NCT02298764

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P50-P75 for not_applicable low-back-pain

Timeline
Completed

Started Feb 2013

Longer than P75 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

November 12, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 24, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

November 15, 2016

Status Verified

November 1, 2016

Enrollment Period

3.6 years

First QC Date

November 12, 2014

Last Update Submit

November 14, 2016

Conditions

Low Back PainPTSD

Outcome Measures

Primary Outcomes (1)

  • Functional status, Roland Morris Scale

    scale ranging from 0-24

    0, 1 year

Secondary Outcomes (2)

  • Harvard Trauma Questionnaire

    0, 1 year

  • Back pain intensity, numeric rating scale

    0, 1 year

Study Arms (2)

standard + 10 psychotherapeutic sessions

ACTIVE COMPARATOR

\- 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

ACTIVE COMPARATOR

Standard back pain treatment

Other: Standard back pain treatment

Interventions

Standard back pain treatmentOTHER

Standard back pain treatment

Standard back pain treatment
Standard back pain treatment + 10 psychotherapeutic sessionsOTHER

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

standard + 10 psychotherapeutic sessions

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Southern Denmark

Odense, Fyn, 5000, Denmark

Location

MeSH Terms

Conditions

Low Back PainStress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsStress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Tonny E Andersen, PhD

    University of Southern Denmark, Department of Psychology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

November 12, 2014

First Posted

November 24, 2014

Study Start

February 1, 2013

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

November 15, 2016

Record last verified: 2016-11

Locations

DK(1)