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Enrolling by invitation NCT05757960

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

No phase Interventional Hypermobile Ehlers-Danlos Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Physiotherapy.
Who it may be relevant to
Registry conditions: Hypermobile Ehlers-Danlos Syndrome. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Procedure Physiotherapy
    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 outcome measures

  • Reduction of temporomandibular pain [Time frame: Up to 3 months after the last physiotherapy intervention]
Secondary outcome measures (2)
  • Effects on psychosocial impairment [Time frame: Up to 3 months after the last physiotherapy intervention]
  • Effects on oral health-related quality of life (OHRQoL) [Time frame: Up to 3 months after the last physiotherapy intervention]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Germany · 1 center
  • Department for Prosthodontics and Biomaterials, University Hospital Münster — Münster

Identifiers

NCT: NCT05757960 · CMD_Physio_EDS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