Adjunctive Acupuncture for Persistent Myofascial Temporomandibular Disorder Pain

NCT07820488 | Completed DMC

• 2 other identifiers: FMDUP-ACUTMD-202510/2025
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Temporomandibular disorders (TMDs) can cause persistent pain in the jaw muscles and limitations in jaw function. Occlusal splints are commonly used to manage these symptoms, but some patients continue to experience pain despite long-term splint use. The purpose of this exploratory study was to describe short-term changes after adding acupuncture to ongoing occlusal splint therapy in adults with persistent myofascial TMD pain. The study included 30 adults who had experienced pain in the masseter and/or temporalis muscles for more than 12 months and had used a maxillary full-arch stabilization splint for at least five consecutive years while remaining symptomatic. All participants continued their occlusal splint therapy and received four 30-minute acupuncture sessions, administered once per week. Assessments were performed before the first acupuncture session and after the fourth session. The assessed outcomes were pain intensity, the amount of pressure required to produce pain in the jaw muscles, maximum mouth opening, and the electrical activity of the masseter and temporalis muscles. All participants received the same intervention, and there was no control or comparison group. The study was therefore designed to characterize short-term changes within participants rather than to determine whether acupuncture was superior to another treatment or whether it directly caused the observed changes.

Conditions

Temporomandibular Disorders (TMD); Myofascial Pain - Dysfunction Syndrome of TMJ

Outcome Measures

Primary Outcomes (1)

• Change in Pain Intensity Assessed With the 11-Point Numeric Rating Scale

  Participants rated their current orofacial pain intensity using an 11-point Numeric Rating Scale ranging from 0 (no pain) to 10 (worst pain imaginable). Change was calculated as the post-intervention score minus the baseline score. Negative change values indicate a reduction in pain intensity.

  Baseline and week 5.

Secondary Outcomes (6)

• Change in Pressure Pain Threshold of the Masseter and Temporalis Muscles

  Baseline and week 5.

• Change in Maximum Mouth Opening

  Baseline and week 5.

• Change in Surface Electromyographic Root Mean Square Amplitude at Mandibular Rest

  Baseline and week 5.

• Change in Surface Electromyographic Peak Amplitude at Mandibular Rest

  Baseline and week 5.

• Change in Surface Electromyographic Root Mean Square Amplitude During Maximum Intercuspation

  Baseline and week 5.

Study Arms (1)

Adjunctive Acupuncture With Ongoing Occlusal Splint Therapy

EXPERIMENTAL

Participants who remained symptomatic despite at least five years of maxillary full-arch stabilization splint use continued their existing splint regimen and received four 30-minute acupuncture sessions administered once per week. Acupuncture was performed bilaterally at LI4, ST5, ST6, ST7, and ST8. Clinical and surface electromyographic outcomes were assessed before the first acupuncture session and after the fourth session.

Procedure: Adjunctive Acupuncture

Interventions

Adjunctive Acupuncture PROCEDURE

Participants received four acupuncture sessions administered once per week by a practitioner with specific training and experience in acupuncture. Each session lasted 30 minutes. Sterile, single-use stainless-steel needles measuring 0.25 mm × 25 mm were inserted bilaterally at LI4, ST5, ST6, ST7, and ST8. After skin disinfection with 70% alcohol, needles were inserted perpendicularly to a depth of approximately 10-20 mm, adjusted according to the anatomical site and tissue thickness, with stimulation intended to elicit the de qi sensation. Acupuncture was provided as an adjunct to the participants' ongoing maxillary full-arch stabilization splint therapy.

Adjunctive Acupuncture With Ongoing Occlusal Splint Therapy

Eligibility Criteria

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

You may qualify if:

• Age 18 years or older.
• Ability to understand the study procedures and provide written informed consent.
• Diagnosis of myalgia according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) Axis I.
• Persistent or recurrent pain in the masseter and/or temporalis muscles for more than 12 months, including pain during the 30 days before enrollment, with muscular pain confirmed by clinical examination.
• Use of a maxillary full-arch stabilization splint for at least five consecutive years before enrollment.
• Persistence of temporomandibular disorder-related muscular pain despite ongoing occlusal splint use.

You may not qualify if:

• History of significant trauma to the temporomandibular joint.
• Poorly controlled systemic metabolic disease.
• Active cancer.
• Pregnancy.
• Significant neurological disorder.
• Use of medications affecting neuromuscular function during the 30 days before enrollment.
• Needle phobia.
• Inability to comply with the intervention and assessment schedule.

Sponsors & Collaborators

• Universidade do Porto: lead

Study Sites (1)

Faculty of Dental Medicine, university of Porto

Porto, Porto District, 4200-393, Portugal

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2026
• First Posted: September 15, 2026
• Study Start: July 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: September 15, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)