Radial Extracorporeal Shock Wave Therapy is Safe and Effective in the Treatment of Chronic Recalcitrant Plantar Fasciitis: Results of a Confirmatory Randomized Placebo-Controlled Multicenter Study
Background Radial extracorporeal shock wave therapy is an effective treatment for chronic plantar fasciitis that can be administered to outpatients without anesthesia but has not yet been evaluated in controlled trials. Hypothesis There is no difference in effectiveness between radial extracorporeal...
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Veröffentlicht in: | The American journal of sports medicine 2008-11, Vol.36 (11), p.2100-2109 |
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creator | Gerdesmeyer, Ludger Frey, Carol Vester, Johannes Maier, Markus Lowell, Weil Weil, Lowell Russlies, Martin Stienstra, John Scurran, Barry Fedder, Keith Diehl, Peter Lohrer, Heinz Henne, Mark Gollwitzer, Hans |
description | Background
Radial extracorporeal shock wave therapy is an effective treatment for chronic plantar fasciitis that can be administered to outpatients without anesthesia but has not yet been evaluated in controlled trials.
Hypothesis
There is no difference in effectiveness between radial extracorporeal shock wave therapy and placebo in the treatment of chronic plantar fasciitis.
Study Design
Randomized, controlled trial; Level of evidence, 1.
Methods
Three interventions of radial extracorporeal shock wave therapy (0.16 mJ/mm2; 2000 impulses) compared with placebo were studied in 245 patients with chronic plantar fasciitis. Primary endpoints were changes in visual analog scale composite score from baseline to 12 weeks’ follow-up, overall success rates, and success rates of the single visual analog scale scores (heel pain at first steps in the morning, during daily activities, during standardized pressure force). Secondary endpoints were single changes in visual analog scale scores, success rates, Roles and Maudsley score, SF-36, and patients’ and investigators’ global judgment of effectiveness 12 weeks and 12 months after extracorporeal shock wave therapy.
Results
Radial extracorporeal shock wave therapy proved significantly superior to placebo with a reduction of the visual analog scale composite score of 72.1% compared with 44.7% (P = .0220), and an overall success rate of 61.0% compared with 42.2% in the placebo group (P = .0020) at 12 weeks. Superiority was even more pronounced at 12 months, and all secondary outcome measures supported radial extracorporeal shock wave therapy to be significantly superior to placebo (P < .025, 1-sided). No relevant side effects were observed.
Conclusion
Radial extracorporeal shock wave therapy significantly improves pain, function, and quality of life compared with placebo in patients with recalcitrant plantar fasciitis. |
doi_str_mv | 10.1177/0363546508324176 |
format | Article |
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Radial extracorporeal shock wave therapy is an effective treatment for chronic plantar fasciitis that can be administered to outpatients without anesthesia but has not yet been evaluated in controlled trials.
Hypothesis
There is no difference in effectiveness between radial extracorporeal shock wave therapy and placebo in the treatment of chronic plantar fasciitis.
Study Design
Randomized, controlled trial; Level of evidence, 1.
Methods
Three interventions of radial extracorporeal shock wave therapy (0.16 mJ/mm2; 2000 impulses) compared with placebo were studied in 245 patients with chronic plantar fasciitis. Primary endpoints were changes in visual analog scale composite score from baseline to 12 weeks’ follow-up, overall success rates, and success rates of the single visual analog scale scores (heel pain at first steps in the morning, during daily activities, during standardized pressure force). Secondary endpoints were single changes in visual analog scale scores, success rates, Roles and Maudsley score, SF-36, and patients’ and investigators’ global judgment of effectiveness 12 weeks and 12 months after extracorporeal shock wave therapy.
Results
Radial extracorporeal shock wave therapy proved significantly superior to placebo with a reduction of the visual analog scale composite score of 72.1% compared with 44.7% (P = .0220), and an overall success rate of 61.0% compared with 42.2% in the placebo group (P = .0020) at 12 weeks. Superiority was even more pronounced at 12 months, and all secondary outcome measures supported radial extracorporeal shock wave therapy to be significantly superior to placebo (P < .025, 1-sided). No relevant side effects were observed.
