L A C I N I L BULGARIAN EXPERIENCE WITH INJECTABLE ...

PHYSIOLOGICAL REGULATING MEDIC INE 2020

BULGARIAN EXPERIENCE WITHINJECTABLE COLLAGEN GUNAMEDICAL DEVICES INSHOULDER PERIARTHRITIS

R. Nestorova, P. Todorov,T. Petranova, R. Rashkov

CLI

NIC

AL

INTRODUCTION

About 20% of the world populationhave symptoms of pain and limitedmobility of the shoulder (1). Shoulderpain correlates with age. Its frequencyis between 6 and 11% up to 50 years ofage and then increases more than twice,and ranges between 16 and 25% (2).RC is composed of collagen, proteogly-cans (PG), glycosaminoglycans (GAG),water and cells. Light microscopyshows that the primary damage is thedecreasing of collagen type I, in whichfibers become thinner than normal. The extracellular matrix remodeling oc-curs by the impact of metalloproteinaseenzymes which preceded clinical signs.Therefore, the only effective treatmentwould be a structural modifying treat-ment (3).

During the last years doctors have been

looking for medical products for localinjections into the joints different fromthe traditional medicines, such as corti-costeroids. Medical products that com-bine positive effects on joints with noside effects.

− Treatment with injectable collagenGUNA MDs presents a concept basedon the synergistic effect of non conven-tional and conventional medicine. The purpose of the local administrationof the collagen is essentially structuralto provide mechanical support, replace,strengthen, structure and protect thezone where is injected. Due to its lowdose (300 mcg), collagen acts signally,changing extracellular matrix and lead-ing to the activation of cellular func-tions. GUNA MD-Shoulder has analgesic ef-fect on joint pain, reduces degenerativechanges in the RC of the shoulderthrough the enhancement and strength-

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SUMMARY

This article presents two studies, whoseaim was to evaluate the efficacy of colla-gen injections of GUNA MDs regarding painand functional activity of the shoulder inpatients with clinically proved shoulder pe-riarthritis by Musculoskeletal ultrasound(MSUS) assessment.We randomized 20 patients with periarthri-tis and subacromial subdeltoid (SASD) bur-sitis in Study 1, and 22 patients with peri-arthritis and rotator cuff (RC) partial thick-ness tears (PTTs) in Study 2.Combinations of GUNA MDs were appliedin the subacromial space in the totalcourse of treatment (8 weeks), respectivelyGUNA MD-Shoulder + GUNA MD-Matrix inStudy 1 and GUNA MD-Shoulder + GUNAMD-Muscle in Study 2.Clinical assessment included demographicand clinical data, a Visual Analog Scale(VAS) for pain (0-100), Shoulder FunctionAssessment (SFA) scale (0-70) and MSUSevaluation of the shoulder. Appraisal of theefficacy according to the patient and thephysician were performed. Results of both studies showed significantefficacy on pain and improvement of SFAindex. 73 to 80% of all patients had a verygood and good assessment of the efficacy,which coincided with the opinion of thephysician in both trials. We proved by MSUS evaluation reductionor absence of bursitis in 80% of patients inStudy 1 and complete recovery or im-proved structure of the RC in 77% of pa-tients in Study 2. No adverse events were registered.

In conclusion, collagen injections of GUNAMDs significantly reduced pain, led to alack or decrease of bursitis volume, re-paired or improved RC tissues and in-creased functional activity of the shoulder,thereby increasing the quality of life.

C O L L A G E N INJECTIONS GUNA MDs, SHOULDER PERI-ARTHRITIS, SUBACROMIAL SUBDELTOIDBURSITIS, PARTIAL THICKNESS TEARS,ULTRASONOGRAPHY

KEY WORDS

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ening of the collagen matrix in tendons,muscles, ligaments and joint capsule,which reduces pain. GUNA MD-Matrixhas an antioxidant activity, improves thefunctions and regenerates the extracel-lular matrix, activating the cellular func-tions. This results accelerate the healing pro-cess through faster resolution (drain ef-fect) of swelling. GUNA MD-Muscleimproves muscle tone by inhibiting theuptake of calcium and the enzymephosphodiesterase (5,6).

