Low Back Pain and Comorbid Posttraumatic Stress Disorder

NCT03244046 | Unknown

• 1 other identifier: RCT2016PTSD
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Low Back Pain; Posttraumatic Stress Disorder

Keywords

Low Back pain; Pain; Posttraumatic Stress Disorder; PTSD; Somatic Experiencing; SE

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Pain intensity

  baseline, 3, 6 and 12 months

• The Pain Catastrophizing Scale (Sullivan, Bishop, & Pivik, 1995)

  baseline, 3, 6 and 12 months

• the Tampa Scale for Kinesiophobia (TSK: Kori, Miller, & Todd, 1990).

  baseline, 3, 6 and 12 months

• Anxiety and Depression (Hospital and Anxiety Depression Scale, HADS)

  baseline, 3, 6 and 12 months

Study Arms (2)

Physiotherapy (Phys)

ACTIVE COMPARATOR

12 sessions of guided physiotherapy for low back pain. Cognitive Behavioral Therapeutic elements included targeting Fear Avoidance Beliefs.

Behavioral: Physiotherapy

Somatic Experiencing + phys

EXPERIMENTAL

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; Behavioral: Physiotherapy

Interventions

Psychotherapy BEHAVIORAL

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.

Also known as: Somatic Experiencing (SE)

Somatic Experiencing + phys

Physiotherapy BEHAVIORAL

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).

Physiotherapy (Phys); Somatic Experiencing + phys

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Southern Denmark: lead
• Spine Centre of Southern Denmark: collaborator

Related Publications (1)

• 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.

  PMID: 30466429 DERIVED

MeSH Terms

Conditions

Low Back Pain; Stress Disorders, Post-Traumatic; Pain

Interventions

Psychotherapy; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Back Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities; Therapeutics; Rehabilitation

Study Officials

• Berit Schiøttz-Christensen, professor

  Spine Center South

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 31, 2017
• First Posted: August 9, 2017
• Study Start: January 5, 2016
• Primary Completion: December 1, 2017
• Study Completion: July 1, 2018
• Last Updated: August 9, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share