Hypermobile Ehlers-Danlos SyndromeNCT05757960
TMD-specific Physiotherapy in hEDS Patients Individuals With Hypermobile Ehlers-Danlos Syndrome
A study testing Physiotherapy in people with Hypermobile Ehlers-Danlos Syndrome, run by University Hospital Muenster at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypermobile Ehlers-Danlos Syndrome
- What is being tested?
- Physiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteGermany
- Study dates
- 2 Feb 2023to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site
Department for Prosthodontics and Biomaterials, University Hospital Münster
Münster, 48149
About this study
Official title: 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.
- Conditions
- Hypermobile Ehlers-Danlos Syndrome
- Being tested
- Physiotherapy
- Medical subject headings
- Ehlers-Danlos syndrome type 3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhysiotherapyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Physiotherapy | Experimental | Using a strictly defined physiotherapy protocol, the effects on temporomandibular dysfunctions are studied. Receives: Procedure: Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 3 months after the last physiotherapy intervention
Secondary outcomes (2)
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.
Measured: 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.
Measured: Up to 3 months after the last physiotherapy intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start2 Feb 2023
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypermobile Ehlers-Danlos SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Collaborators
- German Society of Craniomandibular Function and Disorders in the DGZMK.
- Responsible party
- Sponsor
- Investigators
- Ole Oelerich, Dr. med. dent., Principal investigator, Department for Prosthodonctics and Biomaterials, University Hospital Münster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05757960
- Sponsor's protocol ID
- CMD_Physio_EDS
- Status last verified
- May 2024
- First submitted
- 23 Feb 2023
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of TMD-specific Physiotherapy in Individuals With Hypermobile Ehlers-Danlos Syndrome
- ClinicalTrials.gov ID
- NCT05757960
- Acronym / sponsor ID
- CMD_Physio_EDS
- Conditions
- Hypermobile Ehlers-Danlos Syndrome
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Collaborators
- German Society of Craniomandibular Function and Disorders in the DGZMK.
- Study start
- 2 Feb 2023 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 7 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physiotherapy | Experimental | Procedure: PhysiotherapyUsing a strictly defined physiotherapy protocol, the effects on temporomandibular dysfunctions are studied. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhysiotherapyVarious 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. | Procedure or surgery | Physiotherapy |
Primary outcome
Reduction of temporomandibular pain
Time frame: 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.
2 secondary outcomes
Effects on psychosocial impairment
Time frame: Up to 3 months after the last physiotherapy intervention
Effects on oral health-related quality of life (OHRQoL)
Time frame: Up to 3 months after the last physiotherapy intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ole Oelerich, Dr. med. dent. principal investigator
Department for Prosthodonctics and Biomaterials, University Hospital Münster
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy in people with Hypermobile Ehlers-Danlos Syndrome, run by University Hospital Muenster at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of temporomandibular pain (time frame: Up to 3 months after the last physiotherapy intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.