Wylde Vikki, Bertram Wendy, Beswick Andrew D, Blom Ashley W, Bruce Julie, Burston Amanda, Dennis Jane, Garfield Kirsty, Howells Nicholas, Lane Athene, McCabe Candy, Moore Andrew J, Noble Sian, Peters Tim J, Price Andrew, Sanderson Emily, Toms Andrew D, Walsh David A, White Simon, Gooberman-Hill Rachael
Musculoskeletal Research Unit, Translational Health Sciences, Bristol Medical School, University of Bristol, Learning and Research Building, Southmead Hospital, Bristol, BS10 5NB, UK.
National Institute for Health Research Bristol Biomedical Research Centre, University Hospitals Bristol NHS Foundation Trust and University of Bristol, Bristol, UK.
Trials. 2018 Feb 21;19(1):132. doi: 10.1186/s13063-018-2516-8.
Approximately 20% of patients experience chronic pain after total knee replacement. There is little evidence for effective interventions for the management of this pain, and current healthcare provision is patchy and inconsistent. Given the complexity of this condition, multimodal and individualised interventions matched to pain characteristics are needed. We have undertaken a comprehensive programme of work to develop a care pathway for patients with chronic pain after total knee replacement. This protocol describes the design of a randomised controlled trial to evaluate the clinical- and cost-effectiveness of a complex intervention care pathway compared with usual care.
This is a pragmatic two-armed, open, multi-centred randomised controlled trial conducted within secondary care in the UK. Patients will be screened at 2 months after total knee replacement and 381 patients with chronic pain at 3 months postoperatively will be recruited. Recruitment processes will be optimised through qualitative research during a 6-month internal pilot phase. Patients are randomised using a 2:1 intervention:control allocation ratio. All participants receive usual care as provided by their hospital. The intervention comprises an assessment clinic appointment at 3 months postoperatively with an Extended Scope Practitioner and up to six telephone follow-up calls over 12 months. In the assessment clinic, a standardised protocol is followed to identify potential underlying causes for the chronic pain and enable appropriate onward referrals to existing services for targeted and individualised treatment. Outcomes are assessed by questionnaires at 6 and 12 months after randomisation. The co-primary outcomes are pain severity and pain interference assessed using the Brief Pain Inventory at 12 months after randomisation. Secondary outcomes relate to resource use, function, neuropathic pain, mental well-being, use of pain medications, satisfaction with pain relief, pain frequency, capability, health-related quality of life and bodily pain. After trial completion, up to 30 patients in the intervention group will be interviewed about their experiences of the care pathway.
If shown to be clinically and cost-effective, this care pathway intervention could improve the management of chronic pain after total knee replacement.
ISRCTN registry ( ISRCTN92545361 ), prospectively registered on 30 August 2016.
约20%的患者在全膝关节置换术后会经历慢性疼痛。几乎没有证据表明存在有效的干预措施来管理这种疼痛，并且当前的医疗服务提供参差不齐且不一致。鉴于这种情况的复杂性，需要与疼痛特征相匹配的多模式和个体化干预措施。我们开展了一项全面的工作项目，以制定全膝关节置换术后慢性疼痛患者的护理路径。本方案描述了一项随机对照试验的设计，以评估一种复杂干预护理路径与常规护理相比的临床和成本效益。
这是一项在英国二级医疗保健机构内进行的务实双臂、开放、多中心随机对照试验。患者将在全膝关节置换术后2个月接受筛查，术后3个月将招募381例慢性疼痛患者。在为期6个月的内部试点阶段，将通过定性研究优化招募流程。患者以2:1的干预组：对照组分配比例进行随机分组。所有参与者都接受其所在医院提供的常规护理。干预措施包括术后3个月与一名扩展范围从业者进行一次评估门诊预约，并在12个月内进行多达六次电话随访。在评估门诊，遵循标准化方案来确定慢性疼痛的潜在根本原因，并进行适当的转诊，以便利用现有服务进行有针对性的个体化治疗。在随机分组后的6个月和12个月通过问卷调查评估结果。共同主要结局是在随机分组后12个月使用简明疼痛量表评估的疼痛严重程度和疼痛干扰。次要结局涉及资源使用、功能、神经性疼痛、心理健康、止痛药物使用、对疼痛缓解的满意度、疼痛频率、能力、健康相关生活质量和身体疼痛。试验完成后，将对干预组中多达30名患者进行访谈，了解他们对护理路径的体验。
如果该护理路径干预措施被证明具有临床和成本效益，那么它可以改善全膝关节置换术后慢性疼痛的管理。
ISRCTN注册库（ISRCTN92545361），于2016年8月30日进行前瞻性注册。
