Study protocol for long-term opioid therapy in spine center outpatients: The Spinal Pain Opioid Cohort (SPOC) [Epub ahead of print]

Tidsskriftartikel - 2020

Resume

BACKGROUND: Spinal pain is the leading worldwide cause of patient-years lived with chronic pain and disability. While 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. Even though opioid addiction in pain patients is 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.

OBJECTIVE: The purpose of this study is to describe baseline and follow-up characteristics of the Spinal Pain Opioid Cohort (SPOC) and to evaluate the general use of opioids in spinal pain when an acute pain episode occurs and to show the prevalence of Long-Term Opioid Therapy (LTOT).

METHODS: Prospective clinical registry data from an outpatient Spine Centre 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.

RESULTS: : From the long-term collection of relevant individual patient data it will be possible to illuminate both the overall group data developments as well as long term developments relating to individual usage of different opioids and to correlate these findings with the individual patient's physical, psychological, and social data. The database will be linked to different national registers in the years to come and provides the opportunity to assess the long-term effects of opioid use.

CONCLUSIONS: : To our knowledge, this survey will be the first study to document the scope of long-term problems regarding LTOT and opioid addiction following new spinal pain episodes and comparing descriptive follow-up data from substance users with non-users.

CLINICALTRIAL: Trial Registration: ISRCTN, ISRCTN69685117. Registered 28 May 2020 - Retrospectively registered, http://www.isrctn.com/ISRCTN69685117.

Reference

Manniche C, Stokholm L, Ravn SL, Andersen TE, Brandt LPA, Rubin KH, Schiøttz-Christensen B, Andersen LL, Skousgaard SG. Study protocol for long-term opioid therapy in spine center outpatients: The Spinal Pain Opioid Cohort (SPOC) [Epub ahead of print]. JMIR Research Protocols 2020.
doi: 10.2196/21380

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