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

Effects of TMD-specific Physiotherapy in 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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Hypermobile Ehlers-Danlos Syndrome
• Intervention / Treatment: Procedure: Physiotherapy

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Münster, Germany, 48149
    • Department for Prosthodontics and Biomaterials, University Hospital Münster

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Physiotherapy; Using a strictly defined physiotherapy protocol, the effects on temporomandibular dysfunctions are studied.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of temporomandibular pain	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.	Up to 3 months after the last physiotherapy intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effects on psychosocial impairment	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.	Up to 3 months after the last physiotherapy intervention
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. 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.	Up to 3 months after the last physiotherapy intervention

Collaborators and Investigators

• Sponsor: University Hospital Muenster
• Collaborators: German Society of Craniomandibular Function and Disorders in the DGZMK.
• Investigators: Principal Investigator: Ole Oelerich, Dr. med. dent., Department for Prosthodonctics and Biomaterials, University Hospital Münster

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2023
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: February 23, 2023
• First Submitted That Met QC Criteria: February 23, 2023
• First Posted (Actual): March 7, 2023

Study Record Updates

• Last Update Posted (Actual): April 27, 2025
• Last Update Submitted That Met QC Criteria: April 23, 2025
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Genetic Diseases, Inborn; Connective Tissue Diseases; Disease; Hematologic Diseases; Skin Diseases; Congenital Abnormalities; Hemostatic Disorders; Hemorrhagic Disorders; Skin Diseases, Genetic; Skin Abnormalities; Collagen Diseases; Syndrome; Ehlers-Danlos Syndrome
• Other Study ID Numbers: CMD_Physio_EDS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No