Back Pain and PostTraumaticStressDisorder. A Randomized Clinical Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Low Back Pain, PTSD

Intervention / Treatment
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* Other: Standard back pain treatment
* Other: Standard back pain treatment + 10 psychotherapeutic sessions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Back pain: from 1/2 Y duration or longer Trauma according to HTQ Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: standard + 10 psychotherapeutic sessions<br>- 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<br>* Standard back pain treatment plus 10 psychotherapeutic session, that will include the shock-trauma method somatic experiencing.<br>|
| Active Comparator: Standard back pain treatment<br>Standard back pain treatment | Other: Standard back pain treatment<br>* Standard back pain treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional status, Roland Morris Scale | scale ranging from 0-24 | 0, 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Harvard Trauma Questionnaire | scale ranging from 17-68 | 0, 1 year | 
| Back pain intensity, numeric rating scale | scale ranging from 0-10 | 0, 1 year |