Researchportal.bath.ac.uk



High Volume Image Guided Injections with or without steroid for mid-portion Achilles Tendinopathy: A Pilot Study(Running title: HVIGI with or without steroid in Achilles tendinopathy)Hatim Abdulhussein MBBS1,2, Otto Chan MBBS FRCS Ed, FRCS Glas, FRCR (UK)2, Sarah Morton MBBS MRCP2, Stephen Kelly MBChB FRCP PhD,3 Nat Padhiar MSc PhD FCPodS FFPM RCPS(Glas)1,2, Xavier Valle MD4, John King MBBS FRCS FISEM FFSEM(UK)1,2, Sean Williams PhD5, Dylan Morrissey PhD MSc MMACP MCSP 1,2,3*1BMI London Independent Hospital, 1 Beaumont Square, Stepney Green,London,E1 4NL2Sports and Exercise Medicine, William Harvey Research Institute, Queen Mary University of London, Mile End Hospital, Bancroft Road, London, E1 4DG3Bart’s Health NHS Trust, London E1, UK4Barcelona FC, Barcelona, Spain5University of Bath, Bath, UK*Corresponding AuthorDr Dylan MorrisseyNIHR/HEE Consultant Physiotherapist and Clinical Reader Sports and Exercise Medicine, William Harvey Research Institute, Queen Mary University of London, a: Mile End Hospital, Bancroft Road, London, E1 4DGt: +447941710273e: d.morrissey@qmul.ac.ukDr Morrissey is part funded by the NIHR/HEE Senior Clinical Lecturer scheme. This report presents independent research funded by the National Institute for Health Research (NIHR). The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health.AbstractObjective: High volume image guided injections of local anaesthetic and saline plus steroid plus structured rehabilitation (HVIGI&SR) have been shown to improve outcomes in Achilles tendinopathy (AT) patients. Due to concerns about steroid safety, our aim was to determine whether omitting the steroid altered the clinical effects of HVIGI&SR. Methods: 23 consecutively recruited patients with AT (26 symptomatic tendons) were treated with a HVIGI composed of 10mls of 0.5% Marcaine mixed with either 40mls of normal saline including 25mg of hydrocortisone or 40mls of saline only. Treatment allocation was determined by patient selection. The VISA-A questionnaire and visual analogue scales (VAS) were administered at pre-injection; 2, 6 and 10 weeks; and 12-month follow-up. Results: VISA-A scores improved significantly in both groups, from a pre-injection mean (± SD) of 42.0 (± 20.5) to 86.9 (± 11.8) (p<0.01) in the ‘with steroid’ group, and from 42.6 (± 9.1) to 83.3 (± 12.2) (p<0.01) in the non-steroid group at final follow-up. VAS scores improved significantly in both groups. There was no statistically significance difference between the groups at baseline or any follow-up, in either VISA-A and VAS changes. A stronger effect size in favour of no steroid was seen at 10 weeks. Conclusion: Overall, HVIGI&SR without steroid yields similar effects on pain reduction and functional improvement in comparison to HVIGI&SR with steroid. These results suggest that the effects of the injection may be mechanical rather than chemical, and that the steroid can be omitted. A randomised controlled trial is required to confirm this. KeywordsInjection; ultrasound; corticosteroid; Achilles tendinopathy; VISA-A; VAS; high volumeIntroductionAchilles tendinopathy is the most common foot and ankle overuse injury in sport. Among runners, Achilles tendinopathy is the most frequent overuse injury, accounting for 6-17% of all running injuries [PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Tb2JoYW5pPC9BdXRob3I+PFllYXI+MjAxMzwvWWVhcj48

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ADDIN EN.CITE.DATA 10]. The diagnosis is a clinical one, best confirmed by imaging. Common imaging signs include tendon thickening, disorganised collagen structure, and neovascularisation around the tendon [ ADDIN EN.CITE <EndNote><Cite><Author>Maffulli N</Author><RecNum>11</RecNum><IDText>Tendon Problems: A basic science primer</IDText><DisplayText><style face="superscript">11</style></DisplayText><record><rec-number>11</rec-number><foreign-keys><key app="EN" db-id="5rrae5fax9wrr8eee28pw0pje5zeepfa2tef">11</key></foreign-keys><ref-type name="Generic">13</ref-type><contributors><authors><author>Maffulli N,</author></authors></contributors><titles><title>Tendon Problems: A basic science primer</title></titles><pages>3-10</pages><volume>21</volume><dates></dates><publisher>J Sports Traumatol</publisher><urls></urls></record></Cite></EndNote>11]. It has been shown by various case series that high volume injections deep to the tendon can alleviate pain and improve performance, and have long term success when combined with structured rehabilitation (SR). These effects are hypothesised to be mediated by local mechanical effects including stretching, breaking or occlusion of neo-vessels with disruption of the associated neural ingrowth [PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5DaGFuPC9BdXRob3I+PFllYXI+MjAwODwvWWVhcj48UmVj

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ADDIN EN.CITE.DATA 12,13]. Other possibilities are a chemical effect of steroid or local anaesthetic, or a combination of mechanisms. A number of studies have evaluated High Volume Image Guided Injection and structured rehabilitation (HVIGI&SR), and consistently found significant improvement in short and medium-term pain and function as well as a reduced grade of neovascularisation and tendon thickness [PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5NYWZmdWxsaTwvQXV0aG9yPjxZZWFyPjIwMTM8L1llYXI+

