THE COMPARISON OF INTRALESIONARY STEROID INJECTION AND AUTOLOGOUS VENOUS BLOOD INJECTION IN PATIENTS WITH PLANTAR FASCIITIS

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1 Acta Medica Mediterranea, 2015, 31: 711 THE COMPARISON OF INTRALESIONARY STEROID INJECTION AND AUTOLOGOUS VENOUS BLOOD INJECTION IN PATIENTS WITH PLANTAR FASCIITIS FARUK YESILTAS 1, UMIT AYDOGAN 2, ADEM PARLAK 3, OKTAY SARI 2, VEYSEL AKGUN 4, MUSTAFA KURKLU 5, YÜKSEL YURTTAS 5, KENAN SAGLAM 6, MUTLU SAGLA 4 1 Family Physician, Izmir Military Hospital, Department of Family Medicine, Izmir - 2 Gulhane School of Medicine, Department of Family Medicine, Ankara - 3 Family Physician, Gulhane School of Medicine, Department of Family Medicine, Ankara - 4 Gulhane School of Medicine, Department of Radiology, Ankara - 5 Gulhane School of Medicine, Department of Orthopedy, Ankara - 6 Gulhane School of Medicine, Department of Internal Medicine, Ankara, Turkey ABSTRACT Aims: Plantar fasciitis (PF) is a degenerative disease of the plantar fascia caused from recurrent replicable micro-trauma of the radix part of the calcaneus. The comparison of the effectiveness of the intralesionary autologous venous blood injection (AVBI) and intralesionary steroid injection (ISI) was aimed with this study. Materials and methods: In this study, we included forty-nine patients with PF. AVBI was applied to 28 patients while the remaining 21 patients underwent ISI. Visual Analogue Scale (VAS) was used to measure the pain intensity of the patients. Results: Statistically significant differences were detected in both groups when baseline VAS scores compared with the ones collected during treatment at 6th week, 3 th month and 6 th month. While the changes in VAS scores of group ISI and group AVBI at the 6th month after treatment were respectively -44,52 ± 2.51, -37,35 ± 30,62; there was no statistically significant difference detected between groups (p=0.41). Conclusions: In this study, it is established that AVBI and ISI treatments could relieve the pain due to PF. AVBI might be seen as a good alternative for ISI when disadvantages of the ISI like possible complications are thought. Key words: Plantar Fasciitis, autologous venous blood, intralesionary steroid, visual analog scale. Received June 18, 2014; Accepted April 02, 2015 Introduction Heel pain is a frequently encountered problem in daily life and one of the most common disorders for adults (1). Pain in specific anatomical areas of the foot is often attributed clinically to specific conditions, and therefore observing pain at a specific site can give greater insights into the underlying pathology (2). Chronicle damages and recurrent microtrauma of small foot muscles and insertion of the plantar aponeurosis resulting from recurrent sprains play significant role in pathogenesis (1). Recurrent microtrauma of medial tubercle of calcaneus cause periostitis and traction epiphysitis. This microtrauma lead chronic degenerative inflammation by the time and resulted with clinical manifestation called plantar fasciitis (PF) (3). PF is the most common cause of pain beneath the heel, constituting 11-15% of the foot symptoms requiring professional care among adults (4,5). Although there is no reliable population-based incidence, plantar fasciitis are associated with 10% of injuries due to running and reported to be common among military personnel (6-9). The incidence peaks between the ages of years in the general population and can be seen in runners at an earlier age (10-12). Gender dominance shows difference among the studies (8,11,13).

