Tag: guna md

  • THE ROLE OF MD-HIP IN ULTRASOUND-GUIDED INJECTION THERAPY IN OSTEOARTHRITIS OF THE HIP

    ABSTRACT

    Osteoarthritis of the hip is a commonly observed disease in outpatient clinics dedicated to musculoskeletal pain management. The non-surgical therapeutic tools at our disposal are few and not always effective, especially in the advanced stages of the disease, in which joint damage is considerable.

    In recent years, joint injection therapy with hyaluronic acid has become common, using an ultrasound-guided technique to improve the safety and appropriateness of the injection.

    In literature, data on the efficacy of this treatment are more than encouraging. – The combined use of hyaluronic acid and Collagen Medical Device MD-HIP via intra-articular and peri-articular injections are a valuable therapeutic tool in the treatment of hip osteoarthritis.

    Key Words

    COLLAGEN MEDICAL DEVICE, HYALURONIC ACID, MD-HIP, OSTEOARTHRITIS, PAIN, REHABILITATION, INJECTION, ULTRASOUND

    INTRODUCTION

    Osteoarthritis (OA) is the most common arthritic condition and the main cause of disability amongst the elderly population.

    – The hip is the second most commonly affected joint, with a prevalence range between 3% and 11% in the population over 35 years of age.

    OA of the hip is characterised by the progressive de-structuration of the joint cartilage. Clinically, it presents a progressive increase in pain symptoms associated with joint movement, leading to a loss of segmental function and alteration of motor dynamics.

    At the current time, both the pharmacological (NSAIDs, cortisones, low dose medicines and herbal remedies) and non-pharmacological (rehabilitation, physiotherapy, acupuncture) treatment options aim to control pain symptoms, improve the consequent disability and, where possible, restrict the structural damage to the affected joint.

    – Over the past 15 years, intra-articular injection therapy with hyaluronic acid (HA) has become increasingly extensively used worldwide, supported by the good results obtained in certain investigational clinical studies on the reduction of pain and improvement in joint function, making it possible to postpone the need for hip replacement surgery by several years. HA is a high-molecular-weight glycosaminoglycan, constituted by a sequential repetition of glucuronic acid and N-acetylglucosamine. In joints affected by OA, the concentration and molecular weight of physiological HA undergo a 33 – 50% reduction, with an obvious reduction in its effectiveness in protecting the joint. Intra-articular viscoinduction and viscosupplementation are based on HA’s physiological capacity to restore synovial fluid to an optimum viscosity and elasticity and its natural joint-protecting function, overcoming the loss of HA and stimulating its endogenous production, as well as controlling the production and activity of the pro-inflammatory mediators and matrix metalloproteinases. – Guna Collagen Medical Devices (MDs) constitute a significant part of the possible options and therapeutic solutions for

    the treatment of painful and dysfunctional musculoskeletal conditions, such as OA. – With their porcine collagen content and ancillary substances of natural origin (vehicular excipients), they allow a new structuring of the intra-articular tissues (ligaments and joint cartilage) and extra-articular tissues [ligaments, joint capsule, tendons (which are primarily constituted by collagen) and muscles], providing a mechanical scaffold to favour the best arrangement of the damaged collagen fibres and to counter any joint laxity that may cause pain. – In addition, the Guna Collagen MDs improve the viscoelastic properties of the intra-articular fluid, thanks to the cementing function of the collagen fibres of the proteoglycans of the extracellular matrix.

    HA + Guna Collagen MD combination therapy is even more interesting considering the most recent physiopathological hypotheses regarding OA, according to which it is precisely the extra-articular segment, which is far more-richly vascularised, that is the primum movens of the pathological process.

    – The aim of this study was to evaluate the therapeutic efficacy of HA + MD combination therapy in osteoarthritis of the hip.

