Temporomandibular Disorders (TMD)NCT07744893
Transcutaneous Electrical Nerve Stimulation for Early Pain Control in Temporomandibular Disorders
A study testing Standard Conservative Therapy and Transcutaneous Electrical Nerve Stimulation (TENS) in people with Temporomandibular Disorders (TMD), run by Balikesir University at 1 site in Turkey (Türkiye).
Trial summary
To evaluate whether adding conventional transcutaneous electrical nerve stimulation (TENS) to a standard conservative regimen (patient education, pharmacotherapy, and a home exercise programme) provides additional short- and medium-term benefit for pain, mandibular function, and quality of life in patients with… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Temporomandibular Disorders (TMD)
- What is being tested?
- Standard Conservative Therapy and Transcutaneous Electrical Nerve Stimulation (TENS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2011to 1 May 2013
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged between 18 and 65 years.
- Patients diagnosed with temporomandibular disorders (TMD) according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) Axis I.
- Patients who agreed to participate and signed the informed consent form.
Who cannot join
- Facial pain attributable to another condition (sinusitis, migraine, tension-type headache, trigeminal neuralgia).
- TMJ involvement secondary to an inflammatory systemic disease.
- TMJ subluxation.
- Degenerative cervical disease restricting neck movement.
- Any contraindication to TENS.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Necmettin Erbakan University
Konya, Konya, 42090
About this study
Official title: Transcutaneous Electrical Nerve Stimulation as an Adjunct to Standard Conservative Therapy in Temporomandibular Disorders: A Prospective Non-Randomized Controlled Clinical Trial
To evaluate whether adding conventional transcutaneous electrical nerve stimulation (TENS) to a standard conservative regimen (patient education, pharmacotherapy, and a home exercise programme) provides additional short- and medium-term benefit for pain, mandibular function, and quality of life in patients with temporomandibular disorders (TMD).
Read the detailed description
This was a prospective, single-centre, two-arm, parallel-group non-randomized controlled clinical trial conducted at Necmettin Erbakan University, Meram Faculty of Medicine (Konya, Türkiye) between April 2011 and May 2013 as the specialty thesis of Dr Tayfun Güngör (Council of Higher Education National Thesis Center, thesis no. 376785). Forty-eight adults with temporomandibular disorders (TMD) classified with reference to the RDC/TMD Axis I were allocated 1:1 by alternating sequential assignment in order of presentation (no random sequence and no allocation concealment). Both groups received identical patient education, a two-week course of dexketoprofen (50 mg/day) plus thiocolchicoside (16 mg/day) and a home exercise programme; the TENS group additionally received high-frequency (conventional) TENS (100 Hz, 200 µs, sensory level, 30 min per session, 5 sessions per week for 2 weeks). There was no sham stimulation and no blinding. Assessments were performed at baseline, after treatment (week 2) and at 3 months (week 12). The trial was registered retrospectively; individual participant data were not retained.
- Conditions
- Temporomandibular Disorders (TMD)
- Being tested
- Standard Conservative Therapy, Transcutaneous Electrical Nerve Stimulation (TENS)
- Keywords
- temporomandibular disorders, transcutaneous electric nerve stimulation, orofacial pain, quality of life, physical therapy modalities
- Medical subject headings
- Temporomandibular Joint Disorders, Facial Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Conservative TherapyOther
Also called Pharmacotherapy and Home Exercise Programme
Patient education about the resting position of the tongue and mandible and avoidance of parafunctional habits; dexketoprofen 50 mg/day and thiocolchicoside 16 mg/day for 2 weeks; and a standardised home exercise programme of translation-control exercises, self-assisted stretching of mouth opening (thumb and index finger) in patients with restricted opening, isotonic strengthening exercises and postural exercises (2 sets of 10 repetitions twice daily).
Transcutaneous Electrical Nerve Stimulation (TENS)Device
Also called Conventional TENS, High-frequency TENS
High-frequency (conventional) TENS delivered with an Intelect TENS device through one channel, with the positive electrode over the affected temporomandibular joint (preauricular region) and the negative electrode over the masseter muscle; pulse width 200 µs, frequency 100 Hz, amplitude set to a comfortable, non-painful paraesthesia (sensory level). Sessions of 30 minutes, 5 days per week for 2 weeks (10 clinic sessions), in addition to the standard conservative regimen.
| Study group | Role | What they receive |
|---|---|---|
| TENS Group | Experimental | Patients received conventional TENS (100 Hz, 200 µs, sensory-level, 30 min/session, 5 sessions/week for 2 weeks) in addition to a standard conservative regimen consisting of patient education, pharmacotherapy, and a home exercise programme Receives: Device: Transcutaneous Electrical Nerve Stimulation (TENS) |
| Control Group | Active comparator | Patients received a standard conservative regimen alone, consisting of patient education, a two-week pharmacological course of dexketoprofen (50 mg/day) plus thiocolchicoside (16 mg/day), and a standardised home exercise programme. No TENS was applied. Receives: Other: Standard Conservative Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain at rest assessed by Visual Analog Scale (VAS)
Pain intensity at rest will be evaluated using a 10-cm Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores represent worse outcome/greater pain intensity.
