Seqex Therapy in Osteonecrosis of the Femoral Head: A Case Report

The cause of non-traumatic Avascular Necrosis of the femoral head (AVN) is unknown in a large proportion of cases. Unless diagnosed early and treated appropriately, it can progress to collapse of the femoral head leading to early degenerative arthrosis. With the advent of modern imaging techniques, AVN can be detected early. Accurate diagnosis of AVN leads to appropriate selection of effective joint-preserving treatment. Techniques aimed at preserving the femoral head, including core decompression, and vascularized/nonvascularized bone graft which are often advised for early necrosis, have shown varying clinical outcomes. For these reasons, further investigations to better understand the effectiveness of conservative treatments are warranted. Bone marrow-derived mesenchymal stromal cells, hyperbaric oxygen, extracorporeal shock wave therapy and pulsed magnetic fields therapy are some of the technique proposal for AVN treatment. We utilized a new Seqex therapy with total resolution of AVN in early stages.


Introduction
Avascular necrosis of femoral head is characterized by cellular death in subchondral bone due to a deficiency in blood supply.
Although the exact pathological mechanisms of Avascular Necrosis of femoral head (AVN) are not fully understood, both non-traumatic (Including excessive consumption of alcohol, corticosteroid overdose, Caisson disease, hemoglobin disorder (s) [e.g., sickle cell anemia], Gaucher disease, and radiation [e.g., chemoradiation therapy] [1][2][3]) and traumatic causes (e.g., femoral neck fracture, dislocation of the hip) have been known to cause blood circulation disorders, there by changing normal cellular physiology and eventually resulting in necrosis [4,5].
In addition, AVN may also occur abruptly in young adults [6]. Necrosis of subchondral bone usually evolves toward articular cartilage damage, eventually leading to secondary osteoarthritis requiring major surgery, including total hip arthroplasty.
Management of AVN of the femoral head can be grouped into three categories: Non-surgical manage-ment, head preserving surgeries and prosthetic hip replacement.
Given the high efficacy of conservative treatment (s) for AVN, it is recommended that surgical interventions follow image diagnosis and/or when classified as necrosis with symptoms [7][8][9].
Some diseas es are associated with hip symptoms and/ or imaging findings that resemble those of early stages of AVN. Characteristic Magnetic Resonance Imaging (MRI) find ings in the early stage of AVN have been reported [10][11][12][13][14].
Based on the impact of Extracorporeal Shock Wave Therapy (ESWT) on vascularization and osteogenesis, Further, there are a number of studies that compared clinical outcomes of ESWT to conservative drug treatments (e.g., the prostacyclin-analogue iloprost [16] and alendronate [17]) and surgical treatments (e.g., coredecompression, bone graft, and total hip arthroplasty), yet scant information is available regarding changes in clinical aspects and the effects across varying radiographic stages.
However, head preserving surgical procedures which aim at decompression and revascularization of the femoral head have given encouraging results in precollapse stages [18][19][20].
Less invasive alternatives have been suggested to prevent the progression of AVN. Among these, core decompression alone may often lead to a transient benefit with discouraging failure [31]. It is therefore conceivable that bone regeneration may be promoted by a supply of autologous osteogenic cells at the site of AVN [32][33][34].
The actual efficacy of cell therapy for AVN, however, is still controversial because of the harsh conditions at the osteonecrotic site, where ischemia and hypoxia cause apoptosis of bone cells [35]. Another recent introduction therapy but still under development is that of quantum medicine, working on the patient's energy-electromagnetic appearance and consequently on the physiological and pathological aspect [36].
Already in 1985, physicist Abraham R, and his associates demonstrated that coupling a static magnetic field (Terrestrial) to a variable electromagnetic field at lower intensity and at room temperature, By specific frequencies (called cyclotronics), some ions (Ca 2+ , Na + , K + , Li + , Mg + ) can overcome the cell membrane barrier. According to the fact that many pathologies are caused by the loss of substances and ions, redirecting these substances back into the cell constitutes a truly interesting therapeutic possibility [37,38].
This physical therapy, which causes vasodilation, appears to be applicable in the presence of flogic and degenerative processes [39].