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ADDIN EN.CITE.DATA 12-16]. One recent study showed greater improvement in the short term for HVIGI&SR when compared to platelet-rich plasma (PRP) injections and structured rehabilitation [ ADDIN EN.CITE <EndNote><Cite><Author>Boesen</Author><Year>2017</Year><RecNum>11681</RecNum><DisplayText><style face="superscript">17</style></DisplayText><record><rec-number>11681</rec-number><foreign-keys><key app="EN" db-id="2sae5daa2dxdd3exw9qxzd9200w0afta0vw9" timestamp="1498397160">11681</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Boesen, Anders</author><author>Hansen, Rudi</author><author>Boesen, Morten</author><author>Malliaras, Peter</author><author>Langberg, Henning</author></authors></contributors><titles><title>Effect of High-Volume Injection, Platelet-Rich Plasma Plasma, and Sham Treatment in Chronic Midportion Achilles Tendinopathy: A Randomized Double-Blinded Prospective Study</title><secondary-title>American Journal of Sports Medicine</secondary-title></titles><periodical><full-title>American Journal of Sports Medicine</full-title></periodical><edition>22nd May 2017</edition><dates><year>2017</year></dates><urls></urls><electronic-resource-num>10.1177/0363546517702862</electronic-resource-num></record></Cite></EndNote>17].Typically, HVIGI has included 25mg of hydrocortisone acetate - a steroid - although one evaluation with similar results used Aprotinin, a broad-spectrum serine protease inhibitor [ ADDIN EN.CITE <EndNote><Cite><Author>Brown</Author><Year>2006</Year><RecNum>3839</RecNum><DisplayText><style face="superscript">18</style></DisplayText><record><rec-number>3839</rec-number><foreign-keys><key app="EN" db-id="2sae5daa2dxdd3exw9qxzd9200w0afta0vw9" timestamp="1489855907">3839</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Brown, R.</author><author>Orchard, J.</author><author>Kinchington, M.</author><author>Hooper, A.</author><author>Nalder, G.</author></authors></contributors><titles><title>Aprotinin in the management of Achilles tendinopathy: a randomised controlled trial</title><secondary-title>British Journal of Sports Medicine</secondary-title></titles><periodical><full-title>British Journal of Sports Medicine</full-title></periodical><pages>275-279</pages><volume>40</volume><number>3</number><dates><year>2006</year><pub-dates><date>Mar</date></pub-dates></dates><isbn>0306-3674</isbn><accession-num>WOS:000235619900019</accession-num><urls><related-urls><url>&lt;Go to ISI&gt;://WOS:000235619900019</url></related-urls></urls><electronic-resource-num>10.1136/bjsm.2005.021931</electronic-resource-num></record></Cite></EndNote>18]. An early case series suggests promising results of a HVIGI&SR without corticosteroid or aprotinin, but there was no comparison group [ ADDIN EN.CITE <EndNote><Cite><Author>Wheeler</Author><Year>2014</Year><RecNum>27</RecNum><IDText>The use of high volume image guided injections (HVIGI) for Achilles Tendinopathy - A case series and pilot study</IDText><DisplayText><style face="superscript">16</style></DisplayText><record><rec-number>27</rec-number><foreign-keys><key app="EN" db-id="5rrae5fax9wrr8eee28pw0pje5zeepfa2tef">27</key></foreign-keys><ref-type name="Generic">13</ref-type><contributors><authors><author>Wheeler, PC.;</author></authors></contributors><titles><title>The use of high volume image guided injections (HVIGI) for Achilles Tendinopathy - A case series and pilot study</title></titles><pages>96-103</pages><volume>36</volume><number>3</number><dates><year>2014</year></dates><pub-location>International Musculoskeletal Medicine</pub-location><urls></urls></record></Cite></EndNote>16]. The rationale of each chemical additive is to prevent an acute inflammatory reaction in response to the large amount of fluid injected and to inhibit scarring [ ADDIN EN.CITE <EndNote><Cite><Author>Maffulli</Author><Year>2013</Year><RecNum>2324</RecNum><IDText>High volume image guided injections for the management of chronic tendinopathy of the main body of the Achilles tendon</IDText><DisplayText><style face="superscript">13</style></DisplayText><record><rec-number>2324</rec-number><foreign-keys><key app="EN" db-id="2sae5daa2dxdd3exw9qxzd9200w0afta0vw9" timestamp="1489855454">2324</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Maffulli, N.</author><author>Spiezia, F.</author><author>Longo, U. G.</author><author>Denaro, V.</author><author>Maffulli, G. D.</author></authors></contributors><titles><title>High volume image guided injections for the management of chronic tendinopathy of the main body of the Achilles tendon</title><secondary-title>Physical Therapy in Sport</secondary-title></titles><periodical><full-title>Physical Therapy in Sport</full-title></periodical><pages>163-167</pages><volume>14</volume><number>3</number><dates><year>2013</year><pub-dates><date>Aug</date></pub-dates></dates><isbn>1466-853X</isbn><accession-num>WOS:000322802000006</accession-num><urls><related-urls><url>&lt;Go to ISI&gt;://WOS:000322802000006</url></related-urls></urls><electronic-resource-num>10.1016/j.ptsp.2012.07.002</electronic-resource-num></record></Cite></EndNote>13]. The mechanism of action, and indeed requirement for any chemical additive to the saline volume is worthy of investigation so as to minimise the chances of tendon degradation due to steroid administration. 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ADDIN EN.CITE.DATA 20]. The complication rates are not clear from the literature but concerns persist. The aim of this pilot study was to determine whether omitting the steroid from the injectates altered the clinical effects of HVIGI&SR. This would increase understanding of the mechanism of action, and would help determine whether the steroid could be omitted from future preparations of the injection, potentially improving the safety profile without a loss of efficacy. Patient selection was allowed to enable patient choice.Materials and MethodsProcedureEthical approval was granted by the QMUL Ethics of Research Committee and consent for the study to take place granted by the London Independent Hospital medical advisory committee. Patients were sequentially recruited directly from the Sports Medicine clinic at the London Independent Hospital having been referred to one single radiologist for Achillodynia. The clinical diagnosis was ultrasonographically confirmed, via tendon thickness measurement, pain provocation using the ultrasound probe, exclusion of subtle tears and degree of neovascularisation [PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5DaGFuIE88L0F1dGhvcj48WWVhcj4yMDE3PC9ZZWFyPjxS

