Mesa-Castrillon Carlos I, Simic Milena, Ferreira Manuela L, Hatswell Kristy, Luscombe Georgina, de Gregorio Antonio Michell, Davis Phillip R, Bauman Adrian, Bunker Stephen, Clavisi Ornella, Knox Grahame, Bennell Kim L, Ferreira Paulo H
Musculoskeletal Health, Faculty of Medicine and Health, The University of Sydney, 75 East Street, Lidcombe, Sydney, NSW, 1825, Australia.
Faculty of Medicine and Health, The Institute of Bone and Joint Research, The Kolling Institute, The University of Sydney, Sydney, NSW, Australia.
BMC Musculoskelet Disord. 2021 Jan 5;22(1):11. doi: 10.1186/s12891-020-03866-2.
Low back pain (LBP) and knee osteoarthritis (OA) are major contributors to disability worldwide. These conditions result in a significant burden at both individual and societal levels. Engagement in regular physical activity and exercise programs are known to improve physical function in both chronic LBP and knee OA populations. For people residing in rural areas, musculoskeletal conditions are often more frequent and disabling compared to urban populations, which could be the result of reduced access to appropriate health services and resources in rural settings. EHealth is an innovative solution to help provide equitable access to treatment for people with musculoskeletal pain living in rural settings.
METHODS/DESIGN: We will conduct a randomised clinical trial investigating the effects of an eHealth intervention compared to usual care, for people with chronic non-specific LBP or knee OA in rural Australia. We will recruit 156 participants with non-specific chronic LBP or knee OA. Following the completion of baseline questionnaires, participants will be randomly allocated to either the eHealth intervention group, involving a tailored physical activity and progressive resistance exercise program remotely delivered by a physiotherapist (n = 78), or usual care (n = 78) involving referral to a range of care practices in the community. Outcomes will be measured at baseline, 3 and 6 months post-randomisation. The primary outcome will be physical function assessed by the Patient-Specific Functional Scale (PSFS). Secondary outcomes include pain intensity, physical activity levels, activity limitations, quality of life, pain coping. We will also collect process evaluation data such as recruitment rate, attendance and adherence, follow-up rate, participants' opinions and any barriers encountered throughout the trial.
The findings from this trial will establish the effectiveness of eHealth-delivered interventions that are known to be beneficial for people with LBP and knee OA when delivered in person. As a result, this trial will help to inform health care policy and clinical practice in Australia and beyond for those living in non-urban areas.
This study was prospectively registered on the Australian New Zealand Clinical Trials Registry ( ACTRN12618001494224 ) registered 09.05.2018.
腰痛（LBP）和膝关节骨关节炎（OA）是全球残疾的主要原因。这些病症在个人和社会层面都造成了重大负担。众所周知，定期进行体育活动和参与锻炼计划可改善慢性腰痛和膝关节骨关节炎人群的身体功能。与城市人口相比，农村地区居民的肌肉骨骼疾病往往更为常见且致残性更高，这可能是由于农村地区获得适当医疗服务和资源的机会减少所致。电子健康是一种创新解决方案，有助于为农村地区患有肌肉骨骼疼痛的人群提供公平的治疗机会。
方法/设计：我们将进行一项随机临床试验，调查与常规护理相比，电子健康干预对澳大利亚农村地区患有慢性非特异性腰痛或膝关节OA的人群的影响。我们将招募156名患有非特异性慢性腰痛或膝关节OA的参与者。在完成基线问卷后，参与者将被随机分配到电子健康干预组，该组由物理治疗师远程提供量身定制的体育活动和渐进性抗阻运动计划（n = 78），或常规护理组（n = 78），常规护理组包括转介到社区的一系列护理机构。在基线、随机分组后3个月和6个月时测量结果。主要结果将通过患者特异性功能量表（PSFS）评估身体功能。次要结果包括疼痛强度、身体活动水平、活动限制、生活质量、疼痛应对。我们还将收集过程评估数据，如招募率、出勤率和依从性、随访率、参与者的意见以及试验过程中遇到的任何障碍。
该试验的结果将确定电子健康提供的干预措施的有效性，已知这些干预措施在亲自实施时对腰痛和膝关节OA患者有益。因此，该试验将有助于为澳大利亚及其他地区非城市地区居民的医疗保健政策和临床实践提供信息。
本研究已在澳大利亚新西兰临床试验注册中心（ACTRN12618001494224）进行前瞻性注册，注册时间为2018年5月9日。
