Spa Therapy for the Treatment of Fibromyalgia: An Open, Randomized Multicenter Trial
•Fibromyalgia is a frequent chronic pain syndrome with a complex physiopathology.•Non-drug therapies are recommended as first-line treatment.•Three-week spa therapy with standardized treatments is frequently prescribed in France.•Spa therapy improved long-term fibromyalgia-specific quality of life.•...
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Veröffentlicht in: | The journal of pain 2021-08, Vol.22 (8), p.940-951 |
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creator | Maindet, Caroline Maire, Aurore Vermorel, Céline Cracowski, Claire Rolland, Carole Forestier, Romain Comte, Alexa Roques, Christian-François Serra, Eric Bosson, Jean-Luc |
description | •Fibromyalgia is a frequent chronic pain syndrome with a complex physiopathology.•Non-drug therapies are recommended as first-line treatment.•Three-week spa therapy with standardized treatments is frequently prescribed in France.•Spa therapy improved long-term fibromyalgia-specific quality of life.•Spa therapy also improved pain and fatigue, and reduced drug consumption.
Fibromyalgia is a common chronic pain pathology with an incidence of 4.3 per 1,000 person-years. An open, randomized clinical trial of patients with fibromyalgia comparing an immediate vs. delayed 18-day spa therapy in five spa therapy care facilities in France enrolled 220 patients. Randomization was in blocks of four, stratified by center, severity of fibromyalgia and previous spa therapy. Patients continued usual treatment. The main endpoint was the number of patients achieving minimal clinically important difference at 6 months, defined as 14% change in their baseline fibromyalgia impact questionnaire score. The intention-to-treat analysis included 100 and 106 patients in the intervention and control groups, respectively. At 6 months, 45/100 (45.0%) and 30/106 (28.3%) patients in the intervention and control groups, respectively, achieved a minimal clinically important difference (P= .013). There was also a significant improvement in pain, fatigue, and symptom severity (secondary outcomes) in the intervention group but not for generic quality of life (QOL), sleep or physical activity. None of the 33 serious adverse events reported by 25 patients were related to the spa therapy. Our results demonstrate the benefit of spa treatment in patients with fibromyalgia.
A 12-month, open, randomized clinical trial of 220 patients with fibromyalgia compared an immediate versus delayed (ie, after 6 months) 18-day spa therapy. The results showed a clinically significant improvement at 6 months for those who received immediate therapy which was maintained up to 12 months.
ClinicalTrials.gov: NCT02265029 |
doi_str_mv | 10.1016/j.jpain.2021.02.010 |
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Fibromyalgia is a common chronic pain pathology with an incidence of 4.3 per 1,000 person-years. An open, randomized clinical trial of patients with fibromyalgia comparing an immediate vs. delayed 18-day spa therapy in five spa therapy care facilities in France enrolled 220 patients. Randomization was in blocks of four, stratified by center, severity of fibromyalgia and previous spa therapy. Patients continued usual treatment. The main endpoint was the number of patients achieving minimal clinically important difference at 6 months, defined as 14% change in their baseline fibromyalgia impact questionnaire score. The intention-to-treat analysis included 100 and 106 patients in the intervention and control groups, respectively. At 6 months, 45/100 (45.0%) and 30/106 (28.3%) patients in the intervention and control groups, respectively, achieved a minimal clinically important difference (P= .013). There was also a significant improvement in pain, fatigue, and symptom severity (secondary outcomes) in the intervention group but not for generic quality of life (QOL), sleep or physical activity. None of the 33 serious adverse events reported by 25 patients were related to the spa therapy. Our results demonstrate the benefit of spa treatment in patients with fibromyalgia.
A 12-month, open, randomized clinical trial of 220 patients with fibromyalgia compared an immediate versus delayed (ie, after 6 months) 18-day spa therapy. The results showed a clinically significant improvement at 6 months for those who received immediate therapy which was maintained up to 12 months.