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ADDIN EN.CITE.DATA 21-23]. The same ultrasound scanner was used for all patients (Siemens Medical Systems Incorporation, high specification Sonoline Elegra scanner, with a 13MHz linear high-resolution probe). The patient was asked for consent to the injection. Written consent for follow-up measures was obtained and a pre-injection VISA-A questionnaire completed based on the week prior to the injection. Patients were counselled regarding potential adverse events regarding corticosteroid use in the procedure, balanced with our experience of minimal side-effects and published case series, and then asked to make an informed decision as to whether they would receive steroid as part of the injection mixture or not. For the injection, the patient was positioned supine with the hip externally rotated, knees flexed to 45° and ankle plantargrade as per previous reports. Depending on the decision, patients were administered one or other injection using an aseptic technique, via a 21-gauge needle inserted with real time ultrasound guidance between the anterior aspect of the Achilles tendon and Kager’s fat pad, targeting the area of maximal neovascularisation (Figure 1) [ ADDIN EN.CITE <EndNote><Cite><Author>Chan</Author><Year>2008</Year><RecNum>12</RecNum><IDText>High volume image guided injections in chronic Achilles tendinopathy</IDText><DisplayText><style face="superscript">12</style></DisplayText><record><rec-number>12</rec-number><foreign-keys><key app="EN" db-id="5rrae5fax9wrr8eee28pw0pje5zeepfa2tef">12</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Chan, O.</author><author>O&apos;Dowd, D.</author><author>Padhiar, N.</author><author>Morrissey, D.</author><author>King, J.</author><author>Jalan, R.</author><author>Maffulli, N.</author><author>Crisp, T.</author></authors></contributors><auth-address>Department of Imaging, The London Independent Hospital, London, UK.</auth-address><titles><title>High volume image guided injections in chronic Achilles tendinopathy</title><secondary-title>Disabil Rehabil</secondary-title></titles><periodical><full-title>Disabil Rehabil</full-title></periodical><pages>1697-708</pages><volume>30</volume><number>20-22</number><keywords><keyword>Achilles Tendon</keyword><keyword>Adult</keyword><keyword>Anesthetics, Local</keyword><keyword>Anti-Inflammatory Agents</keyword><keyword>Bupivacaine</keyword><keyword>Chronic Disease</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>Hydrocortisone</keyword><keyword>Injections</keyword><keyword>Male</keyword><keyword>Middle Aged</keyword><keyword>Pain Measurement</keyword><keyword>Resistance Training</keyword><keyword>Severity of Illness Index</keyword><keyword>Tendinopathy</keyword><keyword>Ultrasonography, Interventional</keyword><keyword>Young Adult</keyword></keywords><dates><year>2008</year></dates><isbn>0963-8288</isbn><accession-num>18608362</accession-num><urls><related-urls><url> [pii]&#xD;10.1080/09638280701788225</electronic-resource-num><language>eng</language></record></Cite></EndNote>12]. After the injection patients were advised to walk normally but advised to avoid any high impact activity for at least 72 hours. All patients were assessed by a physiotherapist following the injection, who prescribed structured rehabilitation with a focus on eccentric loading exercises to be completed twice daily, alongside any other anti-gravity muscle strengthening and sports-specific conditioning required. Figure 1 about herePatients were emailed follow up VISA-A questionnaires at 2 weeks, 6 weeks and 10 weeks. The final follow up questionnaire at one year included a VAS scale to summarise improvement in pain since the injection.Patients23 consecutive patients with 26 tendinopathic tendons were injected (14 non-steroid, 12 steroid) and included in the study after meeting the inclusion and exclusion criteria outlined. Inclusion criteria were unilateral or bilateral mid-portion Achilles tendinopathy diagnosed clinically and confirmed on ultrasound with a neovascularisation grade of 3 or above, aged over 18 years and sportingly active [ ADDIN EN.CITE <EndNote><Cite><Author>Ohberg</Author><Year>2001</Year><RecNum>788</RecNum><DisplayText><style face="superscript">24</style></DisplayText><record><rec-number>788</rec-number><foreign-keys><key app="EN" db-id="2sae5daa2dxdd3exw9qxzd9200w0afta0vw9" timestamp="1489855032">788</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Ohberg, L.</author><author>Lorentzon, R.</author><author>Alfredson, H.</author></authors></contributors><titles><title>Neovascularisation in Achilles tendons with painful tendinosis but not in normal tendons: an ultrasonographic investigation</title><secondary-title>Knee Surgery Sports Traumatology Arthroscopy</secondary-title></titles><periodical><full-title>Knee Surgery Sports Traumatology Arthroscopy</full-title><abbr-1>Knee Surg. Sports Traumatol. Arthrosc.