<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/NCT03821350</url>
  </required_header>
  <id_info>
    <org_study_id>09.2014.0089</org_study_id>
    <nct_id>NCT03821350</nct_id>
  </id_info>
  <brief_title>The Effect of Comorbid Psychiatric Conditions on Results of Transforaminal Epidural Steroid Injection</brief_title>
  <official_title>The Effect of Comorbid Psychiatric Disorders and Information Leaflet on Results of Transforaminal Epidural Steroid Injection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hitit University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hitit University</source>
  <oversight_info>
    <has_dmc>No</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>
      Low back pain (LBP) and radiculopathic pain are a major socio-economic problem affecting all&#xD;
      age groups. 70% of people consult a doctor at least once in their life due to LBP. Radicular&#xD;
      pain is thought to be caused by inflammation of the spinal nerve roots near the&#xD;
      intervertebral disc injury. In this context, fluoroscopic guided transforaminal epidural&#xD;
      steroid injection (TFESI) has been increasingly preferred in patients who can not benefit&#xD;
      from conservative approach in the treatment of lumbosacral radiculopathic pain due to lumbar&#xD;
      disc herniation in recent years.&#xD;
&#xD;
      The assessment of comorbid psychiatric conditions such as depression, anxiety, and&#xD;
      somatization disorder and given the detailed and visual information to patients who will be&#xD;
      undergone TFESI could affect the result of the treatment in a good way. The pain&#xD;
      questionnaire used for objectively evaluating injection outcomes is personality dependent and&#xD;
      there are many factors that can affect it.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Although information leaflets given to patients prior to surgical or non-surgical&#xD;
      interventions have not yet been used as a standard in each clinic, the effects on patients&#xD;
      have been frequently researched in recently. A detailed description of the treatment, the&#xD;
      devices to be used and the disclosure of the steps of the procedure may have an effect on the&#xD;
      result of the treatment. The aim of the study; (1) the presence of comorbid psychiatric&#xD;
      conditions in patients with lumbar disc hernia and radiculopathy, (2) to evaluate the effect&#xD;
      of the written and visual informative form given before the injection of the lumbosacral&#xD;
      TFESI.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 30, 2013</start_date>
  <completion_date type="Actual">December 25, 2015</completion_date>
  <primary_completion_date type="Actual">December 30, 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Parallel group</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
    <masking_description>The study was designed as prospective, single blinded, randomized controlled study. Patients were randomized into two groups. The enrollment of the participants was carried out by an independent researcher. Pre and post-injection evaluation was performed by the investigators who had no knowledge about the groups</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Numeric rating scale</measure>
    <time_frame>3 months</time_frame>
    <description>The patient is asked to give a score between 1 and 10 to explain the pain level.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Oswestry disability index</measure>
    <time_frame>3 months</time_frame>
    <description>The oswestry disability index is a survey designed to investigate how lumbar and leg pain affects their daily lives. It consists of 10 questions investigating the general life activity of the patient. The patient receives at least 0 points and at most 5 points from each question. The higher scores indicate that increased disability.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hospital Anxiety and Depression Scale</measure>
    <time_frame>3 months</time_frame>
    <description>The Hospital Anxiety and Depression Scale is an easy-to-use questionnaire consisting of 14 questions that examines the symptoms of depression with 7 questions and anxiety with 7 questions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Somatosensory Amplification Scale</measure>
    <time_frame>3 months</time_frame>
    <description>The Somatosensory Amplification Scale is a scale consisting of 10 items. The items include a series of disturbing bodily sensations that do not present a disease.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">166</enrollment>
  <condition>Low Back Pain</condition>
  <condition>Radiculopathy</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group was given verbal information</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Leaflet Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The second group was given verbal information and a detailed information leaflet with written and visual content</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Information leaflet</intervention_name>
    <description>The written and visual information form prepared specifically for the patients was aimed to provide detailed information by clearly expressing the procedure, the suggestions that will be needed before and after injection (what to bring next, what circumstances may not be done, the control visit day after the procedure etc.) to be applied on before the injection day.</description>
    <arm_group_label>Leaflet Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  lumbar radiculopathy due to lumbar disc herniation,&#xD;
&#xD;
          -  unresponsive to conservative treatments,&#xD;
&#xD;
          -  duration of pain is less than 3 months,&#xD;
&#xD;
          -  patients scheduled for the first time with TFESI.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  the cases when fluoroscopy or epidural injection is contraindicated (coagulation&#xD;
             disorders, pregnancy etc...),&#xD;
&#xD;
          -  underwent epidural injection in the last 6 months,&#xD;
&#xD;
          -  to have a history of lumbar spinal surgery,&#xD;
&#xD;
          -  inflammatory diseases (rheumatoid arthritis, spondyloarthropathy),&#xD;
&#xD;
          -  spinal infection or malignancy,&#xD;
&#xD;
          -  to benefit from six-week medical treatment,&#xD;
&#xD;
