Clinical trial NCT03244046: Low Back Pain and Comorbid Posttraumatic Stress Disorder
Official title: Somatic Experiencing for Patients With Low Back Pain and Comorbid Posttraumatic Stress Disorder: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Posttraumatic Stress Disorder
Keywords: Low Back pain
Pain
Posttraumatic Stress Disorder
PTSD
Somatic Experiencing
SE
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Spine Centre of Southern Denmark
First posted: 2017-08-09
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Planned surgery, comorbid psychiatry (except PTSD and mild to moderate depression), personality disorders, drug or medical abuse

Primary outcomes:
measure: Roland Morris Disability Questionnaire (RMDQ; Roland & Morris, 1983)
timeFrame: Change from baseline to 6 months follow-up
measure: Harvard Trauma Questionnaire part IV (Mollica, Caspi-Yavin, Bollini, & Truong, 1992)
timeFrame: Change from baseline to 6 months follow-up
Secondary outcomes:
measure: Pain intensity
timeFrame: baseline, 3, 6 and 12 months
measure: The Pain Catastrophizing Scale (Sullivan, Bishop, & Pivik, 1995)
timeFrame: baseline, 3, 6 and 12 months
measure: the Tampa Scale for Kinesiophobia (TSK: Kori, Miller, & Todd, 1990).
timeFrame: baseline, 3, 6 and 12 months
measure: Anxiety and Depression (Hospital and Anxiety Depression Scale, HADS)
timeFrame: baseline, 3, 6 and 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Spine Center South
name: Berit Schiøttz-Christensen, professor
role: STUDY_DIRECTOR
References:
citation: Andersen TE, Ellegaard H, Schiottz-Christensen B, Manniche C. Somatic experiencing(R) for patients with low back pain and comorbid posttraumatic stress disorder - protocol of a randomized controlled trial. BMC Complement Altern Med. 2018 Nov 22;18(1):308. doi: 10.1186/s12906-018-2370-y.