</abbr-1></periodical><pages>233-238</pages><volume>9</volume><number>4</number><dates><year>2001</year><pub-dates><date>Jul</date></pub-dates></dates><isbn>0942-2056</isbn><accession-num>WOS:000170155100010</accession-num><urls><related-urls><url>&lt;Go to ISI&gt;://WOS:000170155100010</url></related-urls></urls><electronic-resource-num>10.1007/s001670000189</electronic-resource-num></record></Cite></EndNote>24]. Exclusion criteria were: previous Achilles rupture, previous surgery on the Achilles tendon, concurrent inflammatory disease, ultrasound detected tendon tear and an inability to complete questionnaires due to language barriers. Patients had attempted numerous conservative management options prior to injection (eccentric loading exercises, massage therapy, orthotics, physiotherapy, acupuncture). Outcome MeasuresThe primary outcome measure in this study was the Victorian Institute of Sports Assessment – Achilles (VISA-A) questionnaire at 2-weeks, 6-weeks, 10-weeks and 12-months, a valid and reliable self-administered tool in assessment of patients with Achilles Tendinopathy [ ADDIN EN.CITE <EndNote><Cite><Author>Iversen</Author><Year>2012</Year><RecNum>19</RecNum><IDText>The victorian institute of sports assessment - achilles questionnaire (visa-a) - a reliable tool for measuring achilles tendinopathy</IDText><DisplayText><style face="superscript">25</style></DisplayText><record><rec-number>19</rec-number><foreign-keys><key app="EN" db-id="5rrae5fax9wrr8eee28pw0pje5zeepfa2tef">19</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Iversen, J. V.</author><author>Bartels, E. M.</author><author>Langberg, H.</author></authors></contributors><titles><title>The victorian institute of sports assessment - achilles questionnaire (visa-a) - a reliable tool for measuring achilles tendinopathy</title><secondary-title>Int J Sports Phys Ther</secondary-title></titles><periodical><full-title>Int J Sports Phys Ther</full-title></periodical><pages>76-84</pages><volume>7</volume><number>1</number><dates><year>2012</year><pub-dates><date>Feb</date></pub-dates></dates><isbn>2159-2896</isbn><accession-num>22319681</accession-num><urls><related-urls><url>]. The questionnaire was developed specifically to assess function, pain and sporting activity in Achilles tendon pathology, and consists of 8 questions, yielding a measure on a 0-100 scale with 100 reflecting a perfect score [ ADDIN EN.CITE <EndNote><Cite><Author>de Jonge</Author><Year>2011</Year><RecNum>20</RecNum><IDText>One-Year Follow-up of Platelet-Rich Plasma Treatment in Chronic Achilles Tendinopathy A Double-Blind Randomized Placebo-Controlled Trial</IDText><DisplayText><style face="superscript">26</style></DisplayText><record><rec-number>20</rec-number><foreign-keys><key app="EN" db-id="5rrae5fax9wrr8eee28pw0pje5zeepfa2tef">20</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>de Jonge, Suzan</author><author>de Vos, Robert J.</author><author>Weir, Adam</author><author>van Schie, Hans T. M.</author><author>Bierma-Zeinstra, Sita M. A.</author><author>Verhaar, Jan A. N.</author><author>Weinans, Harrie</author><author>Tol, Johannes L.</author></authors></contributors><titles><title>One-Year Follow-up of Platelet-Rich Plasma Treatment in Chronic Achilles Tendinopathy A Double-Blind Randomized Placebo-Controlled Trial</title><secondary-title>American Journal of Sports Medicine</secondary-title></titles><periodical><full-title>American Journal of Sports Medicine</full-title></periodical><volume>39</volume><number>8</number><dates><year>2011</year><pub-dates><date>Aug</date></pub-dates></dates><isbn>0363-5465</isbn><accession-num>WOS:000293387400003</accession-num><urls><related-urls><url>&lt;Go to ISI&gt;://WOS:000293387400003</url></related-urls></urls><electronic-resource-num>10.1177/0363546511404877</electronic-resource-num></record></Cite></EndNote>26]. The secondary outcome measure was a Visual Analogue scale (VAS) (0-100mm) assessing pain and symptoms pre-and post-injection. The VAS consisted of a scale (0-100mm) with 100 representing severe pain or severe symptoms, and 0 representing no pain or no symptoms.Data Analysis Data was analysed using SPSS Statistical Package for Social Scientists, (version 20.0, IBM, UK). Significance was set at p < 0.05. Shapiro Wilks tests were used to determine if outcome measures and baseline characteristics were normally distributed. Independent Student’s t tests were used to test for differences between groups for age, weight, duration of symptoms, sporting participation and VISA Scores at baseline. The non-parametric Mann-Whitney test was used to assess for differences between groups in height. Pearson Chi-Square test was used to test for difference in gender between the two groups. Within group differences were tabulated and plotted to observe for change over time and enable comparison with previously published data. A two-way (Time × Treatment Group) mixed analysis of variance (ANOVA) was used to identify differences in VISA-A scores between treatment conditions. The Greenhouse-Geisser correction was used for epsilon < 0.75, while the Huynh-Feldt correction was used adopted for less severe asphericity. When significant F values were found, Bonferroni corrected P-values were used to determine the location of the variance. Independent t-tests were used to compare changes (preinjection to post-injection) in reported VAS pain and VAS symptoms between the treatment groups. Effect sizes (differences in change scores/pooled baseline [pre-injection] SD) were also used to convey the magnitude of observed differences, and were interpreted with the following scale: <0.2 trivial; 0.2 to 0.6 small; 0.6 to 1.2 moderate; and >1.2 large [ ADDIN EN.CITE <EndNote><Cite><Author>Hopkins</Author><Year>2009</Year><RecNum>21</RecNum><IDText>Progressive statistics for studies in sports medicine and exercise science</IDText><DisplayText><style face="superscript">27</style></DisplayText><record><rec-number>21</rec-number><foreign-keys><key app="EN" db-id="5rrae5fax9wrr8eee28pw0pje5zeepfa2tef">21</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Hopkins, W. G.</author><author>Marshall, S. W.