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OpenTrials
Completed

NCT Number: NCT02298764

Back Pain and PostTraumaticStressDisorder. A Randomized Clinical Trial

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.

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Key information

Conditions

Low Back Pain Back Pain Mental Disorders Neurologic Manifestations PTSD Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Southern Denmark

Odense, Fyn, 5000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

Standard back pain treatment

Other

Standard back pain treatment

Standard back pain treatment + 10 psychotherapeutic sessions

Other

Standard back pain treatment plus 10 psychotherapeutic session, that will include the shock-trauma method "somatic experiencing".

Primary outcomes

  1. Functional status, Roland Morris Scale

    Time frame: 0, 1 year

    scale ranging from 0-24

Secondary outcomes

  1. Harvard Trauma Questionnaire

    Time frame: 0, 1 year

    scale ranging from 17-68

  2. Back pain intensity, numeric rating scale

    Time frame: 0, 1 year

    scale ranging from 0-10

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Collaborators

  • Spine Centre of Southern Denmark

Registry information

Official study title

Somatic Experiencing for Patients With Comorbid Posttraumatic Stress and Back Pain - A Randomized Controlled Trial.

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Nov 24, 2014
Registry last updated
Nov 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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