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Trial record 3 of 2105 for:    Back Pain

Back Pain and PostTraumaticStressDisorder. A Randomized Clinical Trial

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02298764
First Posted: November 24, 2014
Last Update Posted: November 15, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Spine Centre of Southern Denmark
Information provided by (Responsible Party):
Tonny Elmose Andersen, phd., University of Southern Denmark
  Purpose
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.

Condition Intervention
Low Back Pain PTSD Other: Standard back pain treatment Other: Standard back pain treatment + 10 psychotherapeutic sessions

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Somatic Experiencing for Patients With Comorbid Posttraumatic Stress and Back Pain - A Randomized Controlled Trial.

Resource links provided by NLM:


Further study details as provided by Tonny Elmose Andersen, phd., University of Southern Denmark:

Primary Outcome Measures:
  • Functional status, Roland Morris Scale [ Time Frame: 0, 1 year ]
    scale ranging from 0-24


Secondary Outcome 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


Enrollment: 91
Study Start Date: February 2013
Study Completion Date: September 2016
Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: standard + 10 psychotherapeutic sessions
- standard back pain treatment plus 10 psychotherapeutic sessions, that will include the shock-trauma method 'Somatic Experiencing'.
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".
Active Comparator: Standard back pain treatment
Standard back pain treatment
Other: Standard back pain treatment
Standard back pain treatment

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02298764


Locations
Denmark
University of Southern Denmark
Odense, Fyn, Denmark, 5000
Sponsors and Collaborators
University of Southern Denmark
Spine Centre of Southern Denmark
Investigators
Principal Investigator: Tonny E Andersen, PhD University of Southern Denmark, Department of Psychology
  More Information

Responsible Party: Tonny Elmose Andersen, phd., associate professor, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT02298764     History of Changes
Other Study ID Numbers: RCT2014PTSD
First Submitted: November 12, 2014
First Posted: November 24, 2014
Last Update Posted: November 15, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Psychotropic Drugs