Trial document




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  DRKS00011931

Trial Description

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Title

Therapy-induced changes in craniomandibular cerebral representation in CMD patients

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

The mode of action of therapy approaches for craniomandibular dysfunction (CMD) is widely unknown. Research on the level of the temporomandibular jaw could not clearly differentiate pathology from the data of participants without CMD. Although it is known that psychological factors have an important role in the genesis of chronic pain, neurobiological basics of these factors are widely unknown. Our group already identified basics of functional representation of jaw movements and demonstrated characteristics of cerebral representation of occlusal movements in patients with CMD. Using functional magnetic resonance imaging (fMRI) in a longitudinal design, we demonstrated how the representation of occlusal movements in CMD patients were altered during a three week therapy with a Michigan splint. As a functional correlate of affective changes during therapy we identified the anterior insula. Together with other regions, this area has been already reported to show characteristic functional and structural changes generally associated with chronic pain.
In the planned research project we investigate the specific effect of an occlusal contact relevant splint (Michigan type). We will do that by comparing changes on clinical (e.g. pain intensity) and neurophysiological (e.g. functional representation of occlusion) parameters over therapy with those of a splint not affecting the occlusal contact (palatine splint) in a waiting group design. By measurement of functional representation of the occlusion before and after therapy in addition to other parameters of occlusion (symmetry of occlusal movements; activity of the temporomandibular jaw musculature at rest and maximal occlusion) we will be able to identify specific aspects of functional representational changes associated with therapy. We here do evaluate local changes of representation but also changes in the network of regions processing movement control and pain perception. In addition, initial changes in functional representation in these patients and altered behavior and functional representation during emotional extinction will be compared with a matched group of control subjects. Hereby, we will increase insight in the alternations of these patients with respect to affective processing. By a better understanding of the specific effect of splint therapy on the processing of craniomandibular pain and associated affective components we intend to increase the efficiency of these therapies.

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Organizational Data

  •   DRKS00011931
  •   2017/03/31
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  •   yes
  •   Approved
  •   BB 151/15, Ethikkommission an der Medizinischen Fakultät der Ernst-Moritz-Arndt-Universität Greifswald
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Secondary IDs

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Health Condition or Problem studied

  •   K07.6 -  Temporomandibular joint disorders
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Interventions/Observational Groups

  •   An individually adapted upper jaw splint of the michigan type is used for 3 weeks. We measure functional magnetic resonance imaging (fMRI) for evaluation cortical representation of emotional extinction and jaw movements. In addition electromyographic measurements of the jaw-musculature in rest and standardized movements are recorded and jaw movement symmetry is measured. Pain during rest and standardized movements is scaled with a VAS. Alle measures before and after therapy.
  •   Placebo palatine splint for 3 weeks. We measure functional magnetic resonance imaging (fMRI) for evaluation cortical representation of emotional extinction and jaw movements. In addition electromyographic measurements of the jaw-musculature in rest and standardized movements are recorded and jaw movement symmetry is measured. Pain during rest and standardized movements is scaled with a VAS. Alle measures before and after therapy.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, assessor, data analyst
  •   Placebo
  •   Basic research/physiological study
  •   Parallel
  •   II
  •   N/A
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Primary Outcome

Changes in movement associated cerebral representation in the fMRI. Activation (anterior insula) associated with changes in pain at rest (VAS) and EMG and Symmetry of the TMJ-movements.

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Secondary Outcome

STAI-values, stress associated Cortisol, fMRI-activation anterior insula and cingulate, occlusal symmetry, EMG-relaxation during rest, connectivity changes in ROIs

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2017/04/01
  •   64
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
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Additional Inclusion Criteria

cranio-mandibular disorder longer than 6 months more than 4 days a week

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Exclusion Criteria

depression, teeth loss, radiologic damage of the jaw (degeneration, inflammation, fracture), fibromyalgia, malignoma, heart insufficiency, contraindications for an MRI investigation

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Addresses

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    • Universitätsmedizin Greifswald
    • Mr.  Prof. Dr.   Martin  Lotze 
    • Walther-Rathenau-Str. 46
    • 17475  Greifswald
    • Germany
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    • Universitätsmedizin Greifswald
    • Mr.  Prof. Dr.  Martin  Lotze 
    • Walther-Rathenau-Str. 46
    • 17489  Greifswald
    • Germany
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    • Universitätsmedizin Greifswald
    • Mr.  Prof. Dr.  Martin  Lotze 
    • Walther-Rathenau-Str. 46
    • 17489  Greifswald
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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    • Universitätsmedizin Greifswald
    • Mr.  Prof. Dr.  Martin  Lotze 
    • Walther-Rathenau-Str. 46
    • 17489  Greifswald
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.