Effect of transcutaneous electrical nerve stimulation on pain, function, and quality of life in fibromyalgia: a double-blind randomized clinical trial
Fibromyalgia is a common chronic pain condition that has a significant impact on quality of life and often leads to disability. To date, there have been few well-controlled trials assessing the utility of nonpharmacological treatment modalities such as transcutaneous electrical nerve stimulation (TE...
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creator | Noehren, Brian Dailey, Dana L Rakel, Barbara A Vance, Carol G T Zimmerman, Miriam B Crofford, Leslie J Sluka, Kathleen A |
description | Fibromyalgia is a common chronic pain condition that has a significant impact on quality of life and often leads to disability. To date, there have been few well-controlled trials assessing the utility of nonpharmacological treatment modalities such as transcutaneous electrical nerve stimulation (TENS) in the management of pain and improvement in function in individuals with fibromyalgia.
The purpose of this study will be to complete a long-term, multicenter study to assess the effects of TENS in women with fibromyalgia.
This will be a phase II randomized, double-blind, placebo-controlled, multicenter clinical trial.
Three hundred forty-three participants with fibromyalgia will be recruited for this study.
Participants will be randomly assigned to 1 of 3 groups: the intervention (TENS), placebo, or no treatment. After completing the randomized period, all participants will receive the intervention for 1 month. The participants will be asked to use TENS at the highest tolerable level for at least 2 hours daily during physical activity.
The primary outcome will be pain with movement, with secondary outcomes assessing functional abilities, patient-reported outcomes, and quantitative sensory testing.
Because having participants refrain from their typical medications is not practical, their usage and any change in medication use will be recorded.
The results of this study will provide some of the first evidence from a large-scale, double-blind, placebo-controlled trial on the effectiveness of TENS on pain control and quality-of-life changes in patients with fibromyalgia. |
doi_str_mv | 10.2522/ptj.20140218 |
format | Article |
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The purpose of this study will be to complete a long-term, multicenter study to assess the effects of TENS in women with fibromyalgia.
This will be a phase II randomized, double-blind, placebo-controlled, multicenter clinical trial.
Three hundred forty-three participants with fibromyalgia will be recruited for this study.
Participants will be randomly assigned to 1 of 3 groups: the intervention (TENS), placebo, or no treatment. After completing the randomized period, all participants will receive the intervention for 1 month. The participants will be asked to use TENS at the highest tolerable level for at least 2 hours daily during physical activity.
The primary outcome will be pain with movement, with secondary outcomes assessing functional abilities, patient-reported outcomes, and quantitative sensory testing.
Because having participants refrain from their typical medications is not practical, their usage and any change in medication use will be recorded.
The results of this study will provide some of the first evidence from a large-scale, double-blind, placebo-controlled trial on the effectiveness of TENS on pain control and quality-of-life changes in patients with fibromyalgia.</description><identifier>ISSN: 0031-9023</identifier><identifier>EISSN: 1538-6724</identifier><identifier>DOI: 10.2522/ptj.20140218</identifier><identifier>PMID: 25212518</identifier><language>eng</language><publisher>United States: Oxford University Press</publisher><subject>Arthritis ; Care and treatment ; Chronic pain ; Clinical trials ; Diagnosis ; Double-Blind Method ; Drug therapy ; Exercise ; Fatigue ; Fatigue - physiopathology ; Fatigue - therapy ; FDA approval ; Female ; Fibromyalgia ; Fibromyalgia - physiopathology ; Fibromyalgia - psychology ; Fibromyalgia - therapy ; Health aspects ; Humans ; Pain ; Pain management ; Pain Measurement ; Physical fitness ; Physiology ; Protocol ; Quality of Life ; Review boards ; Rheumatic diseases ; Risk factors ; Skin diseases ; Studies ; Transcutaneous Electric Nerve Stimulation ; Transcutaneous electrical nerve stimulation-TENS</subject><ispartof>Physical therapy, 2015-01, Vol.95 (1), p.129-140</ispartof><rights>2015 American Physical Therapy Association.