de Luca Katie, Pollard Henry, Brantingham James, Globe Gary, Cassa Tammy
Private Practice, Australia; Adjunct Research Faculty, Department of Research, Cleveland Chiropractic College, Los Angeles, CA 90004.
J Chiropr Med. 2011 Jun;10(2):86-92. doi: 10.1016/j.jcm.2010.12.002. Epub 2011 Apr 5.
Our objective is to document the methodology of a randomized controlled clinical trial that demonstrates sound research methodology. The chiropractic treatment performed may be useful to allow practitioners to adopt a similar approach when treating hip osteoarthritis.
This study is a registered, ethics-approved, single-blinded, randomized controlled clinical trial. Recruitment included a controlled media release, phone screening, and physical assessment to rule out nonosteoarthritic hip pain. Primary outcome measures were the McMaster Overall Therapy Effectiveness Tool and the Western Ontario and McMaster Universities Osteoarthritis Index, which were assessed at baseline and after 1, 3, 6, and 9 months. Participants were randomly allocated to 1 of 2 intervention groups: protocol A or B. Protocol A received preadjustive stretches of hip musculature, followed by hip manipulation. Protocol B received the above intervention, followed by an additional assessment and chiropractic treatment of the lower limb kinetic chain. Participants received 9 treatments and then after 3 months were offered an additional 6 treatments. Statistics will be performed by an independent biostatistician.
This article provides a valid and reliable protocol for a randomized controlled trial for the treatment of hip osteoarthritis with chiropractic care. Data should be analyzed for statistical significance to provide evidence for the efficacy of the interventions.
This study is an example of sound research methodology, which was scored as excellent on the Physiotherapy Evidence Database scale. Findings may be important in the scope of treatment, providing evidence for conservative management options for hip osteoarthritis.
我们的目的是记录一项展示可靠研究方法的随机对照临床试验的方法。所实施的整脊治疗可能有助于从业者在治疗髋骨关节炎时采用类似方法。
本研究是一项已注册、经伦理批准、单盲的随机对照临床试验。招募工作包括通过媒体发布进行对照、电话筛查以及体格检查以排除非骨关节炎性髋部疼痛。主要结局指标为麦克马斯特总体治疗效果工具以及西安大略和麦克马斯特大学骨关节炎指数，在基线以及1、3、6和9个月后进行评估。参与者被随机分配至2个干预组之一：方案A或方案B。方案A先对髋部肌肉进行调整前拉伸，随后进行髋关节手法治疗。方案B接受上述干预，随后对下肢动力链进行额外评估和整脊治疗。参与者接受9次治疗，然后在3个月后可选择再接受6次治疗。统计分析将由独立的生物统计学家进行。
本文为一项采用整脊疗法治疗髋骨关节炎的随机对照试验提供了有效且可靠的方案。应对数据进行统计学显著性分析，以提供干预措施有效性的证据。
本研究是可靠研究方法的一个范例，在物理治疗证据数据库量表上被评为优秀。研究结果在治疗范围内可能具有重要意义，为髋骨关节炎的保守治疗方案提供了证据。
