<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/NCT03244046</url>
  </required_header>
  <id_info>
    <org_study_id>RCT2016PTSD</org_study_id>
    <nct_id>NCT03244046</nct_id>
  </id_info>
  <brief_title>Low Back Pain and Comorbid Posttraumatic Stress Disorder</brief_title>
  <official_title>Somatic Experiencing for Patients With Low Back Pain and Comorbid Posttraumatic Stress Disorder: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Southern Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Spine Centre of Southern Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Southern Denmark</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>
      The aim is to test whether the psychotherapeutic intervention Somatic Experiencing targeting&#xD;
      Post Traumatic Stress Disorder (PTSD) symptoms will have an additional positive effect on the&#xD;
      outcomes of guided physiotherapy against chronic back pain development.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction: Patients with low back pain after injuries often demonstrate symptoms of PTSD&#xD;
      measured via the Harvard Trauma Questionnaire Scale (HTQ). It has been found that PTSD and&#xD;
      pain may maintain each other.&#xD;
&#xD;
      Methods: Thousand consecutive patients with Low Back Pain (LBP) referred to the Spine Center&#xD;
      are screened for PTSD. It is expected that 140 patients will meet the inclusion criteria and&#xD;
      be randomized to Guided Physiotherapy or to Guided Physiotherapy plus 12 psychotherapeutic&#xD;
      sessions, that will include the shock-trauma method 'Somatic Experiencing'.&#xD;
&#xD;
      Effect parameters are: Pain, daily function, EuroQOL and (HTQ), anxiety and depression, fear&#xD;
      avoidance (Tampa Scale for Kinesiophobia) and pain catastrophizing (PCS) on entry, and at&#xD;
      6/12 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">January 5, 2016</start_date>
  <completion_date type="Anticipated">July 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2017</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Roland Morris Disability Questionnaire (RMDQ; Roland &amp; Morris, 1983)</measure>
    <time_frame>Change from baseline to 6 months follow-up</time_frame>
    <description>The RMDQ is a self-reported outcome measuring the level of disability related to low back pain. The level of disability was measured on 23 statements covering six different domains: physical ability/activity, sleep/rest, psychosocial level of functioning, household management, eating, and pain frequency. Each statement was scored 1 if the patient felt that the statement was descriptive of their circumstances and scored 0 if not. The total RMDQ score ranges from 0 (no disability) to 23 (maximal disability). Scores were converted to percentages with 24 corresponding to 100% disability.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Harvard Trauma Questionnaire part IV (Mollica, Caspi-Yavin, Bollini, &amp; Truong, 1992)</measure>
    <time_frame>Change from baseline to 6 months follow-up</time_frame>
    <description>The Harvard Trauma Questionnaire consists of 17 items with a 4-point Likert scale (1 = not at all to 4 = very often). The 17 items relate to PTSD's core clusters within the Diagnostic and Statistical Manual of Mental Disorders (APA, 1994), 4th Edition (DSM-IV): avoidance (7 items), re-experiencing (5 items), and hyperarousal (5 items). An item was deemed to be positively endorsed if scores were ≥ 3. The Harvard Trauma Questionnaire follows the diagnostic criteria for the PTSD diagnosis according to the DSM-IV. The scale thus makes it possible to measure both the severity of symptoms and to estimate the prevalence of possible PTSD. Following the DSM-IV, a possible PTSD diagnosis was proposed if participants reported at least one re-experiencing symptom, three avoidance symptoms, and two hyperarousal symptoms.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain intensity</measure>
    <time_frame>baseline, 3, 6 and 12 months</time_frame>
    <description>Pain intensity was measured as the average score of three 11-point Likert scales measuring peak pain intensity, average pain intensity over the past 2 weeks as well as current pain intensity (Manniche, Asmussen, Lauritsen, Vinterberg, et Kreiner, 1994). Each scale measured pain intensity on a 0-10 numerical rating scale (NRS: Jensen, Karoly, &amp; Braver, 1986) with 0 defined as no pain and 10 as the worst imaginable pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Pain Catastrophizing Scale (Sullivan, Bishop, &amp; Pivik, 1995)</measure>
    <time_frame>baseline, 3, 6 and 12 months</time_frame>
    <description>The Pain Catastrophizing Scale (Sullivan, Bishop, &amp; Pivik, 1995) was used to measure catastrophic thinking related to pain. Its instructions ask participants to reflect on past painful experiences, and to indicate the degree to which they experienced each of 13 thoughts or feelings when experiencing pain, on a 5-point Likert scale with (0 = not at all, 4 = all the time). A scale sum score was calculated from all items, with a high score indicating a high level of pain catastrophizing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the Tampa Scale for Kinesiophobia (TSK: Kori, Miller, &amp; Todd, 1990).</measure>
    <time_frame>baseline, 3, 6 and 12 months</time_frame>
