Exposure-based Treatment for Avoidant Back Pain Patients (ETABP)

September 1, 2017 updated by: Julia Anna Glombiewski, Philipps University Marburg Medical Center

Exposure Therapy in Chronic Low Back Pain Patients

Chronic low back pain often results in psychosocial and physical disability. A subgroup of these patients shows fear of (re)injury and avoidance behaviour leading to higher disability. The purpose of this study is to determine whether exposure in vivo is more effective in the treatment of fear avoidant chronic back pain patients than psychological treatment as usual (cognitive behavioural psychotherapy).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Marburg, Germany, 35037
        • Philipps University Marburg, Department of Clinical Psychology and Psychotherapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Having at least 3 months back pain
  • Sufficient level on fear avoidance scores (TSK, Phoda)
  • Being German-speaking
  • Agreeing to participate, verified by completion of informed consent

Exclusion Criteria:

  • Red flags
  • Pregnancy
  • Illiteracy
  • Psychoses
  • Alcohol addiction
  • surgeries during the last 6 months or planed surgeries
  • Specific medical disorders or cardiovascular diseases preventing participation in physical exercise
  • Participating in another psychotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: A Exposure long
Exposure in vivo for fear avoidant chronic low back pain patients. This treatment means that the individual is exposed to movements and tasks that have been avoided due to fear of (re)injury. The treatment begins after three educational lessons including the rational and developing a fear hierarchy. Exposure phase includes 10 exposures sessions which are highly individualized. Behavioral experiments can be included to correct catastrophic misinterpretations. The main purpose of this intervention type is to reduce pain related disability via diminishing fear avoidance.
Behavioral: Exposure in vivo
5-10 sessions based on an individualized fear hierarchy
EXPERIMENTAL: B Exposure short
See above exposure long. This treatment comprises 5 exposure sessions.
Behavioral: Exposure in vivo
5-10 sessions based on an individualized fear hierarchy
ACTIVE_COMPARATOR: C Cognitive behavioural psychotherapy
Cognitive behavioural psychotherapy for fear avoidant chronic low back patients. The therapy is modularized in three main parts. The educational lesson is followed by the module graded activity which represents the behavioral part of the program. The second module comprises relaxation. And the last part contains cognitive interventions. Cognitive behavioural intervention techniques are employed to support the patient in the process of coping with chronic pain: i.e. reduction of disability and improving functional ability.
Behavioral: Cognitive Behavioural Psychotherapy
graded activity, relaxation techniques and cognitive interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in pain severity at 3 and 6 months after admission
Time Frame: from Pretest (admission) to Posttest (an expected average of 3 months after admission) to Follow-up (an expected average of 6 months after admission)
Numeric Rating Scale (NRS)
from Pretest (admission) to Posttest (an expected average of 3 months after admission) to Follow-up (an expected average of 6 months after admission)
Change from baseline in pain disability at 3 and 6 months after admission
Time Frame: from Pretest (admission) to Posttest (an expected average of 3 months after admission) to Follow-up (an expected average of 6 months after admission)
Pain Disability Index (PDI) Quebec Back Pain Disability Scale (QBPDS)
from Pretest (admission) to Posttest (an expected average of 3 months after admission) to Follow-up (an expected average of 6 months after admission)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in fear avoidance from Pretest to two in-between time points to Posttest
Time Frame: from Pretest (admission) to one in-between timepoint (an expected 10 weeks after admission) to Posttest (an expected average of 3 months after admission) to Follow-up (an expected average of 6 months after admission)
Tampa Scale of Kinesiophobia (TSK) Pain Anxiety Symptom Scale (PASS)
from Pretest (admission) to one in-between timepoint (an expected 10 weeks after admission) to Posttest (an expected average of 3 months after admission) to Follow-up (an expected average of 6 months after admission)
Change in pain catastrophizing from Pretest to two in-between timepoints to Posttest to Follow-up
Time Frame: from Pretest (admission) to one in-between timepoint (an expected 10 weeks after admission) to Posttest (an expected average of 3 months after admission) to Follow-up (an expected average of 6 months after admission)
Pain Catastrophizing Scale (PCS)
from Pretest (admission) to one in-between timepoint (an expected 10 weeks after admission) to Posttest (an expected average of 3 months after admission) to Follow-up (an expected average of 6 months after admission)
Change in emotional distress from Pretest to two in-between timepoints to Posttest to Follow-up
Time Frame: from Pretest (admission) to one in-between timepoint (an expected 10 weeks after admission) to Posttest (an expected average of 3 months after admission) to Follow-up (an expected average of 6 months after admission)
Hospital Anxiety and Depression Scale (HADS)
from Pretest (admission) to one in-between timepoint (an expected 10 weeks after admission) to Posttest (an expected average of 3 months after admission) to Follow-up (an expected average of 6 months after admission)
Change in quality of life from Pretest to two in-between timepoints to Posttest to Follow-up
Time Frame: from Pretest (admission) to one in-between timepoint (an expected 10 weeks after admission) to Posttest (an expected average of 3 months after admission) to Follow-up (an expected average of 6 months after admission)
EuroQol (EQ-5D)
from Pretest (admission) to one in-between timepoint (an expected 10 weeks after admission) to Posttest (an expected average of 3 months after admission) to Follow-up (an expected average of 6 months after admission)
Change in physical activity from Pretest to two in-between timepoints to Posttest to Follow-up Time
Time Frame: from Pretest (admission) to one in-between timepoint (an expected 10 weeks after admission) to Posttest (an expected average of 3 months after admission) to Follow-up (an expected average of 6 months after admission)
International Physical Activity Questionnaire(IPAQ)
from Pretest (admission) to one in-between timepoint (an expected 10 weeks after admission) to Posttest (an expected average of 3 months after admission) to Follow-up (an expected average of 6 months after admission)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Philipps University Marburg Medical Center

Collaborators

German Research Foundation
Psychotherapie-Ambulanz Marburg e.V.

Investigators

  • Study Director: Winfried Rief, Prof., Philipps University Marburg, Department of Clinical Psychology and Psychotherapy
  • Study Chair: Julia A. Glombiewski, Dr., Philipps University Marburg, Department of Clinical Psychology and Psychotherapy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (ACTUAL)

August 1, 2015

Study Completion (ACTUAL)

August 1, 2017

Study Registration Dates

First Submitted

November 28, 2011

First Submitted That Met QC Criteria

December 1, 2011

First Posted (ESTIMATE)

December 2, 2011

Study Record Updates

Last Update Posted (ACTUAL)

September 5, 2017

Last Update Submitted That Met QC Criteria

September 1, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DFG-GL 607

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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