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

NCT05757960 | Enrolling By Invitation

• 1 other identifier: CMD_Physio_EDS
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Effects on psychosocial impairment

  Up to 3 months after the last physiotherapy intervention

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

  Up to 3 months after the last physiotherapy intervention

Study Arms (1)

Physiotherapy

EXPERIMENTAL

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

Procedure: Physiotherapy

Interventions

Physiotherapy 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.

Physiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Muenster: lead
• German Society of Craniomandibular Function and Disorders in the DGZMK.: collaborator

Study Sites (1)

Department for Prosthodontics and Biomaterials, University Hospital Münster

Münster, 48149, Germany

Location

MeSH Terms

Conditions

Ehlers-Danlos syndrome type 3

Interventions

Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Ole Oelerich, Dr. med. dent.

  Department for Prosthodonctics and Biomaterials, University Hospital Münster

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2023
• First Posted: March 7, 2023
• Study Start: February 2, 2023
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: April 27, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)