Conclusion
Radial extracorporeal shock wave therapy significantly improves pain, function, and quality of life compared with placebo in patients with recalcitrant plantar fasciitis.</description><identifier>ISSN: 0363-5465</identifier><identifier>EISSN: 1552-3365</identifier><identifier>DOI: 10.1177/0363546508324176</identifier><identifier>PMID: 18832341</identifier><identifier>CODEN: AJSMDO</identifier><language>eng</language><publisher>Los Angeles, CA: SAGE Publications</publisher><subject>Activities of Daily Living ; Adult ; Biological and medical sciences ; Diseases of the osteoarticular system ; Elbow ; Electroconvulsive therapy ; Fasciitis, Plantar - therapy ; Female ; Humans ; Lithotripsy ; Male ; Medical sciences ; Middle Aged ; Pain ; Quality of Life ; Sports medicine ; Success ; Treatment Outcome ; Ultrasonic imaging ; Ultrasonic Therapy - adverse effects ; Ultrasonic Therapy - methods</subject><ispartof>The American journal of sports medicine, 2008-11, Vol.36 (11), p.2100-2109</ispartof><rights>2008 American Orthopaedic Society for Sports Medicine</rights><rights>2009 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c409t-f194b70cce319375231aab931d0715ec17b99726d553ddb1475dd5848ee5bd293</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://journals.sagepub.com/doi/pdf/10.1177/0363546508324176$$EPDF$$P50$$Gsage$$H</linktopdf><linktohtml>$$Uhttps://journals.sagepub.com/doi/10.1177/0363546508324176$$EHTML$$P50$$Gsage$$H</linktohtml><link.rule.ids>314,776,780,21798,27901,27902,43597,43598</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=20869842$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/18832341$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Gerdesmeyer, Ludger</creatorcontrib><creatorcontrib>Frey, Carol</creatorcontrib><creatorcontrib>Vester, Johannes</creatorcontrib><creatorcontrib>Maier, Markus</creatorcontrib><creatorcontrib>Lowell, Weil</creatorcontrib><creatorcontrib>Weil, Lowell</creatorcontrib><creatorcontrib>Russlies, Martin</creatorcontrib><creatorcontrib>Stienstra, John</creatorcontrib><creatorcontrib>Scurran, Barry</creatorcontrib><creatorcontrib>Fedder, Keith</creatorcontrib><creatorcontrib>Diehl, Peter</creatorcontrib><creatorcontrib>Lohrer, Heinz</creatorcontrib><creatorcontrib>Henne, Mark</creatorcontrib><creatorcontrib>Gollwitzer, Hans</creatorcontrib><title>Radial Extracorporeal Shock Wave Therapy is Safe and Effective in the Treatment of Chronic Recalcitrant Plantar Fasciitis: Results of a Confirmatory Randomized Placebo-Controlled Multicenter Study</title><title>The American journal of sports medicine</title><addtitle>Am J Sports Med</addtitle><description>Background
Radial extracorporeal shock wave therapy is an effective treatment for chronic plantar fasciitis that can be administered to outpatients without anesthesia but has not yet been evaluated in controlled trials.
Hypothesis
There is no difference in effectiveness between radial extracorporeal shock wave therapy and placebo in the treatment of chronic plantar fasciitis.
Study Design
Randomized, controlled trial; Level of evidence, 1.
Methods
Three interventions of radial extracorporeal shock wave therapy (0.16 mJ/mm2; 2000 impulses) compared with placebo were studied in 245 patients with chronic plantar fasciitis. Primary endpoints were changes in visual analog scale composite score from baseline to 12 weeks’ follow-up, overall success rates, and success rates of the single visual analog scale scores (heel pain at first steps in the morning, during daily activities, during standardized pressure force). Secondary endpoints were single changes in visual analog scale scores, success rates, Roles and Maudsley score, SF-36, and patients’ and investigators’ global judgment of effectiveness 12 weeks and 12 months after extracorporeal shock wave therapy.
Results
Radial extracorporeal shock wave therapy proved significantly superior to placebo with a reduction of the visual analog scale composite score of 72.1% compared with 44.7% (P = .0220), and an overall success rate of 61.0% compared with 42.2% in the placebo group (P = .0020) at 12 weeks. Superiority was even more pronounced at 12 months, and all secondary outcome measures supported radial extracorporeal shock wave therapy to be significantly superior to placebo (P < .025, 1-sided). No relevant side effects were observed.
