Clinical trial NCT01850875: Eye Movement Desensitization and Reprocessing (EMDR) in Non-specific Chronic Back Pain
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-specific Chronic Back Pain
Keywords: Eye-Movement-Desensitization and Reprocessing
EMDR
Chronic back pain
CBP
treatment
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
First posted: 2013-05-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in pain intensity
timeFrame: Change from Baseline Pain intensity at average 6 months
Secondary outcomes:
Other outcomes:
measure: functional and structural changes in fMRI
timeFrame: Change from Baseline fMRI at average 6 months
measure: Change in the pain experience scale - Pain affect
timeFrame: Change from Baseline pain experience scale levels at average 6 months
measure: Change in the Hannover functional ability questionnaire (FFbH) - disability
timeFrame: Change from Baseline disabilty levels at average 6 months
measure: Change in Quantitative sensory testing (QST)profiles
timeFrame: Change from Baseline QST profile at average 6 months
measure: Change in Conditioned Pain Modulation
timeFrame: Change from Baseline conditioned pain modulation activity at average 6 months
measure: Change in Plasma endocannabinoids and lipids
timeFrame: Change from Baseline endocannabinoids and lipids at average 6 months
measure: Change in plasma nerve growth factor levels
timeFrame: Change from Baseline NGF levels at average 6 months
measure: Change in pain drawing/ the spatial extent of the pain
timeFrame: Change from Baseline Pain extent at average 6 months
measure: Change in West Haven-Yale multidimensional pain inventory scores
timeFrame: Change from Baseline West Haven-Yale multidimensional pain inventory scores at average 6 months
measure: Change in chronic pain grade
timeFrame: Change from Baseline chronic pain grade at average 6 months
measure: Change in Resilience Scale (RS-11) scores
timeFrame: Change from Baseline resilience scores at average 6 months
measure: Change in Hospital Anxiety and Depression Scale scores
timeFrame: Change from Baseline anxiety and depression levels at average 6 months
measure: Change in Health Survey scores
timeFrame: Change from baseline quality of life level at average 6 months
measure: Change in somatization scores
timeFrame: Change from Baseline somatization scores at average 6 months
measure: Change in medication intake
timeFrame: Change from Baseline medication intake at average 6 months
measure: Change in dissociation scores
timeFrame: Change from Baseline dissociation at average 6 months
measure: Change in Post Traumatic Diagnostic Scale
timeFrame: Change from Baseline post traumatic diagnostic scale levels at average 6 months
measure: Patient global impression of change
timeFrame: after on average 6 months of treatment
measure: Recruitment potential
timeFrame: 6 months
measure: Retention rate
timeFrame: over average 6 months of treatment
Locations:
city: Heidelberg
country: Germany
facility: University Hospital Heidelberg
state: Baden-Württemberg
Study officials:
affiliation: University Hospital Heidelberg
name: Wolfgang Eich, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gerhardt A, Leisner S, Hartmann M, Janke S, Seidler GH, Eich W, Tesarz J. Eye Movement Desensitization and Reprocessing vs. Treatment-as-Usual for Non-Specific Chronic Back Pain Patients with Psychological Trauma: A Randomized Controlled Pilot Study. Front Psychiatry. 2016 Dec 20;7:201. doi: 10.3389/fpsyt.2016.00201. eCollection 2016.
citation: Tesarz J, Gerhardt A, Leisner S, Janke S, Hartmann M, Seidler GH, Eich W. Effects of eye movement desensitization and reprocessing (EMDR) on non-specific chronic back pain: a randomized controlled trial with additional exploration of the underlying mechanisms. BMC Musculoskelet Disord. 2013 Aug 30;14:256. doi: 10.1186/1471-2474-14-256.