Clinical trial NCT01484418: Exposure-based Treatment for Avoidant Back Pain Patients
Official title: Exposure Therapy in Chronic Low Back Pain Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Philipps University Marburg
Sponsor class: OTHER
Collaborators: name: Psychotherapie-Ambulanz Marburg e.V.
name: German Research Foundation
First posted: 2011-12-02
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Change from baseline in pain severity at 3 and 6 months after admission
timeFrame: from Pretest (admission) to Posttest (an expected average of 3 months after admission) to Follow-up (an expected average of 6 months after admission)
measure: Change from baseline in pain disability at 3 and 6 months after admission
timeFrame: 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 outcomes:
measure: Change in fear avoidance from Pretest to two in-between time points to Posttest
timeFrame: 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)
measure: Change in pain catastrophizing from Pretest to two in-between timepoints to Posttest to Follow-up
timeFrame: 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)
measure: Change in emotional distress from Pretest to two in-between timepoints to Posttest to Follow-up
timeFrame: 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)
measure: Change in quality of life from Pretest to two in-between timepoints to Posttest to Follow-up
timeFrame: 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)
measure: Change in physical activity from Pretest to two in-between timepoints to Posttest to Follow-up Time
timeFrame: 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)
Other outcomes:
Locations:
city: Marburg
country: Germany
facility: Philipps University Marburg, Department of Clinical Psychology and Psychotherapy
Study officials:
affiliation: Philipps University Marburg, Department of Clinical Psychology and Psychotherapy
name: Winfried Rief, Prof.
role: STUDY_DIRECTOR
affiliation: Philipps University Marburg, Department of Clinical Psychology and Psychotherapy
name: Julia A. Glombiewski, Dr.
role: STUDY_CHAIR
References:
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.
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.