide by 5 the mobility of the L4-S1 segment or lumbosacral hinge, which is particularly sensitive to constraints (11). But this type of belt is unusable in everyday and professional activities...

There is still a common misconception among both the general public and health professionals: "don't wear too much belt because you will atrophy your muscles! In Meyer's excellent review of the literature (12), longitudinal studies show no decrease in trunk strength abilities after continuous and prolonged wear for 6 to 12 months and even an increase in lifting abilities in low back pain subjects wearing an inflatable bladder belt after 6 months of wear (13).

It is probably because the immobilization of the trunk has an analgesic effect allowing a quicker return to work that the prescription of lumbar belts is so frequent, but also because of the subjective effect often reported of an impression of thermal comfort induced by the wearing of lumbar belts (14).

The "magneto-active" orthoses, which ensure a light contention respecting the spinal mobility, cannot have analgesic effects by the immobilization but by their mode of action due to the presence of powerful Neodymium Iron Boron medical magnets (3000 Gauss in contact with the skin).

In most cases, the AURIS belt was worn continuously day and night for 7 days, then, depending on the results on the visual analog scale in the first month, then in the second month and in the third month, the belt could be put on simply on request, depending on whether the subject was a responder or not.

Thus, in this study, 2 subjects were non-responders (1 in each group) and 2 men in group 2 (Dr. Marc) had an "ultra-rapid" response from the first days. The other patients, i.e. 16 subjects, found a significant result in the form of a rapid response after the 1st month or a slow response after the 2nd month.

At the third month, the monitoring of analgesic and anti-inflammatory treatment was noted and showed in all patients a slight to significant decrease in the use of oral treatments, thus validating our secondary objective, which is also responsible for a reduction in costs for the social security.

During the study, tolerance was excellent, no local or systemic adverse effects of Auris permanent magnets were reported. The textile support was highly appreciated for its hold while avoiding too much immobilization.

Even though our average age in this work corresponds for the most part to individuals without professional activity or retired, the functional prognosis of low back pain is conditioned by the duration of the work stoppage: the proportion of workers returning to work after 6 months of stoppage is estimated at 50%; it is close to zero after 2 years (17). The socio-economic consequences of low back pain are considerable. According to the INRS report entitled "Work and Low Back Pain" published in February 2011, the average duration of work stoppage for low back pain after a work-related injury increased from 25 days in 1970 to 55 days in 2005.

Through this observational study of 20 patients, it appears that the AURIS belt is able to significantly improve pain and also the quality of life of patients. The primary objective of the study on pain (VAS and DRAD) was largely validated, as was the secondary objective (reduction in the consumption of analgesics and NSAIDs). The magneto-active brace provides relief while respecting spinal mobility, as the textile acts more as a support for magnets than as a coercive immobilization.

Thus, a simple and economic innovative means can bring a real relief to patients, but this observational study with a small number of patients would deserve a larger work with younger patients, still in age to have a professional activity and to look if with a light belt, a resumption of activity would be possible.

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