Musculoskeletal ultrasonography(MSUS) is an approved imaging tech-nique for diagnosis of RC pathology ofthe shoulder and monitoring of therapy(7-18). Sonographic assessment wasperformed according to OMERACTGroup recommendations. All patients

were examined with commercial, real-time equipment Mindray M5 (China) us-ing a 7.5-10 MHz linear phased arraytransducer. A standard scanning proto-col including multiplanar, dynamic andbilateral evaluation was followed in or-der to avoid missing the assessment ofone or more anatomic structures of theshoulder. Transverse and longitudinalplanes from the Biceps tendon (BT),Subscapularis tendon (SSC), Supraspina-tus tendon (SSP), SASD bursa, Infraspina-tus tendon (ISP) and the Acromioclavic-ular joint (ACJ) were scanned. The BT and ACJ were scanned in neutralposition of the shoulder with flexed el-bow at 90°. The SSC tendon was assessed in full ex-ternal rotation of the shoulder. Each pa-tient’s arm was put into full internal ro-tation with the hand placed posterior to

the spine for the assessment of SSP ten-don. The ISP tendon was assessed inshoulder adduction with the hand onthe opposite shoulder. A dynamic viewof the SSP tendon was obtained by mov-ing the patient’s arm from a neutral po-sition to a 90° abduction in order to de-tect encroachment of the acromion intothe RC. The SASD bursa lies betweenthe RC tendons and the Deltoid muscle,overlying the Bicipital groove and it isoften invisible due to the small amountof fluid within it. Bursa can be visible asa thin hypo/anechoic band with thick-ness up to 2 mm under normal condi-tions. Bursitis consists in abnormal hy-po/anechoic intrabursal material that isdisplaceable and compressible. RC tendons are hyperechoic due to theirfibrillar echotexture. PTT is discontinu-ity of fibres without signs of retraction.It can be visible as an anechoic focus in-side the tendon. The tendon surface re-tains with normal convexity. PTTs couldbe classified as Bursal sided, Articularsided and Intra-substance tears accord-ing to their location within the tendon(10-17). To objectify the MSUS evaluation, twotrained and experienced sonographerswith at least 5 years experience inMSUS scanned together each patientand reached consensus on the US find-ings.

Clinical assessment included demo-graphic and clinical data, a Visual Ana-log Scale (VAS) for pain (0-100) andShoulder Function Assessment (SFA)scale (0-70). Evaluation of the efficacyaccording to the patient and the physi-cian were performed (19,20). The SFAtest has 2 items concerning pain on mo-tion and at rest; 4 items for shoulderfunction in daily activities; and 3 objec-tive Range of Motion (ROM) measures.The SFA consists of two Visual AnalogueScales (pain at rest and during move-ment), four multiple choice questionsabout daily activities (dressing, combinghair, washing opposite axilla, and usingthe toilet), and three measures for ROM(total active abduction and two com-bined movements asking the patient toplace the hand on the head with the el-

1 1Inclusion criteria Exclusion criteria

Age 18-80 years Joint inflammatory and rheumatic auto-immune disease, infections

2 2Clinical diagnosis:Shoulder periarthritis

Degenerative arthropathy, traumas, surgery in shoulder (incl. complete ruptures of the RC)

3 3Duration of the symptoms up to 3 months

Physiotherapy and topical corticosteroids application within a month before and during the monitoring

4 4Pain by VAS over 25mm Other diseases – diabetes

mellitus, neurological diseases (incl. brachial plexitis, peripheral neuropathy)

5 5Bursitis of SASD bursa proven by MSUS

Cancer, chemotherapy, radiotherapy

TAB. 1Study 1

− Inclusion and

exclusion criteria.

