Exposure Therapy and Safety-seeking Behavior in Chronic Low Back Pain

Summary

RATIONALE: Exposure in vivo therapy aims to reduce pain-related fear - a key maintaining factor of chronic low back pain- while increasing level of daily functioning, despite the pain. This is done by exposing patients to their most feared activities/movements, while behavioral experiments are performed that serve to correct catastrophic (erroneous) beliefs about pain. Yet, performing exposure exercises might be very threatening for patients and might encourage them to build in subtle safety-seeking behavior. Whether safety-seeking behavior should be allowed or not during therapy is heavily debated. Whereas some argue that it will only interfere with therapeutic progress because it prevents the disconfirming experience exposure tries to offer, other argue that it will facilitate therapeutic progress because it enhances one's sense of control, if used judiciously. So far (clinical-)experimental studies have provided mixed evidence nor have they lead to any clinical recommendation. Hence, in a replicated single-case experiment, we will compare exposure therapy with versus exposure without safety-seeking behavior versus exposure only.

STUDY POPULATION: Participants are chronic low back pain patients seeking treatment, who fulfill all inclusion and exclusion criteria and participate voluntarily.

INTERVENTION: All participants receive exposure therapy at the rehabilitation department of the academic hospital in Maastricht, but with different recommendations for the use of safety-seeking behavior.

We will assess: 1) daily measures of fear, pain intensity and self-reported achievement of goals and 2) non-daily measures of pain disability, pain-related fear, pain catastrophizing, pain solutions, need to control and safety-seeking behavior. To measure to the influence of safety-seeking behavior on actual level of functioning, two behavioral performance tasks will also be presented, ie. a bag carrying task and a personalized task.

BURDEN AND RISKS: There are no risks associated with participation to this study that are not otherwise related to rehabilitation and movement in general and participation is completely voluntary. Participants are requested to fill out questionnaires on a daily basis at home (computerized if possible), as well as on different time points during the study and at follow up and perform two behavioral performance tasks. This study could help to further improve the beneficial long-term effects of exposure.

Conditions

• Chronic Low Back Pain

Interventions

BEHAVIORAL

Exposure therapy

Treatment protocol: 1\) preparation consisting of intake and identification of feared movements, activities and situations and their underlying catastrophic beliefs. 2) education, 3)exposure sessions: patients confront threatening situations and behavioral experiments are performed that are targeted at correcting erroneous catastrophic beliefs. 4) homework assignments.

Sponsors & Collaborators

• KU Leuven

  collaborator OTHER

• Maastricht University

  collaborator OTHER

• Maastricht University Medical Center

  lead OTHER

Principal Investigators

• Johan Vlaeyen, PhD · Maastricht University and University of Leuven

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-02-29

Primary Completion

2014-12-31

Completion

2014-12-31

Countries

• Netherlands

Study Locations