search
Back to results

Low Back Pain and Comorbid Posttraumatic Stress Disorder

Primary Purpose

Low Back Pain, Posttraumatic Stress Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Psychotherapy
Physiotherapy
Sponsored by
University of Southern Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Low Back pain, Pain, Posttraumatic Stress Disorder, PTSD, Somatic Experiencing, SE

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Back pain: from 1/2 Y duration or longer
  • Trauma according to HTQ

Exclusion Criteria:

  • Planned surgery, comorbid psychiatry (except PTSD and mild to moderate depression), personality disorders, drug or medical abuse

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Physiotherapy (Phys)

    Somatic Experiencing + phys

    Arm Description

    12 sessions of guided physiotherapy for low back pain. Cognitive Behavioral Therapeutic elements included targeting Fear Avoidance Beliefs.

    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.

    Outcomes

    Primary Outcome Measures

    Roland Morris Disability Questionnaire (RMDQ; Roland & Morris, 1983)
    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.
    Harvard Trauma Questionnaire part IV (Mollica, Caspi-Yavin, Bollini, & Truong, 1992)
    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.

    Secondary Outcome Measures

    Pain intensity
    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.
    The Pain Catastrophizing Scale (Sullivan, Bishop, & Pivik, 1995)
    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.
    the Tampa Scale for Kinesiophobia (TSK: Kori, Miller, & Todd, 1990).
    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).
    Anxiety and Depression (Hospital and Anxiety Depression Scale, HADS)
    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).

    Full Information

    First Posted
    July 31, 2017
    Last Updated
    August 4, 2017
    Sponsor
    University of Southern Denmark
    Collaborators
    Spine Centre of Southern Denmark
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03244046
    Brief Title
    Low Back Pain and Comorbid Posttraumatic Stress Disorder
    Official Title
    Somatic Experiencing for Patients With Low Back Pain and Comorbid Posttraumatic Stress Disorder: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 5, 2016 (Actual)
    Primary Completion Date
    December 2017 (Anticipated)
    Study Completion Date
    July 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Southern Denmark
    Collaborators
    Spine Centre of Southern Denmark

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Low Back Pain, Posttraumatic Stress Disorder
    Keywords
    Low Back pain, Pain, Posttraumatic Stress Disorder, PTSD, Somatic Experiencing, SE

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    140 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Physiotherapy (Phys)
    Arm Type
    Active Comparator
    Arm Description
    12 sessions of guided physiotherapy for low back pain. Cognitive Behavioral Therapeutic elements included targeting Fear Avoidance Beliefs.
    Arm Title
    Somatic Experiencing + phys
    Arm Type
    Experimental
    Arm 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(s)
    Psychotherapy
    Other Intervention Name(s)
    Somatic Experiencing (SE)
    Intervention 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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Physiotherapy
    Intervention 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).
    Primary Outcome Measure Information:
    Title
    Roland Morris Disability Questionnaire (RMDQ; Roland & Morris, 1983)
    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.
    Time Frame
    Change from baseline to 6 months follow-up
    Title
    Harvard Trauma Questionnaire part IV (Mollica, Caspi-Yavin, Bollini, & Truong, 1992)
    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.
    Time Frame
    Change from baseline to 6 months follow-up
    Secondary Outcome Measure Information:
    Title
    Pain intensity
    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.
    Time Frame
    baseline, 3, 6 and 12 months
    Title
    The Pain Catastrophizing Scale (Sullivan, Bishop, & Pivik, 1995)
    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.
    Time Frame
    baseline, 3, 6 and 12 months
    Title
    the Tampa Scale for Kinesiophobia (TSK: Kori, Miller, & Todd, 1990).
    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).
    Time Frame
    baseline, 3, 6 and 12 months
    Title
    Anxiety and Depression (Hospital and Anxiety Depression Scale, HADS)
    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).
    Time Frame
    baseline, 3, 6 and 12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Back pain: from 1/2 Y duration or longer Trauma according to HTQ Exclusion Criteria: Planned surgery, comorbid psychiatry (except PTSD and mild to moderate depression), personality disorders, drug or medical abuse
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Berit Schiøttz-Christensen, professor
    Organizational Affiliation
    Spine Center South
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    30466429
    Citation
    Andersen TE, Ellegaard H, Schiottz-Christensen B, Manniche C. Somatic experiencing(R) for patients with low back pain and comorbid posttraumatic stress disorder - protocol of a randomized controlled trial. BMC Complement Altern Med. 2018 Nov 22;18(1):308. doi: 10.1186/s12906-018-2370-y.
    Results Reference
    derived

    Learn more about this trial

    Low Back Pain and Comorbid Posttraumatic Stress Disorder

    We'll reach out to this number within 24 hrs