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

Study Description

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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).

Condition or disease	Intervention/treatment	Phase
Low Back Pain	Behavioral: Exposure in vivo; Behavioral: Cognitive Behavioural Psychotherapy	Not Applicable

Study Design

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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

Arms and Interventions

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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

Outcome Measures

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Primary Outcome Measures :

1. 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)
2. 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)

Secondary Outcome Measures :

1. 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)
2. 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)
3. 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)
4. 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)
5. 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)

Eligibility Criteria

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

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

Contacts and Locations

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Locations

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

Sponsors and Collaborators

Philipps University Marburg Medical Center

Psychotherapie-Ambulanz Marburg e.V.

German Research Foundation

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Related Info 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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
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