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NOT YET RECRUITING
NCT07706153
PHASE3

Comparative Analysis of Dry Needling Techniques for Orofacial Myofascial Pain

Sponsor: Flávio Magno Gonçalves

View on ClinicalTrials.gov

Summary

This study aims to compare the clinical effectiveness and individual comfort of three distinct dry needling techniques (dynamic, static, and hybrid) for managing orofacial myofascial pain. Myofascial pain is a highly prevalent manifestation of temporomandibular disorders (TMD), characterized by painful trigger points in the masticatory muscles, such as the masseter and temporalis, which cause pain, muscle tenderness, and jaw movement limitations. While dry needling is widely recognized as an effective minimally invasive therapy to deactivate these trigger points, there is still a lack of consensus in scientific literature regarding the standardization of application protocols. To address this gap, this randomized, triple-blind, parallel-group clinical trial will enroll 45 individuals diagnosed with myofascial pain according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD). Participants will be randomly allocated into three equal groups (15 individuals per group): Group 1 will receive dynamic dry needling (fanning technique); Group 2 will receive static dry needling (needle kept in situ for 10 minutes); and Group 3 will receive a hybrid approach (combining an initial static period followed by dynamic manipulation). The primary outcome will evaluate changes in self-reported pain intensity using a Visual Analog Scale (VAS) from baseline to 7 days post-intervention. Secondary outcomes will assess changes in pressure pain thresholds (PPT) via digital algometry, mandibular range of motion via digital caliper measurements, and the subjective perception of comfort and acceptability of each technique. Evaluations will be conducted at baseline, immediately post-intervention, at 7 days, and at 15 days of follow-up. The findings are expected to contribute to the standardization of more effective and comfortable clinical protocols for managing orofacial pain.

Official title: Comparative Analysis of the Effectiveness and Comfort of Different Dry Needling Techniques in the Treatment of Orofacial Myofascial Pain: A Randomized Clinical Trial

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

45

Start Date

2026-08-01

Completion Date

2027-04-01

Last Updated

2026-07-15

Healthy Volunteers

Yes

Interventions

PROCEDURE

Dry needling

Dry needling therapy targeted at active myofascial trigger points in masseter and temporalis muscles. Sterile, disposable, stainless steel needles (0.25x25mm or 0.25x30mm) will be used based on muscle depth. Procedures will be performed by a single operator with the individual in a supine position, following strict 70% alcohol antisepsis. Mechanical manipulation follows three randomized protocols: * Dynamic: Fast-in and fast-out needle manipulation (Hong's technique) in a fanning shape until local twitch responses cease or tolerance limit is reached. * Static: Direct insertion into the trigger point, remaining completely static in situ for 10 minutes without further stimulation. * Hybrid: Direct needle insertion kept static for 5 minutes for initial desensitization, followed by a brief period of dynamic fanning manipulation.

Locations (1)

Center for Diagnosis and Treatment of the Temporomandibular Joint, Universidade Tuiuti do Paraná (CDATM-UTP)

Curitiba, Paraná, Brazil