With a 6.11 points drop in the pain threshold, the Gonalgis study demonstrated a powerful analgesic effect in patients with severe symptomatic knee osteoarthritis who are sometimes under multiple medications. This drop represents double the amount of the initial target. The Gonalgis study also demonstrated, for a majority of patients, a moderate to significant decrease in oral drug treatment. The authors of the study, Doctor Renevier and Doctor Marc, as well as the patients, were greatly surprised by the almost constant painful decrease in all patients, and its sustainability over time.
Once again, AURIS therapeutic magnets proved their efficiency in reducing pain.
To assess the analgesic impact of the AURIS’ GONOFLEX magnetoactive orthosis (MAO) in patients with severe primary symptomatic or post-traumatic knee osteoarthritis.
Osteoarthritis is becoming a real public health issue with the aging of the population. Osteoarthritis is underestimated. There is an increase in its prevalence [1-2], particularly linked to obesity…. In 2009 in the USA, surgeons performed 686,000 knee replacements and projections predict the implantation of 1,520,000 prostheses in 2020 and 3,480,000 in 2030. Prosthesis replacements continue to progress. A 600% increase is expected by 2030. Regarding the drugs used in arthritis treatment, the French NHS (Securite Sociale), cancelled the refund of the slow-acting symptomatic anti-osteoarthritis drug in march 2015, and the hyaluronic acids in december 2017. They estimated that the medical service provided was not enough to justify being refunded by the national funds. The use of nonsteroidal anti-inflammatory drugs (NSAIDs) often has limited action due to undesirable gastrointestinal, cardiac and renal effects, especially for an elderly population taking multiple medications. With this information, any non-surgical, non-drug approach deserves a careful evaluation.
What about knee orthoses in knee osteoarthritis ?
The question is worth raising after the January 2015 publication of an american research team. They conducted a 6 weeks randomized controlled trial evaluating the efficiency of a patellar knee brace on knee pain and spinal cord injuries of the subchondral bone on patients with knee osteoarthritis. 126 patients with painful patellofemoral osteoarthritis were part of the study and randomized into two groups in order to wear or not a patellar orthosis for 6 weeks. The average time the participants would spend wearing the knee brace was 7.4 hours per day. The idea was to limit mechanical and contact stress on the joint. By resting the patella on the trochlear throat, a patellar knee brace increases the contact surface at the patellofemoral joint and allows the forces to be distributed over a larger area. It should thus decrease the potentially painful stress on the joint. From this study, the team has concluded that the patellar knee brace not only reduced pain but also decreased the extent of subchondral spinal cord injury in the patella. However the short duration of this work is a limiting factor of the interpretation of these results.But this study corresponds to a desire to find non-medical and non-surgical solutions to a disabling disease of great global prevalence. AURIS, expert in magneto therapy, has developed a suitable orthosis : GONOFLEX.
This device of modern and innovative design combines several advantages:
- Lightness due to its silicone composition
- One size fits all, regardless of the morphotypes of this deforming rheumatism of osteoarthritis of the knee. Whether in its primary metabolic form where osteoarthritis lipomatosis contrasts with quadricipital and sural sarcopenia often associated with a venous lymphatic insufficiency (phleb arthrosis) or in its post-traumatic form combining quadricipital atrophy and articular bone hypertrophy. The adjustment is made by 2 femoral and tibial straps respecting completely the popliteal fossa vasculo nervous.
- Symmetrical orthosis therefore without right/left laterality
- Analgesic orthosis with 4 powerful lateral magnets 25mm in diameter/ 3 mm in thickness given their inverted polar surfaces, a powerful continuous magnetic field in the medial and lateral femorotibial. And 4 smaller inverted magnets arranged circumferentially in patellar femoris, 15 mm in diameter/3 mm thick/ each delivering 1.22 tesla per emission, or approximately 0.3 T to the articular skin surface.
Mode of actions of magnetic fields.
Continuous magnetic fields are experiencing a strong resurgence of interest from the medical profession due to their effectiveness, their safety in use but also the discovery of their mechanisms of action on pain and human pathology. Indeed the effectiveness of the static magnetic field of permanent magnets is due to the combination of three effects :
- The magnets reduce the action potential of the C fibers in the peripheral nerves, which means that the magnets decrease the transmission to the brain of afferent pain messages carried by the nerves in the painful area.
