背景:膝骨性关节炎(KOA)是最普遍和增长最快的疼痛原因之一,行动不便,以及全球快速老龄化人口的生活质量差。缺乏关于中药疗效的高质量证据,尤其是针灸,以及缺乏针对独特的人口统计和热带气候而量身定制的KOA实践指南。
目的:我们的HARMOKnee(热和针灸治疗膝关节骨关节炎)试验旨在通过评估针灸与热疗的短期和中期临床和成本效益来解决这些差距,除了标准护理,与标准护理相比。通过稳健的流程和经济评价,我们的目标是为KOA患者提供循证实践,以促进大规模实施协调西医和中医要素的全面整体护理模式.我们假设针灸与热疗作为标准护理的辅助治疗在临床上比单独的标准护理更有效。
方法:多中心,务实,平行臂,单盲,将进行有效性-实施混合随机对照试验.我们打算招募100名KOA患者,随机分为对照组(仅标准治疗)或干预组(针灸加热疗,除了标准护理之外)。纳入标准是社区救护车和主要的KOA,排除继发性关节炎或先前膝关节置换的患者。主要结果指标是6周时的膝骨关节炎结果评分。次要结果指标包括心理,物理,生活质量,满意,以及6周、12周和26周的全球结果指标。通过嵌入式过程评估的混合方法方法将有助于大规模实施。将进行经济评估以评估财务可持续性。
结果:患者登记自2022年8月开始。招聘过程预计将于2024年7月结束,调查结果将在获得后进行分析和公布。截至2023年11月6日,我们的患者登记人数为65人。
结论:我们的HARMOKnee研究结果将为当前有关针灸治疗KOA有效性的文献提供大量证据。此外,我们的目标是促进为循证实践制定标准化的国家指南,这些指南专门针对我们独特的人口统计数据。此外,我们寻求促进针灸和热疗的采用和整合到现有的治疗模式中。
背景:ClinicalTrials.govNCT05507619;https://clinicaltrials.gov/study/NCT05507619。
■DERR1-10.2196/54352。
BACKGROUND: Knee osteoarthritis (KOA) is one of most prevalent and fastest-growing causes of pain, impaired mobility, and poor quality of life in the rapidly aging population worldwide. There is a lack of high-quality evidence on the efficacy of traditional Chinese medicine (TCM), particularly acupuncture, and a lack of KOA practice guidelines that are tailored to unique population demographics and tropical climates.
OBJECTIVE: Our HARMOKnee (Heat and Acupuncture to Manage Osteoarthritis of the Knee) trial aims to address these gaps by evaluating the short- and medium-term clinical and cost-effectiveness of acupuncture with heat therapy in addition to standard care, compared to standard care alone. Through a robust process and economic evaluation, we aim to inform evidence-based practice for patients with KOA to facilitate the large-scale implementation of a comprehensive and holistic model of care that harmonizes elements of Western medicine and TCM. We hypothesize that acupuncture with heat therapy as an adjunct to standard care is clinically more effective than standard care alone.
METHODS: A multicenter, pragmatic, parallel-arm, single-blinded, effectiveness-implementation hybrid randomized controlled trial will be conducted. We intend to recruit 100 patients with KOA randomized to either the control arm (standard care only) or intervention arm (acupuncture with heat therapy, in addition to standard care). The inclusion criteria are being a community ambulator and having primary KOA, excluding patients with secondary arthritis or previous knee replacements. The primary outcome measure is the Knee Osteoarthritis Outcome Score at 6 weeks. Secondary outcome measures include psychological, physical, quality of life, satisfaction, and global outcome measures at 6, 12, and 26 weeks. A mixed method approach through an embedded process evaluation will facilitate large-scale implementation. An economic evaluation will be performed to assess financial sustainability.
RESULTS: Patient enrollment has been ongoing since August 2022. The recruitment process is anticipated to conclude by July 2024, and the findings will be analyzed and publicized as they are obtained. As of November 6, 2023, our patient enrollment stands at 65 individuals.
CONCLUSIONS: The findings of our HARMOKnee study will contribute substantial evidence to the current body of literature regarding the effectiveness of acupuncture treatment for KOA. Additionally, we aim to facilitate the creation of standardized national guidelines for evidence-based practice that are specifically tailored to our unique population demographics. Furthermore, we seek to promote the adoption and integration of acupuncture and heat therapy into existing treatment models.
BACKGROUND: ClinicalTrials.gov NCT05507619; https://clinicaltrials.gov/study/NCT05507619.
UNASSIGNED: DERR1-10.2196/54352.