Non-specific Chronic Back PainLOGIN - EMDRNCT01850875
Eye Movement Desensitization and Reprocessing (EMDR) in Non-specific Chronic Back Pain
A study testing Eye-Movement-Desensitization-Reprocessing in people with Non-specific Chronic Back Pain, run by University Hospital Heidelberg at 1 site in Germany.
Trial summary
The study explores the feasibility of Eye-Movement-Desensitization and Reprocessing (EMDR) in non-specific chronic back pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-specific Chronic Back Pain
- What is being tested?
- Eye-Movement-Desensitization-Reprocessing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- May 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >= 18 years
- non-specific chronic low back pain >= 45 days/3 months
- high emotional distress caused by psychological trauma
- German language skills
Who cannot join
- specific causes of chronic back pain
- application for retirement pension pending
- ongoing psychotherapy
- severe physical or psychiatric comorbidity
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Heidelberg
Heidelberg, Baden-Wurttemberg, 69120
About this study
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
The study explores the feasibility of Eye-Movement-Desensitization and Reprocessing (EMDR) in non-specific chronic back pain.
Read the 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.
- Conditions
- Non-specific Chronic Back Pain
- Being tested
- Eye-Movement-Desensitization-Reprocessing
- Keywords
- Eye-Movement-Desensitization and Reprocessing, EMDR, Chronic back pain, CBP, treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye-Movement-Desensitization-ReprocessingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Eye-Movement-Desensitization-Reprocessing | Experimental | Eye-Movement-Desensitization-Reprocessing Receives: Behavioral: Eye-Movement-Desensitization-Reprocessing |
| Treatment as usual (control group) | No intervention | treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain intensity
Numerical rating scale 0-10
Measured: Change from Baseline Pain intensity at average 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2013 (estimated)
- Study startMay 2013
- Primary completionNov 2014
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Non-specific Chronic Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Wolfgang Eich, University Hospital Heidelberg
- Investigators
- Wolfgang Eich, Prof. Dr., Principal investigator, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01850875
- Sponsor's protocol ID
- 01EC1010A
- Acronym
- LOGIN - EMDR
- Status last verified
- May 2016
- First submitted
- 23 Apr 2013
- Last updated
- 16 May 2016
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 28066274Tesarz 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.
PubMed 23987561
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01850875
- Acronym / sponsor ID
- LOGIN - EMDR / 01EC1010A
- Conditions
- Non-specific Chronic Back Pain
- Keywords
- Eye-Movement-Desensitization and Reprocessing, EMDR, Chronic back pain, CBP, treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 10 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eye-Movement-Desensitization-Reprocessing | Experimental | Behavioral: Eye-Movement-Desensitization-ReprocessingEye-Movement-Desensitization-Reprocessing |
| Treatment as usual (control group) | No intervention | –treatment as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- >= 18 years
- non-specific chronic low back pain >= 45 days/3 months
- high emotional distress caused by psychological trauma
- German language skills
Key exclusion criteria (4 listed)
- specific causes of chronic back pain
- application for retirement pension pending
- ongoing psychotherapy
- severe physical or psychiatric comorbidity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eye-Movement-Desensitization-Reprocessing | Behavioural | Eye-Movement-Desensitization-Reprocessing |
Primary outcome
Change in pain intensity
Time frame: Change from Baseline Pain intensity at average 6 months
Numerical rating scale 0-10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2016.
- Derived from this study: PubMed 28066274Gerhardt 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.
- Derived from this study: PubMed 23987561Tesarz 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.
- Consortium LOGINLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wolfgang Eich, Prof. Dr. principal investigator
University Hospital Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eye-Movement-Desensitization-Reprocessing in people with Non-specific Chronic Back Pain, run by University Hospital Heidelberg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain intensity (time frame: Change from Baseline Pain intensity at average 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01850875, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2016.