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

Primary Purpose

Hypermobile Ehlers-Danlos Syndrome

Status

Recruiting

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Physiotherapy

About this trial

This is an interventional treatment trial for Hypermobile Ehlers-Danlos Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Department for Prosthodontics and Biomaterials, University Hospital MünsterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Physiotherapy

Arm Description

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

Outcomes

Primary Outcome Measures

Reduction of temporomandibular pain

The German version of the "Graded chronic pain scale" is used to measure the level of pain.

Secondary Outcome Measures

Effects on psychosocial impairment

The German version of the "Depression Anxiety Stress Scale" is used to assess psychosocial impairment

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

Full Information

NCT ID

NCT05757960

First Posted

February 23, 2023

Last Updated

February 23, 2023

Sponsor

University Hospital Muenster

Collaborators

German Society of Craniomandibular Function and Disorders in the DGZMK.

1. Study Identification

Unique Protocol Identification Number

NCT05757960

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 2, 2023 (Actual)

Primary Completion Date

February 1, 2024 (Anticipated)

Study Completion Date

August 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital Muenster

Collaborators

German Society of Craniomandibular Function and Disorders in the DGZMK.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypermobile Ehlers-Danlos Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Physiotherapy

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Physiotherapy

Intervention Description

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 Measure Information:

Title

Reduction of temporomandibular pain

Description

The German version of the "Graded chronic pain scale" is used to measure the level of pain.

Time Frame

Up to 3 months after the last physiotherapy intervention

Secondary Outcome Measure Information:

Title

Effects on psychosocial impairment

Description

The German version of the "Depression Anxiety Stress Scale" is used to assess psychosocial impairment

Time Frame

Up to 3 months after the last physiotherapy intervention

Title

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

Description

The German version of the Oral Health Impact Profile (OHIP-G5) is used to assess OHRQoL

Time Frame

Up to 3 months after the last physiotherapy intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ole Oelerich, Dr. med. dent.

Phone

+49(0)2518343664

ole.oelerich@ukmuenster.de

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ole Oelerich, Dr. med. dent.

Organizational Affiliation

Department for Prosthodonctics and Biomaterials, University Hospital Münster

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department for Prosthodontics and Biomaterials, University Hospital Münster

City

Münster

ZIP/Postal Code

48149

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ole Oelerich

Phone

+49(0)2518343664

ole.oelerich@ukmuenster.de

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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