Back Pain and PostTraumaticStressDisorder. A Randomized Clinical Trial
NCT ID: NCT02298764
Last Updated: 2016-11-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
91 participants
INTERVENTIONAL
2013-02-28
2016-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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standard + 10 psychotherapeutic sessions
\- standard back pain treatment plus 10 psychotherapeutic sessions, that will include the shock-trauma method 'Somatic Experiencing'.
Standard back pain treatment + 10 psychotherapeutic sessions
Standard back pain treatment plus 10 psychotherapeutic session, that will include the shock-trauma method "somatic experiencing".
Standard back pain treatment
Standard back pain treatment
Standard back pain treatment
Standard back pain treatment
Interventions
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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".
Eligibility Criteria
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Inclusion Criteria
* Trauma according to HTQ
Exclusion Criteria
18 Years
65 Years
ALL
No
Sponsors
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Spine Centre of Southern Denmark
OTHER
University of Southern Denmark
OTHER
Responsible Party
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Tonny Elmose Andersen, phd.
associate professor
Principal Investigators
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Tonny E Andersen, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Southern Denmark, Department of Psychology
Locations
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University of Southern Denmark
Odense, Fyn, Denmark
Countries
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Other Identifiers
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RCT2014PTSD
Identifier Type: -
Identifier Source: org_study_id