Conclusion
Radial extracorporeal shock wave therapy significantly improves pain, function, and quality of life compared with placebo in patients with recalcitrant plantar fasciitis.</description><subject>Activities of Daily Living</subject><subject>Adult</subject><subject>Biological and medical sciences</subject><subject>Diseases of the osteoarticular system</subject><subject>Elbow</subject><subject>Electroconvulsive therapy</subject><subject>Fasciitis, Plantar - therapy</subject><subject>Female</subject><subject>Humans</subject><subject>Lithotripsy</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Pain</subject><subject>Quality of Life</subject><subject>Sports medicine</subject><subject>Success</subject><subject>Treatment Outcome</subject><subject>Ultrasonic imaging</subject><subject>Ultrasonic Therapy - adverse effects</subject><subject>Ultrasonic Therapy - methods</subject><issn>0363-5465</issn><issn>1552-3365</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2008</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkV1rFDEUhoNY7LZ675UExHo1ms_J5FKWrQoFpa14OWSSM27q7GSbzJbuv_csu2gpqDcJOed5z0deQl5y9o5zY94zWUutas0aKRQ39RMy41qLSspaPyWzXbra5Y_JSSk3jDFkmmfkmDcokIrPyPbShegGurifsvMpr1MGfF4tk_9Jv7s7oNdLyG69pbHQK9cDdWOgi74HP0XMxpFOS4RQNa1gnGjq6XyZ0xg9vQTvBh-xMMa_Dni6TM9d8TFOsTwnR70bCrw43Kfk2_niev6puvjy8fP8w0XlFbNT1XOrOsO8B8mtNFpI7lxnJQ_McA2em85aI-qgtQyh48roEHSjGgDdBWHlKXm7r7vO6XYDZWpXsXgYcB5Im9IawxslBDNInv2TrK1RUtT6v6BgaIi2EsHXj8CbtMkjrttyyxqhlKh3fdme8jmVkqFv1zmuXN62nLU7n9vHPqPk1aHwpltB-CM4GIvAmwOA_-2GHj3wsfzmBGtqi2sjV-254n7Ag-n-1vgXxv26_g</recordid><startdate>20081101</startdate><enddate>20081101</enddate><creator>Gerdesmeyer, Ludger</creator><creator>Frey, Carol</creator><creator>Vester, Johannes</creator><creator>Maier, Markus</creator><creator>Lowell, Weil</creator><creator>Weil, Lowell</creator><creator>Russlies, Martin</creator><creator>Stienstra, John</creator><creator>Scurran, Barry</creator><creator>Fedder, Keith</creator><creator>Diehl, Peter</creator><creator>Lohrer, Heinz</creator><creator>Henne, Mark</creator><creator>Gollwitzer, Hans</creator><general>SAGE Publications</general><general>Sage Publications</general><general>Sage Publications Ltd</general><scope>IQODW</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>7TS</scope><scope>K9.</scope><scope>NAPCQ</scope><scope>U9A</scope><scope>7X8</scope></search><sort><creationdate>20081101</creationdate><title>Radial Extracorporeal Shock Wave Therapy is Safe and Effective in the Treatment of Chronic Recalcitrant Plantar Fasciitis</title><author>Gerdesmeyer, Ludger ; Frey, Carol ; Vester, Johannes ; Maier, Markus ; Lowell, Weil ; Weil, Lowell ; Russlies, Martin ; Stienstra, John ; Scurran, Barry ; Fedder, Keith ; Diehl, Peter ; Lohrer, Heinz ; Henne, Mark ; Gollwitzer, Hans</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c409t-f194b70cce319375231aab931d0715ec17b99726d553ddb1475dd5848ee5bd293</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2008</creationdate><topic>Activities of Daily Living</topic><topic>Adult</topic><topic>Biological and medical sciences</topic><topic>Diseases of the osteoarticular system</topic><topic>Elbow</topic><topic>Electroconvulsive therapy</topic><topic>Fasciitis, Plantar - therapy</topic><topic>Female</topic><topic>Humans</topic><topic>Lithotripsy</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Pain</topic><topic>Quality of Life</topic><topic>Sports medicine</topic><topic>Success</topic><topic>Treatment Outcome</topic><topic>Ultrasonic imaging</topic><topic>Ultrasonic Therapy - adverse effects</topic><topic>Ultrasonic Therapy - methods</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Gerdesmeyer, Ludger</creatorcontrib><creatorcontrib>Frey, Carol</creatorcontrib><creatorcontrib>Vester, Johannes</creatorcontrib><creatorcontrib>Maier, Markus</creatorcontrib><creatorcontrib>Lowell, Weil</creatorcontrib><creatorcontrib>Weil, Lowell</creatorcontrib><creatorcontrib>Russlies, Martin</creatorcontrib><creatorcontrib>Stienstra, John</creatorcontrib><creatorcontrib>Scurran, Barry</creatorcontrib><creatorcontrib>Fedder, Keith</creatorcontrib><creatorcontrib>Diehl, Peter</creatorcontrib><creatorcontrib>Lohrer, Heinz</creatorcontrib><creatorcontrib>Henne, Mark</creatorcontrib><creatorcontrib>Gollwitzer, Hans</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Physical