<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03825991</url>
  </required_header>
  <id_info>
    <org_study_id>SpineCentreSD</org_study_id>
    <nct_id>NCT03825991</nct_id>
  </id_info>
  <brief_title>Psychiatric Comorbidity in Back Pain Disorders</brief_title>
  <official_title>Psychiatric Comorbidity in Back Pain Disorders - Risk, Treatment and Pharmaco-epidemiological Analysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Spine Centre of Southern Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Southern Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Odense University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Spine Centre of Southern Denmark</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Introduction: Studies focusing on back pain do not compare different types of back pain&#xD;
      diagnosis in relation to a specific psychiatric comorbidity, nor if the presence of&#xD;
      psychiatric comorbidity affects treatment. There are limited knowledge on pharmacological&#xD;
      treatment of back pain disorders,and especially if the presence of psychiatric comorbidity is&#xD;
      an ad-on to the dosage of medication prescribed. Investigating the use of opioids and other&#xD;
      pain medication in back patients and the potential effect of concomitant psychiatric&#xD;
      comorbidity as well as taking psychiatric medication under consideration is therefore&#xD;
      relevant.&#xD;
&#xD;
      Aim: This aim of this PhD thesis is:&#xD;
&#xD;
      1) to estimate the prevalence of psychiatric comorbidity in patients with back pain disorders&#xD;
      (BPD) compared to patients with no back pain. 2) Investigate if psychiatric comorbidity&#xD;
      affects the type of treatment given. 3) Examine if the presence of psychiatric comorbidity&#xD;
      affects the levels of pharmacological treatment given with a focus on both pain medication,&#xD;
      such as opioids, as well as treatment with psychotropic medication.&#xD;
&#xD;
      Methods:The association between back pain disorders and psychiatric comorbidity will be&#xD;
      investigated using population-based registry data. The population will be defined as adult&#xD;
      patients (+18) with a relevant back pain disorder using The National Danish Patient Registry.&#xD;
&#xD;
      The following registries will be also utilized: A subdivision of the DNPR, the National&#xD;
      Patient Registry - Psychiatry (NPD-Psych), The Danish National Prescription Database, The&#xD;
      Danish National Health Service Register and the DREAM database. By using the Danish Civil&#xD;
      Registry and the unique personal identification number assigned to all Danish citizens at&#xD;
      birth, data across registries can be linked on an individual level.&#xD;
&#xD;
      Ethics:The Region of Southern Denmark is the data controller for this project, and it is&#xD;
      included in their records of personal data processing activities (file no. (18/3337).).&#xD;
      Additional approvals or consents were not needed for this project based exclusively on&#xD;
      national registries according to Danish law. The data processing was conducted according to&#xD;
      EU and Danish legislation on processing of sensitive personal information and, as complies&#xD;
      with internal regulations from the Region of Southern Denmark.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aim of the thesis&#xD;
&#xD;
      The aim of this PhD thesis is to use population-based registry data to:&#xD;
&#xD;
      1) Estimate the occurrence of psychiatric comorbidity in a Danish nationwide population of&#xD;
      patients with back pain disorders (BPD) diagnosed in 2010-2014; 2) Investigate whether&#xD;
      presence of psychiatric comorbidity affects utilization of pharmacological, surgical and&#xD;
      other types of treatment for patients with back BPD; 3) Investigate whether presence of&#xD;
      psychiatric comorbidity affects utilization and dosages of pharmacological treatment for&#xD;
      patients with BPD.&#xD;
&#xD;
      Clinical contributions of this PhD: This PhD study will contribute with new knowledge on the&#xD;
      association between different types of back pain disorders (BPD) and psychiatric comorbidity.&#xD;
      As BPD affects a large part of the population, this is a very important area of research from&#xD;
      a public health and clinical perspective. Access to nationwide registries facilitates a&#xD;
      comprehensive and population-based dataset, ensuring the ideal circumstances for&#xD;
      investigating the association between BPD and potential psychiatric comorbidity. Furthermore,&#xD;
      the results can be used to increase clinical awareness of vulnerable patients in the&#xD;
      intersection between rheumatology and psychiatry and subsequently improve prevention and&#xD;
      clinical management for a complex and resource-demanding patient population.&#xD;
&#xD;
      Materials and methods&#xD;
&#xD;
      Setting and study population: This PhD project includes a population-based nationwide cohort&#xD;
      based on data from Danish health registries. Danish health registries, including The Danish&#xD;
      National Patient Registry (DNPR), a subdivision of the DNPR, the National Patient Registry -&#xD;
      Psychiatry (NPD-Psych), The Danish National Prescription Database and The Danish National&#xD;
      Health Service Register, contains complete data on hospital contacts, prescription drug use&#xD;
      and services provided by health contractors. By using the Danish Civil Registry and the&#xD;
      unique personal identification number assigned to all Danish citizens at birth, data across&#xD;
      registries can be linked on an individual level.&#xD;
&#xD;
      The study population will be defined as all adult patients (18+) identified in the DNPR,&#xD;
      covering all inpatient and outpatient services in Denmark, in the time period 1th of January&#xD;
      2010 to 31th of December 2014 with a diagnosis of BPD according to the ICD-10 Classification&#xD;
      of Disease (DM*).&#xD;
&#xD;
      Psychiatric comorbidity will be defined as the presence of any of the following diagnosis,&#xD;
      according to ICD-10 classification, obtained from the National Patient Registry - Psychiatry&#xD;
      (NPD-Psych), covering all inpatient and outpatient psychiatric services in Denmark in the&#xD;
      time period 1th January 2007 to 31th December 2017: Organic, including symptomatic, mental&#xD;
      disorders (F00-DF09), Mental and behavioral disorders due to psychoactive substance use&#xD;
      (F10-F19), Schizophrenia, schizotypal and delusional disorders (F20-F29), Mood [affective]&#xD;
      disorders (F30-F39), Neurotic, stress-related and somatoform disorders (F40-F48), Behavioral&#xD;
      syndromes associated with physiological disturbances and physical factors (F50-F59),&#xD;
      Disorders of adult personality and behavior (F60-F69), Mental retardation (F70-F79),&#xD;
      Disorders of psychological development (F80-F89), Behavioral and emotional disorders with&#xD;
      onset usually occurring in childhood and adolescence (F90-F98) and, Unspecified mental&#xD;
      disorder (F99). To qualify as a psychiatric comorbidity to back pain disorder, we define that&#xD;
      the psychiatric diagnosis must be given no earlier than three years prior to back pain&#xD;
