Temporomandibular DisorderNCT04708938
Effectiveness of Different Physiotherapy Practices in Temporomandibular Disorders
A study testing High voltage electrical stimulation+exercise therapy and Exercise therapy in people with Temporomandibular Disorder, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to examine the effect of high voltage electrical stimulation on pain, temporomandibular joint mobility, cervical mobility, head position, tender points and joint sounds in individuals with temporomandibular disorders. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Temporomandibular Disorder
- What is being tested?
- High voltage electrical stimulation+exercise therapy and Exercise therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2021to 1 Dec 2021
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Individuals who have been diagnosed with TMER,
- Comply with the TMD / RDC classification,
- Have Class I-II-III occlusion,
- Volunteer to participate in the study, and fill out the informed consent form will be included.
Who cannot join
- Acute trauma,
- Surgery history,
- Neurological or psychiatric conditions,
- Trigeminal or postherpatic neuralgia,
- Dental or orofacial infection,
- Intraoral infection or tumor,
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- Oligodontics and anadontics,
- High voltage electrical stimulation contraindications,
- Any disease diagnosed in the shoulder and neck areas,
- Receiving another treatment and,
- Individuals under the age of 18 will be excluded in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi University, Faculty of Health Sciences
Ankara, None Selected, 06490
About this study
The aim of the study is to examine the effect of high voltage electrical stimulation on pain, temporomandibular joint mobility, cervical mobility, head position, tender points and joint sounds in individuals with temporomandibular disorders.
Read the detailed description
28 individuals who meet the TMER / Research Diagnostic Criteria classification will be randomly divided into 2 groups. Exercise with high voltage electrical stimulation (YVES) will be applied to the 1st group and only exercise will be applied to the 2nd group. The second group will be the control group of the study. Both groups will be informed about the disease before starting the study before the treatment and patient education will be given about the situations that need attention. Again, 2 groups will be given an exercise program from the day they start the treatment, 3 times a week for 4 weeks during the treatment. As sociodemographic information of the individuals, age, gender, height, weight, body mass index, marital and educational status, occupation, smoking and alcohol use, patient history, family history and complaint sides will be recorded. Before starting treatment, individuals will be evaluated for pain, temporomandibular joint mobility, cervical mobility, tender points, and joint sounds:
- Pain with Visual Analogue Scale (VAS),
- TMJ mobility with a ruler,
- Cervical mobility with C-ROM (Cervical Range of Motion) inclinometer,
- Head position with universal goniometer and ImageJ software,
- Sensitive points with algometer,
- Joint sounds will be evaluated as present / absent as a result of the evaluation of movements in all directions (maximum mouth opening, right / left lateral excursions, protrusion and retrusion).
After 4 weeks of treatment, the measurements will be repeated.
- Conditions
- Temporomandibular Disorder
- Being tested
- High voltage electrical stimulation+exercise therapy, Exercise therapy
- Keywords
- High voltage stimulation, Temporomandibular disorders, Temporomandibular joint, Cervical spine, Pain
- 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.
High voltage electrical stimulation+exercise therapyOther
The effect of high voltage electrical stimulation on temporomandibular disorders
Exercise therapyOther
The effect of high voltage electrical stimulation on temporomandibular disorders
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | High voltage electrical stimulation + exercise therapy Receives: Other: High voltage electrical stimulation+exercise therapy |
| Control group | Active comparator | Exercise therapy Receives: Other: Exercise therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain on temporomandibular joint
Pain with Visual Analogue Scale (VAS)
Measured: Before and after treatment, 4 weeks apart. It takes 10 seconds.
Change in temporomandibular joint mobility
Temporomandibular joint mobility with a ruler
Measured: Before and after treatment, 4 weeks apart. It takes 3 minutes.
Change in cervical mobility
Cervical mobility with C-ROM (Cervical Range of Motion) inclinometer
Measured: Before and after treatment, 4 weeks apart. It takes 5 minutes.
Change in head position
Head position with universal goniometer and ImageJ software
Measured: Before and after treatment, 4 weeks apart. It takes 3 minutes.
Change in tender points
Tender points with algometer
Measured: Before and after treatment, 4 weeks apart. It takes 10 minutes.
Change in joint sounds
Joint sounds as present / absent as a result of the evaluation of movements in all directions (maximum mouth opening, right / left lateral excursions, protrusion and retrusion)
Measured: Before and after treatment, 4 weeks apart. It takes 2 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start1 Feb 2021
- Primary completion1 Jul 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular DisorderStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- 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
- Prospective, randomized-controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Halime ARIKAN, Gazi University
- Investigators
- Halime ARIKAN, MSc., Principal investigator, Gazi University, Faculty of Health SciencesGokhan MARAS, MSc., Principal investigator, Gazi University, Faculty of Health SciencesSeyit CITAKER, Dr., Principal investigator, Gazi University, Faculty of Health SciencesCahit UCOK, Dr., Principal investigator, Ankara University, Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04708938
- Sponsor's protocol ID
- 68869993-511.06-E.239934
- Status last verified
- May 2022
- First submitted
- 10 Jan 2021
- Last updated
- 1 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Different Physiotherapy Practices in Temporomandibular Disorders
- ClinicalTrials.gov ID
- NCT04708938
- Acronym / sponsor ID
- 68869993-511.06-E.239934
- Conditions
- Temporomandibular Disorder
- Keywords
- High voltage stimulation, Temporomandibular disorders, Temporomandibular joint, Cervical spine, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 14 Jan 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.
