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

Sponsor
University Hospital Muenster (Other)
Overall Status
Recruiting
CT.gov ID
NCT05757960
Collaborator
German Society of Craniomandibular Function and Disorders in the DGZMK. (Other)
25
1
1
17.9
1.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Physiotherapy
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
25 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effects of TMD-specific Physiotherapy in Individuals With Hypermobile Ehlers-Danlos Syndrome
Actual Study Start Date :
Feb 2, 2023
Anticipated Primary Completion Date :
Feb 1, 2024
Anticipated Study Completion Date :
Aug 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Reduction of temporomandibular pain [Up to 3 months after the last physiotherapy intervention]

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

Secondary Outcome Measures

  1. Effects on psychosocial impairment [Up to 3 months after the last physiotherapy intervention]

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

  2. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department for Prosthodontics and Biomaterials, University Hospital Münster Münster Germany 48149

Sponsors and Collaborators

  • University Hospital Muenster
  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital Muenster
ClinicalTrials.gov Identifier:
NCT05757960
Other Study ID Numbers:
  • CMD_Physio_EDS
First Posted:
Mar 7, 2023
Last Update Posted:
Mar 7, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 7, 2023