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
Hauptverfasser: 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
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container_end_page 2109
container_issue 11
container_start_page 2100
container_title The American journal of sports medicine
container_volume 36
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
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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 &lt; .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&amp;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 &lt; .025, 1-sided). No relevant side effects were observed. 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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 &lt; .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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