ClinicalTrials.gov: NCT02265029</description><identifier>ISSN: 1526-5900</identifier><identifier>EISSN: 1528-8447</identifier><identifier>DOI: 10.1016/j.jpain.2021.02.010</identifier><identifier>PMID: 33677113</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Adult ; Female ; Fibromyalgia ; Fibromyalgia - rehabilitation ; Humans ; Hydrotherapy ; Male ; Middle Aged ; pain measurement ; patient satisfaction ; spa treatment ; Treatment Outcome</subject><ispartof>The journal of pain, 2021-08, Vol.22 (8), p.940-951</ispartof><rights>2021 The Authors</rights><rights>Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c454t-898e60a69a5b80a583833ea322382a5f3d2611d592ec3f6912faad520b8166e33</citedby><cites>FETCH-LOGICAL-c454t-898e60a69a5b80a583833ea322382a5f3d2611d592ec3f6912faad520b8166e33</cites><orcidid>0000-0002-1921-0097 ; 0000-0003-0967-6026</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S1526590021000316$$EHTML$$P50$$Gelsevier$$Hfree_for_read</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33677113$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Maindet, Caroline</creatorcontrib><creatorcontrib>Maire, Aurore</creatorcontrib><creatorcontrib>Vermorel, Céline</creatorcontrib><creatorcontrib>Cracowski, Claire</creatorcontrib><creatorcontrib>Rolland, Carole</creatorcontrib><creatorcontrib>Forestier, Romain</creatorcontrib><creatorcontrib>Comte, Alexa</creatorcontrib><creatorcontrib>Roques, Christian-François</creatorcontrib><creatorcontrib>Serra, Eric</creatorcontrib><creatorcontrib>Bosson, Jean-Luc</creatorcontrib><title>Spa Therapy for the Treatment of Fibromyalgia: An Open, Randomized Multicenter Trial</title><title>The journal of pain</title><addtitle>J Pain</addtitle><description>•Fibromyalgia is a frequent chronic pain syndrome with a complex physiopathology.•Non-drug therapies are recommended as first-line treatment.•Three-week spa therapy with standardized treatments is frequently prescribed in France.•Spa therapy improved long-term fibromyalgia-specific quality of life.•Spa therapy also improved pain and fatigue, and reduced drug consumption.
Fibromyalgia is a common chronic pain pathology with an incidence of 4.3 per 1,000 person-years. An open, randomized clinical trial of patients with fibromyalgia comparing an immediate vs. delayed 18-day spa therapy in five spa therapy care facilities in France enrolled 220 patients. Randomization was in blocks of four, stratified by center, severity of fibromyalgia and previous spa therapy. Patients continued usual treatment. The main endpoint was the number of patients achieving minimal clinically important difference at 6 months, defined as 14% change in their baseline fibromyalgia impact questionnaire score. The intention-to-treat analysis included 100 and 106 patients in the intervention and control groups, respectively. At 6 months, 45/100 (45.0%) and 30/106 (28.3%) patients in the intervention and control groups, respectively, achieved a minimal clinically important difference (P= .013). There was also a significant improvement in pain, fatigue, and symptom severity (secondary outcomes) in the intervention group but not for generic quality of life (QOL), sleep or physical activity. None of the 33 serious adverse events reported by 25 patients were related to the spa therapy. Our results demonstrate the benefit of spa treatment in patients with fibromyalgia.
A 12-month, open, randomized clinical trial of 220 patients with fibromyalgia compared an immediate versus delayed (ie, after 6 months) 18-day spa therapy. The results showed a clinically significant improvement at 6 months for those who received immediate therapy which was maintained up to 12 months.
ClinicalTrials.gov: NCT02265029</description><subject>Adult</subject><subject>Female</subject><subject>Fibromyalgia</subject><subject>Fibromyalgia - rehabilitation</subject><subject>Humans</subject><subject>Hydrotherapy</subject><subject>Male</subject><subject>Middle Aged</subject><subject>pain measurement</subject><subject>patient satisfaction</subject><subject>spa treatment</subject><subject>Treatment Outcome</subject><issn>1526-5900</issn><issn>1528-8447</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kE1LJDEQhoO4-DH6CwTJ0YPdVpJOOi14EFndBZeBdTyHmu5qzdBfJj3C7K_f1lGPnqoOz1sv9TB2IiAVIMzFKl0N6LtUghQpyBQE7LADoaVNbJblu--7SXQBsM8OY1wBCKHzfI_tK2XyXAh1wBYPA_LFMwUcNrzuAx-fiS8C4dhSN_K-5rd-Gfp2g82Tx0t-3fH5QN05_4td1bf-H1X8z7oZfTnhFKaox-aI_aixiXT8MWfs8fbn4uZXcj-_-31zfZ-Umc7GxBaWDKApUC8toLbKKkWopFRWoq5VJY0QlS4klao2hZA1YqUlLK0whpSasbPt3SH0L2uKo2t9LKlpsKN-HZ3MClsUoEBOqNqiZehjDFS7IfgWw8YJcG863cq963RvOh1IN-mcUqcfBetlS9VX5tPfBFxtAZrefPUUXCw9dSVVPlA5uqr33xb8B8EVhZc</recordid><startdate>202108</startdate><enddate>202108</enddate><creator>Maindet, Caroline</creator><creator>Maire, Aurore</creator><creator>Vermorel, Céline</creator><creator>Cracowski, Claire</creator><creator>Rolland, Carole</creator><creator>Forestier, Romain</creator><creator>Comte, Alexa</creator><creator>Roques, Christian-François</creator><creator>Serra, Eric</creator><creator>Bosson, Jean-Luc</creator><general>Elsevier Inc</general><scope>6I.