Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Trial record 3 of 1945 for:    Back Pain

Back Pain and PostTraumaticStressDisorder. A Randomized Clinical Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by University of Southern Denmark
Sponsor:
Collaborator:
Spine Center of Southern Denmark
Information provided by (Responsible Party):
Tonny Elmose Andersen, phd., University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT02298764
First received: November 12, 2014
Last updated: November 19, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention
Low Back Pain
PTSD
Other: Standard back pain treatment
Other: Standard back pain treatment + 10 psychotherapeutic sessions

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Somatic Experiencing for Patients With Comorbid Posttraumatic Stress and Back Pain - A Randomized Controlled Trial.

Resource links provided by NLM:


Further study details as provided by University of Southern Denmark:

Primary Outcome Measures:
  • Functional status, Roland Morris Scale [ Time Frame: 0, 1 year ] [ Designated as safety issue: No ]
    scale ranging from 0-24


Secondary Outcome Measures:
  • Harward Trauma Questionnaire [ Time Frame: 0, 1 year ] [ Designated as safety issue: No ]
    scale ranging from 17-68

  • Back pain intensiti, numeric rating scale [ Time Frame: 0, 1 year ] [ Designated as safety issue: No ]
    scale ranging from 0-10


Estimated Enrollment: 100
Study Start Date: February 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: standard + 10 psychotherapeutic sessions
- standard back pain treatment plus 10 psychotherapeutic sessions, that will include the shock-trauma method 'Somatic Experiencing'.
Other: Standard back pain treatment + 10 psychotherapeutic sessions
Standard back pain treatment plus 10 psychotherapeutic session, that wikll include the shock-trauma method "somatic experiencing".
Active Comparator: Standard back pain treatment
Standard back pain treatment
Other: Standard back pain treatment
Standard back pain treatment

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 Cohorte Design" is one of the very first studies targeting both PTSD and chronic pain-related symptomatology.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02298764

Contacts
Contact: Tonny E Andersen, PhD +4520612003 tandersen@health.sdu.dk
Contact: Ask Elklit, Professor +4520612003 aelklit@health.sdu.dk

Locations
Denmark
University of Southern Denmark Recruiting
Odense, Fyn, Denmark, 5000
Contact: Claus Manniche, professor    +4526125021    claus.manniche@rsyd.dk   
Sponsors and Collaborators
University of Southern Denmark
Spine Center of Southern Denmark
Investigators
Principal Investigator: Tonny E Andersen, PhD University of Southern Denmark, Department of Psychology
  More Information

No publications provided

Responsible Party: Tonny Elmose Andersen, phd., associate professor, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT02298764     History of Changes
Other Study ID Numbers: RCT2014PTSD
Study First Received: November 12, 2014
Last Updated: November 19, 2014
Health Authority: Denmark: Spinecenter of Southern Denmark

Additional relevant MeSH terms:
Back Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms
Psychotropic Drugs
Central Nervous System Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on March 02, 2015