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INTERNATIONAL JOURNAL OF INTEGRATIVE AND BIO-REGULATORY MEDICINE

COLLAGEN MEDICAL DEVICE LUMBAR

in the combinedtreatment of lumbar

instability-induced pain

E. MILANO

C

M

Y

CM

MY

CY

CMY

K

Cover_PRM_estratto.pdf 1 24/09/19 15:29

PHYSIOLOGICAL REGULATING MEDIC INE 2019-2020

COLLAGEN MEDICAL DEVICE LUMBAR IN THE COMBINED TREATMENTOF LUMBAR INSTABILITY-INDUCED PAIN

E. Milano

CL

INIC

AL

INTRODUCTION

Spondylolisthesis (SL) [from the Greekspóndilos (vertebra) and ólístesis (slip-ping)] is a mechanical alteration in thephysiological vertebral structure that isprimarily characterised by the forwarddisplacement (anterolisthesis) of a partof or whole vertebra on to that below. − Although SL can affect any segment ofthe spine, it is the lumbar segment thatis most commonly affected.

Various authors have estimated the in-cidence of SL in the general populationto be 3-8%; however, it can affect up to

Spondylolisthesis is a mechanicalalteration in the physiological vertebralstructure that is primarily characterisedby the forward displacement of a part ofor whole vertebra on to that below. The L-S rachis segment is mostlyinterested. There are 3 kinds of Spondylolisthesis:dysplastic, due to osteo-articularcongenital alterations; isthmic,characterized by a continuous lesion ofthe isthmus; degenerative.

− The aim of this study is to verify if acombined treatment, Physiokinesitherapy+ ultrasound-guided injection of CollagenMD (Medical Device)-Lumbar, may providemore important and durable clinicalresults rather than Physiokinesitherapyalone. − 20 patients, F and M, aged between40 and 75, have been enrolled; all ofthem suffering from grade 1 and 2Spondylolisthesis.

They were randomised to 2 Groups (10 +10 patients), a treated Group (T) and acontrol Group (NT). − The clinical results, evaluated at 2, 4,8 and 12 months with the NumericRating Scale, the Oswestry DisabilityIndex, the Pain Disability Index and theuse of NSAIDs (tablets/week), allow tostate that the combined treatmentPhysiokinesitherapy + MD-Lumbarobtains a far better and longer-lastingimprovement than Physiokinesitherapyalone.

SPONDYLOLIS-THESIS, MEDICAL DEVICE LUMBAR,COLLAGEN, ARTHROSIS

SUMMARY

KEY WORDS 20% of the individuals involved in oc-cupational activities or sports requiringhyperlordosis (e.g. artistic gymnastics,gymnastic rings, diving, golf) or in thehandling of heavy loads (e.g. weight lift-ing).

− Clinicians are often called on to iden-tify the origin of spinal pain and equallyfrequently forget that even a moderatespinal microinstability, such as SL, maybe the cause.

One particularly important anatomicalpoint in SL is the vertebral isthmus, theelement between the superior and infe-rior apophyses that forms a connection

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between the anterior and posterior por-tion of the vertebra.

Undoubtedly, one of the least resistantpoints of the spine is the lumbosacraljunction (L5-S1), where the slope ofthe upper surface of S1 tends to causethe body of L1 to slip downwards andforwards.− This displacement is restricted by theanatomical connections of the posteriorarch of L5 and, in particular, by the isth-mus.

− SL occurs when the isthmus is subjectto interruption or destruction. Furthermore, in addition to the osteoar-ticular structures, whose focal point arethe spinal facet joints, seat to inflamma-tory processes developed over time driv-en by the pro-inflammatory cytokinenetwork, the tendinous and ligamentousstructures (e.g. the yellow ligament), thecapsular structures, the intervertebraldisc, the muscle structures (the multi-fidus muscle and the iliopsoas muscle)and the deep fasciae structures are alsoinvolved 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 con-genital osseocartilaginous alterations inthe isthmus and consists of 2 main sub-types:

1) the form that is secondary to thesagittal orientation of the articularapophyses of S1 that lose contact withL5, which therefore slips forward;2) the form that is secondary to thepathological elongation of the isthmus-es of L5.

ISTHMIC

In most cases (80%), idiopathic bilateralisthmic lysis involves L5 and is charac-terised by a fracture of the isthmus, whichcauses an increase in the size of thespinal canal, as the posterior portion re-mains in place

The inter-articular portion (i.e. isthmus)is the point of least resistance subject tocontinuous microtraumas that, togetherwith other environmental and geneticfactors, reduce its mechanical re-silience.

