l a c i n i l c treatment of joint conditions with guna … · na-arthro, guna-flam, guna-anti il...

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PHYSIOLOGICAL REGULATING MEDICINE 2018 TREATMENT OF JOINT CONDITIONS WITH GUNA COLLAGEN MEDICAL DEVICES – CLINICAL STUDY ON 257 PATIENTS M. Ottaviani CLINICAL INTRODUCTION Collagen is a glycoprotein characterised by a structure in which a simple basic module is repeated: collagen molecules join together to form a collagen fibril; a union in which each molecule overlaps with that above by one quarter of its length. This creates a kind of wall, in which the Collagen is the main extracellular struc- tural protein to be found in the connective tissue and bone tissue of most animals. In humans aged about 50 years its synthesis begins to reduce, with consequent carti- lage and tendon degeneration and in- evitable development of osteoarthritis and tendonitis. Since these degenerative con- ditions are very common and evolve to- wards pain and joint stiffness, there is an urgent need for tools that allow practition- ers not only to limit this degenerative evo- lution, but also, in certain cases, to induce its regression. This clinical study was conducted on 257 patients with joint and tendon disorders (impingement syndrome, shoulder tendinopathy, hip arthritis, knee arthritis, trapeziometacarpal osteoarthritis, Achilles’ tendinopathy) frequently reflected in clinical evidence, such as pain and joint stiffness; they were all treated exclusively with local injections of Guna Collagen Medical De- vices. The data were collected through self-as- sessment scales, validated by the WHO and the results showed that Guna Collagen MD can give a useful contribution to con- taining the problems associated with joint degeneration. GUNA COLLA- GEN MEDICAL DEVICES, COLLAGEN, OSTEOARTRHITIS, TENDINOPATHY, PAIN SUMMARY PAROLE CHIAVE 19 individual bricks that make it up are staggered in order to achieve consider- able resistance to both incident tangen- tial and perpendicular forces (FIG. 1). – This characteristic arrangement gives the collagen significant sturdiness in terms of resistance, extensibility and in- compressibility, whilst guaranteeing plasticity, flexibility, allowing torsion 67 FIG. 1 Structure of collagen. 1: Sugars bound to collagen. Relationship between sugar (black precipitations) and the density of collagen fibrils (ME 112.000X); 2: Section of a collagen fibril (ME 240.000X). A cycle of 67 nm (670 A) forms on the base of collagen molecules, each of which is staggered by ¼ of their length. http://www.georgeackermanmd.com/knee- osteoarthritis.html

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PHYSIOLOGICAL REGULATING MEDICINE 2018

TREATMENT OF JOINTCONDITIONS WITH GUNA COLLAGEN MEDICAL DEVICES– CLINICAL STUDY ON 257 PATIENTS

M. Ottaviani

CLIN

ICA

L

INTRODUCTION

Collagen is a glycoprotein characterisedby a structure in which a simple basicmodule is repeated: collagen moleculesjoin together to form a collagen fibril; aunion in which each molecule overlapswith that above by one quarter of itslength.This creates a kind of wall, in which the

Collagen is the main extracellular struc-tural protein to be found in the connectivetissue and bone tissue of most animals. Inhumans aged about 50 years its synthesisbegins to reduce, with consequent carti-lage and tendon degeneration and in-evitable development of osteoarthritis andtendonitis. Since these degenerative con-ditions are very common and evolve to-wards pain and joint stiffness, there is anurgent need for tools that allow practition-ers not only to limit this degenerative evo-lution, but also, in certain cases, to induceits regression. This clinical study was conducted on 257patients with joint and tendon disorders(impingement syndrome, shouldertendinopathy, hip arthritis, knee arthritis,trapeziometacarpal osteoarthritis, Achilles’tendinopathy) frequently reflected in clinicalevidence, such as pain and joint stiffness;they were all treated exclusively with localinjections of Guna Collagen Medical De-vices. The data were collected through self-as-sessment scales, validated by the WHOand the results showed that Guna CollagenMD can give a useful contribution to con-taining the problems associated with jointdegeneration.