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68,0

60

First visit Second visit

Pain

dur

ing

the

day

Repeated measures analysis ; F(2, 38) = 93,954, p<0.001

Third visit

40

20

0

19,512,5

PAIN/VAS on visits

34,7

60


SFA

Repeated measures analysis F(2, 38) = 71,577, p < 0.001

Third visit

40

20

0

59,5 61,4

SFA on visits

Very good

Patient’s assessment

Second visit Third visit

70,00%

15,00%

5,00%5,00% 5,00%

5,00%

10,00%

70,00%

15,00%

Good Satisfactory None Deterioration Very good

Physician’s assessment

Second visit Third visit

Good Satisfactory None Deterioration

75,00% 75,00%

5,00% 5,00%

5,00%

5,00%15,00%

15,00%

FIG. 1 FIG. 2

Pain at rest F(2, 38) = 7,914, p = 0.001

Pain during movement F(2, 38) = 74,078, p < 0.001

Dressing F(2, 38) = 72,724, p < 0.001

Combing hair F(2, 38) = 63,317, p < 0.001

Washing opposite axilla F(2, 38) = 25,294, p < 0.001

Using the toilet F(2, 38) = 14,256, p < 0.001

Active abduction F(2, 38) = 64,373, p < 0.001

Hand on the head with the elbow forward F(2, 38) = 33,496, p < 0.001

Hand on the head with the elbow backward F(2, 38) = 53,451, p < 0.001

FIG. 3 FIG. 4

bow forward and backward). The over-all score ranges from 0 (worst shoulderfunction) to 70 (best shoulder function).

STUDY 1− GUNA MDs EFFICACY IN SHOULDER PERIARTHRITIS WITHSUBACROMIAL SUBDELTOID(SASD) BURSITIS

The aim of this study was to evaluate theefficacy of Collagen injections of GU-NA MDs regarding pain and functionalactivity of the shoulder in patients withperiarthritis and bursitis of the SASD

TAB. 2Results for each item in SFA.

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− The combination of 1 vial of GUNAMD-Shoulder + 1 vial of GUNA MD-Matrix was applicated into the subacro-mial space of each patient, a total of 20vials, 2 vials for each application, ac-cording to the scheme: first 2 weeks – 2applications/weekly, followed by 6weeks – 1 application/week in a generalcourse of treatment (8 weeks) (21-24).Collagen application technique:The applications were performed ac-cording to generally accepted rules.The patient’s skin was sterilized with al-cohol and Braunol. Access to the sub-acromial space was achieved with a lat-eral approach, inserting a 21-gauge(0.8X50 mm) needle under the antero-lateral part of the acromion process,passing it through the Deltoid muscle,and directing it medially and slightly an-

terior to the SASD bursa, with care toavoid injection directly into the tendonsof the RC (12, 24).Statistical analysis:For VAS and SFA assessment Repeatedmeasures analysis was used. For assess-ment of Bursitis χ2 analysis was used.

RESULTS

1. VAS Pain during the day: on the sec-ond visit (60th day) the pain during theday reduced threefold and continued toreduce till the third visit (150th day)more than 5 times compared to the firstvisit (FIG. 1).

2. The index of SFA had a statisticallysignificant improvement of all SFA cri-teria which correlated with increasingof the point number with 24.8 points.The improvement continued till thethird visit too (FIG. 2).

3. Patient Assessment: The scale had 5levels of appraisal, from maximal (Verygood) to minimal (Deterioration). Minimum 80% of the patients gave avery good and good assessment of effica-cy of Collagen Medical Devices (FIG. 3).

4. Physician’s Assessment: The scale wassimilar: Maximal evaluation (Very good)to minimal (Deterioration).Physicians gave very good and goodevaluation of the efficacy of GUNA MDstreatment in at least 80% of patients onthe second and third visit (FIG. 4).

5. Bursitis: MSUS evaluation showedthat 80% of patients had reduction orlack of SASD bursitis on the second andthird visit (FIG. 5).We present sonographic images intransverse scan of BT showing SASDbursa before and after the treatmentwith GUNA MDs. IMAGE 1 (baseline)shows the increasing quantity of fluid inthe SASD bursa /hypoechoic distensionof the bursa which is visible over the BT.At the second visit (after treatment) thereis no sign of bursitis (IMAGE 2).

bursa and duration of symptoms up to 3months (21-24).

MATERIALS AND METHODS

We enrolled 20 patients with painfulshoulder and proved by MSUS bursitisof the SASD bursa (TAB. 1). At the baseline visit it was performed astandard X-Ray of the painful shoulder.Clinical assessment, VAS and SFA scaleassessments (TAB. 2) were performed onthe following visits: baseline (First visit),on 60th day (Second visit) and on 150th

day (Third visit), as well as the evalua-tion of the efficacy according to the pa-tient and the physician. MSUS assessment was performed on allthree visits (21-24).

Image 1SASD bursitis

before treatment

Image 2No signs of bursitis

after treatment

Transverse scanBiceps tendon

1,0

Assessment of bursitis

1,0

,8

,6

,4

,2


Patie

nts

with

Bur

sitis

Third visit0

,2 ,2

fivefoldX2 (1) = 26,667, p < 0.001

FIG. 5

IMAGES 1-2

13


physician on 60-th day. MSUS assessment was performed onthe baseline and on 60-th day (25,26).

