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Low Back Pain and Comorbid Posttraumatic Stress Disorder

University of Southern Denmark (SDU) logo

University of Southern Denmark (SDU)

Status

Unknown

Conditions

Posttraumatic Stress Disorder
Low Back Pain

Treatments

Behavioral: Physiotherapy
Behavioral: Psychotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT03244046
RCT2016PTSD

Details and patient eligibility

About

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.

Full 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.

Enrollment

140 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

140 participants in 2 patient groups

Physiotherapy (Phys)
Active Comparator group
Description:
12 sessions of guided physiotherapy for low back pain. Cognitive Behavioral Therapeutic elements included targeting Fear Avoidance Beliefs.
Treatment:
Behavioral: Physiotherapy
Somatic Experiencing + phys
Experimental group
Description:
12 sessions of psychotherapy (somatic experiencing) and 12 sessions of guided physiotherapy for low back pain. Cognitive Behavioral Therapeutic elements included targeting Fear Avoidance Beliefs.
Treatment:
Behavioral: Psychotherapy
Behavioral: Physiotherapy

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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