    PATIENTS AND METHODS

    This clinical study involved patients of both genders (51-77 years of age), who referred to the University Physical Medicine and Rehabilitation Unit – Turin – Italy for hip joint pain. The following inclusion criteria were used:

    • diagnosis of primary OA for more than 12 months, according to American College of Rheumatology criteria;
    • Kellgren-Lawrence radiological classification: grades II-III;
    • moderate-severe pain with Numerical Rating Scale (NRS): score > 5, without taking NSAIDs;
    • walking possible for intermediate distances (> 50 m), without aids.

    Patients satisfying any of the following criteria were excluded from the study: • diagnosis of RA, chondrocalcinosis, psoriasis, metabolic bone disease, gout, active phase infections;

    • OA with rapid impairment, significant or congenital dysplasia of the acetabulum or head of the femur;
    • symptomatic bilateral OA of the hip;
    • previous injections of HA and/or intra- articular or oral cortisone therapy taken in the month prior to inclusion;
    • mental illness;
    • oral anticoagulant therapy, pregnancy, obesity; • orthopaedic or neurological conditions compromising ability to walk.

    Having received specific information on the potential risks of intra-articular therapy and having given their written informed consent – the enrolled patients

    were randomised to one of three Groups (A, B, C). – Group A received a cycle of 3 intraarticular injections of high-molecularweight HA (MW 500-700,000, 20 mg/2mL, Hyalubrix, Fidia Farmaceutici Spa) at 10-day intervals. – Group B received a cycle of 3 intra-articular injections of high-molecular weight HA (MW 500-700,000, 20 mg/2mL, Hyalubrix) and peri-capsular injections of MD-Hip (Guna Spa – Milan) (2 ampoules) at T0, T14 and T35, alternated with 2 peri-/intracapsular injections with MD-Hip (2 ampoules) at T7 and T21. – Group C received a cycle of 2 intraarticular injections of high-molecular weight HA (MW 500- 700,000, 20 mg/2mL, Hyalubrix) and peri-capsular injections of MD-Hip (2 ampoules) at T7 and T14, alternated with 2 peri-/intra-

    capsular injections with MD-Hip (2 ampoules) at T0, T14 and T35.

    The patients included in the 3 Groups were also trained, by means of a short cycle of specific group rehabilitation sessions (Hip School), to correctly perform an exercise protocol to be repeated at home as self-treatment, at least 3 times a week.

    The peri- and intra-articular injection treatment was administered under ultrasound guidance, using a Convex 3.5- MHz transducer with a standard technique (FIG. 1).

    A number of clinical studies published in literature agree on the fact that multiple articular injection treatment does not present a higher risk of adverse events or post-hip replacement infections than single articular injection.

    Clinical and functional outcomes were measured at 3 and 6 months from the first injection treatment.

    The following were quantified:

    1. pain using the NRS;
    2. active range of movement (AROM) of the hip;
    3. functional capacities;
    4. pain using the WOMAC Index (Western Ontario and McMaster Universities Osteoarthritis Index), a multidimensional tool evaluating 17 functional patient activities, in addition to the 5 influenced by pain and the 2 items regarding joint stiffness.

    In addition, any use of NSAIDs by the patients throughout the entire follow-up period and the occurrence of any adverse events was also recorded.

    RESULTS

    The study was conducted on 60 patients who met the inclusion and exclusion criteria and were randomised, stratified by gender and age, in the order of 20 subjects to each treatment Group (Group A, B, and C) (TAB. 2). No patient abandoned the study before the 6-month follow-up. – Pain measured using the NRS had dropped in all 3 treatment Groups at the 3-month visit (T1) and to an even greater extent at 6 months (T2) in Groups B and C

    The active range of movement (AROM) progressively improved on all spatial planes in all 3 Groups (TAB. 4).

    By plotting a graph of the sum of the articular gain obtained by patients in the single Groups at 3 and 6 months, a higher, progressive increase in articular gain is observed for Groups B and C (TAB. 5).