      disorder diagnosis and no later than three years after.&#xD;
&#xD;
      Study 1) Occurrence of Psychiatric comorbidity in back pain disorders&#xD;
&#xD;
      Aim: 1) To estimate occurrence of psychiatric comorbidity in patients with BPD compared to&#xD;
      the background population and 2) occurrence of psychiatric comorbidity in patients with&#xD;
      unspecific BPD compared to patients with specific BPD in a Danish nationwide cohort from&#xD;
      2010-2014.&#xD;
&#xD;
      Hypothesis: 1) There is a higher occurrence of psychiatric comorbidity in BPD patients&#xD;
      compared to the background population and 2) patients with unspecific BPD have a higher&#xD;
      occurrence of psychiatric comorbidity compared to patients with specific BPD.&#xD;
&#xD;
      Design: The study will be a nationwide register-based matched cohort study.&#xD;
&#xD;
      Procedure: Selected BPD patients with the following diagnosis will be identified via the&#xD;
      DNPR: Spondylopathies DM45-49, Other dorsopathies DM 50-54 and Segmental and somatic&#xD;
      dysfunction DM99. Each patient will be matched 1:5 on age and sex with patients without back&#xD;
      disorders by random at Statistics Denmark. The selection of diagnosis is to be able to match&#xD;
      the population with non-BPD patients in the Danish registries.&#xD;
&#xD;
      Information on somatic comorbidity for calculation of Charlson Comorbidity index (CCI) at&#xD;
      time of BPD diagnosis, will be retrieved from the DNPR. Data on psychiatric comorbidity will&#xD;
      be identified using NPD-Psych. Information on marital status, vital status, and immigration&#xD;
      status will be retrieved from the Civil Registration System (CPR). Patients that are not&#xD;
      alive or have emigrated within three years after BPD diagnosis are considered lost to&#xD;
      follow-up and excluded from the cohort. Descriptive data on the socioeconomic status,&#xD;
      education level and equivalent available income will be retrieved from Statistics Denmark.&#xD;
      All data comprising each variable will be retrieved from 1th of January 2007 to 31th of&#xD;
      December 2017 (three years before and after study period).&#xD;
&#xD;
      Statistics: We will use Fisher's exact test and t-test to compare baseline characteristics&#xD;
      with 95% confidence intervals (CI) and p-values. Crude risks of psychiatric comorbidity will&#xD;
      be calculated and logistic regression model will be used, to investigate differences between&#xD;
      the distribution of risk in BPD patients and the background population. A logistic regression&#xD;
      model will also be used to investigate differences between the distribution of psychiatric&#xD;
      comorbidity in the unspecific and specific BPD group compared to the background population.&#xD;
      The logistic regressions will be reported using 95% CI and adjusted for the following&#xD;
      confounders: age, sex, equivalent available income, educational level, CCI, marital status.&#xD;
&#xD;
      Study 2) The effect of psychiatric comorbidity on type of treatment for BPD&#xD;
&#xD;
      Aim: 1) To investigate whether treatment of BPD in patients with psychiatric comorbidity&#xD;
      differ from treatment of patients with BPD without psychiatric comorbidity; 2)To investigate&#xD;
      whether treatment of BPD differs in the following subgroups: a) specific BPD and no&#xD;
      psychiatric comorbidity; b) specific BPD with psychiatric comorbidity; c) unspecific BPD with&#xD;
      no psychiatric comorbidity; d) unspecific BPD with psychiatric comorbidity. Investigation&#xD;
      will be performed in a nationwide Danish cohort in 2010-2014.&#xD;
&#xD;
      Hypothesis: 1) Psychiatric comorbidity affects type of treatment in BPD patients and 2)&#xD;
      psychiatric comorbidity affects type of treatment in subgroups of BPD.&#xD;
&#xD;
      Design and study population: The study will be a nationwide register-based cohort study. The&#xD;
      study population consists of patients with BPD and in the sub-analysis the study population&#xD;
      consists of patients with BPD and psychiatric comorbidity.&#xD;
&#xD;
      Procedure: BPD patients with any BPD diagnosis (DM*) will be identified via the DNPR.&#xD;
      Surgical treatment will be defined as the presence of any procedure code for back surgery&#xD;
      retrieved from DNPR (NOMESCO: KNA-W). Pharmacological treatment of BPD will be defined as any&#xD;
      treatment with the following drugs: NSAID (ATC: N01A*), acetominophen (ATC: N02BE01), opioids&#xD;
      (N02A*), antiepileptica (ATC: N03A) and tricyclic antidepressants (ATC: N06AA)13 identified&#xD;
      using the Register of Medicinal Products Statistics. Data on other types of treatment&#xD;
      (defined as any treatment not surgical or pharmacological) such as physiotherapist,&#xD;
      psychologist, chiropractor or occupational therapist (covered via tax-funded health&#xD;
      insurance) will be obtained via The Danish National Health Insurance Service Register (SSR).&#xD;
      All BPD treatment-related information will be retrieved up to three years after the date of&#xD;
      BPD diagnosis.&#xD;
&#xD;
      Information on somatic comorbidity for calculation of Charlson Comorbidity index(CCI) at time&#xD;
      of BPD diagnosis, will be retrieved from the DNPR. Data on psychiatric comorbidity will be&#xD;
      identified using NPD-Psych. Information on psychiatric comorbidity will be used to define&#xD;
      whether each patient had a psychiatric diagnosis prior to BPD diagnosis, after BPD diagnosis&#xD;
      or no psychiatric diagnosis. If a psychiatric diagnosis occurs both prior to and after BPD&#xD;
      diagnosis, the patient will be defines as having a psychiatric comorbidity prior to BPD&#xD;
      diagnosis.&#xD;
&#xD;
      Information on marital status, vital status, and immigration status will be retrieved from&#xD;
      the Civil Registration System (CPR). Patients that are not alive or have emigrated within&#xD;
      three years after BPD diagnosis are considered lost to follow-up and excluded from the&#xD;
      cohort. Descriptive data on the socioeconomic status, education level and equivalent&#xD;
      available income will be retrieved from Statistics Denmark. All data comprising each variable&#xD;
      will be retrieved from 1th of January 2007 to 31th of December 2017 (three years before and&#xD;
      after study period).&#xD;
&#xD;
      Statistics: We will use Fisher's exact test and t-test to compare patients' baseline&#xD;
      characteristics with 95% confidence intervals (CI) and p-values. For each treatment type we&#xD;
      will use logistic regression model to investigate differences in outcome distribution between&#xD;
      patients with and without psychiatric comorbidity.The logistic regressions will be performed&#xD;
      with 95% CI adjusted for the following confounders: age, sex, CCI, level of education,&#xD;
      equivalent available income, type of BPD (IBD, DBD or UBP) and marital status.&#xD;
&#xD;
      Study 3) Effect of psychiatric comorbidity in pharmacological treatment of BPD.&#xD;
&#xD;
      Aim: 1) To compare dosages of pharmacological treatment in BPD patients with and without the&#xD;
      presence of psychiatric comorbidity in a nationwide Danish cohort study in 2010-2014. 2) To&#xD;