− During development, isthmic SL of-ten occurs following a minor trauma,thus revealing the underlying malfor-mation.The signs and symptoms differ fromthose observed in adults; young patientsexperience mild pain without any spe-cific topographical location, even in thepresence of significant anterior dis-placement. − In some cases, the only sign is hyper-tonia of the posterior thigh muscles,making it difficult to flex the limb at thehip with the knee extended.

DEGENERATIVE

The degenerative form is very commonand is often little considered, partly dueto the minimal likelihood of efficacioustreatment, which constitutes the targetof this study.

− Unlike isthmic SL, the degenerativeform causes a reduction in the dimen-sions of the spinal canal; the favouringfactors are the degeneration of the discand of the articular apophyses and anexcessively vertical orientation of the ar-ticular apophyses.

In addition to low back pain, it can alsobe associated with neurogenic claudi-cation caused by spinal canal stenosis.

Degenerative SL affects adults; it iscaused by long-standing spinal instabil-ity and by alterations secondary to theabnormal displacement of the unstablesegments, i.e. osteoarthritis and/or de-generative disc disease.

This form is 4-6 times more common infemales and affects L4 10 times morefrequently; the anterior displacementcan be up as much as 33%.

The degree of displacement is primarilyassessed using the Meyerding GradingSystem, which classifies it into 4 grades: in grade 1, the displacement is equal toless than 25% of the upper surface ofS1; in grade 2 it is less than 50%;in grade 3 it is less than 75%; in grade 4, the entity of the forward dis-placement can exceptionally reach100%, with the potential displacementof L5 in the pelvis (Spondyloptosis).

− The intervertebral disc is inevitably in-volved; as it is no longer protected bythe posterior structures, it absorbs func-tional overloads that exceed its anatom-ical characteristics, causing it to under-go a degenerative process that leads toflattening and, eventually, to herniationwith an exacerbation of the pain symp-toms of SL.



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The nerve components are often in-volved with the compression of the duralsac and of the nerve roots of L5 and S1.

The severity of the SL does not often cor-relate with the intensity of the painsymptoms.

− The symptoms of SL are 1)mechanicallow back pain, which is made worse bymovement and improves with rest, 2) irradiation of pain to the lower limbs.

− Patients often experience a worseningof the pain when changing posture(from sitting to standing). The following symptoms are less com-mon: discogenic low back pain that getsworse when seated and with the for-ward flexion of the upper body; facetjoint pain that gets worse with the hy-perextension of the upper body andwhen standing; neurogenic claudica-tion (lower extremity asthenia whenwalking) caused by the spinal canalstenosis that is often present.

− Anteroposterior, laterolateral andoblique projection x-rays, in addition toa dynamic x-ray study in the position ofmaximum anterior flexion and maxi-mum extension, are essential for the di-agnosis of SL.MRI is used to evaluate the possiblecompression of the nerve roots and anydisc degeneration and/or bulging.

It is not always simple to correlate insta-

bility (such as moderate degenerativeSL) with pain symptoms and it is evenmore arduous to identify degenerativemicroinstability at an early stage.

The real problem, however, is effica-cious conservative treatment.

Most patients with SL can be treatedconservatively, especially in the pres-ence of the grade 1 and 2 degenerativeforms, in which the displacementevolves in approximately 50% of cases,depending on the case histories consid-ered.

The conservative treatment of SL is es-sentially physiotherapy-rehabilitation-based: the aim is not only to strengthenthe muscles of the upper body in orderto stabilize the spine, but also to im-prove the neuromotor and propriocep-tive control of the pelvic girdle muscles,antigravity muscles and respiratory mus-cles.

− It is, of course, essential to re-educatethe patient on how to maintain a goodstatic and dynamic posture.

In the acute phase, when the clinical sit-uation is characterised by persistent lowback pain, it is necessary to observe asuitable period of bed rest, associatedwith the administration of conventionaland/or low-dose anti-inflammatoriesand muscle-relaxants, either individual-ly or in combination.

The optimisation of the conservativetreatment of low back pain secondary todegenerative SL, taking into account allthe anatomical structures involved inthis aetiopathogenesis, allows to formu-late a number of considerations.

COLLAGEN MEDICAL DEVICES

The use of injectable medical devices(MD) containing porcine collagen al-lows a more efficacious and specific inloco positioning of the collagen, with acarrier and stabilisation function.