The aim of the study is to examine the effect of high voltage electrical stimulation on pain, temporomandibular joint mobility, cervical mobility, head position, tender points and joint sounds in individuals with temporomandibular disorders.
Detailed description
28 individuals who meet the TMER / Research Diagnostic Criteria classification will be randomly divided into 2 groups. Exercise with high voltage electrical stimulation (YVES) will be applied to the 1st group and only exercise will be applied to the 2nd group. The second group will be the control group of the study. Both groups will be informed about the disease before starting the study before the treatment and patient education will be given about the situations that need attention. Again, 2 groups will be given an exercise program from the day they start the treatment, 3 times a week for 4 weeks during the treatment. As sociodemographic information of the individuals, age, gender, height, weight, body mass index, marital and educational status, occupation, smoking and alcohol use, patient history, family history and complaint sides will be recorded. Before starting treatment, individuals will be evaluated for pain, temporomandibular joint mobility, cervical mobility, tender points, and joint sounds:
- Pain with Visual Analogue Scale (VAS),
- TMJ mobility with a ruler,
- Cervical mobility with C-ROM (Cervical Range of Motion) inclinometer,
- Head position with universal goniometer and ImageJ software,
- Sensitive points with algometer,
- Joint sounds will be evaluated as present / absent as a result of the evaluation of movements in all directions (maximum mouth opening, right / left lateral excursions, protrusion and retrusion).
After 4 weeks of treatment, the measurements will be repeated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, randomized-controlled
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Other: High voltage electrical stimulation+exercise therapyHigh voltage electrical stimulation + exercise therapy |
| Control group | Active comparator | Other: Exercise therapyExercise therapy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Individuals who have been diagnosed with TMER,
- Comply with the TMD / RDC classification,
- Have Class I-II-III occlusion,
- Volunteer to participate in the study, and fill out the informed consent form will be included.
Key exclusion criteria (11 listed)
- Acute trauma,
- Surgery history,
- Neurological or psychiatric conditions,
- Trigeminal or postherpatic neuralgia,
- Dental or orofacial infection,
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 |
|---|---|---|
| High voltage electrical stimulation+exercise therapyThe effect of high voltage electrical stimulation on temporomandibular disorders | Other | Treatment group |
| Exercise therapyThe effect of high voltage electrical stimulation on temporomandibular disorders | Other | Control group |
Primary outcome
Change in pain on temporomandibular joint
Time frame: Before and after treatment, 4 weeks apart. It takes 10 seconds.
Pain with Visual Analogue Scale (VAS)
Change in temporomandibular joint mobility
Time frame: Before and after treatment, 4 weeks apart. It takes 3 minutes.
Temporomandibular joint mobility with a ruler
Change in cervical mobility
Time frame: Before and after treatment, 4 weeks apart. It takes 5 minutes.
Cervical mobility with C-ROM (Cervical Range of Motion) inclinometer
Change in head position
Time frame: Before and after treatment, 4 weeks apart. It takes 3 minutes.
Head position with universal goniometer and ImageJ software
Change in tender points
Time frame: Before and after treatment, 4 weeks apart. It takes 10 minutes.
Tender points with algometer
Change in joint sounds
Time frame: Before and after treatment, 4 weeks apart. It takes 2 minutes.
Joint sounds as present / absent as a result of the evaluation of movements in all directions (maximum mouth opening, right / left lateral excursions, protrusion and retrusion)
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 1 Jun 2022.
- Individual participant dataSharing planned: Yes
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Comparing Dextrose Prolotherapy vs. Sodium Hyaluronic Acid Injections for Jaw Joint Internal Derangement
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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.
Halime ARIKAN, MSc. principal investigator
Gazi University, Faculty of Health Sciences
Gokhan MARAS, MSc. principal investigator
Gazi University, Faculty of Health Sciences
Seyit CITAKER, Dr. principal investigator
Gazi University, Faculty of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High voltage electrical stimulation+exercise therapy and Exercise therapy in people with Temporomandibular Disorder, run by Gazi University 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 4 inclusion and 11 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 1 Jun 2022. 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?
Change in pain on temporomandibular joint (time frame: Before and after treatment, 4 weeks apart. It takes 10 seconds.). The study lists 6 primary outcomes in all. 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 1 Jun 2022.