2 712 Faruk Yesiltas, Umit Aydogan et Al Conservative treatments like resting, limiting the potential activities which could exacerbate the seriousness of the pain, exercise, supporting the foot dome, use of anti-inflammatory agents and some interventional treatment such as ultrasonic shock wave, local intralesionary steroid injection and intralesionary autologous venous blood injection are included in the PF therapy (14). Corticosteroids operate their function by inhibiting the enzyme called phospholipase A2 which is responsible to form arachidonic acid from membranous phospholipids (15). In addition, topical corticosteroids act as analgesic by directly blocking the signal transduction of the nociceptive response (16). Local application of AVBI could provide the cellular and humeral mediators that promotes the healing cycle for the tissue. As a treatment, AVBI depends on the theory of promoting an acute inflammation by applying immune cells that are present in the blood to the damaged area (17,18). In this study, we aimed to compare autologous venous blood injection (AVBI) and intralesionary steroid injections (ISI) in terms of the healing process and the effectiveness on pain levels. Follow-up A block size of 30 and an allocation ratio of 1:1 for randomization of patients was established by using opaque envelopes including papers written as ISI or AVBI. Therefore each group had 30 participants. During the study, 2 participants from the AVBI and 9 participants from the ISI, totally 11 patients were exempted from the study as they announced that they had been out of city. Sociodemographical properties of the patients were recorded in order to determine pain severity levels by using visual analog scale (VAS). Patients thickness of heel pad (THP) and diameter of inflammation site that fit the binding area of the planter fascia in the medial tubercle of calcaneus were measured from the plantar side of the plainly heel by the ultrasonography (USG) probe in the longitudinal axis (figure 1). The VAS scores obtained before treatment and after treatment at the 6th week, 3rd month and 6th month, THP thickness and diameter of inflammation site measured before and after treatment were assessed. Material and method Patient selection Between June 2009 and June 2010, forty-nine patients admitted to the Orthopedic outpatient facility at Gulhane School of Medicine, complaining of heel pain and having final diagnosis of PF were included in this study. Patients with congenital or acquired disorders that disturb foot functions (i.e. patients with rheumatoid arthritis, hemiplegia, congenital foot deformity, traumatic foot and leg amputation, broke sequel), with alignments that cause mental disorders and patients who had surgery due to the heel were excluded from study. Participants were informed about the study and their approvals had been taken before the study. Local ethics committee approval was provided from the Gulhane School of Medicine Ethics Committee Administration (03 May 2009 and /1539). Figure 1: Ultrasound imaging of plantar side of the heel in longitudinal axis. Appearance of important structures during ultrasound imaging of heel Treatment The skin covering the region involving intense inflammation, determined by ultrasound imaging during the plantar surface measuring, was marked with surgical signal pen. Also determination of the direction for insertion and the depth of inflammation was performed before the skin preparation for injection. In ISI treatment group, combination of 1cc triamcinolone and 1 cc of distilled water was administered; whereas in AVBI treatment group, 2cc of venous blood drawn from ante-cubital region was injected into the own heel site of the patients within the same day without delay. Any local anesthetic agent was not added into the preparation not to disturb the AVBI solution. Anesthesia therefore was achieved by cooling spray. After both methods of treatments were applied once, the results were monitored.

3 The comparison of intralesionary steroid injection and autologous venous blood injection in patients Statistical analysis Data was combined in a common database and statistical analyses were performed using SPSS 15.0 (SPSS Inc., Chicago, Ill., USA). Kolmogorov- Smirnov was used to test normality of the continuous data. Unpaired sample t test was used for the comparison between two groups while paired sample t test was operated for intergroup comparisons. Calculated data set had a mean ± standard deviation, as well as significance was set at p< Characteristics AVBI group ISI group p Age, year 42,71±8,07 48,28±11,37 >0.05 Length, cm 166,28±8,99 168,38±8,99 >0.05 Weight, kg 82,03±12,08 88,14±11,07 >0.05 BMI, kg/m2 29,67±3,99 31,13±3,56 >0.05 Duration of alignments, month 30,21±30,82 15,52±11, Foot size, number 39,35±2,48 40,61±2,65 >0.05 VAS before treatment 80,50±17,12 83,76±18,57 >0,05 THP before treatment (mm) 14,65±1,78 14,95±1,85 >0,05 Diameter of inflammation before treatment (mm) Sex 4,20±1,07 4,80±1,42 >0,05 Man Woman Family history Yes 9 8 No Heel pain Right 5 3 Left 7 7 Bilateral (right dominance) 9 7 Bilateral (left dominance) 7 4 Set on characteristic of the alignment Suddenly 10 3 Progressively Table 1: Sociodemographic properties of the participants. AVBI; intralesionary autologous venous blood injection, ISI; intra-lesionary steroid injection, THP; thickness of heel pad, VAS; visual analog scale Results In total 49 participants were accepted to the present study. AVBI method was administered to 28 participants (57.1%), while the remaining 21 participants underwent ISI (42.9%). While average age of AVBI group was ± 8.07, average age of ISI group was ± Socio-demographic characteristics of the participants, the side