</rights><rights>COPYRIGHT 2015 Oxford University Press</rights><rights>COPYRIGHT 2015 Oxford University Press</rights><rights>Copyright AMERICAN PHYSICAL THERAPY ASSOCIATION Jan 2015</rights><rights>2015 American Physical Therapy Association 2015</rights><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c690t-5450bd01e2439aa2c402d5a20e5a5a009bc6445b66ce1190a9ef1fdd523398bd3</citedby><cites>FETCH-LOGICAL-c690t-5450bd01e2439aa2c402d5a20e5a5a009bc6445b66ce1190a9ef1fdd523398bd3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,780,784,885,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/25212518$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Noehren, Brian</creatorcontrib><creatorcontrib>Dailey, Dana L</creatorcontrib><creatorcontrib>Rakel, Barbara A</creatorcontrib><creatorcontrib>Vance, Carol G T</creatorcontrib><creatorcontrib>Zimmerman, Miriam B</creatorcontrib><creatorcontrib>Crofford, Leslie J</creatorcontrib><creatorcontrib>Sluka, Kathleen A</creatorcontrib><title>Effect of transcutaneous electrical nerve stimulation on pain, function, and quality of life in fibromyalgia: a double-blind randomized clinical trial</title><title>Physical therapy</title><addtitle>Phys Ther</addtitle><description>Fibromyalgia is a common chronic pain condition that has a significant impact on quality of life and often leads to disability. To date, there have been few well-controlled trials assessing the utility of nonpharmacological treatment modalities such as transcutaneous electrical nerve stimulation (TENS) in the management of pain and improvement in function in individuals with fibromyalgia.
The purpose of this study will be to complete a long-term, multicenter study to assess the effects of TENS in women with fibromyalgia.
This will be a phase II randomized, double-blind, placebo-controlled, multicenter clinical trial.
Three hundred forty-three participants with fibromyalgia will be recruited for this study.
Participants will be randomly assigned to 1 of 3 groups: the intervention (TENS), placebo, or no treatment. After completing the randomized period, all participants will receive the intervention for 1 month. The participants will be asked to use TENS at the highest tolerable level for at least 2 hours daily during physical activity.
The primary outcome will be pain with movement, with secondary outcomes assessing functional abilities, patient-reported outcomes, and quantitative sensory testing.
Because having participants refrain from their typical medications is not practical, their usage and any change in medication use will be recorded.
The results of this study will provide some of the first evidence from a large-scale, double-blind, placebo-controlled trial on the effectiveness of TENS on pain control and quality-of-life changes in patients with fibromyalgia.</description><subject>Arthritis</subject><subject>Care and treatment</subject><subject>Chronic pain</subject><subject>Clinical trials</subject><subject>Diagnosis</subject><subject>Double-Blind Method</subject><subject>Drug therapy</subject><subject>Exercise</subject><subject>Fatigue</subject><subject>Fatigue - physiopathology</subject><subject>Fatigue - therapy</subject><subject>FDA approval</subject><subject>Female</subject><subject>Fibromyalgia</subject><subject>Fibromyalgia - physiopathology</subject><subject>Fibromyalgia - psychology</subject><subject>Fibromyalgia - therapy</subject><subject>Health aspects</subject><subject>Humans</subject><subject>Pain</subject><subject>Pain management</subject><subject>Pain Measurement</subject><subject>Physical fitness</subject><subject>Physiology</subject><subject>Protocol</subject><subject>Quality of Life</subject><subject>Review boards</subject><subject>Rheumatic diseases</subject><subject>Risk factors</subject><subject>Skin diseases</subject><subject>Studies</subject><subject>Transcutaneous Electric Nerve Stimulation</subject><subject>Transcutaneous electrical nerve