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Enrolling by Invitation

NCT Number: NCT05757960

TMD-specific Physiotherapy in hEDS Patients Individuals With Hypermobile Ehlers-Danlos Syndrome

The aim of this study is to analyze the effects of strictly defined physiotherapy in patients temporomandibular dysfunction (TMD) and hypermobile Ehlers-Danlos Syndrome (hEDS). Patients will be clinically examined before starting physiotherapy and fill in the questionnaires. Subsequently, it will be followed up whether changes occur as a result of physiotherapy.

This study is a pilot study and is intended to be hypothesis generating in nature. Based on the resulting hypothesis, it will be verified by a study with a control group.

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Key information

Conditions

Hypermobile Ehlers-Danlos Syndrome Ehlers-Danlos syndrome type 3

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department for Prosthodontics and Biomaterials, University Hospital Münster

Münster, 48149, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • written consent to participate in the study
  • confirmed diagnosis of hEDS (based on the diagnostic criteria of the current classification of 2017).
  • pain in the area of the masticatory muscles and/or the temporomandibular joints
  • command of the German language, both spoken and written

Exclusion criteria

  • currently undergoing TMD-specific treatment (physiotherapy, pain therapy masticatory muscles and/or temporomandibular joint, orthopedic treatment, osteopathic treatment).
  • persons diagnosed with depression, anxiety or stress disorder
  • taking opiates
  • pregnant women
  • minors
  • persons with mental disability
  • persons who are not able to speak and write the German language
  • persons with legal representatives

Treatment and study plan

physiotherapy

Procedure

Various physiotherapeutic techniques are used in three defined sessions. Before the first session, a dental examination is performed and a clinical functional status is obtained to assess the extent of temporomandibular dysfunction. The results are recorded on validated questionnaires.

Primary outcomes

  1. Reduction of temporomandibular pain

    Time frame: Up to 3 months after the last physiotherapy intervention

    The German version of the Graded chronic pain scale (GCS) is used to measure the level of pain.

    The score ranges from level 0-IV, 0 representing no pain, I-II functional pain, and level III-IV dysfunctional, chronic pain.

Secondary outcomes

  1. Effects on psychosocial impairment

    Time frame: Up to 3 months after the last physiotherapy intervention

    The German version of the Depression Anxiety Stress Scale (DASS) is used to assess psychosocial impairment.

    The scale assesses the the dimensions Depression, Anxiety and Stress. The scale comprises a total of 21 questions, 7 questions for each of the named dimensions. Each question can be answered from 0-3, 0 for no impact and 3 for highest impact. The scores for each dimension are added. An increased probability for the occurrence of depression occurs with values from 10, for anxiety from 6 and for stress from 10.

  2. Effects on oral health-related quality of life (OHRQoL)

    Time frame: Up to 3 months after the last physiotherapy intervention

    The German version of the Oral Health Impact Profile (OHIP-G5) is used to assess OHRQoL. The questionnaire consists of 5 questions covering the 4 dimensions Oral Function, Orofascial Pain, Orofacial Appearance and Psychosocial impact. Each question can be answered from 0-4, where 0 stands for no impact and 4 for the highest impact. The values for the individual dimensions are formed and therefore range from 0-4 points; two questions address the Oral Function dimension, which is why values of 0-8 can be achieved here.

Sponsors and collaborators

Lead sponsor

University Hospital Muenster

Other

Collaborators

  • German Society of Craniomandibular Function and Disorders in the DGZMK.

Registry information

Official study title

Effects of TMD-specific Physiotherapy in Individuals With Hypermobile Ehlers-Danlos Syndrome

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Mar 7, 2023
Registry last updated
Apr 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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