椎间盘内注射亚甲蓝治疗慢性盘源性下腰痛的疗效及成本效益：一项随机对照试验的研究方案
Efficacy and cost-effectiveness of intradiscal methylene blue injection for chronic discogenic low back pain: study protocol for a randomized controlled trial.
作者信息
Geurts José W, Kallewaard Jan-Willem, Kessels Alfons, Willems Paul C, van Santbrink Henk, Dirksen Carmen, van Kleef Maarten
机构信息
Department of Anaesthesiology, and Pain Medicine, Maastricht University Medical Centre, Mailbox 5800, 6202, AZ, Maastricht, The Netherlands.
Rijnstate Hospital, Department of Anaesthesiology and Pain Management, Mailbox 9555, 6800, TA, Arnhem, The Netherlands.
出版信息
Trials. 2015 Nov 21;16:532. doi: 10.1186/s13063-015-1058-6.
BACKGROUND
Low back pain (LBP) is a common health problem and a substantial part of LBP is presumed to be attributable to degeneration of the intervertebral disc. For patients suffering from intractable discogenic LBP, there are few evidence-based effective interventional treatment options available. In 2010, the results of a randomized controlled trial (RCT) were published concerning "intradiscal methylene blue injection" (IMBI), in which this intervention appeared to be very successful in relieving discogenic pain. Therefore, we decided to repeat this study to investigate whether we could replicate the published results. The results of our preliminary feasibility study gave reason to set up an RCT. The aim of this RCT is to evaluate if IMBI is a more effective treatment of discogenic low back pain as an intradiscal placebo intervention, and furthermore, to assess the cost-effectiveness of this intervention.
METHODS/DESIGN: Consecutive discogenic low back pain patients referred to four specialized pain treatment facilities are being screened for eligibility. After a positive standardized provocation discography and informed consent, patients are randomized into two groups. The treatment group receives an intradiscal injection with methylene blue, lidocaine, and contrast, and the control group receives intradiscal isotonic saline with lidocaine and contrast. Main outcome measures are pain at the 6-month follow-up, patient's global impression of change, cost-effectiveness, quality of life, disability, and analgesic intake.
DISCUSSION
The importance of this study is emphasized by the fact that for intractable discogenic low back pain patients, evidence-based effective pain treatments are rare. If this study establishes clinical success and cost-effectiveness, IMBI could become the "pain treatment of choice" for a selected group of patients with chronic discogenic low back pain for whom noninvasive treatment options have failed.
TRIAL REGISTRATION
National Trial register NTR2547 Registered at 29 September 2010 and 31 March 2014.
背景
腰痛是一个常见的健康问题，且大部分腰痛被认为可归因于椎间盘退变。对于患有顽固性椎间盘源性腰痛的患者，几乎没有基于证据的有效干预治疗方案。2010年，一项关于“椎间盘内注射亚甲蓝”（IMBI）的随机对照试验（RCT）结果发表，该干预措施在缓解椎间盘源性疼痛方面似乎非常成功。因此，我们决定重复这项研究，以调查我们是否能够重现已发表的结果。我们初步可行性研究的结果为开展一项RCT提供了依据。这项RCT的目的是评估IMBI作为椎间盘内安慰剂干预措施，在治疗椎间盘源性腰痛方面是否比其他方法更有效，此外，还要评估该干预措施的成本效益。
方法/设计：对转诊至四家专业疼痛治疗机构的连续性椎间盘源性腰痛患者进行资格筛查。在标准化激发性椎间盘造影呈阳性并获得知情同意后，将患者随机分为两组。治疗组接受椎间盘内注射亚甲蓝、利多卡因和造影剂，对照组接受椎间盘内注射含利多卡因和造影剂的等渗盐水。主要结局指标包括6个月随访时的疼痛、患者对变化的总体印象、成本效益、生活质量、残疾情况和镇痛药物摄入量。
讨论
对于顽固性椎间盘源性腰痛患者，基于证据的有效疼痛治疗方法很少，这一事实凸显了本研究的重要性。如果本研究证实了临床疗效和成本效益，IMBI可能会成为一类特定慢性椎间盘源性腰痛患者的“首选疼痛治疗方法”，这类患者无创治疗方案已失败。
试验注册
国家试验注册库NTR2547，于2010年9月29日和2014年3月31日注册。
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