Trial document




drksid header

  DRKS00012448

Trial Description

start of 1:1-Block title

Title

Interference of experimental pain and cognition in patients suffering from chronic pain

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

RUMI

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Acute pain has an important warning function and is able to automatically attract attention. This allows us to perform fast withdrawal movements to assure safety and bodily integrity, for example we withdraw our hand from a hotplate. As our attentional capacity is only limited and pain is able to bind a part of this attential capacity, other cognitive functions (e.g. learning, memory) may be impaired by pain. This adaptive phenomenon is well described in healthy subjects. However, there is only limited information of how pain interacts with cognition in patients suffering from chronic pain. This study therefore tests whether cognitive impairment by experimental pain differs in patients suffering from chronic pain (back pain, migraine) and healthy control subjects. Patients and participants (60 per group) perform a memory task, in which images are either presented with electrical pain stimuli applied to the forehead, the lower back or without additional painful stimulation. We will compare, whether memory performance differs between groups and whether the site of painful stimulation affects memory performance. Using magnetic resonance imaging we will test, whether the structure or function of the brain are related to the effect of pain on memory performance.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

The planned study aims to quantify the interference of experimental pain and cognitive funtioning in patients suffering from chronic pain and healthy controls. We will further test whether the interruptive effect of experimental pain depends on the affected body site.
We will perform a 3x3 design, in which 2 patient groups (chronic low back pain, chronic migraine) and a group of healthy control subjects (matched in age, gender, education) will be included. All patients/subjects (60 per group) will perform an experimental paradigm (categorisation task, recognition task), while receiving painful electrical stimulation at the lower back (L3-L5), the forehead (V1) or whithout additional painful stimulation. Primary outcomes are reaction time differences and differences in recognition rates for images previously paired with pain compared to those presented without painful stimulation. Statistical effects (main effects and interactions) will be tested using the general linear model with inner subject factor "stimulation" and between subject factor "group". We hypothesise that patients suffering from chronic pain show greater pain-induced impairments of task performance compared to healthy controls (main effect group), especially for electrical pain applied to the affected body site (group x stimulation interaction). Using magnetic resonance imaging (morphometry, resting state fMRI), we aim to identify structural and/or functional predispositions of interindividual differences of the interference effect of pain. Further, we will test whether psychological variables (e.g. neurocognitive performance, expectancy regarding the effect of pain on cognition, attentional pain bias) are related to pain-induced impairments of task performance.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00012448
  •   2017/05/23
  •   [---]*
  •   yes
  •   Approved
  •   15-6683-BO, Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   M54 -  Dorsalgia
  •   G43 -  Migraine
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Patients suffering from chronic low back pain ( pain > 3 months) perform a categorization and recognition task while receiving either (1) painful stimuli at the lower back, (2) at the forehead or (3) no painful stimulation
  •   Patients suffering from chronic migraine ( pain > 3 months, > 15 days with migraine attacks) perform a categorization and recognition task while receiving either (1) painful stimuli at the lower back, (2) at the forehead or (3) no painful stimulation
  •   healthy subjects (matched in age, gender, education) perform a categorization and recognition task while receiving either (1) painful stimuli at the lower back, (2) at the forehead or (3) no painful stimulation
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Basic research/physiological study
  •   Factorial
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

mean reaction times (ms) (categorisation task) and recognition performance (d prime, recollection and familiarity parameters) for images previously presented with electrical pain stimuli (1) at the lower back (L3-L5), (2) at the forehead (V1) or (3) without additional painful stimulation; Group comparison: (1) patients suffering from chronic lower back pain, (2) patients suffering from chronic migraine and (3) healthy control subjects. interaction effects: group x condition

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

1) mean skin conductance response (amplitude, microsiemens; latency, ms) during painful stimulation and during the recognition task (for each experimental phase: main effect group, main effect stimulation, interaction group x stimulation)

2) Structural and functional predispositions (morphometry, resting state fMRI)

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2017/05/10
  •   180
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   80   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

(1) Age: 18 - 80
(2) voluntary, informed study participation
(3) chronic low back pain or chronic migraine (> 3 months; for migraine: attacks on > 15 days per month); healthy control subjects (matched to pain patients in age, gender, education)

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

(4) participation in other clinical trials testing medication
(5) severe depression or anxiety disorder
(6) pregnancy, nursing
(7) medication-overuse headache (MOH)
(8) other chronic pain conditions except lower back pain or migraine
(esp. radicular pain, neuropathic pain)
(9) intake of highly dosed opioids
(10) contraindication for MR testing, e.g.
• cardiac pacemaker and other magnetizable material within the body
• MR-incompatible metal material
• claustrophobia

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinik Essen AöRKlinik für Neurologie
    • Ms.  Prof. Dr.  Ulrike  Bingel 
    • Hufelandstr. 55
    • 45147  Essen
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Universitätsklinik Essen AöR; Klinik für Neurologie
    • Ms.  Dr.  Katarina  Forkmann 
    • Hufelandstr. 55
    • 45147  Essen
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Universitätsklinik Essen AöR; Klinik für Neurologie
    • Ms.  Dr.  Katarina  Forkmann 
    • Hufelandstr. 55
    • 45147  Essen
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
  • start of 1:1-Block address otherSupport
    • Universitätsklinik Essen AöR; Klinik für Neurologie
    • Ms.  Prof. Dr. med.  Ulrike  Bingel 
    • Hufelandstr. 55
    • 45147  Essen
    • Germany
    end of 1:1-Block address otherSupport
    start of 1:1-Block address contact otherSupport
    end of 1:1-Block address contact otherSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.