Temporomandibular DisorderNCT04755621
The Effect Of Core Stability Training In Temporomandibular Disorders
A study testing Core stability training and Rocabado Exercises in people with Temporomandibular Disorder, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
Trial summary
This study is to investigate the effect of Core stability training on pain, function, quality of life, sleep quality, body posture, foot posture, oral habits and kinesiophobia in individuals with temporomandibular disorder. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Temporomandibular Disorder
- What is being tested?
- Core stability training and Rocabado Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2019to 1 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female patients aged 18-55, diagnosed with temporomandibular disease by a dentist
Who cannot join
- Having received another treatment for TMR other than the use of night plate in the last 6 months
- Having a disease that can cause facial pain such as sinusitis, migraine, tension headache, trigeminal neuralgia
- Skeletal system fractures
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University and Health Sciences Physical Therapy and Rehabilitation
Istanbul, Uskudar, 34668
About this study
Official title: The Effect Of Core Stability Training on Pain, Function and Quality of Life in Individuals With Temporomandibular Disorders
This study is to investigate the effect of Core stability training on pain, function, quality of life, sleep quality, body posture, foot posture, oral habits and kinesiophobia in individuals with temporomandibular disorder.
Materials and Methods: The study included 40 people over the age of 18, who were diagnosed with temporomandibular disorder from the dentist.
- Conditions
- Temporomandibular Disorder
- Being tested
- Core stability training, Rocabado Exercises
- Keywords
- core stability, pain, quality of life, function, temporomandibular disorder
- Medical subject headings
- Temporomandibular Joint Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core stability trainingOther
Core stability exercises
Rocabado ExercisesOther
Exercises for Temporomandibular Disorders
| Study group | Role | What they receive |
|---|---|---|
| Core stability Group | Experimental | Not described Receives: Other: Core stability training |
| Control Group | Active comparator | Not described Receives: Other: Rocabado Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Posture
New York Posture Scale
Measured: 6 weeks
Sleep Quality
Pittsburg Sleep Quality Index
Measured: 6 weeks
Kinesiophobia
Tampa Scale for Kinesiophobia for Temporomandibular Disorders (TSK-TMD)
Measured: 6 weeks
Oral Habits
Oral Behavior Checklist
Measured: 6 weeks
Jaw Function
Jaw Functional Limitation Scale-20
Measured: 6 weeks
Secondary outcomes (2)
Foot Posture
Foot Posture Index-6
Measured: 6 weeks
Graded Pain
Graded Chronic Pain Scale
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start1 Apr 2019
- Primary completion1 Aug 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular DisorderStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised Controlled Trial
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emre Serdar Atalay, Saglik Bilimleri Universitesi
- Investigators
- Emre Serdar Atalay, PhD, Study director, University of Health Sciences, Physical Therapy and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04755621
- Sponsor's protocol ID
- 46418926-050.01.04
- Status last verified
- Feb 2021
- First submitted
- 28 Jan 2021
- Last updated
- 16 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Seyhan M, Atalay ES. Is core stability training effective in temporomandibular disorder? A randomized controlled trial. Clin Oral Investig. 2023 Dec;27(12):7237-7246. doi: 10.1007/s00784-023-05274-x. Epub 2023 Nov 4.
PubMed 37924356
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Core Stability Training on Pain, Function and Quality of Life in Individuals With Temporomandibular Disorders
- ClinicalTrials.gov ID
- NCT04755621
- Acronym / sponsor ID
- 46418926-050.01.04
- Conditions
- Temporomandibular Disorder
- Keywords
- core stability, pain, quality of life, function, temporomandibular disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 16 Feb 2021 (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.
This study is to investigate the effect of Core stability training on pain, function, quality of life, sleep quality, body posture, foot posture, oral habits and kinesiophobia in individuals with temporomandibular disorder.
Materials and Methods: The study included 40 people over the age of 18, who were diagnosed with temporomandibular disorder from the dentist.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Core stability Group | Experimental | Other: Core stability training |
| Control Group | Active comparator | Other: Rocabado Exercises |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Male and female patients aged 18-55, diagnosed with temporomandibular disease by a dentist
Key exclusion criteria (3 listed)
- Having received another treatment for TMR other than the use of night plate in the last 6 months
- Having a disease that can cause facial pain such as sinusitis, migraine, tension headache, trigeminal neuralgia
- Skeletal system fractures
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 |
|---|---|---|
| Core stability trainingCore stability exercises | Other | Core stability Group |
| Rocabado ExercisesExercises for Temporomandibular Disorders | Other | Control Group |
Primary outcome
Posture
Time frame: 6 weeks
New York Posture Scale
Sleep Quality
Time frame: 6 weeks
Pittsburg Sleep Quality Index
Kinesiophobia
Time frame: 6 weeks
Tampa Scale for Kinesiophobia for Temporomandibular Disorders (TSK-TMD)
Oral Habits
Time frame: 6 weeks
Oral Behavior Checklist
Jaw Function
Time frame: 6 weeks
Jaw Functional Limitation Scale-20
2 secondary outcomes
Foot Posture
Time frame: 6 weeks
Graded Pain
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
- Derived from this study: PubMed 37924356Seyhan M, Atalay ES. Is core stability training effective in temporomandibular disorder? A randomized controlled trial. Clin Oral Investig. 2023 Dec;27(12):7237-7246. doi: 10.1007/s00784-023-05274-x. Epub 2023 Nov 4.
- 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. This study is not recruiting at the moment.
Emre Serdar Atalay, PhD study director
University of Health Sciences, Physical Therapy and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Core stability training and Rocabado Exercises in people with Temporomandibular Disorder, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 16 Feb 2021. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Posture (time frame: 6 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04755621, which also lists 1 linked publication.
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 16 Feb 2021.