Skip to content

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

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

Status
Enrolling by invitation
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05757960
Enrollment
25
Registered
2023-03-07
Start date
2023-02-02
Completion date
2027-08-01
Last updated
2025-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypermobile Ehlers-Danlos Syndrome

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.

Interventions

PROCEDUREPhysiotherapy

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.

Sponsors

German Society of Craniomandibular Function and Disorders in the DGZMK.
CollaboratorUNKNOWN
University Hospital Muenster
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Reduction of temporomandibular painUp to 3 months after the last physiotherapy interventionThe 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

MeasureTime frameDescription
Effects on psychosocial impairmentUp to 3 months after the last physiotherapy interventionThe 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 interventionThe 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.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026