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

Primary Purpose

Chronic Low Back Pain

Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Exposure therapy
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low Back Pain focused on measuring Chronic, Back pain, Low back

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Suffer from chronic low back pain not caused by serious spinal injury, for at least 3 to 6 months
  • Report a sufficient level of disability (this is in itself already a criterion to start treatment at the Rehabilitation department) and
  • Moderate to high levels of pain-related fear (TSK > 37 or at least 4 items with a score of 3 or >3)
  • Have a partner willing to participate

Exclusion Criteria:

  • Specific medical disorder or cardiovascular disease preventing participation in physical exercise
  • Serious psychopathologic co-morbidity. This is checked during anamnesis in the intake session with the rehabilitation physician and during the screening (standard care, see session 1 and session 2). When psychopathologic co-morbidity is detected, patients cannot participate in the study and may not be suitable candidates for exposure therapy entirely. Any decision regarding treatment recommendation is made with the entire treatment team. Furthermore, the researcher performing the therapy has a Master's degree in Clinical Psychology, which adds to the treatment team's expertise on psychopathology.
  • Alcohol or drug abuse, i.e., at least one out of the four following criteria needs to be fulfilled: continued use despite social or interpersonal problems; repeated use resulting in failure to fulfill obligations at work, school, or home; repeated use resulting in physically hazardous situations; use resulting in legal problems (according to the Diagnostic Statistical Manual of Mental disorders, 4th ed.). This is assessed by the rehabilitation physician during the first session.
  • Illiteracy
  • Pregnancy
  • Involvement in litigation concerning the patient's ability to work or disability income
  • Non-Dutch speaking

Sites / Locations

  • Maastricht medical care center, department of rehabilitation

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Exposure with safety-seeking behavior

Exposure without safety-seeking behavior

Exposure therapy only

Arm Description

Patients receive exposure therapy. In the current condition, exposure is offered while patients are allowed to use their own safety-seeking behaviors (i.e., behavior believed to be necessary to prevent a feared catastrophe).

Patients receive exposure therapy.In the current condition, exposure is offered while patients are instructed to omit their safety-seeking behavior.

Patients receive exposure therapy. In the current condition, exposure is offered while patients do not receive any specific instructions about what to do with their safety-seeking behavior.

Outcomes

Primary Outcome Measures

Change in pain-related fear level from baseline to end of treatment at 9 weeks and to follow-up at 20 weeks to 51 weeks
Three self-report measures are used: 1) daily measures of fear, 2) The Tampa Scale of Kinesiophobia (TSK): a questionnaire to o assess general level of fear of (re)injury due to movement, 2) The Photograph Series of Daily activities(PHODA) and the PHODA-Short electronic version (PHODA-SeV): a tool to assess the perceived harmfulness of specific daily activities.

Secondary Outcome Measures

Change in back pain-related disability from baseline to end of treatment at 9 weeks and to follow-up at 20 weeks and 51 weeks
Two behavioral tasks assessed at baseline and follow-up. Two types of self-report measure are used: 1) daily measures of perceived level of functioning and ability to achieve desired activities and goals 2) non-daily questionnaire of back pain specific disability
Change in pain from baseline to end of treatment at 9 weeks and to follow up at 20 weeks and 51 weeks
Self-reported pain intensity, pain unpleasantness via daily measures
Change in pain catastrophizing from baseline to end of treatment at 9 weeks and to follow up at 20 weeks and 51 weeks
Self-report: 1) daily measures of catastrophizing levels, 2) pain catastrophizing questionnaire, assessed at baseline and follow-up

Full Information

First Posted
October 23, 2013
Last Updated
October 23, 2013
Sponsor
Maastricht University Medical Center
Collaborators
KU Leuven, Maastricht University
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1. Study Identification

Unique Protocol Identification Number
NCT01971151
Brief Title
Exposure Therapy and Safety-seeking Behavior in Chronic Low Back Pain
Official Title
An Investigation Into the Effectiveness of Treatment of Chronic Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Unknown status
Study Start Date
February 2012 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
Collaborators
KU Leuven, Maastricht University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
Keywords
Chronic, Back pain, Low back