- The magnets induce by a conduction effect (Faraday Effect) a very weak electric current (not perceptible by the consciousness of the individual being treated) in the vessels (moving fluids) under the skin of the area where they are applied. This is the principle of magnetic induction. The brain identifies the “aggressor” signals, geolocates it and in response produces endorphins (our strongest natural painkillers) that are directed through the bloodstream to this area of the electromagnetic signal. Medical magnets therefore stimulate the secretion of our powerful endogenous opioids to relieve us.
- Also, since the discovery of the magnetic field for diagnostic purposes, we know with proton magnetic resonance imaging (MRI) that a diseased area has its magnetic field disturbed which results in an abnormal image. Magnets with a continuous magnetic field make it possible to restore the original magnetic field of the injured area which can only contribute to a return to normal of a diseased area and therefore help to stabilise a lesion or, even to heal. This is what we called the return to the state of magnetic homeostasis.
In terms of tolerance, it is amazing, Magnetic waves in a continuous field have no harmful effects, there is no irradiation as with X-rays, and no risk of burns as with electrotherapy. At most, for some people, with magnets in direct contact with the skin, there may be some benign local skin reactions (erythema,phlyctenules, rarely exulceration) and it can also happen when the magnets stop being used.
This has never happened with magnets included in the textile supports. However, there is a stric contraindication to the use of continuous magnets near pacemakers because of the high risk of magnetic interference with these stimulation probes. We also want to remind you that the power of the magnets decreases very quickly with the square of the distance, which makes them act as a treatment for local purposes.
Materials and Methods :
This is a multicenter, observational, study with a three-months follow up.
To assess the impact of the Auris’ GONOFLEX medical device in patients suffering from knee osteoarthritis using the WOMAC A1 (Western Ontario and McMaster University Osteoarthritis Index) Item A1 focuses on walking pain (see appendix). This is an index of symptomatic severity of osteoarthritis of the lower extremities. The WOMAC is confirmed in the evaluation of osteoarthritis of the lower limbs. The main objective will be achieved if the improvement on EVA is
superior or equal to 2 points.
- To assess the reduction of analgesics and/or NSAIDs
- To check the compliance with the ratio of prescribed wearing time/ estimate the actual wearing time
- To classify according to the response in UFR (Ultra fast responder, a few days), FR (fast responder M+1), SR (slow responder M+2 or M+3) , NR (non responder) and LFU (lost to follow-up).
This is a multicenter, observational, study with a three-months follow up.
Inclusion Criterias :
- Femorotibial and/or patellofemoral gonarthrosis according to the ACR criteria, without intra-articular effusion during the clinical examination.
- Symptomatic gonarthrosis evidenced by a walking pain (WP) (WOMAC A1 assessed over the past 24h on the basis of a numerical scale from 0 to 10 5<WP<9)
- Men or Women aged 45 to 85
- Patients able to understand the requirements of the trial and who have signed a free and informatif consent before entering the study.
- Patients able to read and to understand the written requirements
- Patients with radiological knee osteoarthritis (shown on X-ray less than 6 months old), stage II-III of Kellgren and Lawrence.
- Ambulatory patient, able to walk 50 meters without a cane, crutch or walker.
Exclusion criterias :
- Patients with pacemakers
- Patients with pathologies or conditions which, in the investigator’s opinion, would limit their abilities to fully participate in the study and to meet all its requirements. (example : cancer, inflammatory rheumatism, infection, ect…)
- Pregnants women
- Patients under 18 years old
- Patients on work related injury
- Patients who had a knee surgery or who are waiting for a knee surgery within 3 months
- Patients under morphine treatment
- Patients with radiological knee osteoarthritis (shown on X-ray less than 6 months old) Stage I or IV of Kellgren and Lawrence.
- Patients with a congestive flare-up of osteoarthritis of the knee
Center : 2 centers with independent rheumatologists : Dr Jean-Francois MARC in Roanne (France, 42), and Dr Jean-Luc RENEVIER in Mantes-La-Jolie (France, 78).
Patients : 30 patients will be taking part in the study (15 per center)
Duration : The duration of the inclusion period will be 3 months, with follow up of M1, M2,M3 per patient. The total duration of the study (inclusion of the first patient - discharge of the last patient) will be 6 months.
Data collection : Doctors will report the study data in an observation notebook during the inclusion and then monthly for 3 months.