    The WOMAC global score showed an improvement in functional activities for all patients, especially amongst Group B patients at the 6-month visit (TAB. 6).

    By breaking the WOMAC index down into its 3 main items (pain score, stiffness score, function score), the function score increased progressively at both 3 and 6 months in Groups B and C (TAB. 7).

    In the 3 Groups, there was a modest and homogeneous increase in the use of NSAIDs over time (TAB. 8). No adverse events were recorded.

    – All patients included in the study showed good compliance as regards performance at least three times a week of the home exercise programme that they had been taught

    CONCLUSIONS

    The results obtained in this controlled, randomised, clinical study conducted on a homogeneous population with symptomatic osteoarthritis of the hip were those hypothesised during the initial study design phase.

    – HA + MD-Hip combination therapy makes it possible to obtain a more significant and longer-lasting improvement in terms of pain, overall range of movement of the hip and, above all, its function than with treatment with HA alone.

    The use of MD-Hip fills an unmet therapeutic need, making it possible to obtain better clinical results, by acting on the periarticular tissues that play a crucial role in the pathogenesis of osteoarthritic conditions.

    – Moreover, this combination therapy also makes it possible to reduce the number of articular injections of HA, without compromising the therapeutic result, especially with regard to daily activities.

    – As has already been highlighted several times in literature, good compliance in performing a specific home exercise programme with a certain constancy affects the final therapeutic result.

    – During the clinical study, MD-Hip did not show any negative side effect and was seen to have an excellent safety profile.

    Author
    Dr. Edoardo Milano, MD
    – Physical Medicine and Rehabilitation specialist
    S.C. Medicina Fisica e Riabilitazione Universitaria – Torino [University Physical Medicine and Rehabilitation Unit – Turin] Turin A.O. Città della Salute e della Scienza

    Via San Secondo, 37 I – 10128 Turin

  • COLLAGEN MEDICAL DEVICE LUMBAR IN THE COMBINED TREATMENT OF LUMBAR INSTABILITYINDUCED PAIN

    SUMMARY

    Spondylolisthesis is a mechanical alteration in the physiological vertebral structure that is primarily characterised by the forward displacement of a part of or whole vertebra on to that below.
    The L-S rachis segment is mostly interested.

    There are 3 kinds of Spondylolisthesis: dysplastic, due to osteo-articular congenital alterations; isthmic, characterized by a continuous lesion of the isthmus; degenerative.

    • The aim of this study is to verify if a combined treatment, Physiokinesitherapy ultrasound-guided injection of Collagen MD (Medical Device)-Lumbar, may provide more important and durable clinical results rather than Physiokinesitherapy alone.
    • 20 patients, F and M, aged between 40 and 75, have been enrolled; all of them suffering from grade 1 and 2 Spondylolisthesis.

    They were randomised to 2 Groups (10 + 10 patients), a treated Group (T) and a control Group (NT).

    The clinical results, evaluated at 2, 4, 8 and 12 months with the Numeric Rating Scale, the Oswestry Disability Index, the Pain Disability Index and the use of NSAIDs (number of tablets/week), allow to state that the combined treatment Physiokinesitherapy + MD-Lumbar obtains a far better and longer-lasting improvement than Physiokinesitherapy alone.

    INTRODUCTION
    Spondylolisthesis (SL) [from the Greek spóndilos (vertebra) and ólístesis (slipping)] is a mechanical alteration in the physiological vertebral structure that is primarily characterised by the forward displacement (anterolisthesis) of a part of or whole vertebra onto that below. Although SL can affect any segment of the spine, it is the lumbar segment that is most commonly affected. Various authors have estimated the incidence of SL in the general population to be 3-8%; however, it can affect up to 20% of the individuals involved in occupational activities or sports requiring hyperlordosis (e.g. artistic gymnastics, gymnastic rings, diving, golf) or in the handling of heavy loads (e.g. weightlifting).

