Non-specific Chronic Back Pain Clinical Trial
— LOGIN - EMDROfficial title:
Localized and Generalized Musculoskeletal Pain: Psychobiological Mechanisms and Implications for Treatment (LOGIN) - Subgroups Characterized by Psychological Trauma, Mental Comorbidity, and Psychobiological Patterns and Their Specialized Treatment - Eye Movement Desensitization and Reprocessing (EMDR) in Non-specific Chronic Back Pain
The study explores the feasibility of Eye-Movement-Desensitization and Reprocessing (EMDR) in non-specific chronic back pain.
| Status | Completed |
| Enrollment | 40 |
| Est. completion date | December 2015 |
| Est. primary completion date | November 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - >= 18 years - non-specific chronic low back pain >= 45 days/3 months - high emotional distress caused by psychological trauma - German language skills Exclusion Criteria: - specific causes of chronic back pain - application for retirement pension pending - ongoing psychotherapy - severe physical or psychiatric comorbidity |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Germany | University Hospital Heidelberg | Heidelberg | Baden-Württemberg |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital Heidelberg |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | functional and structural changes in fMRI | Change from Baseline fMRI at average 6 months | No | |
| Other | Change in the pain experience scale - Pain affect | Geisser et al., 1996 | Change from Baseline pain experience scale levels at average 6 months | No |
| Other | Change in the Hannover functional ability questionnaire (FFbH) - disability | Kohlmann et al., 1996 | Change from Baseline disabilty levels at average 6 months | No |
| Other | Change in Quantitative sensory testing (QST)profiles | According to the protocol by Rolke et al. (2006), developed within the Germany Research Network on Neuropathic Pain (DFNS) | Change from Baseline QST profile at average 6 months | No |
| Other | Change in Conditioned Pain Modulation | difference in pressure pain threshold before and after oscillating heat (2 min.) | Change from Baseline conditioned pain modulation activity at average 6 months | No |
| Other | Change in Plasma endocannabinoids and lipids | Plasma levels: AEA (ng/ml), 2-AG (ng/ml), AA (ng/ml), PEA (ng/ml), OEA (ng/ml), AEA (pmol/g), 2-AG (pmol/g), AA (nmol/g), PEA (pmol/g), OEA (pmol/g), | Change from Baseline endocannabinoids and lipids at average 6 months | No |
| Other | Change in plasma nerve growth factor levels | Plasma levels in (pg/ml) | Change from Baseline NGF levels at average 6 months | No |
| Other | Change in pain drawing/ the spatial extent of the pain | Change from Baseline Pain extent at average 6 months | No | |
| Other | Change in West Haven-Yale multidimensional pain inventory scores | Flor et al., 1990 | Change from Baseline West Haven-Yale multidimensional pain inventory scores at average 6 months | No |
| Other | Change in chronic pain grade | von Korff er al., 1992 | Change from Baseline chronic pain grade at average 6 months | No |
| Other | Change in Resilience Scale (RS-11) scores | Schumacher et al., 2004 | Change from Baseline resilience scores at average 6 months | No |
| Other | Change in Hospital Anxiety and Depression Scale scores | Zigmond & Snaith, 1983 | Change from Baseline anxiety and depression levels at average 6 months | No |
| Other | Change in Health Survey scores | SF-12 | Change from baseline quality of life level at average 6 months | No |
| Other | Change in somatization scores | SCL-90R | Change from Baseline somatization scores at average 6 months | No |
| Other | Change in medication intake | Change from Baseline medication intake at average 6 months | No | |
| Other | Change in dissociation scores | DES/FDS-20 | Change from Baseline dissociation at average 6 months | No |
| Other | Change in Post Traumatic Diagnostic Scale | Change from Baseline post traumatic diagnostic scale levels at average 6 months | No | |
| Other | Patient global impression of change | after on average 6 months of treatment | No | |
| Other | Recruitment potential | % of patients eligible for inclusion that give written informed consent | 6 months | No |
| Other | Retention rate | % of patients that finish treatment, including pre- and post-evaluation | over average 6 months of treatment | No |
| Primary | Change in pain intensity | Numerical rating scale 0-10 | Change from Baseline Pain intensity at average 6 months | No |