of the heel where the pain occurs, characteristics of the initial pain, duration of complaints and presence of familial heel spurs in both groups are shown in table 1. Calcaneal spur proven in radiographs were available for all patients who were included in the study. VAS was administered to the participants before and after the treatment on the 6 th week, 3rd month and 6 th month. Changes in VAS scores for intra-group and inter-group after treatment There were no statistical differences between the groups from the point of the averages of the VAS scores before the treatment; scores for AVBI and ISI groups are respectively ± 17.12, ± 18.57, p > Statistically significant improvements were observed when the VAS scores of both groups obtained after the treatment at the 6 th week, 3rd month and 6th months were compared with the VAS scores obtaıned before the treatment (Table 2). There was a statistically relevant advantage in the ISI group after the treatment at the 6th week. The difference measured in ISI and AVBI groups were respectively ± 34.28, ± 27.51, p < VAS score differences of the ISI and AVBI groups were respectively ± 29.51, ± after treatment at 6th month, besides the differences between groups was not statistically significant (p=0.41). Changes in THP and diameter of inflammation site for intra-group and inter-group after treatment Diameter of inflammation site that fits the bond part of the plantar fascia in the medial tubercle of calcaneus and THP were measured before the treatment by ultrasound imaging of heel. THP were measured as averagely ± 1.78 mm for the AVBI group and ± 1.85 mm for the ISI group, and the differences between groups was not statistically significant (p 0.05, table 3). At the end of the 3th month, THP of patients in ISI group was decreased whereas any similar situation could not be observed for the other group (THP measured before

4 714 Faruk Yesiltas, Umit Aydogan et Al Before Treatment 6 th week* 3 rd month* 6 th month* p1 p2 p3 VAS AVBI 80,50±17,12 53,07±30,09 38,21±30,66 43,14±35,03 <0,0001 <0,0001 <0,0001 ISI 83,76±18,57 30,61±31,19 25,23±26,68 39,23±33,26 <0,0001 <0,0001 <0,0001 Table 2: Alterations on the VAS scores which are obtained from the results of AVBI and ISI administrations. *post treatment, p1; p value for statistical analysis of the period between pre-treatment and post-treatment 6th week. p2; p value for statistical analyses of the period between pre-treatment and post-treatment 3rd month. P3; p value for statistical analyses of the period between pre-treatment and post-treatment 6th month. VAS; Visual Analog Scale, AVBI; autologous venous blood injection, ISI; intralesionary steroid injection. Data were presented in the table as mean ± standard deviation and less than. Significant improvements about VAS were founded by AVBI and ISI administrations. the treatment and at the 3th month for the ISI group were respectively ± 1.85 mm and ± 1.67 mm, p < , table 3). Statistically significant differences were detected between the groups regarding the variation in THP. When the period covering before treatment and at the end of 3rd month after treatment were compared, differences in the AVBI and ISI group were respectively ± 1.12 mm, ± 1.37 mm (p = 0.001) (table 3). This present study states that administration of AVBI or ISI could decrease the severity of pain in patients with PF. In addition to this use of ISI cause the decrease in thickness of THP and diameter of inflammation site. Participants of the both groups in our study were all overweight or obese based on body mass index (BMI), suggesting that BMI of the patients with PF are increased as other previous related studies reported. One of the most important factors in Groups Before Treatment 3 rd month* p1 Differences between Before Treatment & 3 rd month* p2 THP Inflammation diameter AVBI Group 14,65±1,78 14,34±1,87 0,05-0,31±1,12 ISI Group 14,95±1,85 13,35±1,67 <0,0001-1,59±1,37 AVBI Group 4,20±1,07 4,29±1,08 0,05 0,08±1,11 ISI Group 4,80±1,42 3,39±0,98 <0,0001-1,40±1,38 0,001 <0,0001 Table 3Comparison of the differences on the THP and diameter of inflammation site between the groups after ISI and AVBI administrations. treatment 3rd month (paired sample t test), p2; p value which is obtained from the divergence between the groups parameters which are recorded before treatment term and post-treatment 3rd month (unpaired sample t test), AVBI; autologous venous blood injection, ISI; intra-lesionary steroid injection, THP; thickness of heel pad. Data were presented in the table as mean ± standard deviation and greater than or less than. At the end of the 3rd month, ISI administration caused decreasing in both THP and diameter of inflammation site while AVBI administration did not cause similar situations. It was observed that ISI treatment led a statistical difference with regard to AVBI treatment from the points of the alteration of the THP and diameter of inflammation site. Any statistically significant difference was not observed in terms of the diameter of the inflammation site fitting bonding location of plantar fascia on the medial tubercle of calcaneus, which had been measured before the treatment, (the ranges belongs to the AVBI and ISI groups were respectively 4.20 ± 1.07 mm, 4.80 ± 1.42 mm, p > 0.05, table 3). At the end of the 3th month, in the ISI group the range decreased while any statistically significant difference was not observed in the AVBI group (for the ISI group 4.80 ± 1.42, 3.39 ± 0.98, p < , table 3). A difference was observed between the groups about the point of inflammations ranges (Table 3). Discussion the PF developing is obesity. Studies about this subject show that there is a relationship between PF and weight (19,20). The risk of developing PF in individuals having BMI more than 30 kg/m2 is 5.6 times higher than the ones who have BMI within normal range (21). Including overweight patients in this study were consistent with other studies. Although Roxas did not mentioned about family history, it is reported that PF could be in relationship with weak biomechanical body (14). It was determined that close relatives of about 1/3 of the patients in both of the group who participate in the study suffer from similar alignments and diagnosed with heel spur. In this study, participants number is so many to be ignored and this brings to the mind