Education Index</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Premium</collection><collection>MEDLINE - Academic</collection><jtitle>The American journal of sports medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Gerdesmeyer, Ludger</au><au>Frey, Carol</au><au>Vester, Johannes</au><au>Maier, Markus</au><au>Lowell, Weil</au><au>Weil, Lowell</au><au>Russlies, Martin</au><au>Stienstra, John</au><au>Scurran, Barry</au><au>Fedder, Keith</au><au>Diehl, Peter</au><au>Lohrer, Heinz</au><au>Henne, Mark</au><au>Gollwitzer, Hans</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Radial Extracorporeal Shock Wave Therapy is Safe and Effective in the Treatment of Chronic Recalcitrant Plantar Fasciitis: Results of a Confirmatory Randomized Placebo-Controlled Multicenter Study</atitle><jtitle>The American journal of sports medicine</jtitle><addtitle>Am J Sports Med</addtitle><date>2008-11-01</date><risdate>2008</risdate><volume>36</volume><issue>11</issue><spage>2100</spage><epage>2109</epage><pages>2100-2109</pages><issn>0363-5465</issn><eissn>1552-3365</eissn><coden>AJSMDO</coden><abstract>Background
Radial extracorporeal shock wave therapy is an effective treatment for chronic plantar fasciitis that can be administered to outpatients without anesthesia but has not yet been evaluated in controlled trials.
Hypothesis
There is no difference in effectiveness between radial extracorporeal shock wave therapy and placebo in the treatment of chronic plantar fasciitis.
Study Design
Randomized, controlled trial; Level of evidence, 1.
Methods
Three interventions of radial extracorporeal shock wave therapy (0.16 mJ/mm2; 2000 impulses) compared with placebo were studied in 245 patients with chronic plantar fasciitis. Primary endpoints were changes in visual analog scale composite score from baseline to 12 weeks’ follow-up, overall success rates, and success rates of the single visual analog scale scores (heel pain at first steps in the morning, during daily activities, during standardized pressure force). Secondary endpoints were single changes in visual analog scale scores, success rates, Roles and Maudsley score, SF-36, and patients’ and investigators’ global judgment of effectiveness 12 weeks and 12 months after extracorporeal shock wave therapy.
Results
Radial extracorporeal shock wave therapy proved significantly superior to placebo with a reduction of the visual analog scale composite score of 72.1% compared with 44.7% (P = .0220), and an overall success rate of 61.0% compared with 42.2% in the placebo group (P = .0020) at 12 weeks. Superiority was even more pronounced at 12 months, and all secondary outcome measures supported radial extracorporeal shock wave therapy to be significantly superior to placebo (P < .025, 1-sided). No relevant side effects were observed.
Conclusion
Radial extracorporeal shock wave therapy significantly improves pain, function, and quality of life compared with placebo in patients with recalcitrant plantar fasciitis.</abstract><cop>Los Angeles, CA</cop><pub>SAGE Publications</pub><pmid>18832341</pmid><doi>10.1177/0363546508324176</doi><tpages>10</tpages></addata></record> |
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subjects | Activities of Daily Living Adult Biological and medical sciences Diseases of the osteoarticular system Elbow Electroconvulsive therapy Fasciitis, Plantar - therapy Female Humans Lithotripsy Male Medical sciences Middle Aged Pain Quality of Life Sports medicine Success Treatment Outcome Ultrasonic imaging Ultrasonic Therapy - adverse effects Ultrasonic Therapy - methods |
title | Radial Extracorporeal Shock Wave Therapy is Safe and Effective in the Treatment of Chronic Recalcitrant Plantar Fasciitis: Results of a Confirmatory Randomized Placebo-Controlled Multicenter Study |
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