Clinical Trials Directory

Trials / Unknown

UnknownNCT03244046

Low Back Pain and Comorbid Posttraumatic Stress Disorder

Somatic Experiencing for Patients With Low Back Pain and Comorbid Posttraumatic Stress Disorder: A Randomized Controlled Trial

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
140 (estimated)
Sponsor
University of Southern Denmark · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

Summary

The aim is to test whether the psychotherapeutic intervention Somatic Experiencing targeting Post Traumatic Stress Disorder (PTSD) symptoms will have an additional positive effect on the outcomes of guided physiotherapy against chronic back pain development.

Detailed description

Introduction: Patients with low back pain after injuries 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 140 patients will meet the inclusion criteria and be randomized to Guided Physiotherapy or to Guided Physiotherapy plus 12 psychotherapeutic sessions, that will include the shock-trauma method 'Somatic Experiencing'. Effect parameters are: Pain, daily function, EuroQOL and (HTQ), anxiety and depression, fear avoidance (Tampa Scale for Kinesiophobia) and pain catastrophizing (PCS) on entry, and at 6/12 months.

Conditions

Interventions

TypeNameDescription
BEHAVIORALPsychotherapyThe SE intervention followed the nine-step model as outlined by Peter Levine (2010) and involved gradually eliciting awareness of body sensations associated with the traumatic event. By the process of 'titration', patients were gradually encouraged to access somatic activation, feelings and body sensations as means to restore equilibrium to the autonomic nervous system and thereby alleviate hyperarousal, re-experiencing and avoidance of trauma-related experiences and thoughts.
BEHAVIORALPhysiotherapyThis treatment consisted of supervised exercises for low back pain delivered in 12 sessions and performed by physiotherapists in the center according to the European guidelines for the management of chronic low back pain (Airaksinen, et al., 2006).

Timeline

Start date
2016-01-05
Primary completion
2017-12-01
Completion
2018-07-01
First posted
2017-08-09
Last updated
2017-08-09

Source: ClinicalTrials.gov record NCT03244046. Inclusion in this directory is not an endorsement.