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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Philipps University Marburg Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Psychotherapie-Ambulanz Marburg e.V.
German Research Foundation
Information provided by (Responsible Party):
Julia Anna Glombiewski, Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier:
NCT01484418
First received: November 28, 2011
Last updated: December 1, 2011
Last verified: November 2011
  Purpose

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 Intervention Phase
Low Back Pain
Behavioral: Exposure in vivo
Behavioral: Cognitive Behavioural Psychotherapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Exposure Therapy in Chronic Low Back Pain Patients

Resource links provided by NLM:


Further study details as provided by Philipps University Marburg Medical Center:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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 [ 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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    International Physical Activity Questionnaire(IPAQ)


Estimated Enrollment: 100
Study Start Date: August 2011
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01484418

Contacts
Contact: Julia A Glombiewski, Dr. 0049/6421/2823617 jg@uni-marburg.de
Contact: Jenny Riecke 0049/6421/2822837 rieckej@staff.uni-marburg.de

Locations
Germany
Philipps University Marburg, Department of Clinical Psychology and Psychotherapy Recruiting
Marburg, Germany, 35037
Contact: Julia A Glombiewski, Dr.    0049/6421/2823617    jg@uni-marburg.de   
Contact: Jenny Riecke    0049/6421/2822837    rieckej@staff.uni-marburg.de   
Principal Investigator: Julia A Glombiewski, Dr.         
Sub-Investigator: Jenny Riecke         
Sub-Investigator: Sebastian Holzapfel         
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

Additional Information:
No publications provided by Philipps University Marburg Medical Center

Additional 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
Study First Received: November 28, 2011
Last Updated: December 1, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by 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

ClinicalTrials.gov processed this record on July 22, 2014