Department of Medical and Health Sciences, Physiotherapy, Linköping University, Linköping, Sweden.
Centre for Clinical Research Sörmland, Uppsala University, Uppsala, Sweden.
BMJ Open. 2019 Feb 19;9(2):e027387. doi: 10.1136/bmjopen-2018-027387.
Patients suffering from remaining disability after anterior cervical decompression and fusion (ACDF) surgery for cervical disc disease may be prescribed physical activity (PPA) or neck-specific exercises (NSEs). Currently, we lack data for the success of either approach. There is also a knowledge gap concerning the use of internet-based care for cervical disc disease. The scarcity of these data, and the high proportion of patients with various degrees of incapacity following ACDF, warrant increased efforts to investigate and improve cost-effective rehabilitation. The objective is to compare the effectiveness of a structured, internet-based NSE programme, versus PPA following ACDF surgery.
This is a prospective, randomised, multicentre study that includes 140 patients with remaining disability (≥30% on the Neck Disability Index, NDI) following ACDF for radiculopathy due to cervical disc disease. Patient recruitment occurs following attendance at routine clinical appointments, scheduled at 3 months postsurgery. Patients are then randomised to one of two groups (70 patients/group) for a 3-month treatment programme/period of either internet-based NSE or PPA. Questionnaires on background data, pain and discomfort, physical and mental capacity, satisfaction with care, and health and workplace factors are completed, along with physical measures of neck-related function conducted by independent test leaders blinded to randomisation. Measures are collected at inclusion, after the 3-month treatments (end of treatment) and at a 2-year follow-up. Radiography will be completed at the 2-year follow-up. Preoperative data will be collected from the Swedish Spine Registry. Data on healthcare consumption, drug use and sick leave will be requested from the relevant national registers.
This study was approved by the Regional Ethical Review Board in Linköping Ref. 2016/283-31 and 2017/91- 32. The scientists are independent with no commercial ties. Patients are recruited after providing written informed consent. Patient data are presented at group level such that no connection to any individual can be made. All data are anonymised when reported, and subject to the Swedish Official Secrets Health Acts. The test leaders are independent and blinded for randomisation. Exercises, both general and neck-specific, have been used extensively in clinical practice and we anticipate no harm from their implementation other than a risk of muscle soreness. Both randomisation groups will receive care that is expected to relieve pain, although the group receiving NSE is expected to demonstrate a greater and more cost-effective improvement versu s the PPA group. Any significant harm or unintended effects in each group will be collected by the test leaders. All questionnaires and test materials are coded by the research group, with code lists stored in locked, fireproof file cabinets, housed at the university in a room with controlled (card-based) access. Only individuals in receipt of a unique website address posted by the researchers can access the programme; patients can neither communicate with each other nor with caregivers via the programme.Study participation might lead to improved rehabilitation versus non-participation, and might therefore be of benefit. The results of this study should also contribute to more effective and flexible rehabilitation, shorter waiting times, lower costs and the possibility to implement our findings on a wider level.
If effective, the protocols used in this study can be implemented in existing healthcare structures. The results of the study will be presented in scientific journals and popular science magazines of relevance to health. The findings will also be presented at local, regional, national and international conferences and meetings, as well as in the education of university students and at public lectures. Information about the results will be communicated to the general population in cooperation with patient organisations and the media.
NCT03036007.
患有颈椎间盘疾病的患者在接受颈椎前路减压融合术 (ACDF) 后仍存在残疾，可能会被开具物理活动 (PPA) 或颈部特定运动 (NSE) 的处方。目前，我们缺乏这两种方法成功的相关数据。对于颈椎间盘疾病的互联网护理，我们也存在知识空白。这些数据的缺乏，以及 ACDF 后存在各种程度功能障碍的患者比例较高，都需要我们加强努力，调查并改善具有成本效益的康复方法。我们的目的是比较基于互联网的结构化 NSE 计划与 ACDF 手术后 PPA 在疗效上的差异。
这是一项前瞻性、随机、多中心研究，纳入了 140 名因颈椎间盘疾病导致神经根病而行 ACDF 术后仍存在残疾（NDI 评分≥30%）的患者。患者是在常规临床预约就诊后招募的，预约时间为术后 3 个月。随后，患者被随机分为两组（每组 70 名患者），进行为期 3 个月的治疗计划/治疗期，分别为基于互联网的 NSE 或 PPA。通过独立的测试负责人进行问卷调查，以了解患者的背景数据、疼痛和不适、身体和精神能力、对护理的满意度、健康和工作场所因素，同时还进行了与颈部相关的功能的物理测量，这些测试负责人是独立的，对随机分组不知情。测量结果在纳入时、3 个月治疗结束时（治疗结束时）和 2 年随访时收集。在 2 年随访时将进行 X 光检查。术前数据将从瑞典脊柱登记处收集。将从相关国家登记处请求有关医疗保健消费、药物使用和病假的数据。
本研究得到了林雪平地区伦理审查委员会的批准，注册号为 2016/283-31 和 2017/91-32。科学家们是独立的，没有商业联系。患者在提供书面知情同意书后被招募。患者数据以群体水平呈现，因此无法与任何个体建立联系。所有数据在报告时均进行匿名处理，并受瑞典官方机密健康法案的约束。测试负责人是独立的，对随机分组不知情。一般和颈部特定的运动在临床实践中已经广泛使用，我们预计除了肌肉酸痛的风险外，其实施不会造成任何伤害。两组随机分组都将接受预期能缓解疼痛的护理，但接受 NSE 的组预计会比接受 PPA 的组在改善方面取得更大和更具成本效益的效果。每个组中任何显著的伤害或意外影响都将由测试负责人收集。所有问卷和测试材料都由研究小组进行编码，代码列表存储在锁着的防火文件柜中，存放在大学的一个通过卡片控制（card-based）访问的房间内。只有收到研究人员发布的唯一网站地址的个人才能访问该计划；患者既不能通过该计划与彼此沟通，也不能与护理人员沟通。参与研究可能会带来比不参与更好的康复效果，因此可能对患者有益。该研究的结果也应有助于更有效和灵活的康复、缩短等待时间、降低成本以及实施我们在更广泛范围内的发现的可能性。
如果有效，本研究中使用的方案可以在现有的医疗保健结构中实施。研究结果将在相关的科学期刊和大众科学杂志上发表。研究结果还将在地方、区域、国家和国际会议和会议上以及在大学生教育和公开讲座中呈现。还将与患者组织和媒体合作，向公众传播研究结果。
NCT03036007。
