Plain English Summary
Background and study aims
Spinal pain is the leading worldwide cause of 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 reduced effect of pain relief as well as the development of addictive behaviour. Opioid addiction in pain patients is a major problem experienced in the outpatient clinic from which this study is run, no research has yet been completed on the long-term problems and link to clinical outcomes in patients who are prescribed novel opioid medication for chronic back pain.
In Denmark, a large number of different national registers of health data are available. The data from SpineData, the Danish National Patient Register, and The Danish National Prescription Registry will be used to assess different long-term effects of opioid use on a patient’s physical, psychological, and social health. The study will also investigate trends in how opioids are prescribed, how many patients are opioids for a short period when a short term episode of pain occurs, how many patients are being prescribed Long-Term Opioid Therapy (LTOT) for their chronic pain.
Who can participate?
Adult patients with a new spinal pain which lasted for more than 2 months, who attended their first outpatient visit at the participating centre between 2012 and 2013.
What does the study involve?
The participants received an electronic questionnaire three times - at their first visit in the Spinecenter, after 1 year and after 5 years. All participants will have received standard treatment based on their individual needs. No other changes beyond standard care are part of this study.
What are the possible benefits and risks of participating?
The only changes beyond standard care in this study are the completion of three electronic questionnaires, so there is not thought to be an added risk or benefit to participants.
Where is the study run from?
The Spinecenter of Southern Denmark (Denmark)
When is the study starting and how long is it expected to run for?
From January 2018 to June 2021
Who is funding the study?
The Danish Victim Fund, Offerfonden (Denmark)
Who is the main contact?
Prof Claus Manniche
cmanniche2@gmail.com
Trial website
Contact information
Type
Scientific
Primary contact
Prof Claus Manniche
ORCID ID
https://orcid.org/0000-0001-5938-1483
Contact details
claus.manniche2@rsyd.dk
Department of Occupational and Environmental Medicine
Odense University Hospital and Institute of Clinical Research
University of Southern Denmark
Odense M
5230
Denmark
+45 60825021
cmanniche2@gmail.com
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
Danish Data Protection Agency 2008-58-0035
Study information
Scientific title
Long-Term Opioid Therapy in Spine Center Outpatients: The Spinal Pain Opioid Cohort (SPOC)
Acronym
SPOC
Study hypothesis
To collate relevant individual patient data over a decade in order to illuminate both the overall group data developments as well as developments relating to individual usage of different opioids during this period and to correlate these findings with the individual patient’s physical, psychological, and social data over a 10-year period.
Ethics approval
Approved 13/09/2017, the Scientific Ethics Committee of the Region of Southern Denmark (Regionshuset, Damhaven 12, 7100 Vejle, Denmark; +45 7663 8221; komite@regionsyddanmark.dk), ref: S-200112000-29
Study design
Observational longitudinal study using prospective clinical registry data
Primary study design
Observational
Secondary study design
Longitudinal study
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
No participant information sheet available
Condition
Chronic back pain and long term opioid treatment
Intervention
Clinical data will be collected from 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 to the outpatient Spine Centre setting during 2012-2013. The data will be collected from data in SpineData, the Danish National Patient Register, and The Danish National Prescription Registry between 2012 and 2021. Participants will have been asked to complete follow-up questionnaires in SpineData at the time of their first outpatient Spine Centre visit, and again at 1 and 5 years.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Prevalence of patients receiving Long-Term Opioid Therapy (LTOT), defined as receiving six or more opioid prescriptions in a single one-year interval, calculated using clinical data in SpineData, the Danish National Patient Register, and The Danish National Prescription Registry for yearly intervals between 2012 and 2021
Secondary outcome measures
Prevalence of patients receiving at least one opioid prescription in a single one-year interval, calculated using clinical data in SpineData, the Danish National Patient Register, and The Danish National Prescription Registry for yearly intervals between 2012 and 2021
Overall trial start date
01/01/2018
Overall trial end date
30/06/2021
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged between 18 and 65 years
2. Experiencing a new pain episode for more than 2 months
3. Presenting at their first outpatient visit at The Spine Centre between 01/11/2012 and 31/12/2013
4. No indications for acute spinal surgery intervention
5. Baseline questionnaires completed with no missing data related to pain intensity
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
8000
Participant exclusion criteria
1. Basis questionnaires not filled out in SpineData
2. Experiencing symptoms, which indicate serious systemic diseases such as cancer, infections, or inflammatory spondylopathies
Recruitment start date
01/01/2018
Recruitment end date
30/06/2021
Locations
Countries of recruitment
Denmark
Trial participating centre
Spinecenter of Southern Denmark
Østre Hougvej 55
Middelfart
5500
Denmark
Sponsor information
Organisation
Danish Victim Fund
Sponsor details
2. sal Toldboden 2
Viborg
8800
Denmark
+45 3392 3334
www.offerfonden@civilstyrelsen.dk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Offerfonden
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication of 10 papers between 2020 and 2022
IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date
Intention to publish date
01/06/2020
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2020 protocol in https://pubmed.ncbi.nlm.nih.gov/32663155/ (added 20/07/2020)