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Hand Osteoarthritis: investigating Pain Effects of estrogen-containing therapy (HOPE-e): a protocol for a feasibility randomised placebo-controlled trial
Pilot and Feasibility Studies Pub Date : 2021-06-24 , DOI: 10.1186/s40814-021-00869-1
Ioana R Marian 1 , Megan Goff 2, 3 , Jennifer A E Williams 2, 3 , Malvika Gulati 2, 4, 5 , Mae Chester-Jones 1 , Anne Francis 3 , Marion Watson 3, 6 , Tonia L Vincent 2, 4, 5 , Sue Woollacott 2 , Charles Mackworth-Young 4 , Victoria Glover 7 , Dominic Furniss 2, 5 , Matthew Gardiner 2, 8 , Sarah E Lamb 9, 10 , Katy Vincent 11 , Vicki S Barber 3 , Joanna Black 3 , Susan J Dutton 1 , Fiona E Watt 2, 4, 5, 12, 13
Affiliation  

Hand osteoarthritis (OA) is a common condition, causing pain, stiffness and reduced quality of life. Incidence is higher amongst women, particularly around the age of the menopause. Whilst the relationship between sex hormones and OA has been studied in vitro, in epidemiological studies and in clinical trials of hormone replacement therapy (HRT), this study is the first to investigate the effect of estrogen-containing therapy on hand pain in post-menopausal women with symptomatic hand OA in a randomised study design. This is a feasibility study of a double-blinded placebo-controlled intervention with 1:1 randomisation to either a combination of conjugated estrogens 0.45 mg and bazedoxifene acetate 20 mg (Duavive) or placebo. The target population is post-menopausal women with symptomatic hand OA, aiming to recruit 60–90 study participants. The primary objective is to assess the feasibility of a future fully powered randomised controlled trial (RCT). Participants will take the study medication for 24 weeks and be followed up for 28 weeks after randomisation. The primary outcomes used to determine feasibility are eligible participant identification rates and routes; recruitment, randomisation and retention rates of eligible participants; study medication compliance; and the likelihood of unintentional unblinding. Secondary outcomes include measures of hand pain, function, appearance and menopausal symptoms. An end of study questionnaire and focus groups will help to refine the final protocol for a full study. Identifying new treatments for symptomatic hand OA is a recognised research priority. The study will help us to understand whether there are sufficient interested and eligible individuals in this target population who would consider HRT for their hand symptoms. It will provide proof-of-concept RCT data on the effects of HRT on hand pain and other clinically relevant outcomes in this population. The study will gain valuable information on the feasibility of a full RCT and how best to run this. The findings will be published in a peer-reviewed journal and presented at a relevant conference. ISRCTN12196200 registered on 15 January 2019.

中文翻译:

手部骨关节炎:调查含雌激素疗法的疼痛影响 (HOPE-e):可行性随机安慰剂对照试验方案

手部骨关节炎 (OA) 是一种常见病症,会导致疼痛、僵硬和生活质量下降。女性的发病率更高,尤其是在更年期前后。虽然性激素和 OA 之间的关系已经在体外、流行病学研究和激素替代疗法 (HRT) 的临床试验中进行了研究,但这项研究首次调查了含雌激素疗法对绝经后手部疼痛的影响在一项随机研究设计中患有症状性手骨关节炎的女性。这是一项双盲安慰剂对照干预的可行性研究,以 1:1 随机分配结合雌激素 0.45 mg 和醋酸巴多昔芬 20 mg (Duavive) 或安慰剂的组合。目标人群是有症状的手 OA 的绝经后妇女,旨在招募 60-90 名研究参与者。主要目标是评估未来完全有力的随机对照试验 (RCT) 的可行性。参与者将服用研究药物 24 周,并在随机分组后随访 28 周。用于确定可行性的主要结果是合格的参与者识别率和路线;合格参与者的招募、随机化和保留率;研究药物依从性;以及无意揭盲的可能性。次要结果包括手部疼痛、功能、外观和更年期症状的测量。研究问卷和焦点小组的结束将有助于完善完整研究的最终方案。确定有症状的手 OA 的新疗法是公认的研究重点。该研究将帮助我们了解在该目标人群中是否有足够的感兴趣和合格的个体会考虑 HRT 来治疗他们的手部症状。它将提供关于 HRT 对该人群手部疼痛和其他临床相关结果的影响的概念验证 RCT 数据。该研究将获得有关完整 RCT 的可行性以及如何最好地运行它的宝贵信息。研究结果将发表在同行评审的期刊上,并在相关会议上发表。ISRCTN12196200 于 2019 年 1 月 15 日注册。该研究将获得有关完整 RCT 的可行性以及如何最好地运行它的宝贵信息。研究结果将发表在同行评审的期刊上,并在相关会议上发表。ISRCTN12196200 于 2019 年 1 月 15 日注册。该研究将获得有关完整 RCT 的可行性以及如何最好地运行它的宝贵信息。研究结果将发表在同行评审的期刊上,并在相关会议上发表。ISRCTN12196200 于 2019 年 1 月 15 日注册。
更新日期:2021-06-24
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