stimulation-TENS</subject><issn>0031-9023</issn><issn>1538-6724</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNqVk1trFDEUxwdRbK2--SwBXxR21lxnJ30QylJrYbHg5TlkMmfGLJlkO5kprh_Ez2vW3VZXFqkkEDj5nf9JziXLnhM8pYLSN6thOaWYcExJ-SA7JoKVeTGj_GF2jDEjucSUHWVPYlxijMmMy8fZUXIkVJDyOPtx3jRgBhQaNPTaRzMO2kMYIwKX7L012iEP_Q2gONhudHqwwaO0V9r6CWpGbzaWCdK-RtejdnZYb9ScbQBZjxpb9aFba9dafYo0qsNYOcgrZxOfItahs9-hRiYZfgVLMbV7mj1qtIvwbHeeZF_enX-ev88XVxeX87NFbgqJh1xwgasaE6CcSa2pSVmohaYYhBYaY1mZgnNRFYUBQiTWEhrS1LWgjMmyqtlJ9naruxqrDmoDPmXBqVVvO92vVdBW7d94-1W14UZxKgUuWRJ4tRPow_UIcVCdjQac22ZRkULwQhaUynugnJRixgua0Jd_ocsw9j5lYkNRXkoxk7-pVjtQ1jchPdFsRNUZkzMuGCtwovIDVAupqNoFD41N5j1-eoBPq4bOmoMOr_ccEjPAt6HVY4zq8tPH_2A_3JstLxb_-uSONcE5aEGlnplf7fOTLW_6EGMPzV3JCVabsVJprNTtWCX8xZ9tcgffzhH7CdN8Gm4</recordid><startdate>20150101</startdate><enddate>20150101</enddate><creator>Noehren, Brian</creator><creator>Dailey, Dana L</creator><creator>Rakel, Barbara A</creator><creator>Vance, Carol G T</creator><creator>Zimmerman, Miriam B</creator><creator>Crofford, Leslie J</creator><creator>Sluka, Kathleen A</creator><general>Oxford University Press</general><general>American Physical Therapy Association</general><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>8GL</scope><scope>ISN</scope><scope>ISR</scope><scope>3V.</scope><scope>7RQ</scope><scope>7RV</scope><scope>7TS</scope><scope>7X7</scope><scope>7XB</scope><scope>88C</scope><scope>88E</scope><scope>88I</scope><scope>8AO</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>HCIFZ</scope><scope>K9-</scope><scope>K9.</scope><scope>KB0</scope><scope>M0R</scope><scope>M0S</scope><scope>M0T</scope><scope>M1P</scope><scope>M2O</scope><scope>M2P</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>Q9U</scope><scope>S0X</scope><scope>U9A</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20150101</creationdate><title>Effect of transcutaneous electrical nerve stimulation on pain, function, and quality of life in fibromyalgia: a double-blind randomized clinical trial</title><author>Noehren, Brian ; Dailey, Dana L ; Rakel, Barbara A ; Vance, Carol G T ; Zimmerman, Miriam B ; Crofford, Leslie J ; Sluka, Kathleen A</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c690t-5450bd01e2439aa2c402d5a20e5a5a009bc6445b66ce1190a9ef1fdd523398bd3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>Arthritis</topic><topic>Care and treatment</topic><topic>Chronic pain</topic><topic>Clinical trials</topic><topic>Diagnosis</topic><topic>Double-Blind Method</topic><topic>Drug therapy</topic><topic>Exercise</topic><topic>Fatigue</topic><topic>Fatigue - physiopathology</topic><topic>Fatigue - therapy</topic><topic>FDA approval</topic><topic>Female</topic><topic>Fibromyalgia</topic><topic>Fibromyalgia - physiopathology</topic><topic>Fibromyalgia - psychology</topic><topic>Fibromyalgia - therapy</topic><topic>Health aspects</topic><topic>Humans</topic><topic>Pain</topic><topic>Pain management</topic><topic>Pain Measurement</topic><topic>Physical fitness</topic><topic>Physiology</topic><topic>Protocol</topic><topic>Quality of Life</topic><topic>Review boards</topic><topic>Rheumatic diseases</topic><topic>Risk factors</topic><topic>Skin diseases</topic><topic>Studies</topic><topic>Transcutaneous Electric Nerve Stimulation</topic><topic>Transcutaneous electrical nerve stimulation-TENS</topic><toplevel>online_resources</toplevel><creatorcontrib>Noehren, Brian</creatorcontrib><creatorcontrib>Dailey, Dana L</creatorcontrib><creatorcontrib>Rakel, Barbara A</creatorcontrib><creatorcontrib>Vance, Carol G T</creatorcontrib><creatorcontrib>Zimmerman, Miriam B</creatorcontrib><creatorcontrib>Crofford, Leslie J</creatorcontrib><creatorcontrib>Sluka, Kathleen A</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Gale In Context: High School</collection><collection>Gale In Context: Canada</collection><collection>Gale In Context: Science</collection><collection>ProQuest Central (Corporate)</collection><collection>Career & Technical Education Database</collection><collection>Nursing & Allied Health Database</collection><collection>Physical Education Index</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Healthcare Administration Database (Alumni)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Science Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Research