Back Pain and PostTraumaticStressDisorder. A Randomized Clinical Trial
Primary Purpose
Low Back Pain, PTSD
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Standard back pain treatment
Standard back pain treatment + 10 psychotherapeutic sessions
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain
Eligibility Criteria
Inclusion Criteria:
- Back pain: from 1/2 Y duration or longer
- Trauma according to HTQ
Exclusion Criteria:
-
Sites / Locations
- University of Southern Denmark
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
standard + 10 psychotherapeutic sessions
Standard back pain treatment
Arm Description
- standard back pain treatment plus 10 psychotherapeutic sessions, that will include the shock-trauma method 'Somatic Experiencing'.
Standard back pain treatment
Outcomes
Primary Outcome Measures
Functional status, Roland Morris Scale
scale ranging from 0-24
Secondary Outcome Measures
Harvard Trauma Questionnaire
scale ranging from 17-68
Back pain intensity, numeric rating scale
scale ranging from 0-10
Full Information
NCT ID
NCT02298764
First Posted
November 12, 2014
Last Updated
November 14, 2016
Sponsor
University of Southern Denmark
Collaborators
Spine Centre of Southern Denmark
1. Study Identification
Unique Protocol Identification Number
NCT02298764
Brief Title
Back Pain and PostTraumaticStressDisorder. A Randomized Clinical Trial
Official Title
Somatic Experiencing for Patients With Comorbid Posttraumatic Stress and Back Pain - A Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern Denmark
Collaborators
Spine Centre of Southern Denmark
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, PTSD
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
91 (Actual)
8. Arms, Groups, and Interventions
Arm Title
standard + 10 psychotherapeutic sessions
Arm Type
Active Comparator
Arm Description
- standard back pain treatment plus 10 psychotherapeutic sessions, that will include the shock-trauma method 'Somatic Experiencing'.
Arm Title
Standard back pain treatment
Arm Type
Active Comparator
Arm Description
Standard back pain treatment
Intervention Type
Other
Intervention Name(s)
Standard back pain treatment
Intervention Description
Standard back pain treatment
Intervention Type
Other
Intervention Name(s)
Standard back pain treatment + 10 psychotherapeutic sessions
Intervention Description
Standard back pain treatment plus 10 psychotherapeutic session, that will include the shock-trauma method "somatic experiencing".
Primary Outcome Measure Information:
Title
Functional status, Roland Morris Scale
Description
scale ranging from 0-24
Time Frame
0, 1 year
Secondary Outcome Measure Information:
Title
Harvard Trauma Questionnaire
Description
scale ranging from 17-68
Time Frame
0, 1 year
Title
Back pain intensity, numeric rating scale
Description
scale ranging from 0-10
Time Frame
0, 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Back pain: from 1/2 Y duration or longer
Trauma according to HTQ
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tonny E Andersen, PhD
Organizational Affiliation
University of Southern Denmark, Department of Psychology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Southern Denmark
City
Odense
State/Province
Fyn
ZIP/Postal Code
5000
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Back Pain and PostTraumaticStressDisorder. A Randomized Clinical Trial
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