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NCT03825991
Psychiatric Comorbidity in Back Pain Disorders
trial in Back Pain in 500,000 participants. Status unknown.
1 December 2019
Quick facts
| Lead sponsor | Spine Centre of Southern Denmark |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 500,000 |
| Start date | 1 July 2019 |
| Primary completion | 1 December 2019 |
| Estimated completion | 30 June 2021 |
Conditions studied
- Back Pain — all drugs for Back Pain →
- Psychiatric Disorder — all drugs for Psychiatric Disorder →
Sponsor
Spine Centre of Southern Denmark
Who can join
18 and older, any sex, with Back Pain or Psychiatric Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Introduction: Studies focusing on back pain do not compare different types of back pain diagnosis in relation to a specific psychiatric comorbidity, nor if the presence of psychiatric comorbidity affects treatment. There are limited knowledge on pharmacological treatment of back pain disorders,and especially if the presence of psychiatric comorbidity is an ad-on to the dosage of medication prescribed. Investigating the use of opioids and other pain medication in back patients and the potential effect of concomitant psychiatric comorbidity as well as taking psychiatric medication under consideration is therefore relevant. Aim: This aim of this PhD thesis is: 1\) to estimate the prevalence of psychiatric comorbidity in patients with back pain disorders (BPD) compared to patients with no back pain. 2) Investigate if psychiatric comorbidity affects the type of treatment given. 3) Examine if the presence of psychiatric comorbidity affects the levels of pharmacological treatment given with a focus on both pain medication, such as opioids, as well as treatment with psychotropic medication. Methods:The association between back pain disorders and psychiatric comorbidity will be investigated using population-based registry data. The population will be defined as adult patients (+18) with a relevant back pain disorder using The National Danish Patient Registry. The following registries will be also utilized: A subdivision of the DNPR, the National Patient Registry - Psychiatry (NPD-Psych), The Danish National Prescription Database, The Danish National Health Service Register and the DREAM database. By using the Danish Civil Registry and the unique personal identification number assigned to all Danish citizens at birth, data across registries can be linked on an individual level. Ethics:The Region of Southern Denmark is the data controller for this project, and it is included in their records of personal data processing activities (file no. (18/3337).). Additional approvals or consents were not needed for this project based exclusively on national registries according to Danish law. The data processing was conducted according to EU and Danish legislation on processing of sensitive personal information and, as complies with internal regulations from the Region of Southern Denmark.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03825991
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Related trials
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Currently open trials in the same condition.
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Other Spine Centre of Southern Denmark trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03825991 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Spine Centre of Southern Denmark
- Last refreshed: 23 April 2019
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