Acupuncture versus massage for pain in patients living with advanced cancer: a protocol for the IMPACT randomised clinical trial.

Acupuncture versus massage for pain in patients living with advanced cancer: a protocol for the IMPACT randomised clinical trial.
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针灸与按摩治疗晚期癌症患者疼痛:IMPACT随机临床试验方案

DOI:
10.1136/bmjopen-2021-058281
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发表时间:
2022-09-01
期刊:
影响因子:
2.9
通讯作者:
Epstein, Andrew
Epstein, Andrew
中科院分区:
医学3区
文献类型:
--
作者:
Romero, Sally A. D.;Emard, Nicholas;Baser, Raymond E.;Panageas, Katherine;MacLeod, Jodi;Walker, Desiree;Barton-Burke, Margaret;Liou, Kevin;Deng, Gary;Farrar, John;Xiao, Han;Mao, Jun J.;Epstein, Andrew

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疼痛、共病疲劳和睡眠障碍是晚期癌症患者常见且令人痛苦的症状,对他们的生活质量产生负面影响。临床指南推荐非药物干预,包括针灸和按摩,用于成人癌症患者的疼痛管理,以辅助常规护理。然而,关于这些疗法用于症状管理的相对有效性和长期持久性的高质量证据是有限的。我们描述了一项双臂、平行组、多中心随机对照试验的设计,该试验调查了300例不同类型晚期癌症患者中使用针灸与按摩治疗肌肉骨骼疼痛的情况。主要目的是评估针灸与按摩对疼痛(主要结局)和共病症状(疲劳,睡眠障碍和生活质量)的长期有效性(随机化后26周)。次要目的是确定患者水平的人口统计学特征(例如,性别,种族,年龄),临床因素(例如,失眠,疼痛严重程度)和心理属性,这些因素与针灸或按摩的疼痛减轻程度有关。患者将接受每周一次的针灸或按摩治疗,持续10周,然后每月进行一次强化治疗,持续26周。主要终点将是最差疼痛强度评分从基线至第26周的变化。我们将在26周内的多个时间点收集经验证的患者报告结局。纽约Memorial Sloan Kettering癌症中心的机构审查委员会批准了该方案。结果将通过同行评审的科学期刊和会议报告传播。我们的研究结果将帮助患者和医疗保健提供者做出明智的决定,将非药物治疗纳入晚期癌症患者的疼痛管理。NCT 04095234。
Pain, comorbid fatigue and sleep disturbances are common and distressing symptoms for patients with advanced cancer, negatively impacting their quality of life. Clinical guidelines recommend non-pharmacological interventions, including acupuncture and massage, for pain management in adult patients with cancer in adjunct to conventional care. However, high-quality evidence about the comparative effectiveness and long-term durability of these therapies for symptom management is limited. We describe the design of a two-arm, parallel group, multicentre randomised controlled trial that investigates the use of acupuncture versus massage for musculoskeletal pain among 300 patients with diverse types of advanced cancer. The primary aim is to evaluate the long-term effectiveness (26 weeks from randomisation) of acupuncture vs massage for pain (primary outcome) and comorbid symptoms (fatigue, sleep disturbance and quality of life). The secondary aim is to identify patient-level demographic characteristics (eg, sex, race, age), clinical factors (eg, insomnia, pain severity) and psychological attributes that are associated with a greater reduction in pain for either acupuncture or massage. Patients will receive weekly acupuncture or massage treatments for 10 weeks, followed by monthly booster sessions up to 26 weeks. The primary endpoint will be the change in worst pain intensity score from baseline to 26 weeks. We will collect validated patient-reported outcomes at multiple time points over 26 weeks. The Institutional Review Board at Memorial Sloan Kettering Cancer Center in New York approved this protocol. Results will be disseminated via peer-reviewed scientific journals and conference presentations. Our findings will help patients and healthcare providers make informed decisions about incorporating non-pharmacological treatments to manage pain for patients with advanced cancer. NCT04095234.
DOI: 10.1016/s1389-9457(00)00065-4
发表时间: 2001-07-01
期刊: SLEEP MEDICINE
影响因子: 4.8
作者:
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通讯作者: Morin, Charles M.
CDC规定慢性疼痛的阿片类药物的指南 - 美国,2016年。
DOI: 10.1001/jama.2016.1464
发表时间: 2016-04-19
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作者:
Dowell D;Haegerich TM;Chou R
通讯作者: Chou R
DOI: 10.1111/j.2517-6161.1995.tb02031.x
发表时间: 1995-01-01
影响因子: 5.8
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通讯作者: HOCHBERG, Y
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DOI: 10.1016/s0304-3959(00)00339-0
发表时间: 2000-12-01
期刊: PAIN
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