    <description>Fear of re-injury due to movement was measured with the Tampa Scale for Kinesiophobia (TSK: Kori, Miller, &amp; Todd, 1990). TSK is a 17-item scale assessing fear of movement on a 4-point Likert scale ranging from 17 to 68 with higher scores indicating higher levels of kinesiophobia. The scale is commonly used in diverse chronic pain samples and has good construct and predictive validity (Vlaeyen, Kole-Snijders, Boeren, &amp; van Eek, 1995).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety and Depression (Hospital and Anxiety Depression Scale, HADS)</measure>
    <time_frame>baseline, 3, 6 and 12 months</time_frame>
    <description>The scale consists of 14 items, seven relating to anxiety (HADS-A) and seven to depression (HADSD) with responses ranging from 0 (no symptoms) to 3 (maximum impairment). In the present study, we used a subscale cut-off of 8 in order to include all possible cases of anxiety or depression, as suggested by Zigmond and Snaith (1983).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">140</enrollment>
  <condition>Low Back Pain</condition>
  <condition>Posttraumatic Stress Disorder</condition>
  <arm_group>
    <arm_group_label>Physiotherapy (Phys)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>12 sessions of guided physiotherapy for low back pain. Cognitive Behavioral Therapeutic elements included targeting Fear Avoidance Beliefs.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Somatic Experiencing + phys</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>12 sessions of psychotherapy (somatic experiencing) and 12 sessions of guided physiotherapy for low back pain. Cognitive Behavioral Therapeutic elements included targeting Fear Avoidance Beliefs.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Psychotherapy</intervention_name>
    <description>The SE intervention followed the nine-step model as outlined by Peter Levine (2010) and involved gradually eliciting awareness of body sensations associated with the traumatic event. By the process of 'titration', patients were gradually encouraged to access somatic activation, feelings and body sensations as means to restore equilibrium to the autonomic nervous system and thereby alleviate hyperarousal, re-experiencing and avoidance of trauma-related experiences and thoughts.</description>
    <arm_group_label>Somatic Experiencing + phys</arm_group_label>
    <other_name>Somatic Experiencing (SE)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Physiotherapy</intervention_name>
    <description>This treatment consisted of supervised exercises for low back pain delivered in 12 sessions and performed by physiotherapists in the center according to the European guidelines for the management of chronic low back pain (Airaksinen, et al., 2006).</description>
    <arm_group_label>Physiotherapy (Phys)</arm_group_label>
    <arm_group_label>Somatic Experiencing + phys</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Back pain: from 1/2 Y duration or longer&#xD;
&#xD;
          -  Trauma according to HTQ&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Planned surgery, comorbid psychiatry (except PTSD and mild to moderate depression),&#xD;
             personality disorders, drug or medical abuse&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Berit Schiøttz-Christensen, professor</last_name>
    <role>Study Director</role>
    <affiliation>Spine Center South</affiliation>
  </overall_official>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 31, 2017</study_first_submitted>
  <study_first_submitted_qc>August 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 9, 2017</study_first_posted>
  <last_update_submitted>August 4, 2017</last_update_submitted>
  <last_update_submitted_qc>August 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Southern Denmark</investigator_affiliation>
    <investigator_full_name>Tonny Elmose Andersen, phd.</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Low Back pain</keyword>
  <keyword>Pain</keyword>
  <keyword>Posttraumatic Stress Disorder</keyword>
  <keyword>PTSD</keyword>
  <keyword>Somatic Experiencing</keyword>
  <keyword>SE</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Back Pain</mesh_term>
    <mesh_term>Low Back Pain</mesh_term>
    <mesh_term>Stress Disorders, Traumatic</mesh_term>
    <mesh_term>Stress Disorders, Post-Traumatic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03244046
org study id: RCT2016PTSD
nct id: NCT03244046
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim is to test whether the psychotherapeutic intervention Somatic Experiencing targeting
      Post Traumatic Stress Disorder (PTSD) symptoms will have an additional positive effect on the
      outcomes of guided physiotherapy against chronic back pain development.
Introduction: Patients with low back pain after injuries often demonstrate symptoms of PTSD
      measured via the Harvard Trauma Questionnaire Scale (HTQ). It has been found that PTSD and
      pain may maintain each other.

      Methods: Thousand consecutive patients with Low Back Pain (LBP) referred to the Spine Center
      are screened for PTSD. It is expected that 140 patients will meet the inclusion criteria and
      be randomized to Guided Physiotherapy or to Guided Physiotherapy plus 12 psychotherapeutic
      sessions, that will include the shock-trauma method 'Somatic Experiencing'.

