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

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.

Study Overview

• Status: Completed
• Conditions: Non-specific Chronic Back Pain
• Intervention / Treatment: Behavioral: Eye-Movement-Desensitization-Reprocessing

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Baden-Württemberg
    • Heidelberg, Baden-Württemberg, Germany, 69120
      • University Hospital Heidelberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Eye-Movement-Desensitization-Reprocessing	Behavioral: Eye-Movement-Desensitization-Reprocessing
No Intervention: Treatment as usual (control group); treatment as usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain intensity	Numerical rating scale 0-10	Change from Baseline Pain intensity at average 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
functional and structural changes in fMRI		Change from Baseline fMRI at average 6 months
Change in the pain experience scale - Pain affect	Geisser et al., 1996	Change from Baseline pain experience scale levels at average 6 months
Change in the Hannover functional ability questionnaire (FFbH) - disability	Kohlmann et al., 1996	Change from Baseline disabilty levels at average 6 months
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
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
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
Change in plasma nerve growth factor levels	Plasma levels in (pg/ml)	Change from Baseline NGF levels at average 6 months
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	Flor et al., 1990	Change from Baseline West Haven-Yale multidimensional pain inventory scores at average 6 months
Change in chronic pain grade	von Korff er al., 1992	Change from Baseline chronic pain grade at average 6 months
Change in Resilience Scale (RS-11) scores	Schumacher et al., 2004	Change from Baseline resilience scores at average 6 months
Change in Hospital Anxiety and Depression Scale scores	Zigmond & Snaith, 1983	Change from Baseline anxiety and depression levels at average 6 months
Change in Health Survey scores	SF-12	Change from baseline quality of life level at average 6 months
Change in somatization scores	SCL-90R	Change from Baseline somatization scores at average 6 months
Change in medication intake		Change from Baseline medication intake at average 6 months
Change in dissociation scores	DES/FDS-20	Change from Baseline dissociation at average 6 months
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	% of patients eligible for inclusion that give written informed consent	6 months
Retention rate	% of patients that finish treatment, including pre- and post-evaluation	over average 6 months of treatment

Collaborators and Investigators

• Sponsor: University Hospital Heidelberg
• Investigators: Principal Investigator: Wolfgang Eich, Prof. Dr., University Hospital Heidelberg

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• Consortium LOGIN

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: April 23, 2013
• First Submitted That Met QC Criteria: May 7, 2013
• First Posted (Estimate): May 10, 2013

Study Record Updates

• Last Update Posted (Estimate): May 16, 2016
• Last Update Submitted That Met QC Criteria: May 13, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: treatment; EMDR; Chronic back pain; CBP; Eye-Movement-Desensitization and Reprocessing
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain
• Other Study ID Numbers: 01EC1010A