Lindbäck Yvonne, Tropp Hans, Enthoven Paul, Abbott Allan, Öberg Birgitta
Department of Medical and Health Sciences, Division of Physiotherapy, Faculty of Health Sciences, Linköping University, SE-58183, Linköping, Sweden.
Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.
BMC Musculoskelet Disord. 2016 Jul 11;17:270. doi: 10.1186/s12891-016-1126-4.
Current guidelines for the management of patients with specific low back pain pathology suggest non-surgical intervention as first-line treatment, but there is insufficient evidence to make recommendations of the content in the non-surgical intervention. Opinions regarding the dose of non-surgical intervention that should be trialled prior to decision making about surgery intervention vary. The aim of the present study is to investigate if physiotherapy administrated before surgery improves function, pain and health in patients with degenerative lumbar spine disorder scheduled for surgery. The patients are followed over two years. A secondary aim is to study what factors predict short and long term outcomes.
This study is a single blinded, 2-arm, randomized controlled trial with follow-up after the completion of pre-surgery intervention as well as 3, 12 and 24 months post-surgery. The study will recruit men and women, 25 to 80 years of age, scheduled for surgery due to; disc herniation, spinal stenosis, spondylolisthesis or degenerative disc disease. A total of 202 patients will be randomly allocated to a pre-surgery physiotherapy intervention or a waiting list group for 9 weeks. The waiting-list group will receive standardized information about surgery, post-surgical rehabilitation and advice to stay active. The pre-surgery physiotherapy group will receive physiotherapy 2 times per week, consisting of a stratified classification treatment, based on assessment findings. One of the following treatments will be selected; a) Specific exercises and mobilization, b) Motor control exercises or c) Traction. The pre-surgery physiotherapy group will also be prescribed a tailor-made general supervised exercise program. The physiotherapist will use a behavioral approach aimed at reducing patient fear avoidance and increasing activity levels. They will also receive standardized information about surgery, post-surgical rehabilitation and advice to stay active. Primary outcome measure is Oswestry Disability Index. Secondary outcome measures are the visual analogue scale for back and leg pain, pain drawing, health related quality of life, Hospital anxiety and depression scale, Fear avoidance beliefs questionnaire, Self-efficacy scale and Work Ability Index.
The study findings will help improve the treatment of patients with degenerative lumbar spine disorder scheduled for surgery.
ClinicalTrials.gov reference: NCT02454400 (Trial registration date: August 31st 2015) and has been registered on ClinicalTrials.gov, identifier: NCT02454400 .
目前针对特定下腰痛病理患者的管理指南建议将非手术干预作为一线治疗方法，但缺乏足够证据对非手术干预的内容提出建议。关于在决定手术干预之前应试行的非手术干预剂量，各方意见不一。本研究的目的是调查在手术前进行物理治疗是否能改善计划接受手术的退行性腰椎疾病患者的功能、疼痛和健康状况。对患者进行为期两年的随访。次要目的是研究哪些因素可预测短期和长期结果。
本研究是一项单盲、双臂、随机对照试验，在术前干预完成后以及术后3个月、12个月和24个月进行随访。该研究将招募年龄在25至80岁之间、因椎间盘突出、椎管狭窄、椎体滑脱或退行性椎间盘疾病而计划接受手术的男性和女性。总共202名患者将被随机分配到术前物理治疗干预组或等待名单组，为期9周。等待名单组将收到关于手术、术后康复的标准化信息以及保持活动的建议。术前物理治疗组将每周接受2次物理治疗，包括根据评估结果进行的分层分类治疗。将选择以下治疗方法之一：a）特定的锻炼和松动术；b）运动控制锻炼；c）牵引。术前物理治疗组还将被规定一个量身定制的一般监督锻炼计划。物理治疗师将采用行为方法，旨在减少患者的恐惧回避并提高活动水平。他们还将收到关于手术、术后康复的标准化信息以及保持活动的建议。主要结局指标是Oswestry功能障碍指数。次要结局指标包括背部和腿部疼痛的视觉模拟量表、疼痛图、健康相关生活质量、医院焦虑抑郁量表、恐惧回避信念问卷、自我效能量表和工作能力指数。
研究结果将有助于改善计划接受手术的退行性腰椎疾病患者的治疗。
ClinicalTrials.gov标识符：NCT02454400（试验注册日期：2015年8月），已在ClinicalTrials.gov上注册，标识符：NCT02454400 。
