Exposure-based Treatment for Avoidant Back Pain Patients

Not Applicable

Completed

• Conditions: Low Back Pain
• Interventions: Behavioral: Exposure in vivo; Behavioral: Cognitive Behavioural Psychotherapy

• Registration Number: NCT01484418
• Lead Sponsor: Philipps University Marburg Medical Center

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-11-28
• Study First Submitted QC: 2011-12-01
• Study First Posted: 2011-12-02
• Primary Completion: 2015-08
• Study Completion: 2017-08
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-01
• Last Update Posted: 2017-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B Exposure short	Exposure in vivo	See above exposure long. This treatment comprises 5 exposure sessions.
A Exposure long	Exposure in vivo	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.
C Cognitive behavioural psychotherapy	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.

Primary Outcome Measures

Name	Time	Method
Change from baseline in pain severity at 3 and 6 months after admission	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	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

Name	Time	Method
Change in physical activity from Pretest to two in-between timepoints to Posttest to Follow-up Time	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)
Change in pain catastrophizing from Pretest to two in-between timepoints to Posttest to Follow-up	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 quality of life from Pretest to two in-between timepoints to Posttest to Follow-up	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 fear avoidance from Pretest to two in-between time points to Posttest	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 emotional distress from Pretest to two in-between timepoints to Posttest to Follow-up	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)

Trial Locations

Locations (1)

Philipps University Marburg, Department of Clinical Psychology and Psychotherapy; 🇩🇪 Marburg, Germany