Efficacy and cost-effectiveness of intradiscal methylene blue injection for chronic discogenic low back pain: study protocol for a randomized controlled trial.
Efficacy and cost-effectiveness of intradiscal methylene blue injection for chronic discogenic low back pain: study protocol for a randomized controlled trial.
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DOI：
10.1186/s13063-015-1058-6
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发表时间：
2015-11-21
期刊：
影响因子：
2.5
通讯作者：
van Kleef M
中科院分区：
文献类型：
--
作者：
Geurts JW;Kallewaard JW;Kessels A;Willems PC;van Santbrink H;Dirksen C;van Kleef M
下背痛（LBP）是一种常见的健康问题，并且LBP的很大一部分被认为是由于椎间盘的退变。对于患有难治性椎间盘源性LBP的患者，几乎没有基于证据的有效介入治疗选择。2010年，发表了一项关于“椎间盘内亚甲蓝注射”（IMBI）的随机对照试验（RCT）结果，其中该干预措施似乎在缓解椎间盘源性疼痛方面非常成功。因此，我们决定重复这项研究，以研究我们是否可以复制已发表的结果。我们初步可行性研究的结果为建立RCT提供了理由。本随机对照试验的目的是评估IMBI作为椎间盘内安慰剂干预措施是否是椎间盘源性腰痛的更有效治疗方法，并评估该干预措施的成本效益。目前正在对转介到四个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选。在阳性标准化激发椎间盘造影和知情同意后，患者被随机分为两组。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等渗盐水和利多卡因和造影剂。主要结果指标为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、残疾和止痛剂摄入。对于难治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，这一事实强调了本研究的重要性。如果这项研究确立了临床成功和成本效益，IMBI可能成为非侵入性治疗方案失败的慢性椎间盘源性腰痛患者的“疼痛治疗选择”。国家试验登记册NTR 2547于2010年9月29日和2014年3月31日登记。
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. 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. 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. National Trial register NTR2547 Registered at 29 September 2010 and 31 March 2014.