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NCT Number: NCT07123883

Dry Needling for Temporomandibular Disorder

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Atlas University, Istanbul, Turkey (Türkiye)

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About this study

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).

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 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.

Treatment and study plan

dry needling

Procedure

Dry Needling

Sham Needling

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Atlas University

Other

Registry information

Official study title

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

Acronym: DN-TMD

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 14, 2025
Registry last updated
Mar 24, 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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