Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Low Back Pain and Comorbid Posttraumatic Stress Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03244046
Recruitment Status : Enrolling by invitation
First Posted : August 9, 2017
Last Update Posted : August 9, 2017
Sponsor:
Collaborator:
Spine Centre of Southern Denmark
Information provided by (Responsible Party):
Tonny Elmose Andersen, phd., University of Southern Denmark

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.

Condition or disease Intervention/treatment Phase
Low Back Pain Posttraumatic Stress Disorder Behavioral: Psychotherapy Behavioral: Physiotherapy Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Somatic Experiencing for Patients With Low Back Pain and Comorbid Posttraumatic Stress Disorder: A Randomized Controlled Trial
Actual Study Start Date : January 5, 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Physiotherapy (Phys)
12 sessions of guided physiotherapy for low back pain. Cognitive Behavioral Therapeutic elements included targeting Fear Avoidance Beliefs.
Behavioral: Physiotherapy
This 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).

Experimental: Somatic Experiencing + phys
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.
Behavioral: Psychotherapy
The 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.
Other Name: Somatic Experiencing (SE)

Behavioral: Physiotherapy
This 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).




Primary Outcome Measures :
  1. Roland Morris Disability Questionnaire (RMDQ; Roland & Morris, 1983) [ Time Frame: Change from baseline to 6 months follow-up ]
    The RMDQ is a self-reported outcome measuring the level of disability related to low back pain. The level of disability was measured on 23 statements covering six different domains: physical ability/activity, sleep/rest, psychosocial level of functioning, household management, eating, and pain frequency. Each statement was scored 1 if the patient felt that the statement was descriptive of their circumstances and scored 0 if not. The total RMDQ score ranges from 0 (no disability) to 23 (maximal disability). Scores were converted to percentages with 24 corresponding to 100% disability.

  2. Harvard Trauma Questionnaire part IV (Mollica, Caspi-Yavin, Bollini, & Truong, 1992) [ Time Frame: Change from baseline to 6 months follow-up ]
    The Harvard Trauma Questionnaire consists of 17 items with a 4-point Likert scale (1 = not at all to 4 = very often). The 17 items relate to PTSD's core clusters within the Diagnostic and Statistical Manual of Mental Disorders (APA, 1994), 4th Edition (DSM-IV): avoidance (7 items), re-experiencing (5 items), and hyperarousal (5 items). An item was deemed to be positively endorsed if scores were ≥ 3. The Harvard Trauma Questionnaire follows the diagnostic criteria for the PTSD diagnosis according to the DSM-IV. The scale thus makes it possible to measure both the severity of symptoms and to estimate the prevalence of possible PTSD. Following the DSM-IV, a possible PTSD diagnosis was proposed if participants reported at least one re-experiencing symptom, three avoidance symptoms, and two hyperarousal symptoms.


Secondary Outcome Measures :
  1. Pain intensity [ Time Frame: baseline, 3, 6 and 12 months ]
    Pain intensity was measured as the average score of three 11-point Likert scales measuring peak pain intensity, average pain intensity over the past 2 weeks as well as current pain intensity (Manniche, Asmussen, Lauritsen, Vinterberg, et Kreiner, 1994). Each scale measured pain intensity on a 0-10 numerical rating scale (NRS: Jensen, Karoly, & Braver, 1986) with 0 defined as no pain and 10 as the worst imaginable pain.

  2. The Pain Catastrophizing Scale (Sullivan, Bishop, & Pivik, 1995) [ Time Frame: baseline, 3, 6 and 12 months ]
    The Pain Catastrophizing Scale (Sullivan, Bishop, & Pivik, 1995) was used to measure catastrophic thinking related to pain. Its instructions ask participants to reflect on past painful experiences, and to indicate the degree to which they experienced each of 13 thoughts or feelings when experiencing pain, on a 5-point Likert scale with (0 = not at all, 4 = all the time). A scale sum score was calculated from all items, with a high score indicating a high level of pain catastrophizing.

  3. the Tampa Scale for Kinesiophobia (TSK: Kori, Miller, & Todd, 1990). [ Time Frame: baseline, 3, 6 and 12 months ]
    Fear of re-injury due to movement was measured with the Tampa Scale for Kinesiophobia (TSK: Kori, Miller, & Todd, 1990). TSK is a 17-item scale assessing fear of movement on a 4-point Likert scale ranging from 17 to 68 with higher scores indicating higher levels of kinesiophobia. The scale is commonly used in diverse chronic pain samples and has good construct and predictive validity (Vlaeyen, Kole-Snijders, Boeren, & van Eek, 1995).

  4. Anxiety and Depression (Hospital and Anxiety Depression Scale, HADS) [ Time Frame: baseline, 3, 6 and 12 months ]
    The scale consists of 14 items, seven relating to anxiety (HADS-A) and seven to depression (HADSD) with responses ranging from 0 (no symptoms) to 3 (maximum impairment). In the present study, we used a subscale cut-off of 8 in order to include all possible cases of anxiety or depression, as suggested by Zigmond and Snaith (1983).



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03244046


Sponsors and Collaborators
University of Southern Denmark
Spine Centre of Southern Denmark
Investigators
Layout table for investigator information
Study Director: Berit Schiøttz-Christensen, professor Spine Center South

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Tonny Elmose Andersen, phd., Associate Professor, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT03244046     History of Changes
Other Study ID Numbers: RCT2016PTSD
First Posted: August 9, 2017    Key Record Dates
Last Update Posted: August 9, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tonny Elmose Andersen, phd., University of Southern Denmark:
Low Back pain
Pain
Posttraumatic Stress Disorder
PTSD
Somatic Experiencing
SE

Additional relevant MeSH terms:
Layout table for MeSH terms
Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Back Pain
Low Back Pain
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms