Non-specific Chronic Back Pain
Conditions
Keywords
Eye-Movement-Desensitization and Reprocessing, EMDR, Chronic back pain, CBP, treatment
Brief summary
The study explores the feasibility of Eye-Movement-Desensitization and Reprocessing (EMDR) in non-specific chronic back pain.
Detailed description
The study explores the feasibility of Eye-Movement-Desensitization and Reprocessing (EMDR) in non-specific chronic back pain in a randomized controlled trial (RCT) with 6 months follow-up. The treatment consists of 12-sessions EMDR a 60 minutes using eye-movements for bilateral stimulation in addition to treatment as usual (TAU) that is compared to TAU alone.
Interventions
BEHAVIORALEye-Movement-Desensitization-Reprocessing
Sponsors
University Hospital Heidelberg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain intensity | Change from Baseline Pain intensity at average 6 months | Numerical rating scale 0-10 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in the pain experience scale - Pain affect | Change from Baseline pain experience scale levels at average 6 months | Geisser et al., 1996 |
| Change in the Hannover functional ability questionnaire (FFbH) - disability | Change from Baseline disabilty levels at average 6 months | Kohlmann et al., 1996 |
| Change in Quantitative sensory testing (QST)profiles | Change from Baseline QST profile at average 6 months | According to the protocol by Rolke et al. (2006), developed within the Germany Research Network on Neuropathic Pain (DFNS) |
| Change in Conditioned Pain Modulation | Change from Baseline conditioned pain modulation activity at average 6 months | difference in pressure pain threshold before and after oscillating heat (2 min.) |
| Change in Plasma endocannabinoids and lipids | Change from Baseline endocannabinoids and lipids at average 6 months | 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 in plasma nerve growth factor levels | Change from Baseline NGF levels at average 6 months | Plasma levels in (pg/ml) |
| Change in pain drawing/ the spatial extent of the pain | Change from Baseline Pain extent at average 6 months | — |
| Change in West Haven-Yale multidimensional pain inventory scores | Change from Baseline West Haven-Yale multidimensional pain inventory scores at average 6 months | Flor et al., 1990 |
| Change in chronic pain grade | Change from Baseline chronic pain grade at average 6 months | von Korff er al., 1992 |
| functional and structural changes in fMRI | Change from Baseline fMRI at average 6 months | — |
| Change in Hospital Anxiety and Depression Scale scores | Change from Baseline anxiety and depression levels at average 6 months | Zigmond & Snaith, 1983 |
| Change in Health Survey scores | Change from baseline quality of life level at average 6 months | SF-12 |
| Change in somatization scores | Change from Baseline somatization scores at average 6 months | SCL-90R |
| Change in medication intake | Change from Baseline medication intake at average 6 months | — |
| Change in dissociation scores | Change from Baseline dissociation at average 6 months | DES/FDS-20 |
| Change in Post Traumatic Diagnostic Scale | Change from Baseline post traumatic diagnostic scale levels at average 6 months | — |
| Patient global impression of change | after on average 6 months of treatment | — |
| Recruitment potential | 6 months | % of patients eligible for inclusion that give written informed consent |
| Retention rate | over average 6 months of treatment | % of patients that finish treatment, including pre- and post-evaluation |
| Change in Resilience Scale (RS-11) scores | Change from Baseline resilience scores at average 6 months | Schumacher et al., 2004 |
Countries
Germany
Outcome results
None listed