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| Name | Class |
|---|---|
| Psychotherapie-Ambulanz Marburg e.V. | OTHER |
| German Research Foundation | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A Exposure long | Experimental | 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. |
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| B Exposure short | Experimental | See above exposure long. This treatment comprises 5 exposure sessions. |
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| C Cognitive behavioural psychotherapy | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exposure in vivo | Behavioral | 5-10 sessions based on an individualized fear hierarchy |
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| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Winfried Rief, Prof. | Philipps University Marburg, Department of Clinical Psychology and Psychotherapy | Study Director |
| Julia A. Glombiewski, Dr. | Philipps University Marburg, Department of Clinical Psychology and Psychotherapy | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Philipps University Marburg, Department of Clinical Psychology and Psychotherapy | Marburg | 35037 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29781651 | Derived | 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. | |
| 23837551 | Derived | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| Cognitive Behavioural Psychotherapy | Behavioral | graded activity, relaxation techniques and cognitive interventions |
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| 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) |
| D013568 |
| Pathological Conditions, Signs and Symptoms |