      compare high vs. low dosages of pharmacological treatment for BPD in patients with BPD and&#xD;
      psychiatric comorbidity.&#xD;
&#xD;
      Hypothesis: 1) Patients with BPD and psychiatric comorbidity are prescribed a higher dosage&#xD;
      of pain medication for BPD compared with BPD patients without psychiatric comorbidity. 2) BPD&#xD;
      patients with a psychiatric comorbidity with a high (defined as above the 50th percentile)&#xD;
      vs. low (defined as below the 50th percentile) dosage of pain medication are also prescribed&#xD;
      higher dosages of psychiatric medication.&#xD;
&#xD;
      Design and study population: The study will be a nationwide register-based cohort study. The&#xD;
      study population consists of patients with BPD that received pharmacological treatment for&#xD;
      BPD. In the secondary analysis the study population consists of patients with BPD and a&#xD;
      psychiatric comorbidity, who received pharmacological treatment for BPD.&#xD;
&#xD;
      Procedure: BPD patients with any BPD diagnosis (DM*) will be identified via the DNPR.&#xD;
      Pharmacological treatment of BPD will be defined as any treatment with the following drugs:&#xD;
      NSAID (ATC: N01A*), Acetominophen (ATC: N02BE01), Opioids (N02A*). Pharmacological treatment&#xD;
      for psychiatric comorbidity will be defined as any treatment with the following drugs:&#xD;
      Antipsychotics (ATC:N05A), Antidepressants (ATC: N06A), Selective Serotonin Reuptake&#xD;
      Inhibitors (SSRI) (ATC: N06AB), and anxiolytics (ATC: N5B*) Pharmacological treatment that&#xD;
      can be used in the treatment of both BPD and psychiatric disorders will be defined as any&#xD;
      treatment with the following drugs: Antiepileptica (ATC: N03A) and Tricyclic antidepressants&#xD;
      (ATC: N06AA). All data on pharmacological treatment will be identified using the Register of&#xD;
      Medicinal Products Statistics. From time of BPD diagnosis and the following three years,&#xD;
      pharmacological treatment for both somatic illness and psychiatric comorbidity in Daily&#xD;
      Defined Dosage (DDD) per year will be calculated.&#xD;
&#xD;
      Information on somatic comorbidity for calculation of Charlson Comorbidity index (CCI) at&#xD;
      time of BPD diagnosis, will be retrieved from the DNPR. Data on psychiatric comorbidity will&#xD;
      be identified using NPD-Psych. Information on marital status, vital status, and immigration&#xD;
      status will be retrieved from the Civil Registration System (CPR). Patients that are not&#xD;
      alive or have emigrated within three years after BPD diagnosis are considered lost to&#xD;
      follow-up and excluded from the cohort. Descriptive data on the socioeconomic status,&#xD;
      education level and equivalent available income will be retrieved from Statistics Denmark.&#xD;
      All data comprising each variable will be retrieved from 1th of January 2007 to 31th of&#xD;
      December 2017 (three years before and after study period).&#xD;
&#xD;
      Statistics: We will use Fisher's exact test and t-test to compare patients' baseline&#xD;
      characteristics with 95% confidence intervals (CI) and p-values. Time dependent Cox&#xD;
      regression will be performed separately for patients with specific and unspecific BPD to&#xD;
      examine dosage of pharmacological treatment over time comparing patients with and without&#xD;
      psychiatric comorbidity. The analysis will be performed with 95% CI and adjusted for the&#xD;
      following confounders: age, sex, CCI, level of education, equivalent available income,&#xD;
      marital status and the presence of psychopharmacological treatment.&#xD;
&#xD;
      To examine dosage of psychopharmacological treatment over time comparing patients with&#xD;
      psychiatric comorbidity and low vs high dose of pharmacological treatment of BPD, time&#xD;
      dependent Cox regression will be performed reporting 95% CI and adjusting for the following&#xD;
      confounders: age, sex, CCI, level of education, equivalent available income and marital&#xD;
      status.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 1, 2019</start_date>
  <completion_date type="Anticipated">June 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>3 Years</target_duration>
  <primary_outcome>
    <measure>Occurrence of psychiatric comorbidity (%) retrieved from Danish nationwide registries (Study 1)</measure>
    <time_frame>Calculated over a five year period</time_frame>
    <description>The primary outcome is the occurrence of psychiatric comorbidity in patients with back pain compared to the prevalence in a matched population 1:5 without back pain diagnosis. The matched cohort are randomly selected and matched on sex and age.&#xD;
Psychiatric comorbidity will be defined as the presence of any of the following diagnosis, according to ICD-10 classification obtained from the National Patient Registry - Psychiatry (NPD-Psych), covering all inpatient and outpatient psychiatric services in Denmark in the time period 1th January 2007 to 31th December 2017: F00-99*.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Difference in odds of treatment of back pain between patients with psychiatric comorbidity and patients without psychiatric comorbidity (Study 2)</measure>
    <time_frame>Calculated over a five year period</time_frame>
    <description>The primary outcome is the difference in odds between surgical, pharmacological, and usage of supplementary treatment (defined as number of visits at; chiropractor, physiotherapist, psychologist) in patients with back pain and psychiatric comorbidity and back patients without psychiatric comorbidity.The information will be retrieved from the following nationwide Danish registries: The Danish health registries, including The Danish National Patient Registry (DNPR), a subdivision of the DNPR, the National Patient Registry - Psychiatry (NPD-Psych), The Danish National Prescription Database and The Danish National Health Service Register, contains complete data on hospital contacts, prescription drug use and services provided by health contractors. 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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Difference in pharmacological treatment in DDD's (Daily defined dosages) of patients with back pain with and without psychiatric comorbidity, retrieved from the Danish nationwide registries (Study 3).</measure>
    <time_frame>Calculated over a five year period</time_frame>
    <description>Primary outcome is pharmacological treatment in Daily Defined Dosages (DDD)defined as high (above the 50th percentile and low (below the 50th percentile) of pain medication prescribed to patients with back pain. Information on DDD's will be retrieved from the Danish Prescription database. Pharmacological treatment of BPD will be defined as any treatment with the following drugs: NSAID (ATC: N01A*), Acetominophen (ATC: N02BE01), Opioids (N02A*).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Occurrence of psychiatric comorbidity (%) retrieved from Danish nationwide registries (Study 1)</measure>
    <time_frame>Prevalence calculated over the duration of five years</time_frame>