− It makes it possible to replace,strengthen, structure and protect thecartilage, tendons, ligaments and jointcapsules, thereby optimising the struc-ture of the collagen fibres and of all theextra- and intra-articular structures inwhich it is present, thereby providing amechanical support to the District inquestion.

The hypothesis of the study was that atreatment with a specific injectable Col-lagen MD could re-condition theanatomical structure/s impaired by SLand improve the stability of the lum-bosacral spine; that a “combined” treat-ment would have been able to improvethe functional rehabilitation outcomesand/or provide more efficacious paincontrol in the subacute and chronicphases; and that a combined treatmentwould also have been able to positively


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condition the progression of SL with lessfrequent exacerbations.

MATERIALS AND METHODS

In order to explore this hypothesis, 20patients with Physical Medicine outpa-tient clinic appointments for low backpain were recruited and included in thestudy, from January 2018 to January2019. − The patients were randomised to 2treatment groups [TGroup (Physiokine-sis therapy + ultrasound-guided injec-tions of MD-Lumbar) and the NTGroup(Physiokinesis therapy alone)], stratifiedby age and gender; the outcomes wereassessed at 2, 4, 8 and 12 months.

− Inclusion criteria

F and M patients aged between 40 and75 years; clinical and instrumental diag-nosis of grade 1 and 2 Spondylolisthe-sis; NRS (Numeric Rating Scale) > 5, nouse of NSAIDs, corticosteroids or opi-oids.

− Exclusion criteria

Rheumatoid arthritis, chondrocalci-nosis, psoriasis, metabolic bone dis-eases, gout, active infections, clinicaland instrumental diagnosis of grade 3and 4 spondylolisthesis, spondylolysis,polyneuropathy, previous local/ epidu-ral corticosteroid injections (> 3 years),use of oral corticosteroid and/or opioidtherapy in the past 6 months, use of an-ticoagulants, pregnancy, mental dis-eases.

Both the T and the NT Groups were ad-ministered the same intra-hospital reha-bilitation protocol (diagnostic and ther-apeutic care programme) based on neu-romotor treatment for the propriocep-tive reconditioning of the posteriorback, lumbosacral girdle and respiratorymuscles.

− The protocol also included ergonomiceducation and occupational therapy.

Numeric Rating Scale - NRS

Group T Group NT

10

9

8

7

6

5

4

3

2

1

0T(0) 2 months 4 months 8 months 12 months

Oswestry Disability Index - ODI

Group T Group NT

0

5

10

15

20

25

30

35

40

45

50

T(0) 2 months 4 months 8 months 12 months

TAB. 2

TAB. 1

Pain Disability Index - PDI

0

10

20

30

40

50

60

70

T(0) 2 months 4 months 8 months 12 months

Group T Group NT

TAB. 3


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The rehabilitation treatment consistedin: daily individual motor rehabilitationtreatment for a total of ten 45-minutesessions; individual assessmentby the occupational therapist at the 5thand 10th sessions; provision of abrochure illustrating the physiokinesistherapy exercises to be performed bypatients at home and ergonomic ad-vices; group treatment (max. 4 patients)one month after the last individual ses-sion, on 2 consecutive days, in 30-minute sessions.

• Group T (Treatment) also received ul-trasound-guided injection therapy (Clar-ius Ultrasound portable system, Convexprobe) according to the following pro-tocol:5 sessions (1/week for 4 consecutiveweeks and 1 after 15 days); 2 vials ofMD-Lumbar per treatment. − Half a vial (1 mL) for each facet joint;2 joints were treated at each treatment,alternating the upper and lower facetjoints; at the 5th session the 2 most im-paired joints (as shown by MRI) weretreated.

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

CONCLUSIONS

The data obtained (TAB. 5) allow us toconclude that in the treatment of grade

1 and 2 Spondylolisthesis combinedtreatment with physiokinesis therapy +injection of MD-Lumbar makes it possi-ble to obtain a far better and longer-lasting improvement, in terms of1) pain 2) motor function 3) the impairment caused by spinal in-stability4) reduced use of NSAIDs.

Furthermore, the combined treatmentproposed herein, for the first time in the

USE OF NSAIDS (tablets/week)

3,5

3

2,5

2

1,5

1

0,5

02 months 4 months 8 months 12 months

Group T Group NT

TAB. 4

T (0)

6,9 7,1 1,7 4,5 1,9 5,0 2,5 5,5 2,5 5,7

41,0 42,0 5,0 21,0 7,0 25,0 12,0 31,0 14,0 34,0

64,0 62,0 40,0 56,0 42,0 58,0 40,0 60,0 38,0 64,0

1,3 2,0 1,3 2,7 1,3 2,7 1,4 3,0

GROUPS

NRSNumeric Rating Scale

ODIOswestry Disability Index

PDIPain Disability Index

NSAIDstablets/week

T NT T NT T NT T NT T NT

2 months 4 months 8 months 12 monthsOUTCOMES

TAB. 5

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%).


