Low Back Pain Clinical Trial
Official title:
Somatic Experiencing for Patients With Comorbid Posttraumatic Stress and Back Pain - A Randomized Controlled 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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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