    <description>The secondary outcome is occurrence of psychiatric comorbidity in patients with specific back pain compared to patients with unspecific back pain .Both groups will be compared to the background population matched 1:5 on sex and age. Psychiatric comorbidity will be defined as the presence of any of the following diagnosis, according to ICD-10 classification obtained from the National Patient Registry - Psychiatry (NPD-Psych), covering all inpatient and outpatient psychiatric services in Denmark in the time period 1th January 2007 to 31th December 2017: DF00-99*.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in odds of treatment of back pain between patients with specific and unspecific back pain with presence of psychiatric comorbidity (Study 2)</measure>
    <time_frame>Calculated over a five year period</time_frame>
    <description>The secondary outcome is the difference between surgical and pharmacological treatment and usage of supplementary treatment (defined as number of visits at; chiropractor, physiotherapist, psychologist) in the following 4 groups: 1) patients with specific BPD, 2) patients with specific BPD and psychiatric comorbidity, 3) patients with unspecific BPD, 4) patients with unspecific BPD and psychiatric comorbidity. The information will be retrieved from the The Danish National Patient Registry (DNPR), the National Patient Registry - Psychiatry (NPD-Psych), The Danish National Prescription Database and The Danish National Health Service Register, which contains complete data on hospital contacts, prescription drug use and services provided by health contractors. The Danish Civil Registry and the Civil Registration number will link between registries.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference between patients with back pain and psychiatric comorbidity with high vs. low dosage of pain medication calculated in DDDs (daily defined dosage) in treatment with psychiatric medication retrieved from Danish nationwide registries (Study 3)</measure>
    <time_frame>Calculated over a five year period</time_frame>
    <description>The secondary outcome is difference in dosages of psychiatric medication in back pain patients with psychiatric comorbidity with a high (defined as above the 50th percentile) vs. low (defined as below the 50th percentile) dosage of pain medication calculated in DDD's.&#xD;
Information on DDD's will be retrieved from the Danish Prescription database. Pharmacological treatment of BPD will be defined as any treatment with the following drugs: NSAID (ATC: N01A*), Acetominophen (ATC: N02BE01), Opioids (N02A*).&#xD;
Treatment with psychiatric medication in BPD patients will be defined as any treatment with the following drugs: NSAID (ATC: N01A*), Acetominophen (ATC: N02BE01), Opioids (N02A*)13. Pharmacological treatment for psychiatric comorbidity will be defined as any treatment with the following drugs: Antipsychotics (ATC:N05A), Antidepressants (ATC: N06A), Selective Serotonin Reuptake Inhibitors (SSRI) (ATC: N06AB), and anxiolytics (ATC: N5B*).</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Anticipated">500000</enrollment>
  <condition>Back Pain</condition>
  <condition>Psychiatric Disorder</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <description>Cohort 1 is a a control group matched 1:5 to the exposed group on sex and age. This group i randomly assigned via Statistics Denmark and does not have a diagnosis of back pain in the time period 2008-2013. They do however have another diseases registered in the Danish Patient Registry, which only contains information on patients having had contacts with the hospital sector i Denmark. Used for study 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Specific back pain (unexposed)</arm_group_label>
    <description>Cohort 2 consists of patients registered with one of the following diagnosis in the time period 2008-2013 in Denmark: Spinal Disc Herniation DM51.1 and Spinal stenosis DM48.0 (ICD-10 classification).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Unspecific back pain (exposed)</arm_group_label>
    <description>Cohort 3 consists of patients registered with one of the following diagnosis in the time period 2008-2013 in Denmark: Other intervertebral disc disorders DM51*-51.1, Dorsalgia DM54, Other disorders of muscle DM62, Postprocedural musculoskeletal disorders not elsewhere classified DM96 and Segmental and somatic dysfunction DM99 (ICD-10 classification)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Total population (DM*)</arm_group_label>
    <description>Cohort 4 is the total population including all BPD diagnosis in the time period 2008-2013 in Denmark. This cohort will be used as basis for study 2 and 3, although de definitions of the groups specific back pain (unexposed) and unspecific back pain (exposed) will used in sub-analysis.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        All adult patients (+18) retrieved from the Danish National Patient Registry (DNPR) with a&#xD;
        diagnosis of back pain DM* (ICD-10) is eligible for this study.The DNPR is registry with&#xD;
        mandatory reporting from the secondary sector on a national level in Denmark.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18+&#xD;
&#xD;
          -  ICD-10 diagnosis of a relevant back pain disorder (DM*)&#xD;
&#xD;
          -  Registered in the Danish National Patient Registry in the time period 2010-2014.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pernille S Ljungdalh, MscPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Spine Centre of Southern Denmark and Institute for Regional Health Research, University of Southern Denmark</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Berit Sciottz-Christensen, PhD, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>Spine Centre of Southern Denmark and Institute for Regional Health Research, University of Southern Denmark</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Elsebeth Stenager, Professor</last_name>
    <role>Study Director</role>
    <affiliation>Odense University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Maria Iachina, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Odense University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Pernille S Ljungdalh, MscPH</last_name>
    <phone>+45 63484523</phone>
    <phone_ext>+45 60119329</phone_ext>
    <email>Pernille.ljungdalh@rsyd.dk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Berit Sciøttz-Christensen, PhD</last_name>
    <phone>+45 21552927</phone>
    <email>Berit.Sciottz-Christensen@rsyd.dk</email>
  </overall_contact_backup>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>January 14, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>April 21, 2019</last_update_submitted>
  <last_update_submitted_qc>April 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pharmacoepidemiology</keyword>
  <keyword>Back pain</keyword>
  <keyword>Psychiatric disorder</keyword>
  <keyword>Psychiatric comorbidity</keyword>
  <keyword>Comorbidity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Back Pain</mesh_term>
    <mesh_term>Mental Disorders</mesh_term>
    <mesh_term>Problem Behavior</mesh_term>
    <mesh_term>Somatoform Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 29, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/91/NCT03825991/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03825991
org study id: SpineCentreSD
nct id: NCT03825991
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
Aim of the thesis

