Effectiveness of a high volume injection as treatment for chronic Achilles tendinopathy: randomised controlled trial
AbstractObjectiveTo study whether a high volume injection without corticosteroids improves clinical outcome in addition to usual care for adults with chronic midportion Achilles tendinopathy.DesignPatient and assessor blinded, placebo controlled randomised clinical trial.SettingSports medicine depar...
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description | AbstractObjectiveTo study whether a high volume injection without corticosteroids improves clinical outcome in addition to usual care for adults with chronic midportion Achilles tendinopathy.DesignPatient and assessor blinded, placebo controlled randomised clinical trial.SettingSports medicine department of a large district general hospital, the Netherlands.Participants80 adults (aged 18-70 years) with clinically diagnosed chronic midportion Achilles tendinopathy and neovascularisation on ultrasonography. 39 were randomised to a high volume injection without corticosteroids and 41 to placebo.InterventionsParticipants were instructed to perform an exercise programme for 24 weeks (usual care) combined with one 50 mL high volume injection of saline and lidocaine (intervention group) or one 2 mL placebo injection of saline and lidocaine (placebo group) at baseline.Main outcome measuresPrimary outcome was pain and function assessed using the validated Victorian Institute of Sports Assessment-Achilles (VISA-A) questionnaire at 24 weeks (analysed using a generalised estimation equations model). Secondary outcomes were patient satisfaction, return to sport, degree of ultrasonographic Doppler flow, visual analogue scale on 10 hop test, power and flexibility of the gastrocnemius and soleus muscles, pain detect questionnaire for neuropathic pain, and pain coping inventory. Participants were evaluated at baseline and at 2, 6, 12, and 24 weeks.ResultsOnly one participant (1%) was lost to follow-up. The estimated mean VISA-A score improved significantly, from 40.4 (95% confidence interval 32.0 to 48.7) at baseline to 59.1 (50.4 to 67.8) at 24 weeks in the high volume injection group and from 36.9 (27.1 to 46.8) to 58.5 (47.9 to 69.1) in the placebo group. The VISA-A score over time did not differ between the groups (adjusted between group difference at 24 weeks 0.5 points, 95% confidence interval −17.8 to 18.8). No significant between group differences were found for patient satisfaction (21/37 (57%) v 19/39 (49%) patients, P=0.50) and return to desired sport (15/29 (52%) v 19/31 (61%) patients active in sports, P=0.65) at 24 weeks. None of the other secondary outcomes differed between the two groups.ConclusionsA high volume injection without corticosteroids in addition to usual care is not effective for symptom reduction in patients with chronic midportion Achilles tendinopathy. On the basis of our findings, we cannot recommend the use of a high volume injection in thi |
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fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_7479639</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2441188255</sourcerecordid><originalsourceid>FETCH-LOGICAL-b462t-dd265a914755b597cab68f223332fe0d5890c231a1e97dbde3a1304a000de8bc3</originalsourceid><addsrcrecordid>eNp9kUtLJDEUhYMoKurCPyABdTGL1jwq9XAhiDgqCG50HVLJLStNVdIm6Qb_velp7VEEVzdwvpx7LgehQ0rOKOXleTtOz0ZOWLWBdmklygmtOd_88t5BBzFOCSGMV3VTim20wzmnQtTlLko3XQc62QU4iBH7Divc25ceL_wwHwFbN13K3mEVcQqg0ggu4c4HrPvgndX4Svd2GCDL4Ix1fqZS_3aBg3LGjzaCwdq7FHxmTLawathHW50aIhx8zD30_Pfm6fpu8vB4e3999TBpi5KliTGsFKqhRSVEK5pKq7asO8ZyetYBMaJuiGacKgpNZVoDXFFOCpVPNVC3mu-hy5XvbN6OYHROHtQgZ8GOKrxJr6z8rjjbyxe_kFVRNSVvssHxh0Hwr3OISU79PLicWbKioLSumRCZ-rOidPAxBujWGyiRy45k7kj-6yizR18jrcnPRjJwsgKWf37zOf2PrUP95N4BeIunrA</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2441188255</pqid></control><display><type>article</type><title>Effectiveness of a high volume injection as treatment for chronic Achilles tendinopathy: randomised controlled trial</title><source>MEDLINE</source><source>Jstor Complete Legacy</source><creator>van der Vlist, Arco C ; van Oosterom, Robert F ; van Veldhoven, Peter L J ; Bierma-Zeinstra, Sita M A ; Waarsing, Jan H ; Verhaar, Jan A N ; de