Background:Despite therapeutic advances,treatment of patients with axial spondyloarthritis(axSpA)continue to pose as a challenge as many do not respond well to conventional Western medications,such as nonsteroidal ant...Background:Despite therapeutic advances,treatment of patients with axial spondyloarthritis(axSpA)continue to pose as a challenge as many do not respond well to conventional Western medications,such as nonsteroidal anti-inflammatory drugs(NSAIDs)and biologic diseasemodifying antirheumatic drugs(bDMARDs).Hence,acupuncture is a possible alternative.Some studies found electroacupuncture to be better than manual acupuncture,though no trials have been conducted in patients with axSpA.This clinical trial aims to evaluate the clinical efficacy,safety,and cost-effectiveness of electroacupuncture compared to manual acupuncture for patients with axSpA.Methods/Design:This randomized controlled trial will recruit 100 patients diagnosed with axSpA,who have active disease despite NSAIDs and bDMARDs.Eligible patients will be randomized to receive either electroacupuncture or manual acupuncture in a 1:1 ratio.All participants will receive standard rheumatologic care in addition to 20 acupuncture sessions.The mean difference in Bath Ankylosing Spondylitis Disease Activity Index score between the 2 groups over 12 weeks will serve as the primary outcome.Secondary outcomes include improvements in other clinical,quality of life,and economic outcomes over 24 weeks.All adverse events will be recorded.Discussion:Results from this trial may provide evidence regarding the clinical effectiveness,safety,and cost-effectiveness of electroacupuncture compared to manual acupuncture for patients with axSpA,and guide implementation into clinical practice.Limitations of this trial include the lack of patient blinding,use of a repeated measures design,and possible variation in acupuncture technique amongst the various Traditional Chinese Medicine practitioners.展开更多
基金Reverie Rheumatology Research Fund,Spondyloarthritis:Excelling in Research for best Outcomes(SPERO)。
文摘Background:Despite therapeutic advances,treatment of patients with axial spondyloarthritis(axSpA)continue to pose as a challenge as many do not respond well to conventional Western medications,such as nonsteroidal anti-inflammatory drugs(NSAIDs)and biologic diseasemodifying antirheumatic drugs(bDMARDs).Hence,acupuncture is a possible alternative.Some studies found electroacupuncture to be better than manual acupuncture,though no trials have been conducted in patients with axSpA.This clinical trial aims to evaluate the clinical efficacy,safety,and cost-effectiveness of electroacupuncture compared to manual acupuncture for patients with axSpA.Methods/Design:This randomized controlled trial will recruit 100 patients diagnosed with axSpA,who have active disease despite NSAIDs and bDMARDs.Eligible patients will be randomized to receive either electroacupuncture or manual acupuncture in a 1:1 ratio.All participants will receive standard rheumatologic care in addition to 20 acupuncture sessions.The mean difference in Bath Ankylosing Spondylitis Disease Activity Index score between the 2 groups over 12 weeks will serve as the primary outcome.Secondary outcomes include improvements in other clinical,quality of life,and economic outcomes over 24 weeks.All adverse events will be recorded.Discussion:Results from this trial may provide evidence regarding the clinical effectiveness,safety,and cost-effectiveness of electroacupuncture compared to manual acupuncture for patients with axSpA,and guide implementation into clinical practice.Limitations of this trial include the lack of patient blinding,use of a repeated measures design,and possible variation in acupuncture technique amongst the various Traditional Chinese Medicine practitioners.
