Exposure-based Treatment for Avoidant Back Pain Patients (ETABP)
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ClinicalTrials.gov Identifier: NCT01484418 |
Recruitment Status
:
Completed
First Posted
: December 2, 2011
Last Update Posted
: September 5, 2017
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Condition or disease | Intervention/treatment | Phase |
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Low Back Pain | Behavioral: Exposure in vivo Behavioral: Cognitive Behavioural Psychotherapy | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 68 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Exposure Therapy in Chronic Low Back Pain Patients |
Study Start Date : | August 2011 |
Actual Primary Completion Date : | August 2015 |
Actual Study Completion Date : | August 2017 |

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.
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Behavioral: Exposure in vivo
5-10 sessions based on an individualized fear hierarchy
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Experimental: B Exposure short
See above exposure long. This treatment comprises 5 exposure sessions.
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Behavioral: Exposure in vivo
5-10 sessions based on an individualized fear hierarchy
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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.
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Behavioral: Cognitive Behavioural Psychotherapy
graded activity, relaxation techniques and cognitive interventions
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- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01484418
Germany | |
Philipps University Marburg, Department of Clinical Psychology and Psychotherapy | |
Marburg, Germany, 35037 |
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 |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Julia Anna Glombiewski, Ph.D, Licensed Psychologist, Principal Investigator, Philipps University Marburg Medical Center |
ClinicalTrials.gov Identifier: | NCT01484418 History of Changes |
Other Study ID Numbers: |
DFG-GL 607 |
First Posted: | December 2, 2011 Key Record Dates |
Last Update Posted: | September 5, 2017 |
Last Verified: | September 2017 |
Keywords provided by Julia Anna Glombiewski, Philipps University Marburg Medical Center:
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 |
Additional relevant MeSH terms:
Back Pain Low Back Pain Pain |
Neurologic Manifestations Nervous System Diseases Signs and Symptoms |