    Clinicians are often called on to identify the origin of spinal pain and equally frequently forget that even a moderate spinal microinstability, such as SL, maybe the cause. One particularly important anatomical point in SL is the vertebral isthmus, the element between the superior and inferior apophyses that forms a connection between the anterior and posterior portion of the vertebra. Undoubtedly, one of the least resistant points of the spine is the lumbosacral junction (L5-S1), where the slope of the upper surface of S1 tends to cause the body of L1 to slip downwards and forwards. This displacement is restricted by the anatomical connections of the posterior arch of L5 and, in particular, by the isthmus.

    SL occurs when the isthmus is subject to interruption or destruction. Furthermore, in addition to the osteoarticular structures, whose focal point are the spinal facet joints, seat to inflammatory processes developed over time driven by the pro-inflammatory cytokine network, the tendinous and ligamentous structures (e.g. the yellow ligament), the capsular structures, the intervertebral disc, the muscle structures (the multifidus muscle and the iliopsoas muscle) and the deep fasciae structures are also involved in the origin of SL-induced pain (mechanical low back pain).


    • There are 3 main types of SL:


    DYSPLASTIC
    The dysplastic form is secondary to congenital osteocartilaginous alterations in the isthmus and consists of 2 main subtypes

    1) the form that is secondary to the sagittal orientation of the articular apophyses of S1 that lose contact with L5, which therefore slips forward;

    2) the form that is secondary to the pathological elongation of the isthmuses of L5.

    ISTHMIC
    In most cases (80%), idiopathic bilateral isthmic lysis involves L5 and it is characterised by a fracture of the isthmus, which causes an increase in the size of the spinal canal, as the posterior portion remains in place
    The inter-articular portion (i.e. isthmus) is the point of least resistance subject to continuous microtraumas that, together with other environmental and genetic factors, reduce its mechanical resilience.

    During development, isthmic SL often occurs following a minor trauma, thus revealing the underlying malformation. The signs and symptoms differ from those observed in adults; young patients experience mild pain without any specific topographical location, even in the presence of significant anterior displacement. In some cases, the only sign is hypertonia of the posterior thigh muscles, making it difficult to flex the limb at the hip with the knee extended.

    DEGENERATIVE
    The degenerative form is very common and is often little considered, partly due to the minimal likelihood of efficacious treatment, which constitutes the target of this study. Unlike isthmic SL, the degenerative form causes a reduction in the dimensions of the spinal canal; the favouring factors are the degeneration of the disc and of the articular apophyses, and an excessively vertical orientation of the articular apophyses.

    In addition to low back pain, it can also be associated with neurogenic claudication caused by spinal canal stenosis. Degenerative SL affects adults; it is caused by long-standing spinal instability and by alterations secondary to the abnormal displacement of the unstable segments, i.e. osteoarthritis and/or degenerative disc disease. This form is 4-6 times more common in females and affects L4 10 times more
    frequently; the anterior displacement can be up as much as 33%.

    The degree of displacement is primarily assessed using the Meyerding Grading System, which classifies it into 4 grades: in grade 1, the displacement is equal to less than 25% of the upper surface of S1; in grade 2 it is less than 50%; in grade 3 it is less than 75%; in grade 4, the entity of the forward displacement can exceptionally reach 100%, with the potential displacement of L5 in the pelvis (Spondyloptosis). The intervertebral disc is inevitably involved; as it is no longer protected by the posterior structures, it absorbs functional overloads that exceed its anatomical characteristics, causing it to undergo a degenerative process that leads to flattening and, eventually, to herniation with an exacerbation of the pain symptoms of SL.

    The nerve components are often involved with the compression of the dural sac and of the nerve roots of L5 and S1. The severity of the SL does not often correlate with the intensity of the pain symptoms.