      The aim of this PhD thesis is to use population-based registry data to:

      1) Estimate the occurrence of psychiatric comorbidity in a Danish nationwide population of
      patients with back pain disorders (BPD) diagnosed in 2010-2014; 2) Investigate whether
      presence of psychiatric comorbidity affects utilization of pharmacological, surgical and
      other types of treatment for patients with back BPD; 3) Investigate whether presence of
      psychiatric comorbidity affects utilization and dosages of pharmacological treatment for
      patients with BPD.

      Clinical contributions of this PhD: This PhD study will contribute with new knowledge on the
      association between different types of back pain disorders (BPD) and psychiatric comorbidity.
      As BPD affects a large part of the population, this is a very important area of research from
      a public health and clinical perspective. Access to nationwide registries facilitates a
      comprehensive and population-based dataset, ensuring the ideal circumstances for
      investigating the association between BPD and potential psychiatric comorbidity. Furthermore,
      the results can be used to increase clinical awareness of vulnerable patients in the
      intersection between rheumatology and psychiatry and subsequently improve prevention and
      clinical management for a complex and resource-demanding patient population.

      Materials and methods

      Setting and study population: This PhD project includes a population-based nationwide cohort
      based on data from Danish health registries. Danish health registries, including The Danish
      National Patient Registry (DNPR), a subdivision of the DNPR, the National Patient Registry -
      Psychiatry (NPD-Psych), The Danish National Prescription Database and The Danish National
      Health Service Register, contains complete data on hospital contacts, prescription drug use
      and services provided by health contractors. 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.

      The study population will be defined as all adult patients (18+) identified in the DNPR,
      covering all inpatient and outpatient services in Denmark, in the time period 1th of January
      2010 to 31th of December 2014 with a diagnosis of BPD according to the ICD-10 Classification
      of Disease (DM*).

