Back Pain and PostTraumaticStressDisorder. A Randomized Clinical Trial

Overview

Aim The aim is to test whether a short psychotherapeutic intervention targeting Post Traumatic Stress Disorder (PTSD) symptoms will have an additional positive effect on the outcomes of the Standard Multidisciplinary Program (SMP) against chronic back pain development.

Full Title of Study: “Somatic Experiencing for Patients With Comorbid Posttraumatic Stress and Back Pain – A Randomized Controlled Trial.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: September 2016

Detailed Description

Focus Patients with back pain 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 100 patients will meet the inclusion criteria and be randomized to SMP or to SMP plus 10 psychotherapeutic sessions, that will include the shock-trauma method 'Somatic Experiencing'. Conclusion The project started in 2013, so there have not yet been any results. Currently total reached 65 back pain patients; 34 patients in the SMP + sessions intervention arm. Effect parameters are: Pain, daily function, EuroQOL and (HTQ), anxiety and depression, fear avoidance (Tampa Scale for Kinesiophobia) on entry, and at 6/12 months. This "Nested Randomized Trial in a Cohort Design" is one of the very first studies targeting both PTSD and chronic pain-related symptomatology.

Interventions

  • Other: Standard back pain treatment
    • Standard back pain treatment
  • Other: Standard back pain treatment + 10 psychotherapeutic sessions
    • Standard back pain treatment plus 10 psychotherapeutic session, that will include the shock-trauma method “somatic experiencing”.

Arms, Groups and Cohorts

  • Active Comparator: standard + 10 psychotherapeutic sessions
    • – standard back pain treatment plus 10 psychotherapeutic sessions, that will include the shock-trauma method ‘Somatic Experiencing’.
  • Active Comparator: Standard back pain treatment
    • Standard back pain treatment

Clinical Trial Outcome Measures

Primary Measures

  • Functional status, Roland Morris Scale
    • Time Frame: 0, 1 year
    • scale ranging from 0-24

Secondary Measures

  • Harvard Trauma Questionnaire
    • Time Frame: 0, 1 year
    • scale ranging from 17-68
  • Back pain intensity, numeric rating scale
    • Time Frame: 0, 1 year
    • scale ranging from 0-10

Participating in This Clinical Trial

Inclusion Criteria

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

-

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Southern Denmark
  • Collaborator
    • Spine Centre of Southern Denmark
  • Provider of Information About this Clinical Study
    • Principal Investigator: Tonny Elmose Andersen, phd., associate professor – University of Southern Denmark
  • Overall Official(s)
    • Tonny E Andersen, PhD, Principal Investigator, University of Southern Denmark, Department of Psychology

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.