</author><author>Batterham, A. M.</author><author>Hanin, J.</author></authors></contributors><titles><title>Progressive statistics for studies in sports medicine and exercise science</title><secondary-title>Med Sci Sports Exerc</secondary-title></titles><periodical><full-title>Med Sci Sports Exerc</full-title></periodical><pages>3-13</pages><volume>41</volume><number>1</number><keywords><keyword>Biomedical Research</keyword><keyword>Data Interpretation, Statistical</keyword><keyword>Exercise</keyword><keyword>Humans</keyword><keyword>Research Design</keyword><keyword>Sample Size</keyword><keyword>Sports Medicine</keyword></keywords><dates><year>2009</year><pub-dates><date>Jan</date></pub-dates></dates><isbn>1530-0315</isbn><accession-num>19092709</accession-num><urls><related-urls><url>].ResultsThere were no significant differences between groups at baseline in age, gender, duration of symptoms, height, weight, duration of weekly sporting activity and pre-injection VISA-A scores (Table 1). No patients were lost to follow up at 10 weeks. 3 patients failed to complete the 12-month follow up questionnaire (2 steroid, 1 non-steroid). The two-way mixed ANOVA showed a significant effect of Time (p<0.001), but no significant effect for Treatment Group (p=0.53) or for the interactive effect of Time × Treatment Group (p=0.07). Effect sizes (ES) for the differences in change scores between treatment groups were all trivial (<0.20), except for the 10-weeks post-injection time point, which displayed a moderate (ES=-0.87) effect size in favour of the non-steroid group (Figure 2). Individual patient data are shown in Table 2. Table 1 about hereFigure 2 about hereTable 2 about hereVISA-APatients showed significant improvements from pre-injection to all follow ups in VISA-A scores in both the steroid and non-steroid groups. VASThere was no statistically significant difference in the VAS changes for pain (p=0.42) or symptoms (p=0.23) between the two treatment groups. Effect sizes for the difference in change scores between treatment groups were small (ES=-0.36) and large (ES=-0.59) for pain and symptoms, respectively, with both suggesting a larger improvement in the non-steroid group in comparison to the steroid group (Figure 3). Figure 3 about here In the steroid cohort, the pre-injection VAS scores improved by 40.8mm for pain (p=0.01), and 31.7mm (p=0.05) for symptoms post injection. An improvement of 49.7mm for pain (p<0.01), and 46.3mm for symptoms (p<0.01) was seen in the non-steroid cohort. DiscussionThis prospective pilot study showed encouraging short-term outcomes in patients with chronic Achilles tendinopathy receiving a high-volume injection of normal saline with anaesthetic, with similar impressive results after treatment to patients receiving a high-volume injection with the traditional steroid component. HVIGI&SR both with and without steroid improved self-reported pain, function and resulted in a return to sporting participation in the majority of patients. This is similar to the recent findings by Boesen et al [ ADDIN EN.CITE <EndNote><Cite><Author>Boesen</Author><Year>2017</Year><RecNum>11681</RecNum><DisplayText><style face="superscript">17</style></DisplayText><record><rec-number>11681</rec-number><foreign-keys><key app="EN" db-id="2sae5daa2dxdd3exw9qxzd9200w0afta0vw9" timestamp="1498397160">11681</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Boesen, Anders</author><author>Hansen, Rudi</author><author>Boesen, Morten</author><author>Malliaras, Peter</author><author>Langberg, Henning</author></authors></contributors><titles><title>Effect of High-Volume Injection, Platelet-Rich Plasma Plasma, and Sham Treatment in Chronic Midportion Achilles Tendinopathy: A Randomized Double-Blinded Prospective Study</title><secondary-title>American Journal of Sports Medicine</secondary-title></titles><periodical><full-title>American Journal of Sports Medicine</full-title></periodical><edition>22nd May 2017</edition><dates><year>2017</year></dates><urls></urls><electronic-resource-num>10.1177/0363546517702862</electronic-resource-num></record></Cite></EndNote>17]. Short-term post injection soreness was reported by a patient in the non-steroid group; Resteghini et al. also reported this side effect in patients receiving a HVIGI&SR with steroid [ ADDIN EN.CITE <EndNote><Cite><Author>Resteghini P</Author><Year>2012</Year><RecNum>14</RecNum><IDText>High Volume Injection in the management of recalcitrant mid-portion Achilles Tendinopathy: A prospective case series assessing the influence of neovascularity and outcome</IDText><DisplayText><style face="superscript">14</style></DisplayText><record><rec-number>14</rec-number><foreign-keys><key app="EN" db-id="5rrae5fax9wrr8eee28pw0pje5zeepfa2tef">14</key></foreign-keys><ref-type name="Generic">13</ref-type><contributors><authors><author>Resteghini P, Yeoh J</author></authors></contributors><titles><title>High Volume Injection in the management of recalcitrant mid-portion Achilles Tendinopathy: A prospective case series assessing the influence of neovascularity and outcome</title></titles><dates><year>2012</year></dates><pub-location>International Musculoskeletal Medicine</pub-location><urls></urls></record></Cite></EndNote>14]. There was no significant difference between groups at any time stage although the effects of the injection without steroid were more marked at 10 weeks. Injections for Achilles tendinopathy have become commonplace within the Sports Medicine fields, with numerous substances used by clinicians. Research on the use of Platelet Rich Plasma, ADDIN EN.CITE <EndNote><Cite><Author>de Jonge</Author><Year>2011</Year><RecNum>20</RecNum><IDText>One-Year Follow-up of Platelet-Rich Plasma Treatment in Chronic Achilles Tendinopathy A Double-Blind Randomized Placebo-Controlled Trial</IDText><DisplayText><style face="superscript">26</style></DisplayText><record><rec-number>20</rec-number><foreign-keys><key app="EN" db-id="5rrae5fax9wrr8eee28pw0pje5zeepfa2tef">20</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>de Jonge, Suzan</author><author>de Vos, Robert J.