          -  be reluctant to participate in the work and follow up,&#xD;
&#xD;
          -  who are illiterate,&#xD;
&#xD;
          -  the patients with psychiatric disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <reference>
    <citation>Coudeyre E, Poiraudeau S, Revel M, Kahan A, Drape JL, Ravaud P. Beneficial effects of information leaflets before spinal steroid injection. Joint Bone Spine. 2002 Dec;69(6):597-603. doi: 10.1016/s1297-319x(02)00457-8.</citation>
    <PMID>12537268</PMID>
  </reference>
  <reference>
    <citation>Sivaganesan A, Chotai S, Parker SL, Asher AL, McGirt MJ, Devin CJ. Predictors of the efficacy of epidural steroid injections for structural lumbar degenerative pathology. Spine J. 2016 Aug;16(8):928-34. doi: 10.1016/j.spinee.2015.11.058. Epub 2015 Dec 9.</citation>
    <PMID>26689476</PMID>
  </reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 25, 2019</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>January 28, 2019</last_update_submitted>
  <last_update_submitted_qc>January 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 29, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hitit University</investigator_affiliation>
    <investigator_full_name>Yeliz Bahar Ozdemir</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Transforaminal epidural steroid injection</keyword>
  <keyword>Radicular pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Radiculopathy</mesh_term>
    <mesh_term>Low Back Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03821350
org study id: 09.2014.0089
nct id: NCT03821350
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Low back pain (LBP) and radiculopathic pain are a major socio-economic problem affecting all
      age groups. 70% of people consult a doctor at least once in their life due to LBP. Radicular
      pain is thought to be caused by inflammation of the spinal nerve roots near the
      intervertebral disc injury. In this context, fluoroscopic guided transforaminal epidural
      steroid injection (TFESI) has been increasingly preferred in patients who can not benefit
      from conservative approach in the treatment of lumbosacral radiculopathic pain due to lumbar
      disc herniation in recent years.

      The assessment of comorbid psychiatric conditions such as depression, anxiety, and
      somatization disorder and given the detailed and visual information to patients who will be
      undergone TFESI could affect the result of the treatment in a good way. The pain
      questionnaire used for objectively evaluating injection outcomes is personality dependent and
      there are many factors that can affect it.
Although information leaflets given to patients prior to surgical or non-surgical
      interventions have not yet been used as a standard in each clinic, the effects on patients
      have been frequently researched in recently. A detailed description of the treatment, the
      devices to be used and the disclosure of the steps of the procedure may have an effect on the
      result of the treatment. The aim of the study; (1) the presence of comorbid psychiatric
      conditions in patients with lumbar disc hernia and radiculopathy, (2) to evaluate the effect
      of the written and visual informative form given before the injection of the lumbosacral
      TFESI.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Parallel group
primary purpose: Treatment
masking: Single (Investigator)
masking description: The study was designed as prospective, single blinded, randomized controlled study. Patients were randomized into two groups. The enrollment of the participants was carried out by an independent researcher. Pre and post-injection evaluation was performed by the investigators who had no knowledge about the groups
measure: Numeric rating scale
time frame: 3 months
description: The patient is asked to give a score between 1 and 10 to explain the pain level.
measure: Oswestry disability index
time frame: 3 months
description: The oswestry disability index is a survey designed to investigate how lumbar and leg pain affects their daily lives. It consists of 10 questions investigating the general life activity of the patient. The patient receives at least 0 points and at most 5 points from each question. The higher scores indicate that increased disability.
measure: Hospital Anxiety and Depression Scale
time frame: 3 months
description: The Hospital Anxiety and Depression Scale is an easy-to-use questionnaire consisting of 14 questions that examines the symptoms of depression with 7 questions and anxiety with 7 questions.
measure: Somatosensory Amplification Scale
time frame: 3 months
description: The Somatosensory Amplification Scale is a scale consisting of 10 items. The items include a series of disturbing bodily sensations that do not present a disease.
arm group label: Control Group
arm group type: No Intervention
description: The control group was given verbal information
arm group label: Leaflet Group
arm group type: Experimental
description: The second group was given verbal information and a detailed information leaflet with written and visual content
intervention type: Other
intervention name: Information leaflet
description: The written and visual information form prepared specifically for the patients was aimed to provide detailed information by clearly expressing the procedure, the suggestions that will be needed before and after injection (what to bring next, what circumstances may not be done, the control visit day after the procedure etc.) to be applied on before the injection day.
arm group label: Leaflet Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
citation: Coudeyre E, Poiraudeau S, Revel M, Kahan A, Drape JL, Ravaud P. Beneficial effects of information leaflets before spinal steroid injection. Joint Bone Spine. 2002 Dec;69(6):597-603. doi: 10.1016/s1297-319x(02)00457-8.
PMID: 12537268
citation: Sivaganesan A, Chotai S, Parker SL, Asher AL, McGirt MJ, Devin CJ. Predictors of the efficacy of epidural steroid injections for structural lumbar degenerative pathology. Spine J. 2016 Aug;16(8):928-34. doi: 10.1016/j.spinee.2015.11.058. Epub 2015 Dec 9.
PMID: 26689476
responsible party type: Principal Investigator
investigator affiliation: Hitit University
investigator full name: Yeliz Bahar Ozdemir
investigator title: Principal Investigator
mesh term: Radiculopathy
mesh term: Low Back Pain
sharing ipd: Undecided