Dry Needling for Temporomandibular Disorder (DN-TMD)

March 23, 2026 updated by: Atlas University

Dry Needle Treatment for Acute Temporomandibular Disorders (TMD): A Clinical Perspective

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.

Study Overview

Status

Completed

Detailed Description

Temporomandibular disorders (TMDs) are a common group of musculoskeletal conditions affecting the jaw joint and surrounding muscles, often characterized by pain, limited mandibular mobility, and muscle tenderness. Among the various subtypes of TMD, myofascial pain is the most prevalent and typically involves the presence of myofascial trigger points (MTrPs) in the masticatory muscles. Dry needling (DN) is a minimally invasive technique that targets MTrPs using monofilament needles to induce a local twitch response and disrupt dysfunctional motor end plate activity.

This single-blinded, randomized controlled trial aims to evaluate the acute clinical effectiveness of DN compared to conventional physical therapy in individuals with myofascial TMD. In our study, 36 participants were randomly assigned to one of two groups: the dry needling group or the sham group, using a randomization process conducted through random.org. The study aimed to examine the acute effects following a single application. A double-blind design was employed, with separate physiotherapists responsible for administering the intervention and conducting the assessments. The study consisted of three stages: pre-intervention assessment, intervention, and post-intervention assessment.

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

Surface electromyographic (sEMG) activity of the jaw muscles was recorded bilaterally from the anterior temporalis (TA-R, TA-L) and masseter (MM-R, MM-L) muscles using the BioPAK System (version 7.2; BioResearch Associates Inc., Milwaukee, WI, USA).

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Istanbul
      • Istanbul, Istanbul, Turkey (Türkiye), 34403
        • Faculty of Dentistry, Atlas University
    • Kagithane
      • Istanbul, Kagithane, Turkey (Türkiye), 34403
        • Istanbul Atlas University, Faculty of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • 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.
  • Self-reported jaw muscle fatigue or stiffness, particularly upon awakening. Exclusion Criteria
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dry Needling Group (DNG)
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
Dry Needling
Sham Comparator: Sham Group (SG)
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
In the SG, a validated sham needling procedure was simulated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Jaw pain intensity
Time Frame: Baseline and After 10-minute
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surface electromyographic (sEMG)
Time Frame: Baseline and After 10-minute
Surface electromyographic (sEMG) activity of the jaw muscles was recorded bilaterally from the anterior temporalis (TA-R, TA-L) and masseter (MM-R, MM-L) muscles using the BioPAK System (version 7.2; BioResearch Associates Inc., Milwaukee, WI, USA).
Baseline and After 10-minute

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 28, 2025

Primary Completion (Actual)

August 8, 2025

Study Completion (Actual)

August 30, 2025

Study Registration Dates

First Submitted

July 21, 2025

First Submitted That Met QC Criteria

August 12, 2025

First Posted (Actual)

August 14, 2025

Study Record Updates

Last Update Posted (Actual)

March 24, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

September 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The individual participant data will not be shared due to privacy and confidentiality concerns and because data sharing is not required for the objectives of this study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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