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

• Sponsor: University Hospital Heidelberg (Other)
• Overall Status: Completed
• CT.gov ID: NCT01850875
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Duration (Months): 31
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief Summary

The study explores the feasibility of Eye-Movement-Desensitization and Reprocessing (EMDR) in non-specific chronic back pain.

Condition or Disease	Intervention/Treatment	Phase
Non-specific Chronic Back Pain	Behavioral: Eye-Movement-Desensitization-Reprocessing	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• 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
• Study Start Date: May 1, 2013
• Actual Primary Completion Date: Nov 1, 2014
• Actual Study Completion Date: Dec 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in pain intensity [Change from Baseline Pain intensity at average 6 months]

   Numerical rating scale 0-10

Other Outcome Measures

1. functional and structural changes in fMRI [Change from Baseline fMRI at average 6 months]

2. Change in the pain experience scale - Pain affect [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 [Change from Baseline disabilty levels at average 6 months]

   Kohlmann et al., 1996

4. Change in Quantitative sensory testing (QST)profiles [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 [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 [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 [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 [Change from Baseline Pain extent at average 6 months]

9. Change in West Haven-Yale multidimensional pain inventory scores [Change from Baseline West Haven-Yale multidimensional pain inventory scores at average 6 months]

   Flor et al., 1990

10. Change in chronic pain grade [Change from Baseline chronic pain grade at average 6 months]

    von Korff er al., 1992

11. Change in Resilience Scale (RS-11) scores [Change from Baseline resilience scores at average 6 months]

    Schumacher et al., 2004

12. Change in Hospital Anxiety and Depression Scale scores [Change from Baseline anxiety and depression levels at average 6 months]

    Zigmond & Snaith, 1983

13. Change in Health Survey scores [Change from baseline quality of life level at average 6 months]

    SF-12

14. Change in somatization scores [Change from Baseline somatization scores at average 6 months]

    SCL-90R

15. Change in medication intake [Change from Baseline medication intake at average 6 months]

16. Change in dissociation scores [Change from Baseline dissociation at average 6 months]

    DES/FDS-20

17. Change in Post Traumatic Diagnostic Scale [Change from Baseline post traumatic diagnostic scale levels at average 6 months]

18. Patient global impression of change [after on average 6 months of treatment]

19. Recruitment potential [6 months]

    % of patients eligible for inclusion that give written informed consent

20. Retention rate [over average 6 months of treatment]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Heidelberg	Heidelberg	Baden-Württemberg	Germany	69120

Sponsors and Collaborators

• University Hospital Heidelberg

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Consortium LOGIN

Publications

None provided.

• Responsible Party: Prof. Dr. Wolfgang Eich, Prof. Dr., University Hospital Heidelberg
• ClinicalTrials.gov Identifier: NCT01850875
• Other Study ID Numbers: 01EC1010A
• First Posted: May 10, 2013
• Last Update Posted: May 16, 2016
• Last Verified: May 1, 2016

• Keywords provided by Prof. Dr. Wolfgang Eich, Prof. Dr., University Hospital Heidelberg: Eye-Movement-Desensitization and Reprocessing; EMDR; Chronic back pain; CBP; treatment
• Additional relevant MeSH terms: Back Pain

Study Results

No Results Posted as of May 16, 2016