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Eye Movement Desensitization and Reprocessing (EMDR) in Non-specific Chronic Back Pain (LOGIN - EMDR)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01850875
First Posted: May 10, 2013
Last Update Posted: May 16, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Prof. Dr. Wolfgang Eich, University Hospital Heidelberg
  Purpose
The study explores the feasibility of Eye-Movement-Desensitization and Reprocessing (EMDR) in non-specific chronic back pain.

Condition Intervention
Non-specific Chronic Back Pain Behavioral: Eye-Movement-Desensitization-Reprocessing

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Prof. Dr. Wolfgang Eich, University Hospital Heidelberg:

Primary Outcome Measures:
  • Change in pain intensity [ Time Frame: Change from Baseline Pain intensity at average 6 months ]
    Numerical rating scale 0-10


Other Outcome Measures:
  • functional and structural changes in fMRI [ Time Frame: Change from Baseline fMRI at average 6 months ]
  • Change in the pain experience scale - Pain affect [ Time Frame: Change from Baseline pain experience scale levels at average 6 months ]
    Geisser et al., 1996

  • Change in the Hannover functional ability questionnaire (FFbH) - disability [ Time Frame: Change from Baseline disabilty levels at average 6 months ]
    Kohlmann et al., 1996

  • Change in Quantitative sensory testing (QST)profiles [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Change from Baseline NGF levels at average 6 months ]
    Plasma levels in (pg/ml)

  • Change in pain drawing/ the spatial extent of the pain [ Time Frame: Change from Baseline Pain extent at average 6 months ]
  • Change in West Haven-Yale multidimensional pain inventory scores [ Time Frame: Change from Baseline West Haven-Yale multidimensional pain inventory scores at average 6 months ]
    Flor et al., 1990

  • Change in chronic pain grade [ Time Frame: Change from Baseline chronic pain grade at average 6 months ]
    von Korff er al., 1992

  • Change in Resilience Scale (RS-11) scores [ Time Frame: Change from Baseline resilience scores at average 6 months ]
    Schumacher et al., 2004

  • Change in Hospital Anxiety and Depression Scale scores [ Time Frame: Change from Baseline anxiety and depression levels at average 6 months ]
    Zigmond & Snaith, 1983

  • Change in Health Survey scores [ Time Frame: Change from baseline quality of life level at average 6 months ]
    SF-12

  • Change in somatization scores [ Time Frame: Change from Baseline somatization scores at average 6 months ]
    SCL-90R

  • Change in medication intake [ Time Frame: Change from Baseline medication intake at average 6 months ]
  • Change in dissociation scores [ Time Frame: Change from Baseline dissociation at average 6 months ]
    DES/FDS-20

  • Change in Post Traumatic Diagnostic Scale [ Time Frame: Change from Baseline post traumatic diagnostic scale levels at average 6 months ]
  • Patient global impression of change [ Time Frame: after on average 6 months of treatment ]
  • Recruitment potential [ Time Frame: 6 months ]
    % of patients eligible for inclusion that give written informed consent

  • Retention rate [ Time Frame: over average 6 months of treatment ]
    % of patients that finish treatment, including pre- and post-evaluation


Enrollment: 40
Study Start Date: May 2013
Study Completion Date: December 2015
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Eye-Movement-Desensitization-Reprocessing
Eye-Movement-Desensitization-Reprocessing
Behavioral: Eye-Movement-Desensitization-Reprocessing
No Intervention: Treatment as usual (control group)
treatment as usual

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01850875


Locations
Germany
University Hospital Heidelberg
Heidelberg, Baden-Württemberg, Germany, 69120
Sponsors and Collaborators
University Hospital Heidelberg
Investigators
Principal Investigator: Wolfgang Eich, Prof. Dr. University Hospital Heidelberg
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Dr. Wolfgang Eich, Prof. Dr., University Hospital Heidelberg
ClinicalTrials.gov Identifier: NCT01850875     History of Changes
Other Study ID Numbers: 01EC1010A
First Submitted: April 23, 2013
First Posted: May 10, 2013
Last Update Posted: May 16, 2016
Last Verified: May 2016

Keywords provided by Prof. Dr. Wolfgang Eich, University Hospital Heidelberg:
Eye-Movement-Desensitization and Reprocessing
EMDR
Chronic back pain
CBP
treatment

Additional relevant MeSH terms:
Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms