Back Pain and PostTraumaticStressDisorder. A Randomized Clinical Trial

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02298764

Enrollment

Registered

2014-11-24

Start date

2013-02-28

Completion date

2016-09-30

Last updated

2016-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain, PTSD

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.

Interventions

OTHERStandard back pain treatment

Standard back pain treatment

OTHERStandard back pain treatment + 10 psychotherapeutic sessions

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

Design outcomes

Primary

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

Secondary

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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026