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

May 13, 2016 updated by: Prof. Dr. Wolfgang Eich, University Hospital Heidelberg

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in pain intensity
Time Frame: Change from Baseline Pain intensity at average 6 months
Numerical rating scale 0-10
Change from Baseline Pain intensity at average 6 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
functional and structural changes in fMRI
Time Frame: Change from Baseline fMRI at average 6 months
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 from Baseline pain experience scale levels at average 6 months
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 from Baseline disabilty levels at average 6 months
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 from Baseline QST profile at average 6 months
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 from Baseline conditioned pain modulation activity at average 6 months
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 from Baseline endocannabinoids and lipids at average 6 months
Change in plasma nerve growth factor levels
Time Frame: Change from Baseline NGF levels at average 6 months
Plasma levels in (pg/ml)
Change from Baseline NGF levels at average 6 months
Change in pain drawing/ the spatial extent of the pain
Time Frame: Change from Baseline Pain extent at average 6 months
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 from Baseline West Haven-Yale multidimensional pain inventory scores at average 6 months
Change in chronic pain grade
Time Frame: Change from Baseline chronic pain grade at average 6 months
von Korff er al., 1992
Change from Baseline chronic pain grade at average 6 months
Change in Resilience Scale (RS-11) scores
Time Frame: Change from Baseline resilience scores at average 6 months
Schumacher et al., 2004
Change from Baseline resilience scores at average 6 months
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 from Baseline anxiety and depression levels at average 6 months
Change in Health Survey scores
Time Frame: Change from baseline quality of life level at average 6 months
SF-12
Change from baseline quality of life level at average 6 months
Change in somatization scores
Time Frame: Change from Baseline somatization scores at average 6 months
SCL-90R
Change from Baseline somatization scores at average 6 months
Change in medication intake
Time Frame: Change from Baseline medication intake at average 6 months
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 from Baseline dissociation at average 6 months
Change in Post Traumatic Diagnostic Scale
Time Frame: Change from Baseline post traumatic diagnostic scale levels at average 6 months
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
after on average 6 months of treatment
Recruitment potential
Time Frame: 6 months
% of patients eligible for inclusion that give written informed consent
6 months
Retention rate
Time Frame: over average 6 months of treatment
% of patients that finish treatment, including pre- and post-evaluation
over average 6 months of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital Heidelberg

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Wolfgang Eich, Prof. Dr., University Hospital Heidelberg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 23, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 10, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 16, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 01EC1010A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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