The Effect of the McKenzie Method as Compared With That of Manipulation When Applied Adjunctive to Information and Advice for Patients With Clinical Signs of Disc-related Chronic Low Back Pain: Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 350
- 试验地点
- 2
- 主要终点
- Disability
研究概览
简要总结
Introduction:
The McKenzie method as well as spinal manipulation is commonly used for the treatment of low back pain throughout the western world. Recently, the need for studies testing the effect of treatment strategies to specific diagnostic subgroups of patients has been emphasized. The present study aims to compare the effectiveness of the McKenzie method and chiropractic manipulation, information, and advice for patients with clinical signs of persistent symptoms originating from a diskus in the low back.
Methods:
After clinical screening 350 patients with or without leg pain who presented with centralization of symptoms or signs of disc herniation were randomized to the McKenzie group or the manipulation group. The outcome measures, Roland Morris Disability Questionnaire, 11 point numerical pain scale, 6 point global perceived change scale, and quality of life (Short Form-36) were assessed at baseline, at end of treatment, and at 2 and 12 months follow-up.
详细描述
In 1998, Cherkin et al. published a study showing no difference between outcomes following the McKenzie method, chiropractic manipulation, or the provision of an educational booklet for the treatment of patients with acute non-specific low back pain. Recently, the need for studies testing the effect of treatment strategies to specific diagnostic subgroups of patients has been emphasized. The present study aims to compare the effectiveness of the McKenzie method and chiropractic manipulation, information, and advice for patients with clinical signs of disc-related symptoms for duration of more than 6 Weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 60 years of age
- •suffering from low back pain (LBP) with or without leg pain for a period of more than 6 weeks
- •able to speak and understand the Danish language
- •with a presentation of clinical signs of disc-related symptoms.
排除标准
- •positive non-organic signs
- •serious pathology suspected based on physical examination and/or magnetic resonance imaging
- •application for disability pension or pending litigation
- •pregnancy
- •comorbidity
- •recent back surgery
- •problems with communication
结局指标
主要结局
Disability
时间窗: two months after treatment
Problems performing daily activities measured on the 23-item modified Roland Morris Disability Questionnaire (worst: 23 points, best:0 points).
Number of Patients With Treatment Success
时间窗: Two months posttreatment
Treatment success was defined as a reduction of at least 5 points or an absolute score below 5 points on the 23-item modified Roland Morris Disability Questionnaire (best value: 0 points, worst value 23 points)
次要结局
- Pain(twelve months posttreatment)
- Number of Patients on Sick Leave(twelve months posttreatment)
- Quality of Life(twelve months posttreatment)
- Cost Effectiveness(twelve months posttreatment)