    The symptoms of SL are 1) mechanical low back pain, which is made worse by movement and improves with rest; 2) irradiation of pain to the lower limbs. Patients often experience a worsening of the pain when changing posture (from sitting to standing). The following symptoms are less common: discogenic low back pain that gets worse when seated and with the forward flexion of the upper body; facet joint pain that gets worse with the hyperextension of the upper body and when standing; neurogenic claudication
    (lower extremity asthenia when walking) caused by the spinal canal stenosis that is often present.

    Anteroposterior, laterolateral and oblique projection x-rays, in addition to a dynamic x-ray study in the position of maximum anterior flexion and maximum extension, are essential for the diagnosis of SL. MRI is used to evaluate the possible compression of the nerve roots and any disc degeneration and/or bulging. It is not always simple to correlate instability (such as moderate degenerative SL) with pain symptoms and it is even more arduous to identify degenerative microinstability at an early stage. The real problem, however, is efficacious conservative treatment. Most patients with SL can be treated conservatively, especially in the presence of the grade 1 and 2 degenerative forms, in which the displacement evolves in approximately 50%of cases, depending on the case histories considered. The conservative treatment of SL is essentially physiotherapy-rehabilitationbased: the aim is not only to strengthen the muscles of the upper body in order to stabilize the spine, but also to improve the neuromotor and proprioceptive control of the pelvic girdle muscles, antigravity muscles and respiratory muscles. It is, of course, essential to re-educate the patient on how to maintain a good static and dynamic posture. In the acute phase, when the clinical situation is characterised by persistent low back pain, it is necessary to observe a suitable period of bed rest, associated with the administration of conventional and/or low-dose anti-inflammatories and muscle-relaxants, either individually or in combination. The optimisation of the conservative treatment of low back pain secondary to degenerative SL, taking into account all the anatomical structures involved in
    this aetiopathogenesis, allows to formulate a number of considerations.

    COLLAGEN MEDICAL DEVICES
    The use of injectable medical devices (MD) containing porcine collagen allows a more efficacious and specific in loco positioning of the collagen, with a carrier and stabilisation function. It makes it possible to replace, strengthen, structure and protect the cartilage, tendons, ligaments and joint capsules, thereby optimising the structure of the collagen fibres and of all the extra- and intra-articular structures in which it is present, thereby providing a mechanical support to the anatomical district in question.

    The hypothesis of the study was that a treatment with a specific injectable Collagen MD could re-condition the anatomical structure/s impaired by SL and improve the stability of the lumbosacral spine; that a “combined” treatment would have been able to improve the functional rehabilitation outcomes and/or provide more efficacious pain control in the subacute and chronic phases; and that a combined treatment would also have been able to positively condition the progression of SL with less frequent exacerbations.

    MATERIALS AND METHODS
    In order to explore this hypothesis, 20 patients with Physical Medicine outpatient clinic appointments for low back pain were recruited and included in the study, from January 2018 to January 2019. The patients were randomised to 2 treatment groups [T Group (Physiokinesis therapy + ultrasound-guided injections of MD-Lumbar) and the NT Group (Physiokinesis therapy alone)], stratified by age and gender; the outcomes were assessed at 2, 4, 8 and 12 months.

    Inclusion Criteria

    F and M patients aged between 40 and 75 years; clinical and instrumental diagnosis of grade 1 and grade 2 Spondylolisthesis; NRS (Numeric Rating Scale) 5, no use of NSAIDs, corticosteroids or opioids.


    Exclusion Criteria

    Rheumatoid arthritis, chondrocalcinosis, psoriasis, metabolic bone diseases, gout, active infections, clinical and instrumental diagnosis of grade 3 and grade 4 spondylolisthesis, spondylolysis, polyneuropathy, previous local/ epidural corticosteroid injections (> 3 years), use of oral corticosteroid and/or opioid therapy in the past 6 months, use of anticoagulants, pregnancy, mental diseases.