Vos, Robert-Jan</creator><creatorcontrib>van der Vlist, Arco C ; van Oosterom, Robert F ; van Veldhoven, Peter L J ; Bierma-Zeinstra, Sita M A ; Waarsing, Jan H ; Verhaar, Jan A N ; de Vos, Robert-Jan</creatorcontrib><description>AbstractObjectiveTo study whether a high volume injection without corticosteroids improves clinical outcome in addition to usual care for adults with chronic midportion Achilles tendinopathy.DesignPatient and assessor blinded, placebo controlled randomised clinical trial.SettingSports medicine department of a large district general hospital, the Netherlands.Participants80 adults (aged 18-70 years) with clinically diagnosed chronic midportion Achilles tendinopathy and neovascularisation on ultrasonography. 39 were randomised to a high volume injection without corticosteroids and 41 to placebo.InterventionsParticipants were instructed to perform an exercise programme for 24 weeks (usual care) combined with one 50 mL high volume injection of saline and lidocaine (intervention group) or one 2 mL placebo injection of saline and lidocaine (placebo group) at baseline.Main outcome measuresPrimary outcome was pain and function assessed using the validated Victorian Institute of Sports Assessment-Achilles (VISA-A) questionnaire at 24 weeks (analysed using a generalised estimation equations model). Secondary outcomes were patient satisfaction, return to sport, degree of ultrasonographic Doppler flow, visual analogue scale on 10 hop test, power and flexibility of the gastrocnemius and soleus muscles, pain detect questionnaire for neuropathic pain, and pain coping inventory. Participants were evaluated at baseline and at 2, 6, 12, and 24 weeks.ResultsOnly one participant (1%) was lost to follow-up. The estimated mean VISA-A score improved significantly, from 40.4 (95% confidence interval 32.0 to 48.7) at baseline to 59.1 (50.4 to 67.8) at 24 weeks in the high volume injection group and from 36.9 (27.1 to 46.8) to 58.5 (47.9 to 69.1) in the placebo group. The VISA-A score over time did not differ between the groups (adjusted between group difference at 24 weeks 0.5 points, 95% confidence interval −17.8 to 18.8). No significant between group differences were found for patient satisfaction (21/37 (57%) v 19/39 (49%) patients, P=0.50) and return to desired sport (15/29 (52%) v 19/31 (61%) patients active in sports, P=0.65) at 24 weeks. None of the other secondary outcomes differed between the two groups.ConclusionsA high volume injection without corticosteroids in addition to usual care is not effective for symptom reduction in patients with chronic midportion Achilles tendinopathy. On the basis of our findings, we cannot recommend the use of a high volume injection in this patient group.Trial registrationClinicalTrials.gov NCT02996409</description><identifier>ISSN: 1756-1833</identifier><identifier>ISSN: 0959-8138</identifier><identifier>EISSN: 1756-1833</identifier><identifier>DOI: 10.1136/bmj.m3027</identifier><identifier>PMID: 33315586</identifier><language>eng</language><publisher>England: British Medical Journal Publishing Group</publisher><subject>Achilles Tendon ; Adolescent ; Adult ; Aged ; Anesthetics, Local - administration & dosage ; Anesthetics, Local - therapeutic use ; Ankle ; Chronic Disease ; Clinical trials ; Combined Modality Therapy ; Corticosteroids ; Doppler effect ; Dose-Response Relationship, Drug ; Double-Blind Method ; Drug Therapy, Combination ; Exercise Therapy ; Female ; Follow-Up Studies ; Humans ; Injection ; Injections ; Lidocaine ; Lidocaine - administration & dosage ; Lidocaine - therapeutic use ; Male ; Medical referrals ; Medical research ; Middle Aged ; Muscles ; Neuralgia ; Pain ; Patient satisfaction ; Patients ; Questionnaires ; Saline Solution - administration & dosage ; Saline Solution - therapeutic use ; Sports medicine ; Tendinopathy - diagnosis ; Tendinopathy - drug therapy ; Tendinopathy - therapy ; Tendons ; Treatment Outcome ; Ultrasonic imaging ; Young Adult</subject><ispartof>BMJ (Online), 2020-09, Vol.370, p.m3027</ispartof><rights>Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.</rights><rights>Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.</rights><rights>2020 Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. BMJ http://creativecommons.org/licenses/by-nc/4.0/ This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ . Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. 2020 BMJ</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-b462t-dd265a914755b597cab68f223332fe0d5890c231a1e97dbde3a1304a000de8bc3</citedby><cites>FETCH-LOGICAL-b462t-dd265a914755b597cab68f223332fe0d5890c231a1e97dbde3a1304a000de8bc3</cites><orcidid>0000-0003-4238-3540 ; 0000-0003-0372-0188</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,776,780,881,27903,27904</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33315586$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>van der Vlist, Arco C</creatorcontrib><creatorcontrib>van Oosterom, Robert F</creatorcontrib><creatorcontrib>van Veldhoven, Peter L J</creatorcontrib><creatorcontrib>Bierma-Zeinstra, Sita M A</creatorcontrib><creatorcontrib>Waarsing, Jan H</creatorcontrib><creatorcontrib>Verhaar, Jan A N</creatorcontrib><creatorcontrib>de Vos, Robert-Jan</creatorcontrib><title>Effectiveness of a high volume injection as treatment for chronic Achilles tendinopathy: randomised controlled trial</title><title>BMJ (Online)</title><addtitle>BMJ</addtitle><addtitle>BMJ</addtitle><description>AbstractObjectiveTo study whether a high volume injection without corticosteroids improves clinical outcome in addition to usual care for adults with chronic midportion Achilles tendinopathy.DesignPatient and assessor blinded, placebo controlled randomised clinical trial.SettingSports medicine department of a large district general hospital, the Netherlands.Participants80 adults (aged 18-70 years) with clinically diagnosed chronic midportion Achilles tendinopathy and neovascularisation on ultrasonography. 39 were randomised to a high volume injection without corticosteroids and 41 to placebo.InterventionsParticipants were instructed to perform an exercise programme for 24 weeks (usual care) combined with one 50 mL high volume injection of saline and lidocaine (intervention group) or one 2 mL placebo injection of saline and lidocaine (placebo group) at baseline.Main outcome measuresPrimary outcome was pain and function assessed using the validated Victorian Institute of Sports Assessment-Achilles (VISA-A) questionnaire at 24 weeks (analysed using a generalised estimation equations model). Secondary outcomes were patient satisfaction, return to sport, degree of ultrasonographic Doppler flow, visual analogue scale on 10 hop test, power and flexibility of the gastrocnemius and soleus muscles, pain detect questionnaire for neuropathic pain, and pain coping inventory. Participants were evaluated at baseline and at 2, 6, 12, and 24 weeks.ResultsOnly one participant (1%) was lost to follow-up. The estimated mean VISA-A score improved significantly, from 40.4 (95% confidence interval 32.0 to 48.7) at baseline to 59.1 (50.4 to 67.8) at 24 weeks in the high volume injection group and from 36.9 (27.1 to 46.8) to 58.5 (47.9 to 69.1) in the placebo group. The VISA-A score over time did not differ between the groups (adjusted between group difference at 24 weeks 0.5 points, 95% confidence interval −17.8 to 18.8). No significant between group differences were found for patient satisfaction (21/37 (57%) v 19/39 (49%) patients, P=0.50) and return to desired sport (15/29 (52%) v 19/31 (61%) patients active in sports, P=0.65) at 24 weeks. None of the other secondary outcomes differed between the two groups.ConclusionsA high volume injection without corticosteroids in addition to usual care is not effective for symptom reduction in patients with chronic midportion Achilles tendinopathy. On the basis of our findings, we cannot recommend the use of a high volume injection in this patient group.Trial registrationClinicalTrials.gov NCT02996409</description><subject>Achilles Tendon</subject><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Anesthetics, Local - administration & dosage</subject><subject>Anesthetics, Local - therapeutic use</subject><subject>Ankle</subject><subject>Chronic Disease</subject><subject>Clinical trials</subject><subject>Combined Modality Therapy</subject><subject>Corticosteroids</subject><subject>Doppler effect</subject><subject>Dose-Response Relationship, Drug</subject><subject>Double-Blind Method</subject><subject>Drug