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11. Pavelka K. et Al. – Chronic Low Back Pain: Cur-rent Pharmacotherapeutic Therapies and a NewBiological Approach. Current Medical Chemistry,2018 May 13, 25: 1-8.

12. Russo G. – Portale Medicinafisica.it; 2019.13. Shahidi B. et Al. – Lumbar multifidus muscle de-

generates in individuals with chronic degenera-tive lumbar spine pathology. J. Orthop Res. 35:2700; 2017.

14. Tian G., Qi L. – Correlation between facet tropismand lumbar degenerative disease: a retrospectiveanalysis. BMC Musculoskeletal Disorders, 18:483; 2017.

15. Wagner S.C. et Al. – Sever lumbar disability isassociated with decreased psoas cross-section-al area in degenerative spondylolistesis. GlobalSpine Journal, 8: 716; 2018.

16. Zocco R. et Al. – Effectiveness of integratedmedicine in the control of pain in vertebral disor-ders: observational study. Physiological Regulat-ing Medicine, 2012; 41.

Fig. p. 4https://urbanministries.com/wp-content/uploads/2019/01/iStock-927091262-Pain.jpg

Fig. p. 5Left:https://eorthopod.com/images/ContentImages/spine/spine_lumbar/lumbar_spondylolistheis/lumbar_spondylolisthesis_cause02.jpgRight:https://www.brainspinesurgery.com/uploads/img/_800xAUTO_crop_center-center_60/Spondylolisthesis-Spine-Condition-and-Symptoms-Xrayy.png

Literature7, 8, 9, 10, 11, and 16 are available online:collagenmd.guna.com

author

Dott. Edoardo Milano– Physical Medicine and Rehabilita-tion specialist

– Director of the Department of Phys-ical Medicine and RehabilitationSan Camillo Hospital - Turin (I)

Via San Secondo, 37

I – 10128 Torino

treatment of Spondylolisthesis, wouldappear to allow a better control overdisease progression and a reduction inexacerbations over time (pro-inflamma-tory cytokine network control).

•MD-Lumbar improves the stabilityof the lumbosacral spine and organ-ically reconditions the impairedanatomical structures (joint capsules,yellow ligament, antigravity musclesand connective deep fascia), therebymaking a considerable contributionto the promotion of neuromotor andproprioceptive capacity.

Over the next few months, we hope tobe able to confirm the results obtainedby expanding the study sample and, inparticular, to identify the optimum tim-ing for further injection therapy withMD-Lumbar as part of an individualmaintenance rehabilitation pro-gramme. �

Literature

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3. Evans N. et Al. – Management of symptomaticdegenerative low-grade lumbar spondylolisthe-sis. EFORT Open Rev. 3: 620; 2018.

4. Hildebrandt M. et Al. – Correlation between lum-bar dysfunction and fat infiltration in lumbar mul-tifidus muscles in patients with low back pain.BMC musculoskeletal Disorders. 18: 12; 2017.

5. Huang K.Y. et Al. – The roles of IL 19 and IL 20 inthe infiammation of degenerative lumbar spondy-lolisthesis. Journal of Inflammation. 15: 19; 2018.

6. Jae-Sung K. et Al. – Characterization of degen-erative human facet joints and facet joint capsulartissues. Osteoarthritis Cartilage 23: 2242; 2015.

7. Massullo C. – I Guna Collagen Medical Devicenella ripresa funzionale dopo traumi sportivi.La Med. Biol., 2017/2; 45-50.

8. Milani L. – Un nuovo e raffinato trattamento ini-ettivo delle patologie algiche dell’Apparato loco-motore. Le proprietà bio-scaffold del collagene esuo utilizzo clinico. La Med. Biol., 2010/3; 3-15.

9. Milani L. – I Guna Collagen Medical Devices 10anni dopo. Analisi ragionata di 2 recenti impor-tanti ricerche e update della letteratura. La Med.Biol., 2019/2; 3-18.

10. Pavelka K. et Al. – MD-Lumbar. MD-Muscle eMD-Neural nella terapia locale del dolore lombare.La Med. Biol., 2012/4; 13-17.


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