Low Back Pain
Conditions
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
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).
Interventions
BEHAVIORALExposure in vivo
5-10 sessions based on an individualized fear hierarchy
BEHAVIORALCognitive Behavioural Psychotherapy
graded activity, relaxation techniques and cognitive interventions
Sponsors
Psychotherapie-Ambulanz Marburg e.V.
German Research Foundation
Philipps University Marburg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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 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 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 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) |
Countries
Germany
Outcome results
None listed