Therapy, Combination</subject><subject>Exercise Therapy</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Humans</subject><subject>Injection</subject><subject>Injections</subject><subject>Lidocaine</subject><subject>Lidocaine - administration & dosage</subject><subject>Lidocaine - therapeutic use</subject><subject>Male</subject><subject>Medical referrals</subject><subject>Medical research</subject><subject>Middle Aged</subject><subject>Muscles</subject><subject>Neuralgia</subject><subject>Pain</subject><subject>Patient satisfaction</subject><subject>Patients</subject><subject>Questionnaires</subject><subject>Saline Solution - administration & dosage</subject><subject>Saline Solution - therapeutic use</subject><subject>Sports medicine</subject><subject>Tendinopathy - diagnosis</subject><subject>Tendinopathy - drug therapy</subject><subject>Tendinopathy - therapy</subject><subject>Tendons</subject><subject>Treatment Outcome</subject><subject>Ultrasonic imaging</subject><subject>Young 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der Vlist, Arco C</creator><creator>van Oosterom, Robert F</creator><creator>van Veldhoven, Peter L J</creator><creator>Bierma-Zeinstra, Sita M A</creator><creator>Waarsing, Jan H</creator><creator>Verhaar, Jan A N</creator><creator>de Vos, Robert-Jan</creator><general>British Medical Journal Publishing Group</general><general>BMJ Publishing Group LTD</general><general>BMJ Publishing Group 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of a high volume injection as treatment for chronic Achilles tendinopathy: randomised controlled trial</title><author>van der Vlist, Arco C ; van Oosterom, Robert F ; van Veldhoven, Peter L J ; Bierma-Zeinstra, Sita M A ; Waarsing, Jan H ; Verhaar, Jan A N ; de Vos, Robert-Jan</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-b462t-dd265a914755b597cab68f223332fe0d5890c231a1e97dbde3a1304a000de8bc3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Achilles Tendon</topic><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Anesthetics, Local - administration & dosage</topic><topic>Anesthetics, Local - therapeutic use</topic><topic>Ankle</topic><topic>Chronic Disease</topic><topic>Clinical trials</topic><topic>Combined Modality Therapy</topic><topic>Corticosteroids</topic><topic>Doppler effect</topic><topic>Dose-Response Relationship, Drug</topic><topic>Double-Blind Method</topic><topic>Drug Therapy, Combination</topic><topic>Exercise Therapy</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Humans</topic><topic>Injection</topic><topic>Injections</topic><topic>Lidocaine</topic><topic>Lidocaine - administration & dosage</topic><topic>Lidocaine - therapeutic use</topic><topic>Male</topic><topic>Medical referrals</topic><topic>Medical research</topic><topic>Middle Aged</topic><topic>Muscles</topic><topic>Neuralgia</topic><topic>Pain</topic><topic>Patient satisfaction</topic><topic>Patients</topic><topic>Questionnaires</topic><topic>Saline Solution - administration & dosage</topic><topic>Saline Solution - therapeutic use</topic><topic>Sports medicine</topic><topic>Tendinopathy - diagnosis</topic><topic>Tendinopathy - drug therapy</topic><topic>Tendinopathy - therapy</topic><topic>Tendons</topic><topic>Treatment Outcome</topic><topic>Ultrasonic imaging</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>van der Vlist, Arco C</creatorcontrib><creatorcontrib>van Oosterom, Robert F</creatorcontrib><creatorcontrib>van Veldhoven, Peter L J</creatorcontrib><creatorcontrib>Bierma-Zeinstra, Sita M A</creatorcontrib><creatorcontrib>Waarsing, Jan H</creatorcontrib><creatorcontrib>Verhaar, Jan A N</creatorcontrib><creatorcontrib>de Vos, Robert-Jan</creatorcontrib><collection>BMJ Open Access Journals</collection><collection>BMJ Journals:Open Access</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 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Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest Central Basic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>BMJ (Online)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>van der Vlist, Arco C</au><au>van Oosterom, Robert F</au><au>van Veldhoven, Peter L J</au><au>Bierma-Zeinstra, Sita M A</au><au>Waarsing, Jan H</au><au>Verhaar, Jan A N</au><au>de Vos, Robert-Jan</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Effectiveness