Measured: Baseline, week 2 (immediately post-treatment), and week 12 (3 months follow-up)
Secondary outcomes (5)
Pain during jaw function assessed by Visual Analog Scale (VAS)
Pain intensity during jaw movement/function will be evaluated using a 10-cm Visual Analog Scale (VAS), where 0 indicates "no pain" and 10 indicates "the worst possible pain." Higher scores reflect greater pain intensity.
Measured: Baseline, week 2 (immediately post-treatment), and week 12 (3 months follow-up)
Temporomandibular joint dysfunction assessed by the Modified Helkimo Clinical Dysfunction Index
Clinical dysfunction of the temporomandibular joint (TMJ) will be evaluated using the Modified Helkimo Clinical Dysfunction Index. The index yields a total score ranging from 0 to 25, categorised as follows: 0 = clinically symptom-free (Di0), 1-4 = mild dysfunction (DiI), 5-9 = moderate dysfunction (DiII), and 10-25 = severe dysfunction (DiIII). Higher total scores indicate worse clinical dysfunction.
Measured: Baseline, week 2 (immediately post-treatment), and week 12 (3 months follow-up)
Mandibular range of motion
Maximum interincisal mouth opening, protrusion and right and left lateral excursions, measured in millimetres. Higher values indicate greater range of motion.
Measured: Baseline, week 2 (immediately post-treatment), and week 12 (3 months follow-up)
Health-related quality of life (Short Form-36, Turkish version)
Eight subscales (physical function, physical role, emotional role, social function, bodily pain, vitality, mental health, general health), each scored 0-100; higher scores indicate better health. Specified in the 2011 thesis protocol.
Measured: Baseline, week 2 (immediately post-treatment), and week 12 (3 months follow-up)
Disease-specific quality of life questionnaire
Effect of TMD on sleep, social activity, appetite, work efficiency, tension, depressed mood, speaking and chewing, each rated from 0 (none) to 4 (severe); adapted from previous work and not formally validated. Specified in the 2011 thesis protocol.
Measured: Baseline, week 2 (immediately post-treatment), and week 12 (3 months follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start1 Apr 2011
- Primary completion1 May 2013
- Study completion1 May 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Disorders (TMD)Studies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balikesir University
- Sponsor type
- University, hospital or other
- Collaborators
- Necmettin Erbakan University
- Responsible party
- Principal investigator, Nilay Sahin, Balikesir University
- Investigators
- Nilay Şahin, Prof. Dr., Study director, Balikesir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07744893
- Sponsor's protocol ID
- 2011-083-TMJ-thesis-Tayfun
- Status last verified
- Jul 2026
- First submitted
- 28 Jul 2026
- Last updated
- 4 Nov 2026
- 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 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Electrical Nerve Stimulation as an Adjunct to Standard Conservative Therapy in Temporomandibular Disorders: A Prospective Non-Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07744893
- Acronym / sponsor ID
- 2011-083-TMJ-thesis-Tayfun
- Conditions
- Temporomandibular Disorders (TMD)
- Keywords
- temporomandibular disorders, transcutaneous electric nerve stimulation, orofacial pain, quality of life, physical therapy modalities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Balikesir UniversityUniversity, hospital or other
- Collaborators
- Necmettin Erbakan University
- Study start
- 1 Apr 2011 (actual)
- Primary completion
- 1 May 2013 (actual)
- Study completion
- 1 May 2013 (actual)
- First posted
- 4 Aug 2026 (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.
To evaluate whether adding conventional transcutaneous electrical nerve stimulation (TENS) to a standard conservative regimen (patient education, pharmacotherapy, and a home exercise programme) provides additional short- and medium-term benefit for pain, mandibular function, and quality of life in patients with temporomandibular disorders (TMD).
