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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Veröffentlicht in:BMJ (Online) 2020-09, Vol.370, p.m3027
Hauptverfasser: 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
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container_start_page m3027
container_title BMJ (Online)
container_volume 370
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
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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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 &amp; 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 &amp; dosage ; Lidocaine - therapeutic use ; Male ; Medical referrals ; Medical research ; Middle Aged ; Muscles ; Neuralgia ; Pain ; Patient satisfaction ; Patients ; Questionnaires ; Saline Solution - administration &amp; 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/ . 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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 &amp; 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 &amp; 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 &amp; 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 Adult</subject><issn>1756-1833</issn><issn>0959-8138</issn><issn>1756-1833</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>9YT</sourceid><sourceid>ACMMV</sourceid><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNp9kUtLJDEUhYMoKurCPyABdTGL1jwq9XAhiDgqCG50HVLJLStNVdIm6Qb_velp7VEEVzdwvpx7LgehQ0rOKOXleTtOz0ZOWLWBdmklygmtOd_88t5BBzFOCSGMV3VTim20wzmnQtTlLko3XQc62QU4iBH7Divc25ceL_wwHwFbN13K3mEVcQqg0ggu4c4HrPvgndX4Svd2GCDL4Ix1fqZS_3aBg3LGjzaCwdq7FHxmTLawathHW50aIhx8zD30_Pfm6fpu8vB4e3999TBpi5KliTGsFKqhRSVEK5pKq7asO8ZyetYBMaJuiGacKgpNZVoDXFFOCpVPNVC3mu-hy5XvbN6OYHROHtQgZ8GOKrxJr6z8rjjbyxe_kFVRNSVvssHxh0Hwr3OISU79PLicWbKioLSumRCZ-rOidPAxBujWGyiRy45k7kj-6yizR18jrcnPRjJwsgKWf37zOf2PrUP95N4BeIunrA</recordid><startdate>20200909</startdate><enddate>20200909</enddate><creator>van 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 Ltd</general><scope>9YT</scope><scope>ACMMV</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>88I</scope><scope>8AF</scope><scope>8FE</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>ASE</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BHPHI</scope><scope>BTHHO</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FPQ</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>HCIFZ</scope><scope>K6X</scope><scope>K9.</scope><scope>KB0</scope><scope>LK8</scope><scope>M2O</scope><scope>M2P</scope><scope>M7P</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>Q9U</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0003-4238-3540</orcidid><orcidid>https://orcid.org/0000-0003-0372-0188</orcidid></search><sort><creationdate>20200909</creationdate><title>Effectiveness 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 &amp; 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 &amp; 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 &amp; 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 &amp; 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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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source MEDLINE; Jstor Complete Legacy
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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