5 The comparison of intralesionary steroid injection and autologous venous blood injection in patients that weak biomechanical body could be familial situation. However, some more comprehensive research is needed to support this. PF is an inflammatory process limited in the foot plantar aponeurotic area and is reported as the most common reason of the sub-heel pain (22). Etiology is not fully understood but the theory in the mainstream is that degeneration and chronic inflammation are present in the fascia of the plantar aponeurosis, which is placed on the tuberositas calcanei (19). Corticosteroids perform anti-inflammatory and immunosuppressive activity by suppressing the activity of phospholipase A2, antigen presenting cells and T cells. And also act as an analgesic by inhibiting the up-regulation of prostaglandin E2, cytokines glutamate and substance P which are hyper-algesic molecules (16,23). Steroid administration to the patients with PF is reported to be a safe and effective method in previous studies (24-28). In the present study it is determined that administration of ISI had reduced both inflammation and pain in patients. No side effect was observed during the study from participants who ISI had been administered. By the end of the 3th month, it was observed that use of corticosteroids caused significant decreasing in diameter of inflammation site besides that THP thickness gets thinner. Besides administering corticosteroids as a common choice for PF treatment among clinicians, it is reported that activity of the method is short term and method could be a choice only for patients whose alignment is not severe (29). It has been shown by some studies that corticosteroid administrations could cause rupture of plantar fascia, infections, atrophy in fat pad and skin (20,30-35). Decreasing of THP thickness was also observed in the present study as well as in the others where corticosteroids had been used. Administering plasma including platelet derived growth factors into variety of tissues externally have been found to provide improvements in bone, tendon damage and wounds. By the activation of platelets, growth factors are released and body natural healing mechanisms get activated. It was established that therefore this could be used in PF and some other alignment (36-38). Previous studies have shown that injection of the plasma blood could relive the patients pain. In the present study, similar results were observed. Furthermore, getting thinner of the thickness of THP as an undesirable effect resulted from the corticosteroids administration was not observed. There are lots of treatments have been tried for PF so far, but just one treatment modality come to the fore. Lee TG and et al. compared the results of the administrations of AVBI and ISI on the chronic PF. Authors reported that both treatment modalities had decreased the VAS scores of the patients but no one was superior to the other in terms of treatment efficacy (22). Similar results were obtained in our study. However, in the 6 weeks term, decreasing of the score resulted from the ISI method more certain than AVBI make considered that corticosteroids set on is faster. It was observed that VAS values of both of the group had enhanced a little at 6 th month compared to 3 th month. These enhance in the VAS scores make considered that both of the treatment might be repeated at the 6 th month. We believe that AVBI administration could be preferred over the ISI method when considering the possible complications that could arise during the repeated ISI administrations. Additionally not causing immunological reactions, ease of extraction and preparation of material, being cheap and more acceptable method for the patients with PF are other advantages of the AVBI administration which positively affect the preference of treatment modality. Establishing no placebo group could be considered as a main restriction of this study. Also monitoring of participants during 24 weeks may help to determine the side effects of the treatments which occur in long term. Patients in both groups received a treatment just once during the follow-up. Lee TG and et al. had repeated the treatment per 12 weeks. Although just one administration was performed, expected levels of improvement in pain intensity was observed in this study. In the present study, it was established that AVBI and ISI administrations provide decreased in patients pain severity. At the end of the 6th week, ISI administration caused decreasing in both THP thickness and inflammation severity while AVBI administration did not cause similar situations. If a long standing treatment is intended, side effect of repeated ISI treatment must be considered. In this respect, it has to be remembered that AVBI is a safer method for this patients. References 1) Lareau CR, Sawyer GA, Wang JH, Di Giovanni CW. Plantar and medial heel pain: diagnosis and management. J Am Acad Orthop Surg 2014; 22(6): ) Chatterton BD, Muller S, Roddy E. Epidemiology of posterior heel pain in the general population: cross-

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