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NCT02298764 Clinical Trial

Back Pain and PostTraumaticStressDisorder. A Randomized Clinical Trial

Low Back Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02298764
Other study ID # RCT2014PTSD
Secondary ID
Status Completed
Phase N/A
First received November 12, 2014
Last updated November 14, 2016
Start date February 2013
Est. completion date September 2016

Study information
Verified date November 2016
Source University of Southern Denmark
Contact n/a
Is FDA regulated No
Health authority Denmark: The Regional Committee on Biomedical Research Ethics
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 91
Est. completion date September 2016
Est. primary completion date September 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Back pain: from 1/2 Y duration or longer

- Trauma according to HTQ

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Denmark University of Southern Denmark Odense Fyn

Sponsors (2)
Lead Sponsor Collaborator
University of Southern Denmark Spine Centre of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Functional status, Roland Morris Scale scale ranging from 0-24 0, 1 year No
Secondary Harvard Trauma Questionnaire scale ranging from 17-68 0, 1 year No
Secondary Back pain intensity, numeric rating scale scale ranging from 0-10 0, 1 year No
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