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

Hypermobile Ehlers-Danlos Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05757960
• Other study ID #: CMD_Physio_EDS
• Status: Recruiting
• Phase: N/A
• Start date: February 2, 2023
• Est. completion date: August 1, 2024

Study information

• Verified date: January 2023
• Source: University Hospital Muenster
• Contact: Ole Oelerich, Dr. med. dent.
• Phone: +49(0)2518343664
• Email: ole.oelerich[@]ukmuenster.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: August 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. written consent to participate in the study

2. confirmed diagnosis of hEDS (based on the diagnostic criteria of the current classification of 2017).

3. pain in the area of the masticatory muscles and/or the temporomandibular joints

4. command of the German language, both spoken and written

Exclusion Criteria:

1. currently undergoing TMD-specific treatment (physiotherapy, pain therapy masticatory muscles and/or temporomandibular joint, orthopedic treatment, osteopathic treatment).

2. persons diagnosed with depression, anxiety or stress disorder

3. taking opiates

4. pregnant women

5. minors

6. persons with mental disability

7. persons who are not able to speak and write the German language

8. persons with legal representatives

Related Conditions & MeSH terms

• Ehlers-Danlos Syndrome
• Hypermobile Ehlers-Danlos Syndrome
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
Germany	Department for Prosthodontics and Biomaterials, University Hospital Münster	Münster

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Muenster	German Society of Craniomandibular Function and Disorders in the DGZMK.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of temporomandibular pain	The German version of the "Graded chronic pain scale" is used to measure the level of pain.	Up to 3 months after the last physiotherapy intervention
Secondary	Effects on psychosocial impairment	The German version of the "Depression Anxiety Stress Scale" is used to assess psychosocial impairment	Up to 3 months after the last physiotherapy intervention
Secondary	Effects on oral health-related quality of life (OHRQoL)	The German version of the Oral Health Impact Profile (OHIP-G5) is used to assess OHRQoL	Up to 3 months after the last physiotherapy intervention