</author><author>Weir, Adam</author><author>van Schie, Hans T. M.</author><author>Bierma-Zeinstra, Sita M. A.</author><author>Verhaar, Jan A. N.</author><author>Weinans, Harrie</author><author>Tol, Johannes L.</author></authors></contributors><titles><title>One-Year Follow-up of Platelet-Rich Plasma Treatment in Chronic Achilles Tendinopathy A Double-Blind Randomized Placebo-Controlled Trial</title><secondary-title>American Journal of Sports Medicine</secondary-title></titles><periodical><full-title>American Journal of Sports Medicine</full-title></periodical><volume>39</volume><number>8</number><dates><year>2011</year><pub-dates><date>Aug</date></pub-dates></dates><isbn>0363-5465</isbn><accession-num>WOS:000293387400003</accession-num><urls><related-urls><url>&lt;Go to ISI&gt;://WOS:000293387400003</url></related-urls></urls><electronic-resource-num>10.1177/0363546511404877</electronic-resource-num></record></Cite></EndNote> sclerosing injections, corticosteroid and Aprotinin have shown less than promising long-term results [ ADDIN EN.CITE <EndNote><Cite><Author>Brown</Author><Year>2006</Year><RecNum>3839</RecNum><IDText>Aprotinin in the management of Achilles tendinopathy: a randomised controlled trial</IDText><DisplayText><style face="superscript">18</style></DisplayText><record><rec-number>3839</rec-number><foreign-keys><key app="EN" db-id="2sae5daa2dxdd3exw9qxzd9200w0afta0vw9" timestamp="1489855907">3839</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Brown, R.</author><author>Orchard, J.</author><author>Kinchington, M.</author><author>Hooper, A.</author><author>Nalder, G.</author></authors></contributors><titles><title>Aprotinin in the management of Achilles tendinopathy: a randomised controlled trial</title><secondary-title>British Journal of Sports Medicine</secondary-title></titles><periodical><full-title>British Journal of Sports Medicine</full-title></periodical><pages>275-279</pages><volume>40</volume><number>3</number><dates><year>2006</year><pub-dates><date>Mar</date></pub-dates></dates><isbn>0306-3674</isbn><accession-num>WOS:000235619900019</accession-num><urls><related-urls><url>&lt;Go to ISI&gt;://WOS:000235619900019</url></related-urls></urls><electronic-resource-num>10.1136/bjsm.2005.021931</electronic-resource-num></record></Cite></EndNote>18,26,28,29]. A number of studies examining high volume injections as an alternative to other injection treatments for Achilles tendinopathy have shown improvements in both sonographic and clinical outcomes [PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5DaGFuPC9BdXRob3I+PFllYXI+MjAwODwvWWVhcj48UmVj

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ADDIN EN.CITE.DATA 12,13]. The possibility of removing the steroid from the injectates has been postulated for some time, with patients declining corticosteroid administration providing a unique control group in which to compare the effects of each technique. A single case series has been performed demonstrating positive outcomes for a HVIGI&SR without steroid or aprotinin [ ADDIN EN.CITE <EndNote><Cite><Author>Wheeler</Author><Year>2014</Year><RecNum>27</RecNum><IDText>The use of high volume image guided injections (HVIGI) for Achilles Tendinopathy - A case series and pilot study</IDText><DisplayText><style face="superscript">16</style></DisplayText><record><rec-number>27</rec-number><foreign-keys><key app="EN" db-id="5rrae5fax9wrr8eee28pw0pje5zeepfa2tef">27</key></foreign-keys><ref-type name="Generic">13</ref-type><contributors><authors><author>Wheeler, PC.;</author></authors></contributors><titles><title>The use of high volume image guided injections (HVIGI) for Achilles Tendinopathy - A case series and pilot study</title></titles><pages>96-103</pages><volume>36</volume><number>3</number><dates><year>2014</year></dates><pub-location>International Musculoskeletal Medicine</pub-location><urls></urls></record></Cite></EndNote>16]. This was the first to directly compare outcomes with a group of patients receiving a HVIGI with steroid. The results suggest that the injection effect is the local mechanical effect of the high volume of fluid with the drug effects being negligible. However, we cannot yet judge the extent of the role of the local anaesthetic in the therapeutic effect of the injections. The strengths of this study were the presence of two treatment groups, the prospective nature of the study, the use of an independent assessor of outcome blinded to the radiographic assessment and use of steroid, the use of a validated outcome measure (VISA-A questionnaire), the presence of multiple follow ups including a long-term measure, a structured rehabilitation programme and a single radiologist assessing and injecting all patients. The main weakness is that patients were allowed to choose their treatment, although within the health service patient choice is deemed exceptionally important. Expectation theory suggests that ‘people make decisions among alternate plans of behaviour based on their perceptions of the degree to which a given behaviour will lead to desired outcomes’ [ ADDIN EN.CITE <EndNote><Cite><Author>Mathibe</Author><Year>2008</Year><RecNum>28</RecNum><IDText>Expectancy Theory and its implications for employee motivation</IDText><DisplayText><style face="superscript">30</style></DisplayText><record><rec-number>28</rec-number><foreign-keys><key app="EN" db-id="5rrae5fax9wrr8eee28pw0pje5zeepfa2tef">28</key></foreign-keys><ref-type name="Generic">13</ref-type><contributors><authors><author>Mathibe, I.R.;</author></authors></contributors><titles><title>Expectancy Theory and its implications for employee motivation</title></titles><volume>6</volume><number>3</number><dates><year>2008</year></dates><pub-location>Academic Leadership Journal</pub-location><urls></urls></record></Cite></EndNote>30]. The idea behind this theory is that an individual will be inclined to believe their decision will lead to the desired outcome [ ADDIN EN.CITE <EndNote><Cite><Author>Redmond</Author><Year>2010</Year><RecNum>29</RecNum><IDText>Lesson 4: Expectancy Theory: Is there a link between my effort and what I want?