Manual acupuncture plus usual care versus usual care alone in the treatment of endometriosis-related chronic pelvic pain: study protocol for a randomised controlled feasibility study
Identifieur interne : 000388 ( Main/Exploration ); précédent : 000387; suivant : 000389Manual acupuncture plus usual care versus usual care alone in the treatment of endometriosis-related chronic pelvic pain: study protocol for a randomised controlled feasibility study
Auteurs : Mike Armour [Australie] ; Caroline A. Smith [Australie] ; Siobhan Schabrun [Australie] ; Genevieve Z. Steiner [Australie] ; Xiaoshu Zhu [Australie] ; Kenny Lawson [Australie] ; Jing Song [Australie]Source :
- Pilot and Feasibility Studies [ 2055-5784 ] ; 2017.
Abstract
Endometriosis is the most common cause of chronic pelvic pain worldwide. Non-surgical treatments are effective for only 30–50% of women and have a significant side effect burden that leads to high discontinuation rates. Surgery can be effective but is expensive and invasive, and symptoms tend to recur within 5 years. There is early evidence that acupuncture may be effective in treating endometriosis-related chronic pelvic pain, showing clinically significant analgesia. Both levels of inflammation and pain processing have been shown to be altered in women with chronic pelvic pain. Acupuncture has been shown to reduce inflammation and change central pain processing in other conditions, but research on women with endometriosis is currently lacking. The aim of this feasibility study is to provide data on recruitment rates, retention, appropriateness of outcome measures, minimal clinically important difference in numeric rated scales for pain and the potential effect of acupuncture on pain processing and markers of inflammation in endometriosis-related CPP.
We will include women aged 18–45 years with a diagnosis of endometriosis via laparoscopy in the past 5 years. A total of 30 participants will be recruited and randomly allocated in a 1:1 ratio to receive acupuncture or usual care. Women in the acupuncture group will receive two 45-min treatment sessions per week for 8 weeks (total of 16 sessions). Women in the usual care group will continue with their current treatment regimen. The primary feasibility outcomes are recruitment rates, retention rates and the safety and acceptability of the intervention; secondary patient-centred outcomes include a change in 0–10 daily pelvic pain ratings, the Endometriosis Health Profile 30 (EHP-30) and changes in conditioned pain modulation, resting and task-related EEG activity and inflammatory markers. Analyses will be performed blind to group allocation.
This is a two-armed, assessor blind, randomised controlled feasibility trial. Data will be compared at baseline and trial completion 8 weeks later. Outcomes from this feasibility study will inform a larger, fully powered clinical trial should the treatment show trends for potential effectiveness.
Australian New Zealand Clinical Trials Registry, ACTRN12617000053325 (
The online version of this article (doi:10.1186/s40814-017-0152-9) contains supplementary material, which is available to authorized users.
Url:
DOI: 10.1186/s40814-017-0152-9
PubMed: 28694989
PubMed Central: 5500924
Affiliations:
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Smith</name><affiliation wicri:level="3"><nlm:aff id="Aff1"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 1936 834X</institution-id><institution-id institution-id-type="GRID">grid.1013.3</institution-id><institution>NICM,</institution><institution>Western Sydney University,</institution></institution-wrap>Campbelltown Campus, Sydney, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Campbelltown Campus, Sydney</wicri:regionArea><placeName><settlement type="city">Sydney</settlement><region type="état">Nouvelle-Galles du Sud</region></placeName></affiliation></author><author><name sortKey="Schabrun, Siobhan" sort="Schabrun, Siobhan" uniqKey="Schabrun S" first="Siobhan" last="Schabrun">Siobhan Schabrun</name><affiliation wicri:level="3"><nlm:aff id="Aff2"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 1936 834X</institution-id><institution-id institution-id-type="GRID">grid.1013.3</institution-id><institution>Brain Rehabilitation and Neuroplasticity unit,</institution><institution>Western Sydney University,</institution></institution-wrap>Campbelltown Campus, Sydney, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Campbelltown Campus, Sydney</wicri:regionArea><placeName><settlement type="city">Sydney</settlement><region type="état">Nouvelle-Galles du Sud</region></placeName></affiliation></author><author><name sortKey="Steiner, Genevieve Z" sort="Steiner, Genevieve Z" uniqKey="Steiner G" first="Genevieve Z." last="Steiner">Genevieve Z. Steiner</name><affiliation wicri:level="3"><nlm:aff id="Aff1"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 1936 834X</institution-id><institution-id institution-id-type="GRID">grid.1013.3</institution-id><institution>NICM,</institution><institution>Western Sydney University,</institution></institution-wrap>Campbelltown Campus, Sydney, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Campbelltown Campus, Sydney</wicri:regionArea><placeName><settlement type="city">Sydney</settlement><region type="état">Nouvelle-Galles du Sud</region></placeName></affiliation></author><author><name sortKey="Zhu, Xiaoshu" sort="Zhu, Xiaoshu" uniqKey="Zhu X" first="Xiaoshu" last="Zhu">Xiaoshu Zhu</name><affiliation wicri:level="3"><nlm:aff id="Aff1"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 1936 834X</institution-id><institution-id institution-id-type="GRID">grid.1013.3</institution-id><institution>NICM,</institution><institution>Western Sydney University,</institution></institution-wrap>Campbelltown Campus, Sydney, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Campbelltown Campus, Sydney</wicri:regionArea><placeName><settlement type="city">Sydney</settlement><region type="état">Nouvelle-Galles du Sud</region></placeName></affiliation></author><author><name sortKey="Lawson, Kenny" sort="Lawson, Kenny" uniqKey="Lawson K" first="Kenny" last="Lawson">Kenny Lawson</name><affiliation