GUNA COLLA-GEN MEDICAL DEVICES, COLLAGEN,OSTEOARTRHITIS, TENDINOPATHY, PAIN

SUMMARY

PAROLE CHIAVE

19

individual bricks that make it up arestaggered in order to achieve consider-able resistance to both incident tangen-tial and perpendicular forces (FIG. 1).

– This characteristic arrangement givesthe collagen significant sturdiness interms of resistance, extensibility and in-compressibility, whilst guaranteeingplasticity, flexibility, allowing torsion

67

FIG. 1

Structure of collagen.

1: Sugars bound to collagen.

Relationship between sugar

(black precipitations) and the

density of collagen fibrils

(ME 112.000X);

2: Section of a collagen fibril

(ME 240.000X).

A cycle of 67 nm (670 A) forms on

the base of collagen molecules,

each of which is staggered by ¼

of their length.http://www.georgeackermanmd.com/knee-

osteoarthritis.html

20

PHYSIOLOGICAL REGULATING MEDICINE 2018

and great resistance to load. In order to be functional, almost alljoints must possess two, apparently con-tradictory, characteristics: stability andmobility.The articular stabilisation systems con-sist of the structures pertaining to boththe extra-articular component and theintra-articular component; collagen is

present in abundance in both of thesestructures.

– The extra-articular component con-sists of ligaments, the articular capsule,tendons and muscles; the intra-articularcomponent is formed of ligaments (forthe knee and hip joints only) and ofjoint cartilage (FIG. 2).

4 - Muscle-tendon

3 - Extra articular ligaments

2 - Articular capsule

Articularcartilage

1 - Synovial membrane

FIG. 2

Extra-articular

containment

system.

FIG. 3

Age-related biosynthesis of collagen, proteoglycans, and elastin.

One of the most important causes ofjoint pain is the laxity of the intra- andextra-articular stabilisation structures;lax containment systems result in artic-ular hypermobility, especially in non-physiological directions and at non-physiological angles that, on the onehand, lead to greater, early wear of thecontainment systems themselves and,on the other, cause progressive cartilagedegeneration.

The mechanical support providedby collagen represents an effectivenatural scaffolding.

– In humans, the biosynthesis of colla-gen starts to decrease at 55-60 years ofage (FIG. 3); From this age onwards, there is a quan-titative and qualitative deterioration inthe joint structures. More specifically, inthe musculoskeletal system, the carti-lage surfaces become thinner and de-generate to osteoarthritis, whereas thetendinous and ligamentous structuresbecome less elastic and progress totendinoses and tendinopathies of vary-ing severities. Often in musculoskeletalconditions, the instrumental diagnosticevidence (x-ray, ultrasound, etc.) is notconsistent with the clinical findings.

The term Osteoarthritis state is used toindicate physiological age-related artic-ular ageing; it is a paraphysiologicalcondition that does not cause any clini-cal situation and is often incidentallyobserved during imaging studies per-formed for other reasons (e.g. injury).However, when osteoarthritis makes it-self felt by causing the characteristic on-set symptoms, such as stiffness and jointpain, we talk about osteoarthritis dis-ease. Osteophytes are irregular beak- orcrest-shaped proliferations of bone tis-sue that form in the vicinity of joints af-fected by a number of pathological pro-cesses, but above all in the presence ofosteoarthritis. Their presence can in-volve disorders of various types, with re-strictions to joint movement or the com-pression and irritation of nearby struc-tures, in particular, nerve branches andtendon insertions. Osteophytes are the

21

PHYSIOLOGICAL REGULATING MEDICINE 2018

bone tissue’s attempt to increase the sur-face area of the heads of the articularbones damaged by osteoarthritis, in anattempt to stabilize the joint (FIG. 4).

