Cheng Sheung-Tak, Chan Ka Long, Lam Rosanna W L, Mok Monique H T, Chen Phoon Ping, Chow Yu Fat, Chung Joanne W Y, Law Alexander C B, Lee Jenny S W, Leung Edward M F, Tam Cindy W C
Department of Health and Physical Education, The Education University of Hong Kong, 10 Lo Ping Road, Tai Po, New Territories, Hong Kong.
Department of Clinical Psychology, Norwich Medical School, University of East Anglia, Norfolk, NR4 7TJ, UK.
Trials. 2017 Nov 9;18(1):528. doi: 10.1186/s13063-017-2270-3.
BACKGROUND: Studies have shown that physical interventions and psychological methods based on the cognitive behavioral approach are efficacious in alleviating pain and that combining both tends to yield more benefits than either intervention alone. In view of the aging population with chronic pain and the lack of evidence-based pain management programs locally, we developed a multicomponent intervention incorporating physical exercise and cognitive behavioral techniques and examined its long-term effects against treatment as usual (i.e., pain education) in older adults with chronic musculoskeletal pain in Hong Kong. METHODS/DESIGN: We are conducting a double-blind, cluster-randomized controlled trial. A sample of 160 participants aged ≥ 60 years will be recruited from social centers or outpatient clinics and will be randomized on the basis of center/clinic to either the multicomponent intervention or the pain education program. Both interventions consist of ten weekly sessions of 90 minutes each. The primary outcome is pain intensity, and the secondary outcomes include pain interference, pain persistence, pain self-efficacy, pain coping, pain catastrophizing cognitions, health-related quality of life, depressive symptoms, and hip and knee muscle strength. All outcome measures will be collected at baseline, postintervention, and at 3 and 6 months follow-up. Intention-to-treat analysis will be performed using mixed-effects regression to see whether the multicomponent intervention alleviates pain intensity and associated outcomes over and above the effects of pain education (i.e., a treatment × time intervention effect). DISCUSSION: Because the activities included in the multicomponent intervention were carefully selected for ready implementation by allied health professionals in general, the results of this study, if positive, will make available an efficacious, nonpharmacological pain management program that can be widely adopted in clinical and social service settings and will hence improve older people's access to pain management services. TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR-IIR-16008387. Registered on 28 April 2016.
背景:研究表明,基于认知行为方法的物理干预和心理方法在减轻疼痛方面是有效的,并且将两者结合起来往往比单独使用任何一种干预措施能产生更多益处。鉴于慢性疼痛的老年人口不断增加,且本地缺乏循证疼痛管理方案,我们开发了一种包含体育锻炼和认知行为技术的多组分干预措施,并在香港患有慢性肌肉骨骼疼痛的老年人中,将其长期效果与常规治疗(即疼痛教育)进行了对比研究。 方法/设计:我们正在进行一项双盲、整群随机对照试验。将从社会中心或门诊诊所招募160名年龄≥60岁的参与者,并根据中心/诊所将其随机分为多组分干预组或疼痛教育组。两种干预措施均包括每周一次、每次90分钟、共十次的课程。主要结局是疼痛强度,次要结局包括疼痛干扰、疼痛持续时间、疼痛自我效能感、疼痛应对、疼痛灾难化认知、健康相关生活质量、抑郁症状以及髋部和膝部肌肉力量。所有结局指标将在基线、干预后以及干预后3个月和6个月随访时收集。将使用混合效应回归进行意向性分析,以观察多组分干预措施在疼痛教育效果之上是否能减轻疼痛强度及相关结局(即治疗×时间干预效应)。 讨论:由于多组分干预措施中包含的活动经过精心挑选,便于一般的专职医疗人员实施,因此本研究结果若为阳性,将提供一种有效的非药物疼痛管理方案,该方案可在临床和社会服务环境中广泛采用,从而改善老年人获得疼痛管理服务的机会。 试验注册:中国临床试验注册中心,ChiCTR-IIR-16008387。于2016年4月28日注册。
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