Dry Needling for Temporomandibular Disorder

NCT07123883 | Completed

• 1 other identifier: Atlas E-22686390-050.99-72665
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

This randomized controlled trial investigates the clinical effectiveness of dry needling in individuals with myofascial temporomandibular disorder (TMD). The study compares dry needling applied to trigger points in the masseter and temporalis muscles with conventional physical therapy. Primary outcomes include changes in pain intensity, and muscle EMG. Given these considerations, this study aims to investigate the clinical acute effectiveness of dry needling applied to the masseter and temporalis muscles in individuals diagnosed with myofascial TMD.

Conditions

TMD/Orofacial Pain; Muscle Spasm

Keywords

Dry needling; Temporomandibular Disorders; Muscle Pain Dysfunction

Outcome Measures

Primary Outcomes (1)

• Jaw pain intensity

  Jaw pain intensity was evaluated at the end of the range of motion using a 100 mm VAS, a tool recognized for its high reliability in musculoskeletal assessments. All participants were asked to indicate their pain level on the VAS, allowing for a subjective quantification of perceived pain intensity . Pain intensity was assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain), with higher scores indicating worse outcomes.

  Baseline and After 10-minute

Secondary Outcomes (1)

• Surface electromyographic (sEMG)

  Baseline and After 10-minute

Study Arms (2)

Dry Needling Group (DNG)

EXPERIMENTAL

In the DNG, under aseptic conditions, the needle was inserted into the predetermined trigger point of the masseter muscle using a guide tube. It was then advanced deeply into the muscle tissue and manipulated using a pistoning technique involving approximately ten in-and-out movements without complete withdrawal. The direction of the needle was systematically varied to stimulate adjacent regions of the muscle, maintaining an average insertion rate of one movement per second. Local twitch responses (LTRs) were elicited and monitored throughout the procedure. Upon completion, the needle was withdrawn, and gentle pressure was applied to the insertion site with a sterile cotton pad to prevent bleeding

Procedure: Dry Needling

Sham Group (SG)

SHAM COMPARATOR

In the SG, a validated sham needling procedure was simulated. Participants were positioned identically to the DNG and the same type of needle and guide tube were used. However, the safety lock on the needle was left intact, preventing skin penetration. A cotton pad was applied with light pressure to the skin surface, mimicking the procedure used in the DNG. This approach has been previously validated as a reliable sham control in dry needling research

Other: sham needling

Interventions

Dry Needling PROCEDURE

Dry Needling

Dry Needling Group (DNG)

sham needling OTHER

In the SG, a validated sham needling procedure was simulated.

Sham Group (SG)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients aged between 18 and 45 years presenting with complaints of jaw pain to the Department of Dentistry at A University.
• Diagnosed with myofascial pain associated with temporomandibular dysfunction by a dentist, based on the Axis I criteria of the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD).
• Jaw pain persisting for at least three months.
• Pain elicited upon palpation of the masseter and/or temporalis muscles.
• Presence of clicking or crepitus in the temporomandibular joint during mandibular movements.

You may not qualify if:

• History of any confirmed or suspected inflammatory or neurological condition.
• Presence of any oral or dental infection.
• Any cognitive or communication impairment affecting data collection.
• History of head or facial trauma.
• Allergy to metals.

Sponsors & Collaborators

• Atlas University: lead

Study Sites (2)

Faculty of Dentistry, Atlas University

Istanbul, Istanbul, 34403, Turkey (Türkiye)

Location

Istanbul Atlas University, Faculty of Dentistry

Istanbul, Kagithane, 34403, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Spasm; Temporomandibular Joint Disorders

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants in the study were randomly assigned to one of two groups: the dry needling group (DNG) or the sham needling group (SG). In the DNG, deep dry needling was administered to the most sensitive myofascial trigger point identified in either the masseter or anterior temporalis muscle using a sterile acupuncture needle (0.20 × 13 mm, Qinzhou, China). The procedure was performed by a physiotherapist with seven years of clinical experience, under the supervision of a licensed physician.

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: August 14, 2025
• Study Start: July 28, 2025
• Primary Completion: August 8, 2025
• Study Completion: August 30, 2025
• Last Updated: March 24, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)