      Psychiatric comorbidity will be defined as the presence of any of the following diagnosis,
      according to ICD-10 classification, obtained from the National Patient Registry - Psychiatry
      (NPD-Psych), covering all inpatient and outpatient psychiatric services in Denmark in the
      time period 1th January 2007 to 31th December 2017: Organic, including symptomatic, mental
      disorders (F00-DF09), Mental and behavioral disorders due to psychoactive substance use
      (F10-F19), Schizophrenia, schizotypal and delusional disorders (F20-F29), Mood [affective]
      disorders (F30-F39), Neurotic, stress-related and somatoform disorders (F40-F48), Behavioral
      syndromes associated with physiological disturbances and physical factors (F50-F59),
      Disorders of adult personality and behavior (F60-F69), Mental retardation (F70-F79),
      Disorders of psychological development (F80-F89), Behavioral and emotional disorders with
      onset usually occurring in childhood and adolescence (F90-F98) and, Unspecified mental
      disorder (F99). To qualify as a psychiatric comorbidity to back pain disorder, we define that
      the psychiatric diagnosis must be given no earlier than three years prior to back pain
      disorder diagnosis and no later than three years after.

      Study 1) Occurrence of Psychiatric comorbidity in back pain disorders

      Aim: 1) To estimate occurrence of psychiatric comorbidity in patients with BPD compared to
      the background population and 2) occurrence of psychiatric comorbidity in patients with
      unspecific BPD compared to patients with specific BPD in a Danish nationwide cohort from
      2010-2014.

      Hypothesis: 1) There is a higher occurrence of psychiatric comorbidity in BPD patients
      compared to the background population and 2) patients with unspecific BPD have a higher
      occurrence of psychiatric comorbidity compared to patients with specific BPD.

      Design: The study will be a nationwide register-based matched cohort study.

      Procedure: Selected BPD patients with the following diagnosis will be identified via the
      DNPR: Spondylopathies DM45-49, Other dorsopathies DM 50-54 and Segmental and somatic
      dysfunction DM99. Each patient will be matched 1:5 on age and sex with patients without back
      disorders by random at Statistics Denmark. The selection of diagnosis is to be able to match
      the population with non-BPD patients in the Danish registries.

      Information on somatic comorbidity for calculation of Charlson Comorbidity index (CCI) at
      time of BPD diagnosis, will be retrieved from the DNPR. Data on psychiatric comorbidity will
      be identified using NPD-Psych. Information on marital status, vital status, and immigration
      status will be retrieved from the Civil Registration System (CPR). Patients that are not
      alive or have emigrated within three years after BPD diagnosis are considered lost to
      follow-up and excluded from the cohort. Descriptive data on the socioeconomic status,
      education level and equivalent available income will be retrieved from Statistics Denmark.
      All data comprising each variable will be retrieved from 1th of January 2007 to 31th of
      December 2017 (three years before and after study period).

      Statistics: We will use Fisher's exact test and t-test to compare baseline characteristics
      with 95% confidence intervals (CI) and p-values. Crude risks of psychiatric comorbidity will
      be calculated and logistic regression model will be used, to investigate differences between
      the distribution of risk in BPD patients and the background population. A logistic regression
      model will also be used to investigate differences between the distribution of psychiatric
      comorbidity in the unspecific and specific BPD group compared to the background population.
      The logistic regressions will be reported using 95% CI and adjusted for the following
      confounders: age, sex, equivalent available income, educational level, CCI, marital status.

      Study 2) The effect of psychiatric comorbidity on type of treatment for BPD

      Aim: 1) To investigate whether treatment of BPD in patients with psychiatric comorbidity
      differ from treatment of patients with BPD without psychiatric comorbidity; 2)To investigate
      whether treatment of BPD differs in the following subgroups: a) specific BPD and no
      psychiatric comorbidity; b) specific BPD with psychiatric comorbidity; c) unspecific BPD with
      no psychiatric comorbidity; d) unspecific BPD with psychiatric comorbidity. Investigation
      will be performed in a nationwide Danish cohort in 2010-2014.

      Hypothesis: 1) Psychiatric comorbidity affects type of treatment in BPD patients and 2)
      psychiatric comorbidity affects type of treatment in subgroups of BPD.

      Design and study population: The study will be a nationwide register-based cohort study. The
      study population consists of patients with BPD and in the sub-analysis the study population
      consists of patients with BPD and psychiatric comorbidity.

      Procedure: BPD patients with any BPD diagnosis (DM*) will be identified via the DNPR.
      Surgical treatment will be defined as the presence of any procedure code for back surgery
      retrieved from DNPR (NOMESCO: KNA-W). Pharmacological treatment of BPD will be defined as any
      treatment with the following drugs: NSAID (ATC: N01A*), acetominophen (ATC: N02BE01), opioids
      (N02A*), antiepileptica (ATC: N03A) and tricyclic antidepressants (ATC: N06AA)13 identified
      using the Register of Medicinal Products Statistics. Data on other types of treatment
      (defined as any treatment not surgical or pharmacological) such as physiotherapist,
      psychologist, chiropractor or occupational therapist (covered via tax-funded health
      insurance) will be obtained via The Danish National Health Insurance Service Register (SSR).
      All BPD treatment-related information will be retrieved up to three years after the date of
      BPD diagnosis.

      Information on somatic comorbidity for calculation of Charlson Comorbidity index(CCI) at time
      of BPD diagnosis, will be retrieved from the DNPR. Data on psychiatric comorbidity will be
      identified using NPD-Psych. Information on psychiatric comorbidity will be used to define
      whether each patient had a psychiatric diagnosis prior to BPD diagnosis, after BPD diagnosis
      or no psychiatric diagnosis. If a psychiatric diagnosis occurs both prior to and after BPD
      diagnosis, the patient will be defines as having a psychiatric comorbidity prior to BPD
      diagnosis.

      Information on marital status, vital status, and immigration status will be retrieved from
      the Civil Registration System (CPR). Patients that are not alive or have emigrated within
      three years after BPD diagnosis are considered lost to follow-up and excluded from the
      cohort. Descriptive data on the socioeconomic status, education level and equivalent
      available income will be retrieved from Statistics Denmark. All data comprising each variable
      will be retrieved from 1th of January 2007 to 31th of December 2017 (three years before and
      after study period).

