*School of Health Professions †School of Psychology and Exercise Science ‡Department of Mathematics & Statistics, School of Engineering and Information Technology, Murdoch University, Murdoch, Australia; and §Centre for Health, Exercise & Sports Medicine, The University of Melbourne, Melbourne, Australia.
Spine (Phila Pa 1976). 2013 Sep 15;38(20):1723-9. doi: 10.1097/BRS.0b013e31829fefe4.
Blinded parallel-group randomized controlled trial.
Establish the frequency and severity of adverse effects from short-term usual chiropractic treatment of the spine when compared with a sham treatment group.
Previous studies have demonstrated that adverse events occur during chiropractic treatment. However, as a result of design limitations in previous studies, particularly the lack of sham-controlled randomized trials, understanding of these adverse events and their relation with chiropractic treatment is suboptimal.
We conducted a trial to examine the occurrence of adverse events resulting from chiropractic treatment. It was conducted across 12 chiropractic clinics in Perth, Western Australia. The participants comprised 183 adults, aged 20 to 85 years, with spinal pain. Ninety-two participants received individualized care consistent with the chiropractors' usual treatment approach; 91 participants received a sham intervention. Each participant received 2 treatments.
Completed adverse questionnaires were returned by 94.5% of the participants after appointment 1 and 91.3% after appointment 2. Thirty-three percent of the sham group and 42% of the usual care group reported at least 1 adverse event. Common adverse events were increased pain (sham 29%; usual care 36%), muscle stiffness (sham 29%; usual care 37%), and headache (sham 17%; usual care 9%). The relative risk (RR) was not significant for adverse event occurrence (RR = 1.24; 95% CI: 0.85-1.81), occurrence of severe adverse events (RR = 1.9; 95% CI: 0.98-3.99), adverse event onset (RR = 0.16; 95% CI: 0.02-1.34), or adverse event duration (RR = 1.13; 95% CI: 0.59-2.18). No serious adverse events were reported.
A substantial proportion of adverse events after chiropractic treatment may result from natural history variation and nonspecific effects.
双盲平行组随机对照试验。
与假治疗组相比，确定短期常规脊椎推拿治疗的频率和严重程度的不良反应。
先前的研究表明，在脊椎推拿治疗过程中会出现不良反应。然而，由于先前研究的设计限制，特别是缺乏假对照随机试验，因此对这些不良反应及其与脊椎推拿治疗的关系的理解并不完善。
我们进行了一项试验，以检查脊椎推拿治疗引起的不良反应的发生情况。该试验在澳大利亚珀斯的 12 家脊椎推拿诊所进行。参与者包括 183 名年龄在 20 至 85 岁之间、患有脊椎疼痛的成年人。92 名参与者接受了符合脊椎治疗师常规治疗方法的个性化治疗；91 名参与者接受了假干预。每位参与者接受 2 次治疗。
在第 1 次预约后，94.5%的参与者和第 2 次预约后 91.3%的参与者返回了完整的不良反应问卷。假治疗组 33%和常规治疗组 42%的参与者报告至少有 1 种不良反应。常见的不良反应是疼痛加重（假治疗组 29%；常规治疗组 36%）、肌肉僵硬（假治疗组 29%；常规治疗组 37%）和头痛（假治疗组 17%；常规治疗组 9%）。不良反应发生的相对风险（RR）无显著意义（RR=1.24；95%CI：0.85-1.81），严重不良反应发生的 RR 也无显著意义（RR=1.9；95%CI：0.98-3.99），不良反应的发生时间（RR=0.16；95%CI：0.02-1.34）或不良反应的持续时间（RR=1.13；95%CI：0.59-2.18）也无显著意义。没有报告严重的不良反应。
脊椎推拿治疗后出现的大量不良反应可能是由自然病史变化和非特异性效应引起的。
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