Low Back Pain and Comorbid Posttraumatic Stress Disorder
Primary Purpose
Low Back Pain, Posttraumatic Stress Disorder
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Psychotherapy
Physiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring Low Back pain, Pain, Posttraumatic Stress Disorder, PTSD, Somatic Experiencing, SE
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Physiotherapy (Phys)
Somatic Experiencing + phys
Arm Description
12 sessions of guided physiotherapy for low back pain. Cognitive Behavioral Therapeutic elements included targeting Fear Avoidance Beliefs.
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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).
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).
Full Information
NCT ID
NCT03244046
First Posted
July 31, 2017
Last Updated
August 4, 2017
Sponsor
University of Southern Denmark
Collaborators
Spine Centre of Southern Denmark
1. Study Identification
Unique Protocol Identification Number
NCT03244046
Brief Title
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
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 5, 2016 (Actual)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
July 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern Denmark
Collaborators
Spine Centre of Southern Denmark
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Posttraumatic Stress Disorder
Keywords
Low Back pain, Pain, Posttraumatic Stress Disorder, PTSD, Somatic Experiencing, SE
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Physiotherapy (Phys)
Arm Type
Active Comparator
Arm Description
12 sessions of guided physiotherapy for low back pain. Cognitive Behavioral Therapeutic elements included targeting Fear Avoidance Beliefs.
Arm Title
Somatic Experiencing + phys
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Psychotherapy
Other Intervention Name(s)
Somatic Experiencing (SE)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Physiotherapy
Intervention Description
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 Measure Information:
Title
Roland Morris Disability Questionnaire (RMDQ; Roland & Morris, 1983)
Description
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.
Time Frame
Change from baseline to 6 months follow-up
Title
Harvard Trauma Questionnaire part IV (Mollica, Caspi-Yavin, Bollini, & Truong, 1992)
Description
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.
Time Frame
Change from baseline to 6 months follow-up
Secondary Outcome Measure Information:
Title
Pain intensity
Description
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.
Time Frame
baseline, 3, 6 and 12 months
Title
The Pain Catastrophizing Scale (Sullivan, Bishop, & Pivik, 1995)
Description
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.
Time Frame
baseline, 3, 6 and 12 months
Title
the Tampa Scale for Kinesiophobia (TSK: Kori, Miller, & Todd, 1990).
Description
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).
Time Frame
baseline, 3, 6 and 12 months
Title
Anxiety and Depression (Hospital and Anxiety Depression Scale, HADS)
Description
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).
Time Frame
baseline, 3, 6 and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Berit Schiøttz-Christensen, professor
Organizational Affiliation
Spine Center South
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30466429
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.
Results Reference
derived
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Low Back Pain and Comorbid Posttraumatic Stress Disorder
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