In addition, it is common for ultrasoundscans and MRI studies to show com-plete or multiple tendon damage, de-spite the presence of little or no signsand symptoms; conversely, in other cas-es, the tendon is intact but the patientexperiences very severe pain and func-tional impairment.As regards the tendinous-ligamentoussub-system, an anatomopathologicaldistinction can be made between ten-dinites or tenosynovitis, tendinoses andtendon injuries of various degrees.

– Tendinites or tenosynovites are inflam-matory states of the tendon and possiblyalso of its sheath, with or without peri-tendinous effusion; they may be a con-sequence of either a traumatic event ora functional overload.

When the repair process of the affectedelement starts in the presence of inflam-mation, the scar tissue that forms is aconnective tissue that is devoid of thecharacteristics of elasticity and resis-tance that are typical of native tendons;this makes the structure more prone topartial or complete tears.

– For this reason, an inflammatory pro-cess affecting a tendinous or ligamen-tous structure should not be underesti-mated, rather it should be kept underclose observation and resolved as soonas possible.

Also on the basis of our experience wecan undoubtedly state that clinical anddiagnostic evidence are not always con-sistent. In Italy, osteoarthritis accountsfor 72.6% of all rheumatic diseases andis responsible for 70% of cases ofchronic pain. The potential therapeuticapproach to osteoarthritis, andtendinopathy, can be of different types:– educational– pharmacological– rehabilitative– surgical.

that osteoarthritis is a process that is, atleast in part, reversible.Given the ongoing rise in the popula-tion’s average age, it goes without say-ing that having access to tools able tomaintain high quality of life standardsdespite chrono-aging is an importantbreakthrough.

Guna Collagen Medical Devices areproducts for local injection constitutedby collagen of porcine origin (porcinetissues have a very high collagen con-tent) and a substance known as an an-cillary or vehicle, of plant or mineralorigin, characterised by a particulartropism for the specific articular seg-ments.A tangential filtration process, com-bined with sterilisation and control ofthe molecular weight, makes it possi-ble to obtain a pure product with stan-dard chemical and physical character-istics.The availability of Guna Collagen Med-ical Devices for local injection is a de-termining factor in the repair processthat follows anti-inflammatory interven-tion.Lax joint support elements cause localnociceptor stimulation and excessivetension and stress: which explains whythe reinforcement of these structures isanalgesic as well as regenerative.

The educational approach is represent-ed by an improvement in quality of lifeincluding health education interven-tion, the use of braces, where necessary,and weight loss, when appropriate.The conventional medicinal productsused to treat osteoarthritis andtendinopathies (NSAIDs, Coxibs, Parac-etamol, Steroids, and Opioids) have asymptomatic action and are used onboth systemic and local levels (e.g. in-tra-articular steroid injections).There are other medicinal products,whose real efficacy is not recognised byall Authors, which are thought to exerta slow chondroprotective action, theseare: glucosamine sulphate, chondroitinsulphate, and hyaluronic acid.

The local use – and therefore – the in-tra-articular injection of hyaluronic acidboosts its efficacy; this kind of treatmentis referred to as “visco-supplementa-tion” and it has only a lubricating andshock-absorbing action.

Until just a few years ago, osteoarthritiswas considered a progressive degener-ative disease; subsequently, a preven-tion campaign against the progressionof osteoarthritis with the use of “Carti-lage integrators”, was started.

– For some years now, it possible to state

FIG. 4

X-ray of the L-S spine of an individual with severe low back pain without osteoarthritic skeletal

alterations (1); of a L-S spine with significant radiological signs of osteoarthritic degeneration (2)

in an asymptomatic patient; osteophytes (3).

(3)(2)(1)

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PHYSIOLOGICAL REGULATING MEDICINE 2018

impaired: it replaces the bricks wherethe wall had crumbled.

– Guna Collagen Medical Devices canbe used alone or in home combinationswith conventional or Physiological Reg-ulating Medicine (PRM) products as Gu-na-Arthro, Guna-Flam, Guna-Anti IL 1,Guna-Interleukin 10; the treatment pro-gramme may also include other sys-temic pharmacological and rehabilita-tion treatments.

