Looking back at health data collected over 9 years to assess the long term effects of using opioids to treat chronic back pain
| ISRCTN | ISRCTN69685117 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN69685117 |
| Secondary identifying numbers | Danish Data Protection Agency 2008-58-0035 |
- Submission date
- 24/05/2020
- Registration date
- 28/05/2020
- Last edited
- 20/07/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
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
Contact information
Scientific
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
 ORCID ID |
0000-0001-5938-1483 |
|---|---|
| Phone | +45 60825021 |
| cmanniche2@gmail.com |
Study information
| Study design | Observational longitudinal study using prospective clinical registry data |
|---|---|
| Primary study design | Observational |
| Secondary study design | Longitudinal study |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | No participant information sheet available |
| Scientific title | Long-Term Opioid Therapy in Spine Center Outpatients: The Spinal Pain Opioid Cohort (SPOC) |
| Study acronym | SPOC |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/01/2018 |
| Completion date | 30/06/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 8000 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2018 |
| Date of final enrolment | 30/06/2021 |
Locations
Countries of recruitment
- Denmark
Study participating centre
Middelfart
5500
Denmark
Sponsor information
Government
2. sal Toldboden 2
Viborg
8800
Denmark
| Phone | +45 3392 3334 |
|---|---|
| www.offerfonden@civilstyrelsen.dk | |
| Website | http//offerfonden.dk |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 01/06/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Planned publication of 10 papers between 2020 and 2022 |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 19/08/2020 | 20/07/2020 | Yes | No |
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.
