Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00010459

Trial Description

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Title

Effectiveness of osteopathic treatment compared to manual therapy in patients with craniomandibular disorders

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

Many people sufferd from disorders of the jaw with pain and disturbance of the function. Different hand-on treatments can reduce pain and improve function of the temporomandibular joint. Effectiveness of osteopathic treatment is still unclear.
The main purpose of this study is to examine the effect of osteopathic treatment compared to established manual therapy treatment in patients with pain and dysfunction in temporomandibular joint.

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Brief Summary in Scientific Language

Temporomandibular disorder (TMD) is the most frequent form of face pain. International prevalence in adults is according to the country 14% - 40%. There is convincing evidence for the effectiveness for manual therapy. The effectiveness of osteopathic treatment is still unclear.
In this randomized controlled trial the effectiveness of osteopathic treatemt compared to manual therapy and no treatment will be investigated. After randomization to three groups participants in the two treatment groups will be treated 4 times within a period of 4 weeks. Before first treatment and after last treatment self-reportet pain, mouth opening and quality of life will be measured. Differences between groups will be calculated by ANOVA with repeated measurements.

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Organizational Data

  •   DRKS00010459
  •   2016/05/10
  •   [---]*
  •   yes
  •   Approved
  •   013-05, Ethikkommission des Osteopathic Research Institute Mexikoring 19 22297 Hamburg
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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

  •   Osteopathic treatment, 1/week within 4 weeks a 30 min
  •   Manual Therapy treatment, 1/week within 4 weeks a 30 min
  •   no treatment
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   data analyst
  •   Active control (effective treament of control group), Control group receives no treatment
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Self-reportet pain (VAS), before first treatment, after last treatment, 6 weeks follow up after last treatment

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Secondary Outcome

Mouth opening, measured by caliper, before first treatment, after last treatment, 6 weeks follow up after last treatment
Self-reportet quality of life, measured by SF-36 questionnaire, before first treatment, after last treatment, 6 weeks follow up after last treatment

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2013/04/01
  •   69
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

18 to 60 years of age, medically diagnosed by their dentist with CMD (craniomandibular disorders) by fulfilling the diagnostic criteria of the International RDC-TMD Consortium. At least two of following criteria must be existent: (a) Pain in the region of mastication muscles; (b) pain in the region of the temporomandibular joint; (c) restricted mouth opening; (d) bruxism; (e) cracking during mouth opening

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Exclusion Criteria

suffered from malocclusion, systemic conditions with facial pain, neurological signs, mental disorders, any kind of surgery of the head or/and neck, any kind of other treatments for CMD (medication, massage, exercise, splint)

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Addresses

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    • Praxis
    • Ms.  BSc  Michaela  Grosse 
    • Buchenweg 37
    • 75228  Ispringen
    • Germany
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    • Universität Hamburg Fakultät für Psychologie und BewegungswissenschaftInstitut für BewegungswissenschaftArbeitsbereich Sport- und Bewegungsmedizin
    • Mr.  Dr., BSc, MSc  Tobias  Schmidt 
    • Turmweg 2
    • 20148  Hamburg
    • Germany
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    • Universität Hamburg Fakultät für Psychologie und BewegungswissenschaftInstitut für BewegungswissenschaftArbeitsbereich Sport- und Bewegungsmedizin
    • Mr.  Dr., BSc, MSc  Tobias  Schmidt 
    • Turmweg 2
    • 20148  Hamburg
    • Germany
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Sources of Monetary or Material Support

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    • Praxis
    • Ms.  BSc  Michaela  Grosse 
    • Buchenweg 37
    • 75228  Ispringen
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2013/09/15
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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.