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Completed

NCT Number: NCT01850875

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.

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Key information

Conditions

Non-specific Chronic Back Pain

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Eye-Movement-Desensitization-Reprocessing

Behavioral

Primary outcomes

  1. Change in pain intensity

    Time frame: Change from Baseline Pain intensity at average 6 months

    Numerical rating scale 0-10

Other outcomes

  1. functional and structural changes in fMRI

    Time frame: Change from Baseline fMRI at average 6 months

  2. 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

  3. Change in the Hannover functional ability questionnaire (FFbH) - disability

    Time frame: Change from Baseline disabilty levels at average 6 months

    Kohlmann et al., 1996

  4. 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)

  5. 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.)

  6. 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),

  7. Change in plasma nerve growth factor levels

    Time frame: Change from Baseline NGF levels at average 6 months

    Plasma levels in (pg/ml)

  8. Change in pain drawing/ the spatial extent of the pain

    Time frame: Change from Baseline Pain extent at average 6 months

  9. 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

  10. Change in chronic pain grade

    Time frame: Change from Baseline chronic pain grade at average 6 months

    von Korff er al., 1992

  11. Change in Resilience Scale (RS-11) scores

    Time frame: Change from Baseline resilience scores at average 6 months

    Schumacher et al., 2004

  12. Change in Hospital Anxiety and Depression Scale scores

    Time frame: Change from Baseline anxiety and depression levels at average 6 months

    Zigmond & Snaith, 1983

  13. Change in Health Survey scores

    Time frame: Change from baseline quality of life level at average 6 months

    SF-12

  14. Change in somatization scores

    Time frame: Change from Baseline somatization scores at average 6 months

    SCL-90R

  15. Change in medication intake

    Time frame: Change from Baseline medication intake at average 6 months

  16. Change in dissociation scores

    Time frame: Change from Baseline dissociation at average 6 months

    DES/FDS-20

  17. Change in Post Traumatic Diagnostic Scale

    Time frame: Change from Baseline post traumatic diagnostic scale levels at average 6 months

  18. Patient global impression of change

    Time frame: after on average 6 months of treatment

  19. Recruitment potential

    Time frame: 6 months

    % of patients eligible for inclusion that give written informed consent

  20. Retention rate

    Time frame: over average 6 months of treatment

    % of patients that finish treatment, including pre- and post-evaluation

Sponsors and collaborators

Lead sponsor

University Hospital Heidelberg

Other

Registry information

Official study 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

Acronym: LOGIN - EMDR

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
May 10, 2013
Registry last updated
May 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.