MATERIALS AND METHODS

A total of 257 patients (36.5% M;63.5% F) were enrolled in this clinicalstudy. The mean age was 58.7 years,with a range of 32-82 years.TAB. 1 shows the joint segments consid-ered and treated and the correspondingepidemiological characteristics of thecaseload.

More specifically, because of the type ofassessment scale used, the “Shoulderand upper limb (SUL)” Group included124 patients with problems relating tothe shoulder alone (rotator cuff syn-drome, with possible tendon lesions);the remaining 23 had a number of otherconditions, such as trapeziometacarpalosteoarthritis, epicondylitis and gan-glion cysts of the wrist (U.L.). It was consequently decided to analysethe results of these two sub-Groups in-dependently (FIG. 5).

As far as the “Knee” Group was con-cerned, all 53 treated cases were classi-fied as stage I, II and III osteoarthritis ofthe knee using the Kellgren-Lawrenceradiological scale.In the “Hip” Group, the treated hipjoint (s) were affected by mild and mod-erate primary hip osteoarthritis (stage Iand II); in this Group (30 patients), pa-tients were considered holistically, andonly patients with a normal physiquewere included, so that the needle usedwas able to reach the pericapsular area. In the “Achilles” Group, all the casestreated were mono- or bilateral Achilles’tendinopathies; 11 cases of tendonitis inthe same area with ultrasound-docu-mented exudate were also treated.All patients were told about the type oftreatment that they were being offeredand the main differences that it wouldhave compared to a similar injectiontherapy with hyaluronic acid or GunaCollagen MDs. They all signed the in-formed consent form. The clinical and symptomatic findingsof the patients enrolled were collectedusing assessment questionnaires validat-ed by the WHO, more specifically:• the Pain symptom was measured

using a five-point visual-analoguescale (VAS), in which “0” = no painand “5” = unbearable pain;

• D.A.S.H. (Disability for Arm, Shoul-der and Hand) for the shoulder, el-bow, hand, and wrist (range 0-100,in which 0 = no disability) (TAB. 2);

• O.K.S. (Oxford Knee Score) for theknee (range 48-0, in which 48 = nodisability) (TAB. 3);

• O.H.S. (Oxford Hip Score) for the

AREA

Total

N.

Age -

average

SHOULDER, UPPER LIMB

30%

66%

30%

20%

70%

34%

70%

80%

147

53

30

27

53,5

67,5

67

43,3

34-78

55-82

53-78

32-63

M

F

Age -range

KNEE

HIP

ACHILLES

TAB. 1

General caseload. Patient distribution according to gender and age.

150

250

300

200

0

100

Number

50

Average age - years

124

23

53

30

27

49,3

57,8

67,5

67

43,3

Shoulder U.L. Knee Hip Achilles

FIG. 5

General caseload.

– Number and mean

age of patients

included in the

study per individual

condition

considered.

– These characteristics translate direct-ly into organoleptic properties: colla-gen is a tissue structurer (structuralprotein) and also possesses lubricatingqualities.

– These bases form the significant dif-ference between the properties ofcollagen and those of hyaluronicacid.

The latter is a lubricant (high viscosity)only of the articular cavity, that acts onthe intra-articular component only, pri-marily in the large joints. Collagen also and primarily, acts on thestructures of the extra-articular compo-nent (capsule, ligaments, tendons) ofsmall, medium, and large joints.In addition, hyaluronic acid is effica-cious in cases of modest and intermedi-ate clinical severity, whereas collagen isalso efficacious in those cases in whichthe patient’s mobility is more severely

23

PHYSIOLOGICAL REGULATING MEDICINE 2018

� Pain

The pain assessment scale showed a re-duction from 3.06 (initial mean valueincluding all the cases analysed) to a fi-nal value of 1.34.– The variation in the pain experiencedin the various segments is shown inFIG. 6.

Shoulder and upper limb Group(FIG. 7)

D.A.S.H. is an assessment questionnairethat considers a number of everyday sit-uations facing the patient (disabilityconcerning movements of the shoulder,hand, and elbow). The worst score is100 and describes an extremely invali-dating situation; a normal situation co-incides with a score of 0.

In the caseload managed in this studyregarding conditions of the Shoulder,the score dropped from an initial aver-age of 78.7 to a final score of 17.3.As far as the Upper limb Group is con-cerned, from the initial mean of 66.8 thescore dropped to 18.2.

– In this case, the use of the D.A.S.H.questionnaire proved to be a disputablechoice, as it pooled the results for anumber of different segments. In the fu-ture, we intend to use a dedicated score,such as the Oxford Shoulder Score toassess shoulder function.

Knee Group

O.K.S. (The Oxford Knee Score) is anassessment scale including differentcommon situations of everyday life. The patient is invited to reply with regardto the 4 months prior to completion ofthe questionnaire; for obvious time rea-sons, post-treatment completion refersto the time at which it is filled out.A score of 0 coincides with the most im-paired situation, whereas a score of 48coincides with a condition of full func-tion. Of the 53 patients included (FIG. 8),the average initial score was 13.6,whereas a score of 35.8was achieved atthe end of treatment.

hip (range 48-0, in which 48 = nodisability) (TAB. 4);

• V.I.S.A.-A (Victorian Institute of SportAssessment – Achilleus) for theAchilles’ tendon (range 68-0, inwhich 68 = no disability) (TAB. 5).

The questionnaires were filled out bypatients; the dedicated questionnairewas administered at the first visit and atthe end of treatment. Patients were administered intra-articu-lar (shoulder, elbow, wrist, hand andknee), pericapsular (hip) and local (ten-dons) injections with the appropriateand specific MDs; 5 cc disposable sy-ringes were used, with 23G x 1-1/2 -mm 0.60 x 40 needles for the hip, knee,and shoulder injections and 26G x 1/2 -mm 0.40 x 16 needles for hand, wrist,elbow, and foot injections. Before administration, the skin was dis-infected using a liquid product contain-ing quaternary ammonium salt.

– In those segments in which adminis-tration was intra-articular, sterile surgi-cal gloves were used and the injectionarea was disinfected thoroughly usingsterile gauze soaked in surgical Beta-dine. In certain segments that are partic-ularly rich in pain-sensitive nerve termi-nations, spray “ice” was used for anal-gesic purposes. The injections were ad-ministered twice-weekly for 5 consecu-tive weeks (total = 10 injections).

– The patients treated for chronic degen-erative diseases (knee osteoarthritis, hiposteoarthritis, trapeziometacarpal os-teoarthritis and one case of severeAchilles’ tendinopathy in a semi-profes-sional dancer) continued with mainte-nance therapy (1 session a month for6 consecutive months, then every 3months). In no case was it suggested forthe pharmacological therapy to be sus-pended or varied; patients taking NSAIDsor Paracetamol were asked to use thistherapy only when absolutely necessary. The evolution of the pain symptom inparticular was monitored in the 8 pa-tients who were taking opioid anal-gesics, in order to gradually reduce theposology of these drugs.

RESULTS

All the patients included in this studycompleted the treatment. None of themreported any side effect after the admin-istration of the Guna Collagen MedicalDevices. In those patients on anti-platelet or dicoumarol therapy, small ar-eas of ecchymosis were observed at theinjection site, but it reabsorbed rapidlywithout requiring any particular inter-vention. All patients considerably reduced theiruse of conventional medicinal productsand in 75% ≈ of all cases their admin-istration was not considered necessary.

– Of the 8 patients on treatment with opi-oid analgesics, 3 continued taking thesemedicinal products, albeit at consider-ably lower doses, whereas the remaining5 gradually discontinued their use.