    Both the T and the NT Groups were administered the same intra-hospital rehabilitation protocol (diagnostic and therapeutic care programme) based on neuromotor treatment for the proprioceptive reconditioning of the posterior back, lumbosacral girdle and respiratory muscles.

    The protocol also included ergonomic education and occupational therapy. The rehabilitation treatment consisted in: daily individual motor rehabilitation treatment for a total of ten 45-minute sessions; individual assessment by the occupational therapist at the 5th and 10th session; provision of a brochure illustrating the physiokinesis therapy exercises to be performed by patients at home and ergonomic advices; group treatment (max. 4 patients) one month after the last individual session, on 2 consecutive days, in 30-minute sessions.

    Group T (Treatment) also received ultrasound-guided injection therapy (Clarius Ultrasound portable system, Convex probe) according to the following protocol:

    GUNA MD LUMBAR Pack of 10 Ampoules of 2ml – Urenus

    5 sessions (1/week for 4 consecutive weeks and 1 after 15 days); 2 vials of MD-Lumbar per treatment. − Half a vial (1 mL) for each facet joint; 2 joints were treated at each treatment, alternating the upper and lower facet joints; at the 5th session the 2 most impaired joints (as shown by MRI) were treated.

    A number of clinical and functional outcomes were investigated:
    1) Numeric Rating Scale (NRS)
    2) Oswestry Disability Index (ODI)
    3) Pain Disability Index (PDI)
    4) use of NSAIDs during the follow-up period (TABLES 1, 2 ,3 and 4).

    CONCLUSIONS
    The data obtained (TAB. 5) allow to conclude that in the treatment of grade 1 and grade 2 Spondylolisthesis combined treatment with physiokinesis therapy + injection of MD-Lumbar makes it possible to obtain a far better and longerlasting improvement, in terms of

    1. pain
    2. motor function
    3. impairment caused by spinal instability
    4. reduced use of NSAIDs.

    Furthermore, the combined treatment proposed herein, for the first time in the treatment of Spondylolisthesis, would appear to allow a better control over disease progression and a reduction in exacerbations over time (pro-inflammatory cytokine network control).

    From the data obtained, it emerges that:
    − NRS. Group T (Physiokinesis therapy + ultrasound-guided injection therapy of MD-Lumbar) passes from 6.9 (T0) to 2.5 after 12 months (-63.8%).
    Group NT (Physiokinesis therapy alone) passes from 7.1 (T0) to 5.7 after 12 months (-19.7%).
    − ODI. Group T passes from 41.0 (T0) to 14.0 after 12 months (-65.9%). Group NT passes from 42.0 (T0) to 34.0 after 12 months (-19.1%).
    − PDI. Group T passes from 64.0 (T0) to 38.0 after 12 months (-40.6%). Group NT passes from 62.0 (T0) to 64.0 after 12 months (±0%).
    − NSAIDs (tablets/week). Group T passes from 1.3 at 2 months to 1.4 at 12 months (±0%). Group NT passes from 2.0 at 2 months to 3.0 at 12
    months (+50%).

    MD-Lumbar improves the stability of the lumbosacral spine and organically reconditions the impaired anatomical structures (joint capsules, yellow ligament, antigravity muscles and connective deep fascia), thereby making a considerable contribution to the promotion of neuromotor and proprioceptive capacity.

    Over the next few months, we hope to be able to confirm the results obtained by expanding the study sample and, in particular, to identify the optimum timing for further injection therapy with MD-Lumbar as part of an individual maintenance rehabilitation programme.

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    Fig. p. 40
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    Fig. p. 41

    Left:
    https://eorthopod.com/images/ContentImages/spine/spine_lumbar/lumbar_spondylolistheis/lumbar_spondylolisthesis_cause02.jpg
    Right:
    https://www.brainspinesurgery.com/uploads/img/_800xAUTO_crop_center-center_60/Spondylolisthesis-Spine-Condition-and-Symptoms-Xrayy.png