</IDText><DisplayText><style face="superscript">31</style></DisplayText><record><rec-number>29</rec-number><foreign-keys><key app="EN" db-id="5rrae5fax9wrr8eee28pw0pje5zeepfa2tef">29</key></foreign-keys><ref-type name="Generic">13</ref-type><contributors><authors><author>Redmond, B.;</author></authors></contributors><titles><title>Lesson 4: Expectancy Theory: Is there a link between my effort and what I want?</title></titles><dates><year>2010</year></dates><pub-location>The Pennsylvania State University Website</pub-location><urls></urls></record></Cite></EndNote>31]. In this study, the most common desired outcome was to reduce pain and increase activity. The choice of steroid or non-steroid could determine the approach of the patient to the outcome, adherence to the structured loading programme, and could therefore lead to positive outcomes by different mechanisms than those induced by the injection and rehabilitation alone. The potential for clinician induced bias due to injection selection was controlled for by standardising the rhetoric to all patients in order to facilitate clinician and patient equipoise. However, as a pilot study this does demonstrate that further research is required and a randomised trial is now warranted to confirm the results. A limitation is that the study did not assess any imaging outcomes, limiting possible exploration of differential effects on tendon structure or neovascularity, and therefore the mode of action of the injection without steroid. While the length of final follow-up gives a long-term indication of the clinical outcome of the injection, the presence of an imaging follow-up assessing changes in neovascularisation and maximal tendon thickness would add to the validity and clinical applicability of the findings. All patients were recruited from the same centre, a private hospital. However, the location of the hospital in the multicultural and diverse district of East London adds to the applicability of the findings, as does the mixed nature of professional, recreational and non-sporting participants that are referred to the clinic. The positive improvements seen in this study are broadly in line with previous research conducted on HVIGI&SR (Figure 4) [PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5DaGFuPC9BdXRob3I+PFllYXI+MjAwODwvWWVhcj48UmVj

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ADDIN EN.CITE.DATA 12-16]. Whilst at the 2 week follow up the improvement seen in the VISA score is less than the numbers reported by Humphrey et al. and Chan et al., at the final follow up the mean change in VISA-A score seen in the non-steroid group is higher [12,15]. Resteghini et al. used the same HVIGI&SR procedure and found comparable results at 3 months while the one year follow up VISA-A is higher in each group of the current study compared to the study using aprotinin, no longer licensed for the purpose of HVIGI&SR [14]. The findings of a similar outcome between the two groups in this study suggest a HVIGI&SR without steroid could be the ideal treatment initially, as it can be considered as theoretically safer without the potential risks of the steroid component, more appropriate for competing athletes and marginally cheaper. Figure 4 about hereConclusionHVIGI&SR is likely an effective treatment in patients with Achilles tendinopathy struggling with conservative management options. This pilot prospective cohort study showed HVIGI&SR with just saline is just as effective in improving clinical outcome in patients with Achilles tendinopathy, and could be the better management option. The necessity of further research is highlighted, such as including imaging outcome measures, a larger sample size, actively seeking adverse event notifications, randomisation and blinding of participants, but the findings from this initial study encourage reconsideration of injection contents and increase understanding of the mechanisms underlying observed effects. Full scale clinical trials are warranted. References ADDIN EN.REFLIST 1. Sobhani S, Dekker R, Postema K, Dijkstra PU (2013) Epidemiology of ankle and foot overuse injuries in sports: A systematic review. Scand J Med Sci Sports 23: 669-686. 2. Longo UG, Rittweger J, Garau G, Radonic B, Gutwasser C, Gilliver SF, et al (2009) No influence of age, gender, weight, height, and impact profile in achilles tendinopathy in masters track and field athletes. Am J Sports Med 37: 1400-1405. . Knobloch K, Yoon U, Vogt PM (2008) Acute and overuse injuries correlated to hours of training in master running athletes. Foot Ankle Int 29: 671-676. . Sankey RA, Brooks JH, Kemp SP, Haddad FS (2008) The epidemiology of ankle injuries in professional rugby union players. Am J Sports Med 36: 2415-2424. . Walls RJ, Brennan SA, Hodnett P, O'Byrne JM, Eustace SJ, Stephens MM (2010) Overuse ankle injuries in professional Irish dancers. Foot Ankle Surg 16: 45-49. . de Jonge S, van den Berg C, de Vos RJ, van der Heide HJ, Weir A, Verhaar JA et al (2011) Incidence of midportion Achilles tendinopathy in the general population. Br J Sports Med 45: 1026-1028. . Papa