Back Pain and PostTraumaticStressDisorder. A Randomized Clinical Trial

Not Applicable

Completed

• Conditions: Low Back Pain; PTSD
• Interventions: Other: Standard back pain treatment + 10 psychotherapeutic sessions; Other: Standard back pain treatment

• Registration Number: NCT02298764
• Lead Sponsor: University of Southern Denmark

Brief Summary

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

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.

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2014-11-12
• Study First Submitted QC: 2014-11-19
• Study First Posted: 2014-11-24
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-14
• Last Update Posted: 2016-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

Inclusion Criteria

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

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard + 10 psychotherapeutic sessions	Standard back pain treatment + 10 psychotherapeutic sessions	- standard back pain treatment plus 10 psychotherapeutic sessions, that will include the shock-trauma method 'Somatic Experiencing'.
Standard back pain treatment	Standard back pain treatment	Standard back pain treatment

Primary Outcome Measures

Name	Time	Method
Functional status, Roland Morris Scale	0, 1 year	scale ranging from 0-24

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Southern Denmark; 🇩🇰 Odense, Fyn, Denmark