STUDY 2− GUNA MDs EFFICACY INSHOULDER PERIARTHRITIS WITHPARTIAL THICKNESS OF THEROTATOR CUFF TEARS OF THESHOULDER

The aim of this study was to assess theeffectiveness of the injectable collagenGUNA MDs regarding pain, function-ing and recovery of periarticular tissuesof the shoulder in patients with PTTs ofthe RC and duration of symptoms up to7 days (25,26).Based on cadaveric and imaging stud-ies, the prevalence of PTTs ranges from13% to 32%, in part related to its strongcorrelation to patient age. In one MRIstudy of asymptomatic individuals, theoverall prevalence of PTTs was 20%. In patients under the age of 40, theprevalence was approximately 4%;whereas, in patients over the age of 60,the prevalence was 26% (27-28).

MATERIALS AND METHODS

We enrolled 22 patients with painfulshoulder and PTTs of the RC proven byMSUS. Standard X-Ray of the painful shoulderwas made at the baseline visit.Clinical assessment, VAS and SFA scaleassessments were performed on the fol-lowing visits: baseline (First visit), on 30-

th day (Second visit) and on 60-th day(Third visit), as well as evaluation of theefficacy according to the patient and the

1 1Inclusion criteria Exclusion criteria

Age 18-80 years Joint inflammatory and rheumatic auto-immune diseases, infections

2 2Clinical diagnosis:Shoulder periarthritis

Degenerative arthropathy, traumas, shoulder surgery. Full thickness tears of the RC

3 3Duration of the symptoms up to 7 days

Physiotherapy and topical corticosteroids application within a month before and during the monitoring

4 4Pain by VAS over 25mm Other diseases – diabetes

mellitus, neurological diseases (incl. brachial plexitis, peripheral neuropathy)

5 5PTTs of the RC proven by MSUS

Cancer, chemotherapy, radiotherapy

TAB. 3Study 2

− Inclusion and

exclusion criteria.

71

10

PAIN/VAS on visits80

70

60

50

40

30

20

10



Third visit0

32 29

67

SFA on visits80

70

60

50

40

30

20

10



Third visit0

54

FIG. 6 FIG. 7

14


visit and continued to reduce till thethird visit, 7 times compared to the firstvisit (FIG. 6).

2. The SFA index had a statistically sig-nificant improvement of all criteriawhich correlated with an increasing of25 points on the second visit. The im-provement continued till the third visitwith 38 points more compared to thefirst visit (FIG. 7).

3. Patient’s and Physician’s Assessments:73% of the patients gave a very goodand good assessment of efficacy (FIG. 8),which coincided with the opinion of thePhysician (FIG. 9).

4. MSUS evaluation: 77% of patients

− It was administered the combinationof 1 vial GUNA MD-Shoulder + 1 vialGUNA MD-Muscle into the subacromi-al space of each patient, a total of 20vials, 2 vials for each application, ac-cording to the scheme of Study 1, name-ly 2 applications weekly, for 2 weeksfollowed by 1 application weekly for 6weeks (25,26).Collagen application technique wasidentical to the one described above.Statistical analysis:For VAS and SFA assessment Repeatedmeasures analysis was used.

RESULTS

1. VAS for Pain was significantly re-duced more than twofold on the second

had a complete or improved structure ofthe RC at the third visit (FIG. 10).We present sonographic images in trans-verse scan of SSP tendon before treat-ment showing PTT presented as ane-choic band (Intra-substance lesion) onthe background of tendinosis (IMAGE 3)

and recovered tissue of the tendon afterthe treatment with GUNA MDs (IMAGE 4).

CONCLUSIONS

The GUNA MDs injections significantlyaffected pain, SASD bursitis, PTTs of theRC and functional activity of the shoul-der. Efficacy assessment was high: 73 to80% according to the patient and thesame percentage according to thephysician. 80% of patients in the Firststudy were without bursitis after treat-ment and they had full recovering of theRC on the second and third visit. 77% of patients with PTTs in the Sec-ond study had full recovery or signifi-cant sonographic improvement of thefibrillar echotexture of the RC tendons. All these data proved strengthening andrestoring effect of GUNA MDs on colla-gen structures.