Timeline of the study :
D0 : inclusion : WOMAC A1 and traceability of analgesic drugs/ NSAIDs : the patient is required to wear GONOFLEX 12 hours per day the 1st month, then according to the result each month, the carrying time will be adjusted : 12 hours, 6 hours, on demand (OD).
M1 : WOMAC A1 check, prescripted wearing time and actual estimated time worn.
M2 : same process
M3 : same process + traceability of analgesic drugs/NSAIDs.
Time worn P-12-6-OD (P:permanent/12h/6h/On demand)
Study calendar :
- Implementation of the study from October 15, 2018
- Patients inclusion from October 15, 2018 until the end of January 2019 taking into account the end of the year holiday period.
- Patients follow-up from mid January 2019 until mid April 2019
Sex ratio of 20 women and 10 men, average age of 66.5 years old.
No subject has been lost to follow-up but 1 patient of Dr JL RENEVIER stopped wearing the knee brace following a major allergic reaction the first week. It actually turned out to be a skin intolerance to the silicone filling the magnets cover, here to insure the sealing and antioxidant magnet protection. The change of silicone supplier seems to have been effective for the second version of the magneto-active orthosis. The average BMI is 26.8kg/m2 which is an expected overweight for a population over 60 years old with osteoarthritis. Regarding the biological assessment, no inflammatory syndrome was accepted, which was confirmed by the sample taken. The radiological assessment found an average Kellgren and Lawrence grade 2.5 score with a homogeneous distribution of the knees, both right and left. A bilateral involvement is not uncommon given the age and overweight. Thus, the authors of this study noted bilateral
knee osteoarthritis in 86% of the cases.
WOMAC A1 : Initaly close in both centres (7.32 in average center1, Dr JL Renevier. 7.19 in average center 2, Dr JF Marc)or in total, WOMAC A1 at inclusion = 7.25. The improvement was very significant with a monthly progression reaching an average at m1 of 3.34 for the center 1’ patients and of 2.95 for the patients of center2, that is overall, WOMAC A1 M1 = 3.14. The pain regression is confirmed with a WOMAC A1= 2.00 in M2 and a WOMAC A1 = 1.03 in
The results show a progression well above the 2 points expected as the main objective, that is an overall average of 6.22 improvement. Of course the pain always has a personal and subjective dimension, especially when it comes to chronic pain, but the improvement observed in the pain when the subject walks on a flat surface (WOMAC A1) proves the positive effect on pain of wearing the magneto-active orthosis. We recall that the placebo effect is usually evaluated
between 20 and 30% in knee osteoarthritis, much lower than the MAO results.
What to think about orthotic treatment ?
In a text about the wearing of orthosis for internal unicompartmental osteoarthritis of the knee, Pollo and Jackson  mentioned studies showing improvement in pain score with the wearing of a valgicating orthosis. However in the analysis, no clinical study regarding orthotic wear compliance were available, the authors stated that compliance was more than 75% in their own population. However, the American Academy of Orthopaedic Surgeons Clinical Practice Guideline for knee osteoarthritis in 2009 has concluded that the studies did not provide sufficient evidence to recommend the use of valgic or varicose orthosis. But is the progress in the design and comfort of current orthosis a game changer ? From what duration of daily wear can we expect a result and for how long ? And if so, should we wear an orthosis for life ? Are there any recent clinical and radiological studies ? Unfortunately, the answer is not easy. In 2004, a study with a follow-up of more than 2 years in a population of veterans (48 men and 1 woman, average of 57 years old) showed that 76% of the patients used the orthosis at least once a week during the first year and once a week during the second year. Another older study (from 2002) reported improvement in pain in patients who wear a daytime orthosis continuously for more than 8 weeks. Regardless of this positive result, during the second year wear compliance was only 42%. Note that these same patients were contacted again in 2011 as part of a follow-up study : none was still using the orthosis 11 years later ! In 2013, during a standardized clinical and radiological retrospective work on 89 patients  the observance of wearing the orthosis was studied : 28% of the subjects reported wearing the orthosis regularly ( twice a week, one hour each time or more). After 2 years, 25% of the patients were using it regularly.
The lack of significant symptomatic relief, fit discomfort and skin irritation were the main reason for stopping. Analgesic effect when walking on flat ground (main objective)
Through this observational study of 30 patients, it appears that the magneto-active orthosis improves very significantly knee pain. With a drop of 6 points in WOMAC A1 by EVA, the main objective of the study has been largely achieved. This is a positive study.