Case Report
AB patient of 175 cm, 73 kg (BMI: 23.84), who are diagnosed lumbar back pain at another hospital. To clinical examination the lumbar pain appears to be caused by erroneous walking. According to this fact the left hip was suffering to clinical exam. Absence of leg length discrepancies.
In terms of range of motion showed flexion of 90°, complete extension, abduction of 30°, adduction of 20°. He walked with crutches for intensive groin and leg pain, with inability to run, to climb stairs and carrying out the A B In first step we have given him antalgic drug therapy and required to perform pelvis and spine Magnetic Resonance Imaging (MRI).
Ten days later he comes back with slight improvement in symptoms, but still with lameness. Instrumental imaging ( Figure 1) showed AVN of 1 st degree according to Ficat classification [9].
At this time we have prescribed Seqex-magnetotherapy (2 sessions per week) and confirm the same antalgic therapy.
Seqex HC is a Pulsed Magnetic Fields (PEMFs) of new generation. Unlike the others PEMFs it has solenoid mat, the size of an ambulatory bed (Figure 2), voltage pulses from 1 to 80 Hz, magnetic field intensity of 1 Gauss, is sufficient a therapeutic sessions for a maximum of 20 minutes [39]. Compared to other PEMFs, Seqex HC has a wider frequency that allows it to be applied in multiple body 'areas and a less powerful field to allow it to be used even in presence of metal bodies.
Another magnetic resonance step is performed after 2 months and showed improvement of the problem, but not total healing (Figure 3). At this time patient did not need further antalgic therapy.
After 4 months from the beginning of the Seqex-magnetotherapy another MRI (Figure 4) was checked and showed total resolution of the problem. The left hip was completely pain free and with normal range of motion. He walked and running without problems.   Table 1) [40,41].

Discussion
AVN is a relatively common disease, often affecting young and active individuals, that almost inevitably progresses toward osteoarthritis and severe disability of the hip joint. The etiopathology is not clearly understood. However, it is known that interruption of the blood supply to the femoral head leads to cellular death, subchondral fracture, and segmental collapse and at a later stage, secondary degenerative arthrosis [21][22][23][24][25].
To prevent invasive procedures, such as total joint replacement, maximum effort should be made to halt the   Re cently, cell therapy was intro duced with advances in stem cell research and regenerative medicine [34,[58][59][60]. Cell thera py for AVN is typically used at the early stage [61]. For this reason, accurate diagno sis is increasingly important.
Studies have demonstrated the efficacy of Mesenchymal Stem Cells (MSCs) implanted into the femoral head for the treatment of AVN [62,63]. MSCs can be isolated from bone marrow and adipose tissues in adult stages and from Umbilical Cord (UC) blood, and connective tissue of human UC [64][65][66][67]. MSCs can differentiate into specialized cells to repair injured tissues, under certain condi tions based on their potential capacity of multidirectional differentiations [68,69] and studies demonstrated the safety and efficacy of osteoblastic differentiation of MSCs [70].
Few are studies that document satisfactory results in the use of pulsed electromagnetic fields in the AVN [76,77], but in 1983 the first attempts were made [78].
The recent Seqex therapy has allowed a therapeutic improvement, since it is possible to select between 30 different waveforms that provide the best organism response based on the problem to be taken [39]. The computer makes an initial test on the patient and recording data on a personal smart card that is reused at each therapeutic session.
Also with this kind of PEMFs the lesions in early stage respond well to treatment, but with Seqex there is a significant reduction in the number of therapeutic sessions and their duration, with greater patient satisfaction for cost/ benefit ratio.
The USA Food and Drug Administration (FDA) has approved in 1987 the use of this method for the care of "Bone disorders" and shortly after the "spine bifida".
More than a million people have been treated in the US and never are harmful effects from its use have been observed. It should also be noted that magnetic fields that can be generated by these devices are based on the use of extremely low frequencies and "intensity", which does not therefore generate no heat or "ionization" [79].
In case of patients with metal prosthesis, the treatment does not presents contraindication according to the fact that the devices do not generate any thermal effect [37,80].

