Condition category
Musculoskeletal Diseases
Date applied
24/05/2020
Date assigned
28/05/2020
Last edited
20/07/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

http//offerfonden.dk

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)

Publication citations

Additional files

Editorial Notes

20/07/2020: Publication reference added. 28/05/2020: Trial’s existence confirmed by the Scientific Ethics Committee of the Region of Southern Denmark.