Paanalahti Kari, Holm Lena W, Nordin Margareta, Asker Martin, Lyander Jessica, Skillgate Eva
Institute of Environmental Medicine, Karolinska Institutet, Box 210, SE-17177 Stockholm, Sweden.
BMC Musculoskelet Disord. 2014 Mar 12;15:77. doi: 10.1186/1471-2474-15-77.
The safety of the manual treatment techniques such as spinal manipulation has been discussed and there is a need for more information about potential adverse events after manual therapy. The aim of this randomized controlled trial was to investigate differences in occurrence of adverse events between three different combinations of manual treatment techniques used by manual therapists (i.e. chiropractors, naprapaths, osteopaths, physicians and physiotherapists) for patients seeking care for back and/or neck pain. In addition women and men were compared regarding the occurrence of adverse events.
Participants were recruited among patients, ages 18-65, seeking care at the educational clinic of the Scandinavian College of Naprapathic Manual Medicine in Stockholm. The patients (n = 767) were randomized to one of three treatment arms 1) manual therapy (i.e. spinal manipulation, spinal mobilization, stretching and massage) (n = 249), 2) manual therapy excluding spinal manipulation (n = 258) and 3) manual therapy excluding stretching (n = 260). Treatments were provided by students in the seventh semester of total eight. Adverse events were measured with a questionnaire after each return visit and categorized in to five levels; 1) short minor, 2) long minor, 3) short moderate, 4) long moderate and 5) serious adverse events, based on the duration and/or severity of the event. Generalized estimating equations were used to examine the association between adverse event and treatments arms.
The most common adverse events were soreness in muscles, increased pain and stiffness. No differences were found between the treatment arms concerning the occurrence of adverse event. Fifty-one percent of patients, who received at least three treatments, experienced at least one adverse event after one or more visits. Women more often had short moderate adverse events (OR = 2.19 (95% CI: 1.52-3.15)), and long moderate adverse events (OR = 2.49 (95% CI: 1.77-3.52)) compared to men.
Adverse events after manual therapy are common and transient. Excluding spinal manipulation or stretching do not affect the occurrence of adverse events. The most common adverse event is soreness in the muscles. Women reports more adverse events than men.
This trial was registered in a public registry (Current Controlled Trials) (ISRCTN92249294).
诸如脊柱推拿等手法治疗技术的安全性已被讨论，且需要更多关于手法治疗后潜在不良事件的信息。这项随机对照试验的目的是调查手法治疗师（即脊椎按摩师、推拿按摩师、整骨疗法医生、内科医生和物理治疗师）使用的三种不同手法治疗技术组合，在为背部和/或颈部疼痛患者提供治疗时不良事件发生率的差异。此外，还比较了男性和女性不良事件的发生率。
在斯德哥尔摩的斯堪的纳维亚推拿按摩医学学院教育诊所就诊的18至65岁患者中招募参与者。患者（n = 767）被随机分配到三个治疗组之一：1）手法治疗（即脊柱推拿、脊柱松动、拉伸和按摩）（n = 249），2）不包括脊柱推拿的手法治疗（n = 258），3）不包括拉伸的手法治疗（n = 260）。治疗由总共八个学期中第七学期的学生提供。每次复诊后用问卷测量不良事件，并根据事件的持续时间和/或严重程度分为五个级别：1）短期轻微，2）长期轻微，3）短期中度，4）长期中度，5）严重不良事件。使用广义估计方程来检验不良事件与治疗组之间的关联。
最常见的不良事件是肌肉酸痛、疼痛加剧和僵硬。治疗组之间在不良事件发生率方面未发现差异。接受至少三次治疗的患者中，51%在一次或多次就诊后经历了至少一次不良事件。与男性相比，女性更常出现短期中度不良事件（OR = 2.19（95%CI：1.52 - 3.15））和长期中度不良事件（OR = 2.49（95%CI：1.77 - 3.52））。
手法治疗后的不良事件常见且短暂。排除脊柱推拿或拉伸不影响不良事件的发生。最常见的不良事件是肌肉酸痛。女性报告的不良事件比男性多。
本试验在一个公共注册库（当前对照试验）（ISRCTN92249294）中注册。