− Collagen Medical Devices GUNA inpatients with Shoulder periarthritis andbursitis showed the following benefits:1. High individual clinical response:

Patient’s assessment

4%9%

64%

23%

Very good Good

Satisfactory None

FIG. 8 FIG. 9

MSUS assessment

23%18%

59%

Very good Good No change

FIG. 10

Physician’s assessment

4%14%

59%

23%

Very good Good

Satisfactory None

Image 3PTT of SSP tendonbefore treatment

Image 4No signs of PTT after treatment

IMAGES 3-4

15


ing into the tendon tissue.IMAGE 6 shows distended SASD bursa byMDs Shoulder and Muscle. Note ane-choic appearance of the MDs within thebursa. In IMAGE 7 is well visible the hypere-choic profile of the needle reaching theSASD bursa and injecting MD-Shoulderand MD-Muscle.

! In conclusion, the collagen injectionsof GUNA MDs are an innovative and ef-fective approach with regenerative andanalgesic effect in the treatment ofShoulder periarthritis with bursitisand/or PTTs. Their easy application and total absenceof side effects make them a modern de-vice of choice in the physician’s dailypractice. There is a new opportunity to applyGUNA MDs under US control which isa choice of the specialist. "

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pain (VAS), movement (Likert), Patient’sassessment2. High objective clinical response:Tests, SFA, Sonographic assessment,Physicians’s evaluation3. Successful treatment of SASD bursitis4. Strengthening and restoring effect oncollagen structures of the RC tendons,recovery in cases of incomplete RC le-sions5. Maintenance of the result beyond thelast injection6. Increasing patient quality of life7. Total absence of adverse side effects.

GUNA MDs UNDER ULTRASOUND CONTROL IN RC PATHOLOGIES OF THESHOULDER

In the past few years there has been anexponential growth of number of stud-ies published in this field reflecting thegrowing interest to implement thesetechnique as part of the standard clini-cal practice (28).This method of drug application is safeand efficacy is higher than blind injec-tions.Application technique under US controlis performed after skin disinfection ac-cording to generally accepted rules. A 21-gauge (0.8X50 mm) needle pene-tration is “in plane” with angulation of90°. After skin, subcutaneous tissue andDeltoid muscle penetration, the needletip reaches the bursa. Real time injec-tion can be rapidly carried out and drugdeposition and dispersion can bechecked immediately after finalizing theinvasive procedure (28).

− We present some images of SSP tendi-nosis and GUNA MDs applicationswithin the SASD bursa under US con-trol:IMAGE 5 shows SSP tendinosis and notdistended SASD bursa. Tendon is thick-ened and hypoechoic (tendon isswollen and its typical fibrillar echotex-ture is lost). In this case is better to applyGUNA MD injection within the SASDbursa and − this way − to avoid the riskof tendon lesion after the needle enter-

IMAGE 7

Image 7Hyperechoic profile of the needle (arrows)

entering the bursa and filling it with MD-Shoulder and MD-Muscle

Image 5SSP tendonosis

and not distended SASD bursa

Image 6SASD bursa is distended by GUNA MD-Shoulder

IMAGES 5-6

16


first author Rodina Nestorova, MD– Centre of Rheumatology “St. Irina”Sofia, Bulgaria

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24. Nestorova R., Rashkov R., Reshkova V. – Clinicaland sonographic assessment of the effectivenessof collagen injections Guna MDs in shoulder peri-arthritis with bursitis. European Journal of Muscu-loskeletal diseases 2014 (1);15-24.

25. Nestorova R., Rashkov R., Petranova T., Nikolov N.– Clinical and sonographic assessment of the effec-tiveness of collagen injections Guna MDs in patientswith partial thickness rotator cuff tears of the shoul-der. Osteoporosis International 2014; P 266;Springer.

26. Nestorova R., Rashkov R., Petranova T. – Clinicaland sonographic assessment of the effectiveness ofCollagen injections Guna MDs in patients with partialthickness rotator cuff tears of the shoulder. Physio-logical Regulating Medicine. 2016-2017; 35-37.

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Paper presented at the 2nd INTERNATIONAL CONGRESS

”COLLAGEN IN THE PATHOLOGIES OF THE MUSCULO-SKELETAL APPARATUS- Painful diseases of Joint & Muscle System.Important contribution of Collagen MedicalDevices”

Milan, 16th November 2019

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