Transcutaneous Electrical Nerve Stimulation for Early Pain Control in Temporomandibular Disorders

NCT07744893 | Completed

• 1 other identifier: 2011-083-TMJ-thesis-Tayfun
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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).

Conditions

Temporomandibular Disorders (TMD)

Keywords

temporomandibular disorders; transcutaneous electric nerve stimulation; orofacial pain; quality of life; physical therapy modalities

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, week 2 (immediately post-treatment), and week 12 (3 months follow-up)

Secondary Outcomes (3)

• Pain during jaw function assessed by Visual Analog Scale (VAS)

  Baseline, week 2 (immediately post-treatment), and week 12 (3 months follow-up)

• Temporomandibular joint dysfunction assessed by the Modified Helkimo Clinical Dysfunction Index

  Baseline, week 2 (immediately post-treatment), and week 12 (3 months follow-up)

• Mandibular range of motion measured in millimeters using a digital caliper

  Baseline, week 2 (immediately post-treatment), and week 12 (3 months follow-up)

Study Arms (2)

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

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.

Other: Standard Conservative Therapy

Interventions

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

Also known as: Pharmacotherapy and Home Exercise Programme

Control Group

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)

Also known as: Conventional TENS

TENS Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Balikesir University: lead
• Necmettin Erbakan University: collaborator

Study Sites (1)

Necmettin Erbakan University

Konya, Konya, 42090, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Facial Pain

Interventions

Drug Therapy; Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Nilay Şahin, Prof. Dr.

  Balikesir University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: August 4, 2026
• Study Start: April 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: August 4, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)