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

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Exposure in vivo
Cognitive Behavioural Psychotherapy
Sponsored by
Philipps University Marburg Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Chronic Low Back Pain, Cognitive Behavioural Therapy, Exposure, Fear avoidance, Cognitive Behavioural Therapy in chronic low back pain, Exposure in vivo in chronic low back pain

Eligibility Criteria

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

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

Sites / Locations

  • Philipps University Marburg, Department of Clinical Psychology and Psychotherapy

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

A Exposure long

B Exposure short

C Cognitive behavioural psychotherapy

Arm Description

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.

See above exposure long. This treatment comprises 5 exposure sessions.

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.

Outcomes

Primary Outcome Measures

Change from baseline in pain severity at 3 and 6 months after admission
Numeric Rating Scale (NRS)
Change from baseline in pain disability at 3 and 6 months after admission
Pain Disability Index (PDI) Quebec Back Pain Disability Scale (QBPDS)

Secondary Outcome Measures

Change in fear avoidance from Pretest to two in-between time points to Posttest
Tampa Scale of Kinesiophobia (TSK) Pain Anxiety Symptom Scale (PASS)
Change in pain catastrophizing from Pretest to two in-between timepoints to Posttest to Follow-up
Pain Catastrophizing Scale (PCS)
Change in emotional distress from Pretest to two in-between timepoints to Posttest to Follow-up
Hospital Anxiety and Depression Scale (HADS)
Change in quality of life from Pretest to two in-between timepoints to Posttest to Follow-up
EuroQol (EQ-5D)
Change in physical activity from Pretest to two in-between timepoints to Posttest to Follow-up Time
International Physical Activity Questionnaire(IPAQ)

Full Information

First Posted
November 28, 2011
Last Updated
September 1, 2017
Sponsor
Philipps University Marburg Medical Center
Collaborators
Psychotherapie-Ambulanz Marburg e.V., German Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01484418
Brief Title
Exposure-based Treatment for Avoidant Back Pain Patients
Acronym
ETABP
Official Title
Exposure Therapy in Chronic Low Back Pain Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Philipps University Marburg Medical Center
Collaborators
Psychotherapie-Ambulanz Marburg e.V., German Research Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Chronic Low Back Pain, Cognitive Behavioural Therapy, Exposure, Fear avoidance, Cognitive Behavioural Therapy in chronic low back pain, Exposure in vivo in chronic low back pain

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
A Exposure long
Arm Type
Experimental
Arm Description
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.
Arm Title
B Exposure short
Arm Type
Experimental
Arm Description
See above exposure long. This treatment comprises 5 exposure sessions.
Arm Title
C Cognitive behavioural psychotherapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exposure in vivo
Intervention Description
5-10 sessions based on an individualized fear hierarchy
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioural Psychotherapy
Intervention Description
graded activity, relaxation techniques and cognitive interventions
Primary Outcome Measure Information:
Title
Change from baseline in pain severity at 3 and 6 months after admission
Description
Numeric Rating Scale (NRS)
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)
Title
Change from baseline in pain disability at 3 and 6 months after admission
Description
Pain Disability Index (PDI) Quebec Back Pain Disability Scale (QBPDS)
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)
Secondary Outcome Measure Information:
Title
Change in fear avoidance from Pretest to two in-between time points to Posttest
Description
Tampa Scale of Kinesiophobia (TSK) Pain Anxiety Symptom Scale (PASS)
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)
Title
Change in pain catastrophizing from Pretest to two in-between timepoints to Posttest to Follow-up
Description
Pain Catastrophizing Scale (PCS)
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)
Title
Change in emotional distress from Pretest to two in-between timepoints to Posttest to Follow-up
Description
Hospital Anxiety and Depression Scale (HADS)
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)
Title
Change in quality of life from Pretest to two in-between timepoints to Posttest to Follow-up
Description
EuroQol (EQ-5D)
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)
Title
Change in physical activity from Pretest to two in-between timepoints to Posttest to Follow-up Time
Description
International Physical Activity Questionnaire(IPAQ)
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)

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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Winfried Rief, Prof.
Organizational Affiliation
Philipps University Marburg, Department of Clinical Psychology and Psychotherapy
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Julia A. Glombiewski, Dr.
Organizational Affiliation
Philipps University Marburg, Department of Clinical Psychology and Psychotherapy
Official's Role
Study Chair
Facility Information:
Facility Name
Philipps University Marburg, Department of Clinical Psychology and Psychotherapy
City
Marburg
ZIP/Postal Code
35037
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
29781651
Citation
Glombiewski JA, Holzapfel S, Riecke J, Vlaeyen JWS, de Jong J, Lemmer G, Rief W. Exposure and CBT for chronic back pain: An RCT on differential efficacy and optimal length of treatment. J Consult Clin Psychol. 2018 Jun;86(6):533-545. doi: 10.1037/ccp0000298.
Results Reference
derived
PubMed Identifier
23837551
Citation
Riecke J, Holzapfel S, Rief W, Glombiewski JA. Evaluation and implementation of graded in vivo exposure for chronic low back pain in a German outpatient setting: a study protocol of a randomized controlled trial. Trials. 2013 Jul 9;14:203. doi: 10.1186/1745-6215-14-203.
Results Reference
derived
Links:
URL
http://www.uni-marburg.de/fb04/ag-klin/mitarbeiter/jglombiewski
Description
Related Info

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Exposure-based Treatment for Avoidant Back Pain Patients

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