Exposure-based Treatment for Avoidant Back Pain Patients

Low Back Pain Clinical Trial

— ETABP  

Official title:

Exposure Therapy in Chronic Low Back Pain Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01484418
• Other study ID #: DFG-GL 607
• Status: Completed
• Phase: N/A
• First received: November 28, 2011
• Last updated: September 1, 2017
• Start date: August 2011
• Est. completion date: August 2017

Study information

• Verified date: September 2017
• Source: Philipps University Marburg Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: August 2017
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Behavioral:
• Exposure in vivo
5-10 sessions based on an individualized fear hierarchy
• Cognitive Behavioural Psychotherapy
graded activity, relaxation techniques and cognitive interventions

Locations

Country	Name	City	State
Germany	Philipps University Marburg, Department of Clinical Psychology and Psychotherapy	Marburg

Sponsors (3)

Lead Sponsor	Collaborator
Philipps University Marburg Medical Center	German Research Foundation, Psychotherapie-Ambulanz Marburg e.V.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in pain severity at 3 and 6 months after admission	Numeric Rating Scale (NRS)	from Pretest (admission) to Posttest (an expected average of 3 months after admission) to Follow-up (an expected average of 6 months after admission)
Primary	Change from baseline in pain disability at 3 and 6 months after admission	Pain Disability Index (PDI) Quebec Back Pain Disability Scale (QBPDS)	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	Change in fear avoidance from Pretest to two in-between time points to Posttest	Tampa Scale of Kinesiophobia (TSK) Pain Anxiety Symptom Scale (PASS)	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)
Secondary	Change in pain catastrophizing from Pretest to two in-between timepoints to Posttest to Follow-up	Pain Catastrophizing Scale (PCS)	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)
Secondary	Change in emotional distress from Pretest to two in-between timepoints to Posttest to Follow-up	Hospital Anxiety and Depression Scale (HADS)	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)
Secondary	Change in quality of life from Pretest to two in-between timepoints to Posttest to Follow-up	EuroQol (EQ-5D)	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)
Secondary	Change in physical activity from Pretest to two in-between timepoints to Posttest to Follow-up Time	International Physical Activity Questionnaire(IPAQ)	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)

External Links

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