Generally speaking, the pain symptomsstarted to subside from the 4th or 5th ad-ministration; however, in cases of sub-acromial impingement and Achilles’ orelbow tendinopathy the positive effectson pain were observed later. In the osteoarthritic forms, affectingboth the knee and the hip joint, the firsteffect reported by patients was a sensa-tion of a greater range of joint motion;this sensation was perceived by patientsafter the first 2 - 3 sessions.

One particularly complex case was thatof a male patient with polycythaemia,with concomitant severe osteoarthritisof the knee, hip and shoulder joint andsignificant functional impairment. This was the case in which the improve-ment assessed by the questionnairesused in the study was poor; however,considering the initial clinical situation,it can be said that this was the patientwho was most satisfied with the treat-ment received.

– We initially treated the shoulder aloneand only subsequently, at the patient’sinsistence, also treated the knees. At alater date, we will decide if and when totreat the hips.

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PHYSIOLOGICAL REGULATING MEDICINE 2018

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E@KNFI!

RO! E%$+?!0*'-!'%',4!)(6#+$&'(!5*-!0*'-!3*-.a! O! Q! R! S! T!

RQ! B*$+?!0*'-!'%',4!3*-.!/(6,'%(!*5!,-1:!%#*'4;(-!*-!#,+;!2,$+a! ! ! ! ! !

RR! B*$+?!0*'-!3*-.!,%!3(44!,%!0*'!3*'4;!4$.(a! ! ! ! ! !

RS! L2(+;$+?!0*'-!'%',4!,1*'+)!*5!)$1(!;*$+?!0*'-!3*-.a!!

! ! ! ! !"#(!5*44*3$+?!&'(%)$*+%!-(4,)(!)*!)#(!$12,6)!*5!0*'-!,-1%:!%#*'4;(-!*-!#,+;!2-*/4(1!*+!24,0$+?!0*'-!1'%$6,4!$+%)-'1(+)!*-!%2*-)!*-!/*)#8!<5!0*'!24,0!1*-(!)#,+!*+(!%2*-)!*-!$+%)-'1(+)!X*-!24,0!/*)#Y:!24(,%(!,+%3(-!3$)#!-(%2(6)!)*!)#,)!,6)$7$)0!3#$6#!$%!1*%)!$12*-),+)!)*!0*'8!!94(,%(!6$-64(!)#(!+'1/(-!)#,)!/(%)!;(%6-$/(%!0*'-!2#0%$6,4!,/$4$)0!$+!)#(!2,%)!3((.8!!

! B$;!0*'!#,7(!;$55$6'4)0f! @A!

B<CC<DEF"G!

H<FB!

B<CC<DEF"G!

HABIJK"I!

B<CC<DEF"G!

Id"JIH

I!B<CC<DEF"G!

E@KNFI!

RT!E%$+?!0*'-!'%',4!5*-!24,0$+?!0*'-!$+%)-'1(+)!*-!%2*-)a!! O! Q! R! S! T!

RV! 94,0$+?!0*'-!1'%$6,4!$+%)-'1(+)!*-!%2*-)!/(6,'%(!*5!,-1:!%#*'4;(-!*-!#,+;!2,$+a!! O! Q! R! S! T!

RW! 94,0$+?!0*'-!1'%$6,4!$+%)-'1(+)!*-!%2*-)!,%!3(44!,%!0*'!3*'4;!4$.(a!! O! Q! R! S! T!

RZ! L2(+;$+?!0*'-!'%',4!,1*'+)!*5!)$1(!2-,6)$6$+?!*-!24,0$+?!0*'-!!$+%)-'1(+)!*-!%2*-)a!!

!

O! Q! R! S! T!!"#,+.!0*'!5*-!5$44$+?!$+!)#$%!5*-18!!

TAB. 2

D.A.S.H.

– D.A.S.H. (Disability for Arm, Shoulder and Hand) Questionnaire.

