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

Primary Purpose

Non-specific Chronic Back Pain

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Eye-Movement-Desensitization-Reprocessing
Sponsored by
University Hospital Heidelberg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-specific Chronic Back Pain focused on measuring Eye-Movement-Desensitization and Reprocessing, EMDR, Chronic back pain, CBP, treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Heidelberg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Eye-Movement-Desensitization-Reprocessing

Treatment as usual (control group)

Arm Description

Eye-Movement-Desensitization-Reprocessing

treatment as usual

Outcomes

Primary Outcome Measures

Change in pain intensity
Numerical rating scale 0-10

Secondary Outcome Measures

Full Information

First Posted
April 23, 2013
Last Updated
May 13, 2016
Sponsor
University Hospital Heidelberg
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1. Study Identification

Unique Protocol Identification Number
NCT01850875
Brief Title
Eye Movement Desensitization and Reprocessing (EMDR) in Non-specific Chronic Back Pain
Acronym
LOGIN - EMDR
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

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Heidelberg

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-specific Chronic Back Pain
Keywords
Eye-Movement-Desensitization and Reprocessing, EMDR, Chronic back pain, CBP, treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Eye-Movement-Desensitization-Reprocessing
Arm Type
Experimental
Arm Description
Eye-Movement-Desensitization-Reprocessing
Arm Title
Treatment as usual (control group)
Arm Type
No Intervention
Arm Description
treatment as usual
Intervention Type
Behavioral
Intervention Name(s)
Eye-Movement-Desensitization-Reprocessing
Primary Outcome Measure Information:
Title
Change in pain intensity
Description
Numerical rating scale 0-10
Time Frame
Change from Baseline Pain intensity at average 6 months
Other Pre-specified Outcome Measures:
Title
functional and structural changes in fMRI
Time Frame
Change from Baseline fMRI at average 6 months
Title
Change in the pain experience scale - Pain affect
Description
Geisser et al., 1996
Time Frame
Change from Baseline pain experience scale levels at average 6 months
Title
Change in the Hannover functional ability questionnaire (FFbH) - disability
Description
Kohlmann et al., 1996
Time Frame
Change from Baseline disabilty levels at average 6 months
Title
Change in Quantitative sensory testing (QST)profiles
Description
According to the protocol by Rolke et al. (2006), developed within the Germany Research Network on Neuropathic Pain (DFNS)
Time Frame
Change from Baseline QST profile at average 6 months
Title
Change in Conditioned Pain Modulation
Description
difference in pressure pain threshold before and after oscillating heat (2 min.)
Time Frame
Change from Baseline conditioned pain modulation activity at average 6 months
Title
Change in Plasma endocannabinoids and lipids
Description
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),
Time Frame
Change from Baseline endocannabinoids and lipids at average 6 months
Title
Change in plasma nerve growth factor levels
Description
Plasma levels in (pg/ml)
Time Frame
Change from Baseline NGF levels at average 6 months
Title
Change in pain drawing/ the spatial extent of the pain
Time Frame
Change from Baseline Pain extent at average 6 months
Title
Change in West Haven-Yale multidimensional pain inventory scores
Description
Flor et al., 1990
Time Frame
Change from Baseline West Haven-Yale multidimensional pain inventory scores at average 6 months
Title
Change in chronic pain grade
Description
von Korff er al., 1992
Time Frame
Change from Baseline chronic pain grade at average 6 months
Title
Change in Resilience Scale (RS-11) scores
Description
Schumacher et al., 2004
Time Frame
Change from Baseline resilience scores at average 6 months
Title
Change in Hospital Anxiety and Depression Scale scores
Description
Zigmond & Snaith, 1983
Time Frame
Change from Baseline anxiety and depression levels at average 6 months
Title
Change in Health Survey scores
Description
SF-12
Time Frame
Change from baseline quality of life level at average 6 months
Title
Change in somatization scores
Description
SCL-90R
Time Frame
Change from Baseline somatization scores at average 6 months
Title
Change in medication intake
Time Frame
Change from Baseline medication intake at average 6 months
Title
Change in dissociation scores
Description
DES/FDS-20
Time Frame
Change from Baseline dissociation at average 6 months
Title
Change in Post Traumatic Diagnostic Scale
Time Frame
Change from Baseline post traumatic diagnostic scale levels at average 6 months
Title
Patient global impression of change
Time Frame
after on average 6 months of treatment
Title
Recruitment potential
Description
% of patients eligible for inclusion that give written informed consent
Time Frame
6 months
Title
Retention rate
Description
% of patients that finish treatment, including pre- and post-evaluation
Time Frame
over average 6 months of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wolfgang Eich, Prof. Dr.
Organizational Affiliation
University Hospital Heidelberg
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Heidelberg
City
Heidelberg
State/Province
Baden-Württemberg
ZIP/Postal Code
69120
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
28066274
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.
Results Reference
derived
PubMed Identifier
23987561
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.
Results Reference
derived
Links:
URL
http://www.login-verbund.de/index.php?id=2&L=1
Description
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Eye Movement Desensitization and Reprocessing (EMDR) in Non-specific Chronic Back Pain

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