Detailed description
This was a prospective, single-centre, two-arm, parallel-group non-randomized controlled clinical trial conducted at Necmettin Erbakan University, Meram Faculty of Medicine (Konya, Türkiye) between April 2011 and May 2013 as the specialty thesis of Dr Tayfun Güngör (Council of Higher Education National Thesis Center, thesis no. 376785). Forty-eight adults with temporomandibular disorders (TMD) classified with reference to the RDC/TMD Axis I were allocated 1:1 by alternating sequential assignment in order of presentation (no random sequence and no allocation concealment). Both groups received identical patient education, a two-week course of dexketoprofen (50 mg/day) plus thiocolchicoside (16 mg/day) and a home exercise programme; the TENS group additionally received high-frequency (conventional) TENS (100 Hz, 200 µs, sensory level, 30 min per session, 5 sessions per week for 2 weeks). There was no sham stimulation and no blinding. Assessments were performed at baseline, after treatment (week 2) and at 3 months (week 12). The trial was registered retrospectively; individual participant data were not retained.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TENS Group | Experimental | Device: Transcutaneous Electrical Nerve Stimulation (TENS)Patients received conventional TENS (100 Hz, 200 µs, sensory-level, 30 min/session, 5 sessions/week for 2 weeks) in addition to a standard conservative regimen consisting of patient education, pharmacotherapy, and a home exercise programme |
| Control Group | Active comparator | Other: Standard Conservative TherapyPatients received a standard conservative regimen alone, consisting of patient education, a two-week pharmacological course of dexketoprofen (50 mg/day) plus thiocolchicoside (16 mg/day), and a standardised home exercise programme. No TENS was applied. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged between 18 and 65 years.
- Patients diagnosed with temporomandibular disorders (TMD) according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) Axis I.
- Patients who agreed to participate and signed the informed consent form.
Key exclusion criteria (5 listed)
- Facial pain attributable to another condition (sinusitis, migraine, tension-type headache, trigeminal neuralgia).
- TMJ involvement secondary to an inflammatory systemic disease.
- TMJ subluxation.
- Degenerative cervical disease restricting neck movement.
- Any contraindication to TENS.
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 |
|---|---|---|
| Standard Conservative TherapyAlso: Pharmacotherapy and Home Exercise ProgrammePatient education about the resting position of the tongue and mandible and avoidance of parafunctional habits; dexketoprofen 50 mg/day and thiocolchicoside 16 mg/day for 2 weeks; and a standardised home exercise programme of translation-control exercises, self-assisted stretching of mouth opening (thumb and index finger) in patients with restricted opening, isotonic strengthening exercises and postural exercises (2 sets of 10 repetitions twice daily). | Other | Control Group |
| Transcutaneous Electrical Nerve Stimulation (TENS)Also: Conventional TENS, High-frequency TENSHigh-frequency (conventional) TENS delivered with an Intelect TENS device through one channel, with the positive electrode over the affected temporomandibular joint (preauricular region) and the negative electrode over the masseter muscle; pulse width 200 µs, frequency 100 Hz, amplitude set to a comfortable, non-painful paraesthesia (sensory level). Sessions of 30 minutes, 5 days per week for 2 weeks (10 clinic sessions), in addition to the standard conservative regimen. | Device | TENS Group |
Primary outcome
Pain at rest assessed by Visual Analog Scale (VAS)
Time frame: Baseline, week 2 (immediately post-treatment), and week 12 (3 months follow-up)
Pain intensity at rest will be evaluated using a 10-cm Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores represent worse outcome/greater pain intensity.
5 secondary outcomes
Pain during jaw function assessed by Visual Analog Scale (VAS)
Time frame: Baseline, week 2 (immediately post-treatment), and week 12 (3 months follow-up)
Temporomandibular joint dysfunction assessed by the Modified Helkimo Clinical Dysfunction Index
Time frame: Baseline, week 2 (immediately post-treatment), and week 12 (3 months follow-up)
Mandibular range of motion
Time frame: Baseline, week 2 (immediately post-treatment), and week 12 (3 months follow-up)
Health-related quality of life (Short Form-36, Turkish version)
Time frame: Baseline, week 2 (immediately post-treatment), and week 12 (3 months follow-up)
Disease-specific quality of life questionnaire
Time frame: Baseline, week 2 (immediately post-treatment), and week 12 (3 months follow-up)
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 4 Nov 2026.
- 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.
Nilay Şahin, Prof. Dr. study director
Balikesir University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Conservative Therapy and Transcutaneous Electrical Nerve Stimulation (TENS) in people with Temporomandibular Disorders (TMD), run by Balikesir 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 3 inclusion and 5 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 4 Nov 2026. 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?
Pain at rest assessed by Visual Analog Scale (VAS) (time frame: Baseline, week 2 (immediately post-treatment), and week 12 (3 months follow-up)). 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 4 Nov 2026.