Trial document




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  DRKS00003922

Trial Description

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Title

Impairment of Attention in Patients with Chronic Painful Temporomandibular Disorders

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

In this study patients with muscular or temporomandibular joint associated pain in the face shall be compared to painfree controls regarding differences in their attentional performance. Therefore questionnaires and computerassisted procedures will be applied. Patients with temporomandibular disorders and painfree controls shall be compared regarding to the perceived and psychometric attentional performance. The working assumption is, that no differences between the groups exist.

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Brief Summary in Scientific Language

Chronic pain has a significant negative impact on affected patients. Research has shown, inter alia, that chronic pain not only changes the grey matter of the brain but also impairs the cognitive performance. Because of the multitude of limited functions this also holds true for orofacial pain, which is mainly caused by dysfunctions in the areas of the temporomandibular joints and masticatory muscles. After back pain, temporomandibular disorders (TMD) are the second most common group of musculoskeletal problems in humans. The limitations of cognitive processes in TMD-patients have so far not been investigated in depth as the focus of pain research and cognitive research has not yet been on this group of patients. This is due to fact that these patients are primarily treated by dental practitioners. Within the framework of an interdisciplinary cooperation, patients with chronic painful cranio-mandibular dysfunction shall be examined and included in a study regarding their ability of attentional performance in comparison to pain-free control patients. In the process, the subjectively experienced limitations of attention shall be measured using a multi-dimensional instrument in addition to psychometric testing. It is known from literature that the correlations between subjectively perceived cognitive limitations and objective testing are rather small in different patient groups. This makes it all the more important to analyze the coherences and influencing factors of other variables which are due to an illness (e.g. fear, depression, somatisation, pain duration). Thereby a disorder profile of the different aspects of attention can be created, an assessment of the actual consequences can be done, and therapeutical strategies can be developed.

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Organizational Data

  •   DRKS00003922
  •   2012/09/21
  •   [---]*
  •   yes
  •   Approved
  •   276-12-02072012, Ethikkommission an der Medizinischen Fakultät der Universität Leipzig
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Secondary IDs

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Health Condition or Problem studied

  •   K07.6 -  Temporomandibular joint disorders
  •   M79.10 -  [generalization M79.1: Myalgia]
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Interventions/Observational Groups

  •   patients mit painful temporomandibular disorders: assessment of temporomandibular disorders; questionnaires (depression, somatization, oral health related quality of life, pain); attentional performance via computerized tests
  •   controls: assessment of temporomandibular disorders; questionnaires (depression, somatization, oral health related quality of life, pain); attentional performance via computerized tests
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Other
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

what: attentional performance (vigilance, speed of information processing, shared attention, repeating numbers)
when: non-recurring
how: questionnaires (FEDA), computer assisted tests (TAP 2.2)

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Secondary Outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2014/01/01
  •   120
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   30   Years
  •   60   Years
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Additional Inclusion Criteria

• diagnosis of painful temporomandibular disorders according to DC/TMD (if published, otherwise according RDC/TMD)
• pain duration >6 months
xxxx
controls:
• no long lasting pain (>1 day) in the musculoskelettal system or headache during the last month
• no diagnosis according to DC/TMD

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Exclusion Criteria

• insufficient command of the German language
• significant impairment of speech or hearing ability
• pregnancy or lactation
• prediagnosed neurologic or psychiatric disorders and motoric capabilities
• prediagnosed attention deficit syndrome
• use of pain killers in the last 24h
• attention and reactivity impairing medication (ie. antidepressants, muscle relaxants, anesthesia within the last 24 h)

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Addresses

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    • Poliklinik für Zahnärztliche Prothetik und Werkstoffkunde
    • Mr.  Dr.  Oliver  Schierz 
    • Liebigstr. 10-14
    • 04103  Leipzig
    • Germany
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    • Tagesklinik für kognitive Neurologie
    • Ms.  Dr.  Angelika  Thöne-Otto 
    • Liebigstr. 16
    • 04103  Leipzig
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    • Poliklinik für Zahnärztliche Prothetik und Werkstoffkunde
    • Mr.  Dr.  Oliver  Schierz 
    • Liebigstr. 10-14
    • 04103  Leipzig
    • Germany
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    • Poliklinik für Zahnärztliche Prothetik und Werkstoffkunde
    • Mr.  Dr.  Oliver  Schierz 
    • Liebigstr. 10-14
    • 04103  Leipzig
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft e.V.
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting withdrawn before recruiting started
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Trial Publications, Results and other Documents

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