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临床试验/NCT03244046
NCT03244046Unknown不适用

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

University of Southern Denmark0 个研究点目标入组 140 人开始时间: 2016年1月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
140
主要终点
Harvard Trauma Questionnaire part IV (Mollica, Caspi-Yavin, Bollini, & Truong, 1992)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

Physiotherapy (Phys)

Active Comparator

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

干预措施: Physiotherapy (Behavioral)

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.

干预措施: Psychotherapy (Behavioral)

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.

干预措施: Physiotherapy (Behavioral)

结局指标

主要结局

Harvard Trauma Questionnaire part IV (Mollica, Caspi-Yavin, Bollini, & Truong, 1992)

时间窗: 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.

Roland Morris Disability Questionnaire (RMDQ; Roland & Morris, 1983)

时间窗: 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.

次要结局

  • Anxiety and Depression (Hospital and Anxiety Depression Scale, HADS)(baseline, 3, 6 and 12 months)
  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tonny Elmose Andersen, phd.

Associate Professor

University of Southern Denmark

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