Manniche Claus, Stokholm Lonny, Ravn Sophie L, Andersen Tonny E, Brandt Lars Pa, Rubin Katrine H, Schiøttz-Christensen Berit, Andersen Lars L, Skousgaard Søren G
Department of Occupational and Environmental Medicine, Institute of Clinical Research, University of Southern Denmark, Odense, Denmark.
Open Patient Data Explorative Network, Department of Clinical Research, University of Southern Denmark and Odense University Hospital, Odense, Denmark.
JMIR Res Protoc. 2020 Aug 19;9(8):e21380. doi: 10.2196/21380.
Spinal pain is the leading cause of patient-years lived with chronic pain and disability worldwide. Although opioids are well documented as an effective short-term pain-relieving medication, more than a few weeks of treatment may result in a diminishing clinical effect as well as the development of addictive behavior. Despite recognition of opioid addiction in pain patients as a major problem commonly experienced in the clinic, no reference material exists on the scope of long-term problems in novel opioid users and the link to clinical outcomes.
The main aims of this study are to describe baseline and follow-up characteristics of the Spinal Pain Opioid Cohort (SPOC), to evaluate the general use of opioids in spinal pain when an acute pain episode occurs, and to demonstrate the prevalence of long-term opioid therapy (LTOT).
Prospective clinical registry data were collected from an outpatient spine center setting during 2012-2013 including patients with a new spinal pain episode lasting for more than 2 months, aged between 18 and 65 years who had their first outpatient visit in the center. Variables include demographics, clinical data collected in SpineData, the Danish National Patient Register, and The Danish National Prescription Registry. The primary outcome parameter is long-term prescription opioid use registered from 4 years before the first spine center visit to 5 years after.
This is an ongoing survey. It is estimated that more than 8000 patients fulfill the SPOC inclusion criteria. In 2019, we began the intellectual process of identifying the most relevant supplementary data available from the wide range of existing national registries available in Denmark. We have now begun merging SpineData with relevant opioid data from Danish national registers and will continue to extract data up to 2021-2022. We will also be looking at data regarding somatic or psychiatric hospitalization patterns, patient usage of health care resources, as well as their working status and disability pensions.
To our knowledge, this survey will be the first to document the scope of long-term problems regarding LTOT and opioid addiction following new spinal pain episodes and comparing descriptive follow-up data between substance users and nonusers.
ISRCTN Registry ISRCTN69685117; http://www.isrctn.com/ISRCTN69685117.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/21380.
在全球范围内，脊柱疼痛是导致慢性疼痛和残疾患者年数最多的原因。尽管阿片类药物作为一种有效的短期止痛药物已有充分记录，但超过几周的治疗可能会导致临床效果逐渐减弱以及成瘾行为的出现。尽管疼痛患者中的阿片类药物成瘾被认为是临床上常见的主要问题，但关于新型阿片类药物使用者长期问题的范围及其与临床结果的联系，尚无参考资料。
本研究的主要目的是描述脊柱疼痛阿片类药物队列（SPOC）的基线和随访特征，评估急性疼痛发作时阿片类药物在脊柱疼痛中的一般使用情况，并证明长期阿片类药物治疗（LTOT）的患病率。
前瞻性临床登记数据收集于2012年至2013年期间的一家门诊脊柱中心，包括新出现脊柱疼痛发作持续超过2个月、年龄在18至65岁之间且首次在该中心门诊就诊的患者。变量包括人口统计学、在SpineData、丹麦国家患者登记处和丹麦国家处方登记处收集的临床数据。主要结局参数是从首次脊柱中心就诊前4年到就诊后5年登记的长期处方阿片类药物使用情况。
这是一项正在进行的调查。估计有超过8000名患者符合SPOC纳入标准。2019年，我们开始了从丹麦现有的大量国家登记处识别最相关补充数据的知识过程。我们现在已开始将SpineData与丹麦国家登记处的相关阿片类药物数据合并，并将继续提取数据至2021 - 2022年。我们还将研究有关躯体或精神科住院模式、患者对医疗资源的使用情况以及他们的工作状态和残疾抚恤金的数据。
据我们所知，这项调查将首次记录新出现脊柱疼痛发作后LTOT和阿片类药物成瘾的长期问题范围，并比较药物使用者和非使用者之间的描述性随访数据。
ISRCTN注册库ISRCTN69685117；http://www.isrctn.com/ISRCTN69685117。
国际注册报告标识符（IRRID）：DERR1 - 10.2196/21380。
