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

NCT ID: NCT05757960

Last Updated: 2025-04-27

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-02
• Study Completion Date: 2027-08-01

Brief 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.

Conditions

Hypermobile Ehlers-Danlos Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Physiotherapy

Using a strictly defined physiotherapy protocol, the effects on temporomandibular dysfunctions are studied.

Group Type: EXPERIMENTAL

Physiotherapy

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

German Society of Craniomandibular Function and Disorders in the DGZMK.

UNKNOWN

Sponsor Role: collaborator

University Hospital Muenster

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ole Oelerich, Dr. med. dent.

Role: PRINCIPAL_INVESTIGATOR

Department for Prosthodonctics and Biomaterials, University Hospital Münster

Locations

Department for Prosthodontics and Biomaterials, University Hospital Münster

Münster, , Germany

Countries

Germany

Other Identifiers

CMD_Physio_EDS

Identifier Type: -

Identifier Source: org_study_id