      Effect parameters are: Pain, daily function, EuroQOL and (HTQ), anxiety and depression, fear
      avoidance (Tampa Scale for Kinesiophobia) and pain catastrophizing (PCS) on entry, and at
      6/12 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Roland Morris Disability Questionnaire (RMDQ; Roland & Morris, 1983)
time frame: Change from baseline to 6 months follow-up
description: The RMDQ is a self-reported outcome measuring the level of disability related to low back pain. The level of disability was measured on 23 statements covering six different domains: physical ability/activity, sleep/rest, psychosocial level of functioning, household management, eating, and pain frequency. Each statement was scored 1 if the patient felt that the statement was descriptive of their circumstances and scored 0 if not. The total RMDQ score ranges from 0 (no disability) to 23 (maximal disability). Scores were converted to percentages with 24 corresponding to 100% disability.
measure: Harvard Trauma Questionnaire part IV (Mollica, Caspi-Yavin, Bollini, & Truong, 1992)
time frame: Change from baseline to 6 months follow-up
description: The Harvard Trauma Questionnaire consists of 17 items with a 4-point Likert scale (1 = not at all to 4 = very often). The 17 items relate to PTSD's core clusters within the Diagnostic and Statistical Manual of Mental Disorders (APA, 1994), 4th Edition (DSM-IV): avoidance (7 items), re-experiencing (5 items), and hyperarousal (5 items). An item was deemed to be positively endorsed if scores were ≥ 3. The Harvard Trauma Questionnaire follows the diagnostic criteria for the PTSD diagnosis according to the DSM-IV. The scale thus makes it possible to measure both the severity of symptoms and to estimate the prevalence of possible PTSD. Following the DSM-IV, a possible PTSD diagnosis was proposed if participants reported at least one re-experiencing symptom, three avoidance symptoms, and two hyperarousal symptoms.
measure: Pain intensity
time frame: baseline, 3, 6 and 12 months
description: Pain intensity was measured as the average score of three 11-point Likert scales measuring peak pain intensity, average pain intensity over the past 2 weeks as well as current pain intensity (Manniche, Asmussen, Lauritsen, Vinterberg, et Kreiner, 1994). Each scale measured pain intensity on a 0-10 numerical rating scale (NRS: Jensen, Karoly, & Braver, 1986) with 0 defined as no pain and 10 as the worst imaginable pain.
measure: The Pain Catastrophizing Scale (Sullivan, Bishop, & Pivik, 1995)
time frame: baseline, 3, 6 and 12 months
description: The Pain Catastrophizing Scale (Sullivan, Bishop, & Pivik, 1995) was used to measure catastrophic thinking related to pain. Its instructions ask participants to reflect on past painful experiences, and to indicate the degree to which they experienced each of 13 thoughts or feelings when experiencing pain, on a 5-point Likert scale with (0 = not at all, 4 = all the time). A scale sum score was calculated from all items, with a high score indicating a high level of pain catastrophizing.
measure: the Tampa Scale for Kinesiophobia (TSK: Kori, Miller, & Todd, 1990).
time frame: baseline, 3, 6 and 12 months
description: Fear of re-injury due to movement was measured with the Tampa Scale for Kinesiophobia (TSK: Kori, Miller, & Todd, 1990). TSK is a 17-item scale assessing fear of movement on a 4-point Likert scale ranging from 17 to 68 with higher scores indicating higher levels of kinesiophobia. The scale is commonly used in diverse chronic pain samples and has good construct and predictive validity (Vlaeyen, Kole-Snijders, Boeren, & van Eek, 1995).
measure: Anxiety and Depression (Hospital and Anxiety Depression Scale, HADS)
time frame: baseline, 3, 6 and 12 months
description: The scale consists of 14 items, seven relating to anxiety (HADS-A) and seven to depression (HADSD) with responses ranging from 0 (no symptoms) to 3 (maximum impairment). In the present study, we used a subscale cut-off of 8 in order to include all possible cases of anxiety or depression, as suggested by Zigmond and Snaith (1983).
arm group label: Physiotherapy (Phys)
arm group type: Active Comparator
description: 12 sessions of guided physiotherapy for low back pain. Cognitive Behavioral Therapeutic elements included targeting Fear Avoidance Beliefs.
arm group label: Somatic Experiencing + phys
arm group type: Experimental
description: 12 sessions of psychotherapy (somatic experiencing) and 12 sessions of guided physiotherapy for low back pain. Cognitive Behavioral Therapeutic elements included targeting Fear Avoidance Beliefs.
intervention type: Behavioral
intervention name: Psychotherapy
description: The SE intervention followed the nine-step model as outlined by Peter Levine (2010) and involved gradually eliciting awareness of body sensations associated with the traumatic event. By the process of 'titration', patients were gradually encouraged to access somatic activation, feelings and body sensations as means to restore equilibrium to the autonomic nervous system and thereby alleviate hyperarousal, re-experiencing and avoidance of trauma-related experiences and thoughts.
arm group label: Somatic Experiencing + phys
other name: Somatic Experiencing (SE)
intervention type: Behavioral
intervention name: Physiotherapy
description: This treatment consisted of supervised exercises for low back pain delivered in 12 sessions and performed by physiotherapists in the center according to the European guidelines for the management of chronic low back pain (Airaksinen, et al., 2006).
arm group label: Physiotherapy (Phys)
arm group label: Somatic Experiencing + phys
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Berit Schiøttz-Christensen, professor
role: Study Director
affiliation: Spine Center South
responsible party type: Principal Investigator
investigator affiliation: University of Southern Denmark
investigator full name: Tonny Elmose Andersen, phd.
investigator title: Associate Professor
mesh term: Back Pain
mesh term: Low Back Pain
mesh term: Stress Disorders, Traumatic
mesh term: Stress Disorders, Post-Traumatic
sharing ipd: No