JA (2012) Conservative management of Achilles Tendinopathy: a case report. J Can Chiropr Assoc 56: 216-224. . Zanetti M, Metzdorf A, Kundert HP, Zollinger H, Vienne P, Seifert B et al (2003) Achilles tendons: clinical relevance of neovascularization diagnosed with power Doppler US. Radiology 227: 556-560. . Rompe JD, Furia JP, Maffulli N (2008) Mid-portion Achilles tendinopathy--current options for treatment. Disabil Rehabil 30: 1666-1676. . Rowe V, Hemmings S, Barton C, Malliaras P, Maffulli N, Morrissey D (2012) Conservative management of midportion Achilles tendinopathy: a mixed methods study, integrating systematic review and clinical reasoning. Sports Med 42: 941-967. . Maffulli N (1999) Tendon Problems: A basic science primer J Sports Traumatol 21: 3-10.12. Chan O, O'Dowd D, Padhiar N, Morrisse D, King J, Jalan R et al (2008) High volume image guided injections in chronic Achilles tendinopathy. Disabil Rehabil 30: 1697-1708.13. Maffulli N, Spiezia F, Longo UG, Denaro V, Maffulli GD. High volume image guided injections for the management of chronic tendinopathy of the main body of the Achilles tendon. Physical Ther Sport 2013;14: 163-167. . Resteghini P, Yeoh J (2012) High Volume Injection in the management of recalcitrant mid-portion Achilles Tendinopathy: A prospective case series assessing the influence of neovascularity and outcome. International Musculoskeletal Medicine 34: 100-192.15. Humphrey J, Chan O, Crisp T, Padhiar N, Morrissey D, Twycross-Lewis R et al (2010) The short-term effects of high volume image guided injections in resistant non-insertional Achilles tendinopathy. J Sci Med Sport 13: 295-298. . Wheeler P (2014) The use of high volume image guided injections (HVIGI) for Achilles Tendinopathy - A case series and pilot study. International Musculoskeletal Medicine 96-103. . Boesen AP, Hansen R, Boesen MI, Malliaras P, Langberg H (2017) Effect of High-Volume Injection, Platelet-Rich Plasma Plasma, and Sham Treatment in Chronic Midportion Achilles Tendinopathy: A Randomized Double-Blinded Prospective Study. Am J Sports Med 45: 2034-2043. . Brown R, Orchard J, Kinchington M, Hooper A, Nalder G (2006) Aprotinin in the management of Achilles tendinopathy: a randomised controlled trial. Brit J Sports Med 40: 275-279. . Shrier I, Matheson GO, Kohl HW 3rd (1996) Achilles tendonitis: are corticosteroid injections useful or harmful? Clin J Sports Med 6: 245-250. . Coombes BK, Bisset L, Vicenzino B (2010) Efficacy and safety of corticosteroid injections and other injections for management of tendinopathy: a systematic review of randomised controlled trials. Lancet 376: 1751-1767. . Chan O MS, Pritchard M, Parkes T, Malliaras P, Crisp T, Padhiar N, et al (2017) Intratendinous tears of the Achilles tendon - a new pathology? Analysis of a large 4-year cohort. Muscles, ligaments and tendons journal 7: 53-61. . Webborn N, Morrissey D, Sarvananthan K, Chan O (2015) Tears of the Fascia Cruris at the Attachment to the Achilles Tendon. Br J Sports Med 49: 1398-1403. . Morton S, Chan O, Webborn N, Pritchard M, Morrissey D (2016) Tears of the fascia cruris demonstrate characteristic sonographic features: a case series analysis. Muscles Ligaments Tendons J 5: 299-304. . Ohberg L, Lorentzon R, Alfredson H (2001) Neovascularisation in Achilles tendons with painful tendinosis but not in normal tendons: an ultrasonographic investigation. Knee Surg Sports Traumatol Arthrosc 9: 233-238. . Robinson JM, Cook JL, Purdam C, Visentini PJ, Ross J, Maffulli N, et al (2001) The VISA-A questionnaire: a valid and reliable index of the clinical severity of Achilles tendinopathy. Br J Sports Med 35: 335-41. . de Jonge S, de Vos RJ, Weir A, van Schie HT, Bierma-Zeinstra SM, Verhaar JA, et al (2011) One-Year Follow-up of Platelet-Rich Plasma Treatment in Chronic Achilles Tendinopathy A Double-Blind Randomized Placebo-Controlled Trial. Am J Sports Med 39: 1623-1629. . Hopkins WG, Marshall SW, Batterham AM, Hanin J (2009) Progressive statistics for studies in sports medicine and exercise science. Med Sci Sports Exerc 41: 3-13. . van Sterkenburg MN, de Jonge MC, Sierevelt IN, van Dijk CN (2010) Less promising results with sclerosing ethoxysclerol injections for midportion achilles tendinopathy: a retrospective study. Am J Sports Med 38: 2226-2232. . DaCruz DJ, Geeson M, Allen MJ, Phair I (1988) Achilles paratendonitis: an evaluation of steroid injection. Br J Sports Med 22: 64-5. . Mathibe IR (2008) Expectancy Theory and its implications for employee motivation. Academic Leadership Journal 6 . Redmond B (2010) Lesson 4: Expectancy Theory: Is there a link between my effort and what I want? The Pennsylvania State University Website. Available at: . Accessed 5th May 2017. Table LegendsTable 1: Baseline characteristics of patients included in studyTable 2: Responses regarding return to sport, compliance, injection satisfaction and complications. Figure LegendsFigure 1: Transverse plane sonogram of an Achilles tendon under ultrasound. Medial approach of needle. Stripping of the paratenon from the surrounding soft tissues, at the anterior aspect of the Achilles tendon. Figure 2: Graph showing changes in VISA-A scores over time. Error bars represent 95% confidence intervals. Data labels display standardised effect sizes for differences in change scores versus pre-injection.Figure 3: Changes in VAS reported pain and symptoms between pre- and post-injection. Error bars represent 95% confidence intervals. Data labels display standardised effect sizes for differences in change scores versus pre-injection. Figure 4: Summary graph showing mean pre- and post-injection VISA-A scores from data in this study in comparison to other published data ................
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