Conclusion
Hips with AVN in the precollapse stage can be salvaged by core decompression with or without fibular progression of osteoarticular damage and enhance the inherent regenerative potential of bone tissue.
Core decompression is the most popular revascularization procedure which reduces the intra-osseous pressure caused by interstitial edema, improves vascularity, enhances bone healing and therefore relieves pain. It can be achieved by drilling a large single track into the femoral head or by drilling multiple drill holes [42].
Kim, et al. [43] reported better results with multiple drilling compared with single-core decompression.
To prevent the collapse of the subchondral area after removal of the necrotic bone, some authors advocate bone grafting [25,26]. This structural support can be achieved by fibular bone grafting. Core decompression with bone grafting has shown survival rate from 36 to 87% [25,44,45]. Vascularized fibular grafting and muscle pedicle bone grafting further improve the blood supply [11]. Meyers muscle pedicle bone graft was found to be effective in stage I and stage II. However, in stage III, only 4 out of 11 hips had good outcome [46]. In a long-term follow-up in 152 patients, Bakshi, et al. [27] reported excellent to good results in 86% hips following multiple drilling and muscle pedicle bone grafting with tensor fascia lata.
There are several non-invasive therapies for the treatment of AVN; Lee JY, et al. [47] show that all patients with early and mid osteonecrosis (i.e., Ficat I and II stages) who underwent ESWT had significant improvements in pain reduction and HHS.
ESWT is a type of sound wave with high pressure and velocity that can pass through liquid and soft tissues; when it goes toward bone, reflection and precipitation of the shock wave are made on the boundary surface between soft tissue and bone [48]. It has been suggested that these precipitations might positively impact necrosis and angiogenesis and some studies demonstrated its therapeutic potential on AVN [49].
In another study, Levin, et al. [50] demonstrated that hyperbaric oxygen reduces the ranges of femoral head necrosis in rats.
Regional ischemia causes joint structure hypoxia, which is a common feature of AVN. By providing 100% oxygen at elevated atmospheric pressure, Hyperbaric Oxygenation (HBO) increases the partial pressure of oxygen in plasma and in tissues.
As an adjunctive therapy, HBOT has been reported to improve the outcomes in patients suffering from bone diseases [51] and femoral head necrosis [52-54].
Recent works reveal that hyperbaric oxygenation may also accelerate osteoblast differentiation and suppress os-   [43].
ESWT improved the VAS pain score and HHS at 24 months follow-up for AVN patients [49].
Autologous BM-MSCs is based on regenerative approach might increase the chance to obtain an efficient bone tissue regeneration because of the ability of autologous mesenchymal cells to face the hypoxic microenvironment and to undergo the mineralization process [68][69][70].
Uzun G, et al. [81] make a reviewer in which assess that in some studies HBOT was combined with other treatment modalities. Hip survivorship wherein HBOT was used alone was 95.5% in Steinberg Stage I lesions, 89% in Steinberg Stage II lesions and 100% in Ficat Stage II lesions [81]. Seqex seems to be a method that, in view of the choice of the most suitable electromagnetic waves, allows fewer sessions than normal pulsed electromagnetic fields, and being a non-thermogenic therapy makes it usable in everybody district. His target is exclusively the membrane cell.
Probably the effect of pulsed electromagnetic field stimulation may be to protect the articular cartilage from the catabolic effect of inflammation and subchondral bone-marrow edema and promote osteogenic activity at the necrotic area and prevent trabecular fracture and subchondral bone collapse.