wicri:level="3"><nlm:aff id="Aff3"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 1936 834X</institution-id><institution-id institution-id-type="GRID">grid.1013.3</institution-id><institution>Centre for Health Research, Campbelltown Campus,</institution><institution>Western Sydney University,</institution></institution-wrap>Campbelltown Campus, Sydney, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Campbelltown Campus, Sydney</wicri:regionArea><placeName><settlement type="city">Sydney</settlement><region type="état">Nouvelle-Galles du Sud</region></placeName></affiliation></author><author><name sortKey="Song, Jing" sort="Song, Jing" uniqKey="Song J" first="Jing" last="Song">Jing Song</name><affiliation wicri:level="1"><nlm:aff id="Aff4"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0640 3353</institution-id><institution-id institution-id-type="GRID">grid.460708.d</institution-id><institution>Department of Obstetrics and Gynaecology,</institution><institution>SWSLHD Camden and Campbelltown Hospitals,</institution></institution-wrap>Sydney, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Sydney</wicri:regionArea></affiliation></author></analytic><series><title level="j">Pilot and Feasibility Studies</title><idno type="eISSN">2055-5784</idno><imprint><date when="2017">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Background</title><p id="Par1">Endometriosis is the most common cause of chronic pelvic pain worldwide. Non-surgical treatments are effective for only 30–50% of women and have a significant side effect burden that leads to high discontinuation rates. Surgery can be effective but is expensive and invasive, and symptoms tend to recur within 5 years. There is early evidence that acupuncture may be effective in treating endometriosis-related chronic pelvic pain, showing clinically significant analgesia. Both levels of inflammation and pain processing have been shown to be altered in women with chronic pelvic pain. Acupuncture has been shown to reduce inflammation and change central pain processing in other conditions, but research on women with endometriosis is currently lacking. The aim of this feasibility study is to provide data on recruitment rates, retention, appropriateness of outcome measures, minimal clinically important difference in numeric rated scales for pain and the potential effect of acupuncture on pain processing and markers of inflammation in endometriosis-related CPP.</p></sec><sec><title>Methods</title><p id="Par2">We will include women aged 18–45 years with a diagnosis of endometriosis via laparoscopy in the past 5 years. A total of 30 participants will be recruited and randomly allocated in a 1:1 ratio to receive acupuncture or usual care. Women in the acupuncture group will receive two 45-min treatment sessions per week for 8 weeks (total of 16 sessions). Women in the usual care group will continue with their current treatment regimen. The primary feasibility outcomes are recruitment rates, retention rates and the safety and acceptability of the intervention; secondary patient-centred outcomes include a change in 0–10 daily pelvic pain ratings, the Endometriosis Health Profile 30 (EHP-30) and changes in conditioned pain modulation, resting and task-related EEG activity and inflammatory markers. Analyses will be performed blind to group allocation.</p></sec><sec><title>Discussion</title><p id="Par3">This is a two-armed, assessor blind, randomised controlled feasibility trial. Data will be compared at baseline and trial completion 8 weeks later. Outcomes from this feasibility study will inform a larger, fully powered clinical trial should the treatment show trends for potential effectiveness.</p></sec><sec><title>Trial registration</title><p id="Par4">Australian New Zealand Clinical Trials Registry, ACTRN12617000053325 (<ext-link ext-link-type="uri" xlink:href="http://www.anzctr.org.au/ACTRN12617000053325.aspx">http://www.ANZCTR.org.au/ACTRN12617000053325.aspx</ext-link>).</p></sec><sec><title>Electronic supplementary material</title><p>The online version of this article (doi:10.1186/s40814-017-0152-9) contains supplementary material, which is available to authorized users.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Howard, F" uniqKey="Howard F">F Howard</name></author><author><name sortKey="Perry, P" uniqKey="Perry P">P Perry</name></author><author><name sortKey="Carter, J" uniqKey="Carter J">J Carter</name></author><author><name sortKey="El Minawi, A" 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uniqKey="Scullion A">A Scullion</name></author><author><name sortKey="Thomas, Kj" uniqKey="Thomas K">KJ Thomas</name></author><author><name sortKey="Walters, S" uniqKey="Walters S">S Walters</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Armour, M" uniqKey="Armour M">M Armour</name></author><author><name sortKey="Smith, Ca" uniqKey="Smith C">CA Smith</name></author></analytic></biblStruct></listBibl></div1></back></TEI><affiliations><list><country><li>Australie</li></country><region><li>Nouvelle-Galles du Sud</li></region><settlement><li>Sydney</li></settlement></list><tree><country name="Australie"><region name="Nouvelle-Galles du Sud"><name sortKey="Armour, Mike" sort="Armour, Mike" uniqKey="Armour M" first="Mike" last="Armour">Mike Armour</name></region><name sortKey="Lawson, Kenny" sort="Lawson, Kenny" uniqKey="Lawson K" first="Kenny" last="Lawson">Kenny Lawson</name><name sortKey="Schabrun, Siobhan" sort="Schabrun, Siobhan" uniqKey="Schabrun S" first="Siobhan" last="Schabrun">Siobhan Schabrun</name><name sortKey="Smith, Caroline A" sort="Smith, Caroline A" uniqKey="Smith C" first="Caroline A." last="Smith">Caroline A. Smith</name><name sortKey="Song, Jing" sort="Song, Jing" uniqKey="Song J" first="Jing" last="Song">Jing Song</name><name sortKey="Steiner, Genevieve Z" sort="Steiner, Genevieve Z" uniqKey="Steiner G" first="Genevieve Z." last="Steiner">Genevieve Z. Steiner</name><name sortKey="Zhu, Xiaoshu" sort="Zhu, Xiaoshu" uniqKey="Zhu X" first="Xiaoshu" last="Zhu">Xiaoshu Zhu</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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