25

PHYSIOLOGICAL REGULATING MEDICINE 2018

TAB. 3 TAB. 4

O.K.S. - OXFORD KNEE SCORE O.H.S. - OXFORD HIP SCORE

– O.K.S. (Oxford Knee Score) Questionnaire. – O.H.S. (Oxford Hip Score) Questionnaire.

26

PHYSIOLOGICAL REGULATING MEDICINE 2018

At the end of the treatment, patientswere offered the chance to continuewith maintenance therapy: all the pa-tients agreed to continue the treatment,saying that they were satisfied and con-fident. The improvements achievedwere maintained in the followingmonths. In some cases, further improve-ments were seen; however, in order toquantify these data, the situation mustbe evaluated on a case-by-case basis.

Hip Group

O.H.S. (The Oxford Hip Score) is an as-sessment scale for hip joint function.The patient must answer regardinghis/her every day motor performance.Once again, patients were invited to an-swer the end-of-treatment question-naire, by entering their replies at the

time of assessment. Full joint integritycoincides with a score of 48 points,whereas a clinical situation of maxi-mum impairment coincides with ascore of 0.It is important to remember that the pa-tients in this Group presented radio-graphic evidence of a stage I or II con-dition, the phases of the disease inwhich pain and functional impairmentemerge.In this Group, the mean score de-creased from an initial value of 10.2 (in-dicating somewhat severe general im-pairment) to a final score of 37.2 (FIG. 9).

Achilles’ Group

This Group of patients, suffering from aninflammation of the Achilles’ tendon,answered the Victorian Institute of Sport

Assessment (V.I.S.A.-A) questionnaire,which refers to the Achilles’ tendonalone and provides a score of between0 and 68 points; the latter value refers toa condition of complete and perfectfunction.In this case, as shown by the data inFIG. 10, the score increased from an ini-tial value of 21.0, to a final value of54.0 points.The patients in this Group had an ultra-sound study, with a finding of effusionbetween the tendon folds.– As ultrasound is a non-invasive imag-ing technique, at the end of treatmentthe patients had a follow-up ultrasoundscan, to show the reabsorption of thesigns of inflammation (FIG.11).

CONCLUSIONS

All the treated patients declared thatthey were satisfied with the resultachieved.– There were no drop outs, despite thefact that the treatment lasted 5 - 6 weeks.As far as all of the assessment question-naires as a whole are concerned, therewas a considerable, statistically signifi-cant, subjective improvement.To this we must add the objective im-provement, confirmed by imaging stud-ies (follow-up ultrasound) for those pa-tients with Achilles’ tendon conditions,and clinically by range of joint motiontests.After the first 3 - 4 administrations, al-most all patients in the Shoulder, Hipand Knee Groups, expressed their sur-prise at the feeling of greater joint free-dom.The Hip Group was the Group that ex-pressed the greatest and earliest satisfac-tion with the treatment. From a percent-age standpoint, the best result wasachieved in the Achilles’ Group: thiscan be attributed to the fact that thisGroup was constituted by patients withthe lowest average age and that inwhich the condition was not secondaryto an overload or degenerative process.The members of this Group and theShoulder Group were not offered anymaintenance therapy. A single addition-

TAB. 5 V.I.S.A.-A– V.I.S.A.-A (Victorian

Institute of Sport

Assesment- Achilles

tendon)

Questionnaire.

27

PHYSIOLOGICAL REGULATING MEDICINE 2018

al administration was required in justtwo cases, both in the Shoulder Group.For the patients in the Hip, Knee andUpper Limb Groups (in the latter, forcases of trapeziometacarpal osteoarthri-tis only) the treatment is still on-going.Administration is once-monthly for thefirst six months.

Subsequently, if stable remission isachieved, the treatment is administeredonce every two months and, later, onceevery three months.Having been thoroughly informed of therole played by locally-administered col-lagen (Guna Collagen MDs), the pa-tients readily understood that their at-tention to symptoms is fundamental toa successful outcome of treatment, inorder to achieve long-lasting results.

