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

Not Applicable

• Conditions: Hypermobile Ehlers-Danlos Syndrome
• Interventions: Procedure: Physiotherapy

• Registration Number: NCT05757960
• Lead Sponsor: University Hospital Muenster

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-02
• Study First Submitted: 2023-02-23
• Study First Submitted QC: 2023-02-23
• Study First Posted: 2023-03-07
• Status Verified: 2024-05
• Last Update Submitted: 2025-04-23
• Last Update Posted: 2025-04-27
• Primary Completion: 2027-02-01
• Study Completion: 2027-08-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Physiotherapy	Physiotherapy	Using a strictly defined physiotherapy protocol, the effects on temporomandibular dysfunctions are studied.

Primary Outcome Measures

Name	Time	Method
Reduction of temporomandibular pain	Up to 3 months after the last physiotherapy intervention	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.

Secondary Outcome Measures

Name	Time	Method
Effects on psychosocial impairment	Up to 3 months after the last physiotherapy intervention	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.
Effects on oral health-related quality of life (OHRQoL)	Up to 3 months after the last physiotherapy intervention	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.

Trial Locations

Locations (1)

Department for Prosthodontics and Biomaterials, University Hospital Münster; 🇩🇪 Münster, Germany