      Statistics: We will use Fisher's exact test and t-test to compare patients' baseline
      characteristics with 95% confidence intervals (CI) and p-values. For each treatment type we
      will use logistic regression model to investigate differences in outcome distribution between
      patients with and without psychiatric comorbidity.The logistic regressions will be performed
      with 95% CI adjusted for the following confounders: age, sex, CCI, level of education,
      equivalent available income, type of BPD (IBD, DBD or UBP) and marital status.

      Study 3) Effect of psychiatric comorbidity in pharmacological treatment of BPD.

      Aim: 1) To compare dosages of pharmacological treatment in BPD patients with and without the
      presence of psychiatric comorbidity in a nationwide Danish cohort study in 2010-2014. 2) To
      compare high vs. low dosages of pharmacological treatment for BPD in patients with BPD and
      psychiatric comorbidity.

      Hypothesis: 1) Patients with BPD and psychiatric comorbidity are prescribed a higher dosage
      of pain medication for BPD compared with BPD patients without psychiatric comorbidity. 2) BPD
      patients with a psychiatric comorbidity with a high (defined as above the 50th percentile)
      vs. low (defined as below the 50th percentile) dosage of pain medication are also prescribed
      higher dosages of psychiatric medication.

      Design and study population: The study will be a nationwide register-based cohort study. The
      study population consists of patients with BPD that received pharmacological treatment for
      BPD. In the secondary analysis the study population consists of patients with BPD and a
      psychiatric comorbidity, who received pharmacological treatment for BPD.

      Procedure: BPD patients with any BPD diagnosis (DM*) will be identified via the DNPR.
      Pharmacological treatment of BPD will be defined as any treatment with the following drugs:
      NSAID (ATC: N01A*), Acetominophen (ATC: N02BE01), Opioids (N02A*). Pharmacological treatment
      for psychiatric comorbidity will be defined as any treatment with the following drugs:
      Antipsychotics (ATC:N05A), Antidepressants (ATC: N06A), Selective Serotonin Reuptake
      Inhibitors (SSRI) (ATC: N06AB), and anxiolytics (ATC: N5B*) Pharmacological treatment that
      can be used in the treatment of both BPD and psychiatric disorders will be defined as any
      treatment with the following drugs: Antiepileptica (ATC: N03A) and Tricyclic antidepressants
      (ATC: N06AA). All data on pharmacological treatment will be identified using the Register of
      Medicinal Products Statistics. From time of BPD diagnosis and the following three years,
      pharmacological treatment for both somatic illness and psychiatric comorbidity in Daily
      Defined Dosage (DDD) per year will be calculated.

      Information on somatic comorbidity for calculation of Charlson Comorbidity index (CCI) at
      time of BPD diagnosis, will be retrieved from the DNPR. Data on psychiatric comorbidity will
      be identified using NPD-Psych. Information on marital status, vital status, and immigration
      status will be retrieved from the Civil Registration System (CPR). Patients that are not
      alive or have emigrated within three years after BPD diagnosis are considered lost to
      follow-up and excluded from the cohort. Descriptive data on the socioeconomic status,
      education level and equivalent available income will be retrieved from Statistics Denmark.
      All data comprising each variable will be retrieved from 1th of January 2007 to 31th of
      December 2017 (three years before and after study period).

      Statistics: We will use Fisher's exact test and t-test to compare patients' baseline
      characteristics with 95% confidence intervals (CI) and p-values. Time dependent Cox
      regression will be performed separately for patients with specific and unspecific BPD to
      examine dosage of pharmacological treatment over time comparing patients with and without
      psychiatric comorbidity. The analysis will be performed with 95% CI and adjusted for the
      following confounders: age, sex, CCI, level of education, equivalent available income,
      marital status and the presence of psychopharmacological treatment.