</scope><scope>AAFTH</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>7X8</scope><orcidid>https://orcid.org/0000-0002-1921-0097</orcidid><orcidid>https://orcid.org/0000-0003-0967-6026</orcidid></search><sort><creationdate>202108</creationdate><title>Spa Therapy for the Treatment of Fibromyalgia: An Open, Randomized Multicenter Trial</title><author>Maindet, Caroline ; Maire, Aurore ; Vermorel, Céline ; Cracowski, Claire ; Rolland, Carole ; Forestier, Romain ; Comte, Alexa ; Roques, Christian-François ; Serra, Eric ; Bosson, Jean-Luc</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c454t-898e60a69a5b80a583833ea322382a5f3d2611d592ec3f6912faad520b8166e33</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Adult</topic><topic>Female</topic><topic>Fibromyalgia</topic><topic>Fibromyalgia - rehabilitation</topic><topic>Humans</topic><topic>Hydrotherapy</topic><topic>Male</topic><topic>Middle Aged</topic><topic>pain measurement</topic><topic>patient satisfaction</topic><topic>spa treatment</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Maindet, Caroline</creatorcontrib><creatorcontrib>Maire, Aurore</creatorcontrib><creatorcontrib>Vermorel, Céline</creatorcontrib><creatorcontrib>Cracowski, Claire</creatorcontrib><creatorcontrib>Rolland, Carole</creatorcontrib><creatorcontrib>Forestier, Romain</creatorcontrib><creatorcontrib>Comte, Alexa</creatorcontrib><creatorcontrib>Roques, Christian-François</creatorcontrib><creatorcontrib>Serra, Eric</creatorcontrib><creatorcontrib>Bosson, Jean-Luc</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect: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>MEDLINE - Academic</collection><jtitle>The journal of pain</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Maindet, Caroline</au><au>Maire, Aurore</au><au>Vermorel, Céline</au><au>Cracowski, Claire</au><au>Rolland, Carole</au><au>Forestier, Romain</au><au>Comte, Alexa</au><au>Roques, Christian-François</au><au>Serra, Eric</au><au>Bosson, Jean-Luc</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Spa Therapy for the Treatment of Fibromyalgia: An Open, Randomized Multicenter Trial</atitle><jtitle>The journal of pain</jtitle><addtitle>J Pain</addtitle><date>2021-08</date><risdate>2021</risdate><volume>22</volume><issue>8</issue><spage>940</spage><epage>951</epage><pages>940-951</pages><issn>1526-5900</issn><eissn>1528-8447</eissn><abstract>•Fibromyalgia is a frequent chronic pain syndrome with a complex physiopathology.•Non-drug therapies are recommended as first-line treatment.•Three-week spa therapy with standardized treatments is frequently prescribed in France.•Spa therapy improved long-term fibromyalgia-specific quality of life.•Spa therapy also improved pain and fatigue, and reduced drug consumption.
Fibromyalgia is a common chronic pain pathology with an incidence of 4.3 per 1,000 person-years. An open, randomized clinical trial of patients with fibromyalgia comparing an immediate vs. delayed 18-day spa therapy in five spa therapy care facilities in France enrolled 220 patients. Randomization was in blocks of four, stratified by center, severity of fibromyalgia and previous spa therapy. Patients continued usual treatment. The main endpoint was the number of patients achieving minimal clinically important difference at 6 months, defined as 14% change in their baseline fibromyalgia impact questionnaire score. The intention-to-treat analysis included 100 and 106 patients in the intervention and control groups, respectively. At 6 months, 45/100 (45.0%) and 30/106 (28.3%) patients in the intervention and control groups, respectively, achieved a minimal clinically important difference (P= .013). There was also a significant improvement in pain, fatigue, and symptom severity (secondary outcomes) in the intervention group but not for generic quality of life (QOL), sleep or physical activity. None of the 33 serious adverse events reported by 25 patients were related to the spa therapy. Our results demonstrate the benefit of spa treatment in patients with fibromyalgia.
A 12-month, open, randomized clinical trial of 220 patients with fibromyalgia compared an immediate versus delayed (ie, after 6 months) 18-day spa therapy. The results showed a clinically significant improvement at 6 months for those who received immediate therapy which was maintained up to 12 months.
ClinicalTrials.gov: NCT02265029</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>33677113</pmid><doi>10.1016/j.jpain.2021.02.010</doi><tpages>12</tpages><orcidid>https://orcid.org/0000-0002-1921-0097</orcidid><orcidid>https://orcid.org/0000-0003-0967-6026</orcidid><oa>free_for_read</oa></addata></record> |
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subjects | Adult Female Fibromyalgia Fibromyalgia - rehabilitation Humans Hydrotherapy Male Middle Aged pain measurement patient satisfaction spa treatment Treatment Outcome |
title | Spa Therapy for the Treatment of Fibromyalgia: An Open, Randomized Multicenter Trial |
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