Low Back Pain and Comorbid Posttraumatic Stress Disorder

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03244046
• Other study ID #: RCT2016PTSD
• Status: Enrolling by invitation
• Phase: N/A
• First received: July 31, 2017
• Last updated: August 4, 2017
• Start date: January 5, 2016
• Est. completion date: July 2018

Study information

• Verified date: August 2017
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 140
• Est. completion date: July 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Disease
• Low Back Pain
• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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.
• 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).

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern Denmark	Spine Centre of Southern Denmark

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Roland Morris Disability Questionnaire (RMDQ; Roland & Morris, 1983)	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.	Change from baseline to 6 months follow-up
Primary	Harvard Trauma Questionnaire part IV (Mollica, Caspi-Yavin, Bollini, & Truong, 1992)	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.	Change from baseline to 6 months follow-up
Secondary	Pain intensity	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.	baseline, 3, 6 and 12 months
Secondary	The Pain Catastrophizing Scale (Sullivan, Bishop, & Pivik, 1995)	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.	baseline, 3, 6 and 12 months
Secondary	the Tampa Scale for Kinesiophobia (TSK: Kori, Miller, & Todd, 1990).	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).	baseline, 3, 6 and 12 months
Secondary	Anxiety and Depression (Hospital and Anxiety Depression Scale, HADS)	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).	baseline, 3, 6 and 12 months