Symptomatic decrease in drug consumption
A monitoring of the analgesic and anti-inflammatory treatment was noted and traced during the third month; this showed for a majority of patients a moderate to significant decrease in oral treatments, thus validating our secondary objective, which is also responsible for a cost reduction for the french social security contribution. For those who did not reduce their treatment, the reason was a painful joint poly pathology independent of knee osteoarthritis. Therapeutic magnets remain loco-regional treatments.
Response classification (UFR,FR,NR,LFU)
In this study, no treated subject was non-responder (NR), or lost to follow up (LFU), only 1 discontinued for side effect (SE).5 subjects in group 2 (Dr JF Marc), 3 in groupe 1 (Dr JL Renevier) had an “ultra-fast” response for the first days (UFR). The remaining patients, 23 subjects, had a significant result showing as a fast response after the 1st month (FR) or slow after the second month (SR). All patients responded by M2 at the lastest, so there were no slow responders.
The authors and the patients were highly surprised by the extent of the almost constant pain reduction in all patients and for its sustainability over time.
Prescribed and actual wear time In most cases, the magneto-active orthosis was worn continuously during the day (12 hours) for 30 days, then depending on the results during the first month : 12h, 6h, on demand, then the wearing time was adjusted each month depending on the concept of fast-responder,slow or non temporary responder. Analysis of the wearing time of the magneto active orthosis revealed several effects :
- A summation or addition effect : we cannot expect an immediate effect although ultra-fast responders (27%) obtain an analgesic effect in a few days, most often it is necessary to add the 12 hours days of wearing to obtain a fast effect in 1 month and slow in 2 months with a progressive analgesic effect. This time laps of efficiency was an expected effect already mentioned in the “LONBALGIS” study and allows us to classify our patients as UFR,FR,SR.
- A preventive effect : responding patients who have switched to on demand wearing mode instinctively adapted their wearing time of the MAO depending on the workload expected.
- A persistent effect : this sustainable analgesic effect after obtaining the summation effect enabled the patients to alternate wearing time of the magnetoactive orthosis and break time of 2 days up to more than 10 days, without a significant decrease in pain with an analgesic effect re activated when wearing the orthosis again. Note that all of these patients were suffering continuously at inclusion with some fluctuations in intensity from a day to another.
- A dose-dependent effect : a patient has specifically tested the wearing time of the magnetoactive orthosis in decreasing mode : one hour per day Monday to Saturday and a break on Sunday revealing a minimum wearing time threshold of 3 to 4 hours. When re-reading the files of other patients on the on-demand wearing stage, who kept schedules with wearing time systematically, indicated this “dependent individual minimum threshold” was from 2 hours to 6 hours per
day, on average 4 hours.
- A nocturnal effect : In this study, because of skin intolerance to the silicones covering the magnets, some patients switched to alternating diurnal and nocturnal mode, and for one of them, to mostly nocturnal mode (193h versus 30h in a month),each time with a not-degraded analgesic effect by this night wear.
- An alternating effect : some patients with bilateral knee osteoarthritis, and who are relieved on the dominant symptomatic side chosen at inclusion, alternated both sides with a significant bilateral relief that persisted. Some patients alternated daytime and night wear while others alternated diurnal sides exclusively (true alternation).
Sides effects and technical incidents.
During the study, the skin tolerance of the MAO (magneto active orthosis) was pretty average during permanent daytime wearing (12 hours) with a patient quickly discharged due to a significant allergic reaction to the product covering the magnets.One in 3 subjects reported skin “irritation” during permanent daytime wearing, Some have switched to nocturnal mode on their own with a result as good as daytime wear but without the irritation due to mechanical friction
during the day. The simple break from wearing it, sometimes associated with the application of Zn-based ointment was enough for the majority of patients to counter these benign deleterious skin effects (often erythema,sometimes phlyctenules, rarely exulceration) without preventing a good analgesic result. Under study, using microporous material on the skin at the location of the 4 large side magnets was preventive of these skin reactions for the concerned patient.
Patients’ feedback has revealed an issue of insufficient length of the lower strap and two patients have experienced a breakage of anecdotal material (lateral patellar band)self repaired by suturing, preventing neither the wearing of the orthosis nor its analgesic efficiency. These points were mentioned to Auris which subsequently modified this version 1 to version 2 (4 pictures front side and rear side of version 1 and 2) in the interest of the patients.
Even if our average age in this study corresponds for the most part to individuals without professional activity or retirees, the functional prognosis of low back pain is conditioned by the duration of the sick leave. The proportion of workers going back to work after 6 months of leave is estimated at 50% : it was close to 0% 2 years ago (17).
The socio-economic consequences of low back pain are considerable. According to the French National Research and Safety Institute, entitled “Work and low back pain” published in February 2011, the average duration of work leave due to low back pain after a workplace accident went 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 decrease pain, hence, to improve the quality of life of patients.
The main objective of the research on pain (VAS and DSQP) has been wildy validated, as well as the secondary objective (reduction in the consumption of analgesics and NSAIDs). The magneto-active orthosis provides relief while respecting the spinal mobility, the fabric acting more as a support for the magnets than as a coercive immobilisation. Thus, an easy, economical and innovative way can bring 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 observe if with a light belt, a work and daily activities resumption would be possible.
Altman RD. Overview of osteoarthritis. Am J Med. 1987;83:65-9. 4. Blagojevic M, Jinks C, Jeffery A, Jordan KP. Risk factors for onset of osteoarthritis of the knee in older adults: a systematic review and meta-analysis. Osteoarthritis Cartilage. 2010;18:24-33. Niu J, Zhang YQ, Torner J, Nevitt M, Lewis CE, Aliabadi P, Sack B, Clancy M, Sharma L, Felson DT. Is obesity a risk factor for progressive radiographic knee osteoarthritis? Arthritis Rheum. 2009;61:329 35. Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007;89:780-5. Callaghan MJ et coll. A randomised trial of a brace for patellofemoral osteoarthritis targeting knee pain and bone marrow lesions. Ann Rheum Dis, 2015. Okano H. The effects of moderate-intensity gradient static magnetic fields on nerve conduction. Bioelectromagnetics. 2012 Sep; 33(6):518-26. Rosen AD. Membrane response to static magnetic fields: effect of exposure duration, Biochim. Biophys. Acta.1992; vol 1148: 317-20. Rosen AD. Studies on the Effect of Static Magnetic Fields on Biological Systems. PIERS Online.2010; vol 6, n 2: 133-36. Shupak NM. and al. Analgesic and behavioral effects of a 100 mT specific pulsed extremely low frequency magnetic field on control and morphine treated CF-1 mice. Neurosci Lett, 2004; 354: 30 33. Laszlo J. Optimization of Static Magnetic Field Parameters Improves Analgesic Effect in Mice. Bioelectromagnetics. 2007; 28:615-27. Gyires K and al. Pharmacological Analysis of Inhomogeneous Static Magnetic Field- Induced Antinociceptive Action in the Mouse.Bioelectromagnetics. 2008; 29:456-62. Pollo FE, Jackson RW. Knee bracing for unicompartmental osteoarthritis. J Am Acad Orthop Surg. 2006;14:5-11. Richmond J, Hunter D, Irrgang J, Jones MH, Levy B, Marx R, Snyder-Mackler L, Watters WC 3rd, Haralson RH 3rd, Turkelson CM, Wies JL, Boyer KM, Anderson S, St Andre J, Sluka P, McGowan R. American Academy of Orthopaedic Surgeons Treatment of osteoarthritis of the knee (nonarthroplasty). J Am Acad Orthop Surg. 2009;17:591-600. Giori N. Load-shifting brace treatment for osteoarthritis of the knee: a minimum 2½ year follow-up study. J Rehabil Res Dev. 2004;41:187-94. Barnes CL, Cawley PW, Hederman B. Effect of CounterForce brace on symptomatic relief in a group of patients with symptomatic unicompartmental osteoarthritis: a prospective 2-year investigation. Am J Orthop (Belle Mead NJ). 2002;31:396-401. Wilson B, Rankin H, Barnes CL. Long-term results of an unloader brace in patients with unicompartmental knee osteoarthritis. Orthopedics. 2011;34:e334-e337. Squyer E, Stamper DL, Hamilton DT, Sabin JA, Leopold SS. Unloader knee braces for osteoarthritis: do patients actually wear them? Clin Orthop Relat Res. 2013 Jun;471(6): 1982-91.