      To examine dosage of psychopharmacological treatment over time comparing patients with
      psychiatric comorbidity and low vs high dose of pharmacological treatment of BPD, time
      dependent Cox regression will be performed reporting 95% CI and adjusting for the following
      confounders: age, sex, CCI, level of education, equivalent available income and marital
      status.
observational model: Cohort
time perspective: Prospective
measure: Occurrence of psychiatric comorbidity (%) retrieved from Danish nationwide registries (Study 1)
time frame: Calculated over a five year period
description: The primary outcome is the occurrence of psychiatric comorbidity in patients with back pain compared to the prevalence in a matched population 1:5 without back pain diagnosis. The matched cohort are randomly selected and matched on sex and age.
Psychiatric comorbidity will be defined as the presence of any of the following diagnosis, according to ICD-10 classification obtained from the National Patient Registry - Psychiatry (NPD-Psych), covering all inpatient and outpatient psychiatric services in Denmark in the time period 1th January 2007 to 31th December 2017: F00-99*.
measure: Difference in odds of treatment of back pain between patients with psychiatric comorbidity and patients without psychiatric comorbidity (Study 2)
time frame: Calculated over a five year period
description: The primary outcome is the difference in odds between surgical, pharmacological, and usage of supplementary treatment (defined as number of visits at; chiropractor, physiotherapist, psychologist) in patients with back pain and psychiatric comorbidity and back patients without psychiatric comorbidity.The information will be retrieved from the following nationwide Danish registries: The Danish health registries, including The Danish National Patient Registry (DNPR), a subdivision of the DNPR, the National Patient Registry - Psychiatry (NPD-Psych), The Danish National Prescription Database and The Danish National Health Service Register, contains complete data on hospital contacts, prescription drug use and services provided by health contractors. 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.
measure: Difference in pharmacological treatment in DDD's (Daily defined dosages) of patients with back pain with and without psychiatric comorbidity, retrieved from the Danish nationwide registries (Study 3).
time frame: Calculated over a five year period
description: Primary outcome is pharmacological treatment in Daily Defined Dosages (DDD)defined as high (above the 50th percentile and low (below the 50th percentile) of pain medication prescribed to patients with back pain. Information on DDD's will be retrieved from the Danish Prescription database. Pharmacological treatment of BPD will be defined as any treatment with the following drugs: NSAID (ATC: N01A*), Acetominophen (ATC: N02BE01), Opioids (N02A*).
measure: Occurrence of psychiatric comorbidity (%) retrieved from Danish nationwide registries (Study 1)
time frame: Prevalence calculated over the duration of five years
description: The secondary outcome is occurrence of psychiatric comorbidity in patients with specific back pain compared to patients with unspecific back pain .Both groups will be compared to the background population matched 1:5 on sex and age. Psychiatric comorbidity will be defined as the presence of any of the following diagnosis, according to ICD-10 classification obtained from the National Patient Registry - Psychiatry (NPD-Psych), covering all inpatient and outpatient psychiatric services in Denmark in the time period 1th January 2007 to 31th December 2017: DF00-99*.
measure: Difference in odds of treatment of back pain between patients with specific and unspecific back pain with presence of psychiatric comorbidity (Study 2)
time frame: Calculated over a five year period
description: The secondary outcome is the difference between surgical and pharmacological treatment and usage of supplementary treatment (defined as number of visits at; chiropractor, physiotherapist, psychologist) in the following 4 groups: 1) patients with specific BPD, 2) patients with specific BPD and psychiatric comorbidity, 3) patients with unspecific BPD, 4) patients with unspecific BPD and psychiatric comorbidity. The information will be retrieved from the The Danish National Patient Registry (DNPR), the National Patient Registry - Psychiatry (NPD-Psych), The Danish National Prescription Database and The Danish National Health Service Register, which contains complete data on hospital contacts, prescription drug use and services provided by health contractors. The Danish Civil Registry and the Civil Registration number will link between registries.
measure: Difference between patients with back pain and psychiatric comorbidity with high vs. low dosage of pain medication calculated in DDDs (daily defined dosage) in treatment with psychiatric medication retrieved from Danish nationwide registries (Study 3)
time frame: Calculated over a five year period
description: The secondary outcome is difference in dosages of psychiatric medication in back pain patients with psychiatric comorbidity with a high (defined as above the 50th percentile) vs. low (defined as below the 50th percentile) dosage of pain medication calculated in DDD's.
Information on DDD's will be retrieved from the Danish Prescription database. Pharmacological treatment of BPD will be defined as any treatment with the following drugs: NSAID (ATC: N01A*), Acetominophen (ATC: N02BE01), Opioids (N02A*).
Treatment with psychiatric medication in BPD patients will be defined as any treatment with the following drugs: NSAID (ATC: N01A*), Acetominophen (ATC: N02BE01), Opioids (N02A*)13. Pharmacological treatment for psychiatric comorbidity will be defined as any treatment with the following drugs: Antipsychotics (ATC:N05A), Antidepressants (ATC: N06A), Selective Serotonin Reuptake Inhibitors (SSRI) (ATC: N06AB), and anxiolytics (ATC: N5B*).
arm group label: Control group
description: Cohort 1 is a a control group matched 1:5 to the exposed group on sex and age. This group i randomly assigned via Statistics Denmark and does not have a diagnosis of back pain in the time period 2008-2013. They do however have another diseases registered in the Danish Patient Registry, which only contains information on patients having had contacts with the hospital sector i Denmark. Used for study 1.
arm group label: Specific back pain (unexposed)
description: Cohort 2 consists of patients registered with one of the following diagnosis in the time period 2008-2013 in Denmark: Spinal Disc Herniation DM51.1 and Spinal stenosis DM48.0 (ICD-10 classification).
arm group label: Unspecific back pain (exposed)
description: Cohort 3 consists of patients registered with one of the following diagnosis in the time period 2008-2013 in Denmark: Other intervertebral disc disorders DM51*-51.1, Dorsalgia DM54, Other disorders of muscle DM62, Postprocedural musculoskeletal disorders not elsewhere classified DM96 and Segmental and somatic dysfunction DM99 (ICD-10 classification)
arm group label: Total population (DM*)
description: Cohort 4 is the total population including all BPD diagnosis in the time period 2008-2013 in Denmark. This cohort will be used as basis for study 2 and 3, although de definitions of the groups specific back pain (unexposed) and unspecific back pain (exposed) will used in sub-analysis.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pernille S Ljungdalh, MscPH
role: Principal Investigator
affiliation: Spine Centre of Southern Denmark and Institute for Regional Health Research, University of Southern Denmark
last name: Berit Sciottz-Christensen, PhD, Professor
role: Study Chair
affiliation: Spine Centre of Southern Denmark and Institute for Regional Health Research, University of Southern Denmark
last name: Elsebeth Stenager, Professor
role: Study Director
affiliation: Odense University Hospital
last name: Maria Iachina, PhD
role: Study Director
affiliation: Odense University Hospital
last name: Pernille S Ljungdalh, MscPH
phone: +45 63484523
phone ext: +45 60119329
email: Pernille.ljungdalh@rsyd.dk
last name: Berit Sciøttz-Christensen, PhD
phone: +45 21552927
email: Berit.Sciottz-Christensen@rsyd.dk
responsible party type: Sponsor
mesh term: Back Pain
mesh term: Mental Disorders
mesh term: Problem Behavior
mesh term: Somatoform Disorders
sharing ipd: No
provided document: 