of a high volume injection as treatment for chronic Achilles tendinopathy: randomised controlled trial</atitle><jtitle>BMJ (Online)</jtitle><stitle>BMJ</stitle><addtitle>BMJ</addtitle><date>2020-09-09</date><risdate>2020</risdate><volume>370</volume><spage>m3027</spage><pages>m3027-</pages><issn>1756-1833</issn><issn>0959-8138</issn><eissn>1756-1833</eissn><abstract>AbstractObjectiveTo study whether a high volume injection without corticosteroids improves clinical outcome in addition to usual care for adults with chronic midportion Achilles tendinopathy.DesignPatient and assessor blinded, placebo controlled randomised clinical trial.SettingSports medicine department of a large district general hospital, the Netherlands.Participants80 adults (aged 18-70 years) with clinically diagnosed chronic midportion Achilles tendinopathy and neovascularisation on ultrasonography. 39 were randomised to a high volume injection without corticosteroids and 41 to placebo.InterventionsParticipants were instructed to perform an exercise programme for 24 weeks (usual care) combined with one 50 mL high volume injection of saline and lidocaine (intervention group) or one 2 mL placebo injection of saline and lidocaine (placebo group) at baseline.Main outcome measuresPrimary outcome was pain and function assessed using the validated Victorian Institute of Sports Assessment-Achilles (VISA-A) questionnaire at 24 weeks (analysed using a generalised estimation equations model). Secondary outcomes were patient satisfaction, return to sport, degree of ultrasonographic Doppler flow, visual analogue scale on 10 hop test, power and flexibility of the gastrocnemius and soleus muscles, pain detect questionnaire for neuropathic pain, and pain coping inventory. Participants were evaluated at baseline and at 2, 6, 12, and 24 weeks.ResultsOnly one participant (1%) was lost to follow-up. The estimated mean VISA-A score improved significantly, from 40.4 (95% confidence interval 32.0 to 48.7) at baseline to 59.1 (50.4 to 67.8) at 24 weeks in the high volume injection group and from 36.9 (27.1 to 46.8) to 58.5 (47.9 to 69.1) in the placebo group. The VISA-A score over time did not differ between the groups (adjusted between group difference at 24 weeks 0.5 points, 95% confidence interval −17.8 to 18.8). No significant between group differences were found for patient satisfaction (21/37 (57%) v 19/39 (49%) patients, P=0.50) and return to desired sport (15/29 (52%) v 19/31 (61%) patients active in sports, P=0.65) at 24 weeks. None of the other secondary outcomes differed between the two groups.ConclusionsA high volume injection without corticosteroids in addition to usual care is not effective for symptom reduction in patients with chronic midportion Achilles tendinopathy. On the basis of our findings, we cannot recommend the use of a high volume injection in this patient group.Trial registrationClinicalTrials.gov NCT02996409</abstract><cop>England</cop><pub>British Medical Journal Publishing Group</pub><pmid>33315586</pmid><doi>10.1136/bmj.m3027</doi><orcidid>https://orcid.org/0000-0003-4238-3540</orcidid><orcidid>https://orcid.org/0000-0003-0372-0188</orcidid><oa>free_for_read</oa></addata></record> |
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subjects | Achilles Tendon Adolescent Adult Aged Anesthetics, Local - administration & dosage Anesthetics, Local - therapeutic use Ankle Chronic Disease Clinical trials Combined Modality Therapy Corticosteroids Doppler effect Dose-Response Relationship, Drug Double-Blind Method Drug Therapy, Combination Exercise Therapy Female Follow-Up Studies Humans Injection Injections Lidocaine Lidocaine - administration & dosage Lidocaine - therapeutic use Male Medical referrals Medical research Middle Aged Muscles Neuralgia Pain Patient satisfaction Patients Questionnaires Saline Solution - administration & dosage Saline Solution - therapeutic use Sports medicine Tendinopathy - diagnosis Tendinopathy - drug therapy Tendinopathy - therapy Tendons Treatment Outcome Ultrasonic imaging Young Adult |
title | Effectiveness of a high volume injection as treatment for chronic Achilles tendinopathy: randomised controlled trial |
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