– Another positive aspect of treatmentwith Guna Collagen MDs is the rapideffect on pain, even and above all in pa-tients on dicoumarol anti-coagulanttherapy, who cannot take NSAIDs orsteroids.

A positive and somewhat rapid re-sponse was also observed in those pa-tients with heavy pharmacological reg-imens due to comorbidities.It is important to note that, in most of thecases observed in this study (as is thecase for the majority of patients referredto a physiatrist), the patient was referredafter at least two months of attempts us-ing conventional pharmacological ther-apy (NSAIDs, Steroids, Paracetamol)without achieving any stable result.Their body was therefore intoxicated.

– The toxins from conventional anti-in-flammatory drugs accumulate above allin the structures comprising the muscu-loskeletal system.

– Even subjects on heavy chronic phar-macological treatment (steroids, oralhypoglycaemic agents, insulin, antico-agulants), the positive response to ther-apy was achieved without any interfer-ence with their ongoing chronic thera-pies. �

References

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Ed. Cortina. Milano; 1989.

– Lucherini T., Cecchi E., Schiavetti L. –

Reumatismo cronico osteofitico. inTrattato di

Reumatologia. Milano; 1954.

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1,5

2,5

3,5

3

2

0

1

Shoulder

0,5

3,2

PAIN BEFORE TREATMENT PAIN AFTER TREATMENT

UpperLimb

Knee Hip Achilles

1,3

2,8

1,5

3,3

1,1

3

1,51,3

3

PAINFIG. 6

Variation in the pain

symptoms pre- and

post-treatment in

the different Groups

treated with Guna

Collagen MDs.

30

50

80

60

40

0

20

70

D.A.S.H. BEFORE TREATMENT D.A.S.H. AFTER TREATMENT

10

78,7

Shoulder Upper Limb

66,8

17,3 18,2

SHOULDER AND UPPER LIMBFIG. 7

Results of the

analysis of the data

collected using the

D.A.S.H.

questionnaire for

conditions affecting

the shoulder and

upper limb (elbow,

wrist, and hand).

30

40

0

20

O.K.S. BEFORE TREATMENT O.K.S. AFTER TREATMENT

10

13,6

35,8

KNEEFIG. 8

Results of the

analysis of the data

collected using the

O.K.S., for knee

conditions.

28

PHYSIOLOGICAL REGULATING MEDICINE 2018

– Mele G., Ottaviani M., Di Domenica F. – Il

trattamento riabilitativo nell’acromioplastica

secondo Neer in pazienti con lesione della

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cal Assessment 2010-2012. 2013/2, 1-18.

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sindrome da impingement : trattamento riabi-

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diagnostico. La Riabilitazione. 31 (7): 17-24;

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femoro-rotulea con MD Knee + Zeel® T veico-

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condroitinsolfato. La Med. Biol., 2011/3, 3-11.

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fibril morphology and organization: implica-

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2012.

40

0

20

O.H.S. BEFORE TREATMENT O.H.S. AFTER TREATMENT

10,2

37,2

HIPFIG. 9

Results of the

analysis of the data

collected using the

O.H.S., for hip

conditions.

40

60

0

20

V.I.S.A.-A BEFORE TREATMENT V.I.S.A.-A AFTER TREATMENT

21,0

54,0

ACHILLES TENDONFIG. 10

Results of the

analysis of the data

collected using the

V.I.S.A.-A, for

Achilles’ tendon

conditions.

FIG. 11

(A) Achilles’ tendon in the presence of effusion in the peritendineum; (B) The effusion is no longer

visible. A situation of chronic tendinosis persists, with microcalcifications.

(B)(A)

author

Dr. Morena Ottaviani, MD– Physical Medicine and Rehabilita-tion specialist

C.M.R. - Centro Medico Riabilitativo

Via Francolano, 121

I – 16030 Casarza Ligure (GE)