Library (Alumni Edition)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>eLibrary</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Research Library Prep</collection><collection>SciTech Premium Collection</collection><collection>Consumer Health Database (Alumni Edition)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Consumer Health Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Healthcare Administration Database</collection><collection>Medical Database</collection><collection>Research Library</collection><collection>Science Database</collection><collection>Research Library (Corporate)</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest Central Basic</collection><collection>SIRS Editorial</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Physical therapy</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Noehren, Brian</au><au>Dailey, Dana L</au><au>Rakel, Barbara A</au><au>Vance, Carol G T</au><au>Zimmerman, Miriam B</au><au>Crofford, Leslie J</au><au>Sluka, Kathleen A</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Effect of transcutaneous electrical nerve stimulation on pain, function, and quality of life in fibromyalgia: a double-blind randomized clinical trial</atitle><jtitle>Physical therapy</jtitle><addtitle>Phys Ther</addtitle><date>2015-01-01</date><risdate>2015</risdate><volume>95</volume><issue>1</issue><spage>129</spage><epage>140</epage><pages>129-140</pages><issn>0031-9023</issn><eissn>1538-6724</eissn><abstract>Fibromyalgia is a common chronic pain condition that has a significant impact on quality of life and often leads to disability. To date, there have been few well-controlled trials assessing the utility of nonpharmacological treatment modalities such as transcutaneous electrical nerve stimulation (TENS) in the management of pain and improvement in function in individuals with fibromyalgia.
The purpose of this study will be to complete a long-term, multicenter study to assess the effects of TENS in women with fibromyalgia.
This will be a phase II randomized, double-blind, placebo-controlled, multicenter clinical trial.
Three hundred forty-three participants with fibromyalgia will be recruited for this study.
Participants will be randomly assigned to 1 of 3 groups: the intervention (TENS), placebo, or no treatment. After completing the randomized period, all participants will receive the intervention for 1 month. The participants will be asked to use TENS at the highest tolerable level for at least 2 hours daily during physical activity.
The primary outcome will be pain with movement, with secondary outcomes assessing functional abilities, patient-reported outcomes, and quantitative sensory testing.
Because having participants refrain from their typical medications is not practical, their usage and any change in medication use will be recorded.
The results of this study will provide some of the first evidence from a large-scale, double-blind, placebo-controlled trial on the effectiveness of TENS on pain control and quality-of-life changes in patients with fibromyalgia.</abstract><cop>United States</cop><pub>Oxford University Press</pub><pmid>25212518</pmid><doi>10.2522/ptj.20140218</doi><tpages>12</tpages><oa>free_for_read</oa></addata></record> |
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source | MEDLINE; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Oxford University Press Journals All Titles (1996-Current); Alma/SFX Local Collection |
subjects | Arthritis Care and treatment Chronic pain Clinical trials Diagnosis Double-Blind Method Drug therapy Exercise Fatigue Fatigue - physiopathology Fatigue - therapy FDA approval Female Fibromyalgia Fibromyalgia - physiopathology Fibromyalgia - psychology Fibromyalgia - therapy Health aspects Humans Pain Pain management Pain Measurement Physical fitness Physiology Protocol Quality of Life Review boards Rheumatic diseases Risk factors Skin diseases Studies Transcutaneous Electric Nerve Stimulation Transcutaneous electrical nerve stimulation-TENS |
title | Effect of transcutaneous electrical nerve stimulation on pain, function, and quality of life in fibromyalgia: a double-blind randomized clinical trial |
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