Temporomandibular Disorders (TMD)
Conditions
Keywords
temporomandibular disorders, transcutaneous electric nerve stimulation, orofacial pain, quality of life, physical therapy modalities
Brief 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 temporomandibular disorders (TMD).
Detailed description
This was a single-centre, two-arm parallel controlled clinical trial. 48 adults with TMD diagnosed by the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) were enrolled and allocated to a TENS group or a control group. 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 conventional TENS (100 Hz, 200 µs, sensory-level, 30 min/session, 5 sessions/week for 2 weeks). Assessments were performed at baseline, after treatment (week 2), and at 3 months (week 12).
Interventions
Patient education about the resting position of the tongue and mandible and avoidance of parafunctional habits; a two-week pharmacological regimen of dexketoprofen 50 mg/day and thiocolchicoside 16 mg/day; and a standardised home exercise programme comprising active and passive jaw range-of-motion, isometric, and postural exercises
DEVICETranscutaneous Electrical Nerve Stimulation (TENS)
A charge-balanced biphasic waveform with a pulse width of 200 µs, a frequency of 100 Hz, and an amplitude adjusted to produce a comfortable, non-painful paraesthesia using an Intelect® TENS device. Sessions lasted 30 minutes and were applied 5 days per week for 2 weeks (10 sessions)
Sponsors
Balikesir University
Necmettin Erbakan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain at rest assessed by Visual Analog Scale (VAS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain during jaw function assessed by Visual Analog Scale (VAS) | Baseline, week 2 (immediately post-treatment), and week 12 (3 months follow-up) | 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. |
| Temporomandibular joint dysfunction assessed by the Modified Helkimo Clinical Dysfunction Index | Baseline, week 2 (immediately post-treatment), and week 12 (3 months follow-up) | 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. |
| Mandibular range of motion measured in millimeters using a digital caliper | Baseline, week 2 (immediately post-treatment), and week 12 (3 months follow-up) | Mandibular movements, including maximum unassisted mouth opening, maximum assisted mouth opening, right/left lateral excursions, and protrusion, will be measured in millimeters (mm) using a digital caliper/ruler. Higher millimeter values represent greater range of motion and better mobility. |
Countries
Turkey (Türkiye)
Contacts
STUDY_DIRECTORNilay Şahin, Prof. Dr.
Balikesir University
Outcome results
None listed