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NCT Number: NCT07744893

Transcutaneous Electrical Nerve Stimulation for Early Pain Control in Temporomandibular Disorders

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).

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Key information

Conditions

Temporomandibular Disorders (TMD) Craniomandibular Disorders Facial Pain Jaw Diseases Joint Diseases Mandibular Diseases Muscular Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomatognathic Diseases Temporomandibular Joint Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Necmettin Erbakan University

Konya, 42090, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standard Conservative Therapy

Other

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

Other names: Pharmacotherapy and Home Exercise Programme

Transcutaneous Electrical Nerve Stimulation (TENS)

Device

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)

Other names: Conventional TENS

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

    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.

  2. 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)

    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.

  3. Mandibular range of motion measured in millimeters using a digital caliper

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Balikesir University

Other

Collaborators

  • Necmettin Erbakan University

Registry information

Official study title

Ranscutaneous Electrical Nerve Stimulation As An Adjunct To Standard Conservative Therapy For Early Pain Control In Temporomandibular Disorders: A Controlled Clinical Trial

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Aug 4, 2026
Registry last updated
Aug 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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