Exposure-based Treatment for Avoidant Back Pain Patients

Study Overview
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Brief Summary
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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).

Official Title
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Exposure Therapy in Chronic Low Back Pain Patients

Conditions
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Low Back Pain

Intervention / Treatment
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* Behavioral: Exposure in vivo
* Behavioral: Cognitive Behavioural Psychotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A Exposure long<br>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<br>* 5-10 sessions based on an individualized fear hierarchy<br>|
| Experimental: B Exposure short<br>See above exposure long. This treatment comprises 5 exposure sessions. | Behavioral: Exposure in vivo<br>* 5-10 sessions based on an individualized fear hierarchy<br>|
| Active Comparator: C Cognitive behavioural psychotherapy<br>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<br>* graded activity, relaxation techniques and cognitive interventions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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