Psychiatric Comorbidity in Back Pain Disorders

NCT03825991 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 500000

Last updated 2019-04-23

No results posted yet for this study

Summary

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.

Conditions

Sponsors & Collaborators

  • University of Southern Denmark

    collaborator OTHER
  • Odense University Hospital

    collaborator OTHER
  • Spine Centre of Southern Denmark

    lead OTHER

Principal Investigators

  • Pernille S Ljungdalh, MscPH · Spine Centre of Southern Denmark and Institute for Regional Health Research, University of Southern Denmark

  • Berit Sciottz-Christensen, PhD, Professor · Spine Centre of Southern Denmark and Institute for Regional Health Research, University of Southern Denmark

  • Elsebeth Stenager, Professor · Odense University Hospital

  • Maria Iachina, PhD · Odense University Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-01
Primary Completion
2019-12-01
Completion
2021-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03825991 on ClinicalTrials.gov