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exposure with safety-seeking behavior
Arm Type
Experimental
Arm Description
Patients receive exposure therapy. In the current condition, exposure is offered while patients are allowed to use their own safety-seeking behaviors (i.e., behavior believed to be necessary to prevent a feared catastrophe).
Arm Title
Exposure without safety-seeking behavior
Arm Type
Experimental
Arm Description
Patients receive exposure therapy.In the current condition, exposure is offered while patients are instructed to omit their safety-seeking behavior.
Arm Title
Exposure therapy only
Arm Type
Active Comparator
Arm Description
Patients receive exposure therapy. In the current condition, exposure is offered while patients do not receive any specific instructions about what to do with their safety-seeking behavior.
Intervention Type
Behavioral
Intervention Name(s)
Exposure therapy
Other Intervention Name(s)
Cognitive-behavioural therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in pain-related fear level from baseline to end of treatment at 9 weeks and to follow-up at 20 weeks to 51 weeks
Description
Three self-report measures are used: 1) daily measures of fear, 2) The Tampa Scale of Kinesiophobia (TSK): a questionnaire to o assess general level of fear of (re)injury due to movement, 2) The Photograph Series of Daily activities(PHODA) and the PHODA-Short electronic version (PHODA-SeV): a tool to assess the perceived harmfulness of specific daily activities.
Time Frame
baseline and 9 weeks , 20 weeks, and 51 weeks
Secondary Outcome Measure Information:
Title
Change in back pain-related disability from baseline to end of treatment at 9 weeks and to follow-up at 20 weeks and 51 weeks
Description
Two behavioral tasks assessed at baseline and follow-up. Two types of self-report measure are used: 1) daily measures of perceived level of functioning and ability to achieve desired activities and goals 2) non-daily questionnaire of back pain specific disability
Time Frame
baseline, 9 weeks, 20, 51 weeks
Title
Change in pain from baseline to end of treatment at 9 weeks and to follow up at 20 weeks and 51 weeks
Description
Self-reported pain intensity, pain unpleasantness via daily measures
Time Frame
baseline, 9 weeks, 20 weeks and 51 weeks
Title
Change in pain catastrophizing from baseline to end of treatment at 9 weeks and to follow up at 20 weeks and 51 weeks
Description
Self-report: 1) daily measures of catastrophizing levels, 2) pain catastrophizing questionnaire, assessed at baseline and follow-up
Time Frame
baseline, 9 weeks, 20 weeks and 51 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Suffer from chronic low back pain not caused by serious spinal injury, for at least 3 to 6 months Report a sufficient level of disability (this is in itself already a criterion to start treatment at the Rehabilitation department) and Moderate to high levels of pain-related fear (TSK > 37 or at least 4 items with a score of 3 or >3) Have a partner willing to participate Exclusion Criteria: Specific medical disorder or cardiovascular disease preventing participation in physical exercise Serious psychopathologic co-morbidity. This is checked during anamnesis in the intake session with the rehabilitation physician and during the screening (standard care, see session 1 and session 2). When psychopathologic co-morbidity is detected, patients cannot participate in the study and may not be suitable candidates for exposure therapy entirely. Any decision regarding treatment recommendation is made with the entire treatment team. Furthermore, the researcher performing the therapy has a Master's degree in Clinical Psychology, which adds to the treatment team's expertise on psychopathology. Alcohol or drug abuse, i.e., at least one out of the four following criteria needs to be fulfilled: continued use despite social or interpersonal problems; repeated use resulting in failure to fulfill obligations at work, school, or home; repeated use resulting in physically hazardous situations; use resulting in legal problems (according to the Diagnostic Statistical Manual of Mental disorders, 4th ed.). This is assessed by the rehabilitation physician during the first session. Illiteracy Pregnancy Involvement in litigation concerning the patient's ability to work or disability income Non-Dutch speaking
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johan Vlaeyen, PhD
Organizational Affiliation
Maastricht University and University of Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht medical care center, department of rehabilitation
City
Maastricht
ZIP/Postal Code
6202
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
11153970
Citation
Vlaeyen JW, de Jong J, Geilen M, Heuts PH, van Breukelen G. Graded exposure in vivo in the treatment of pain-related fear: a replicated single-case experimental design in four patients with chronic low back pain. Behav Res Ther. 2001 Feb;39(2):151-66. doi: 10.1016/s0005-7967(99)00174-6.
Results Reference
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Exposure Therapy and Safety-seeking Behavior in Chronic Low Back Pain

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