Comparative Analysis of Dry Needling Techniques for Orofacial Myofascial Pain

NCT07706153 — Not applicable, Not yet recruiting, 45 participants, Flávio Magno Gonçalves

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT07706153
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	45 (Estimated)
Sponsor	Flávio Magno Gonçalves (Other)
Conditions	Myofascial Pain Syndromes, Facial Pain, Trigger Points
Interventions	Dry needling (Procedure)
Dates	start 2026-08-01 (estimated), primary completion 2026-12-01 (estimated), completion 2027-04-01 (estimated), first posted 2026-07-15, last updated 2026-07-23
Locations	1 site in Brazil

-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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Dynamic Dry Needling	Active comparator	Procedure: Dry needling	Individuals will receive fast-in and fast-out needle manipulation (Hong's technique) in a fanning shape inside the trigger point of the masseter and/or temporalis muscles. The procedure continues until local twitch responses cease or the individual's tolerance limit is reached.
Static Dry Needling	Active comparator	Procedure: Dry needling	The needle will be inserted directly into the core of the active trigger point in the masseter and/or temporalis muscles and will remain completely static in situ for 10 minutes, focusing on neurophysiological modulation without further mechanical stimulation.
Hybrid Dry Needling	Active comparator	Procedure: Dry needling	A combination protocol where the needle is inserted into the trigger point and kept static for 5 minutes for initial desensitization, followed by a brief period of dynamic fanning manipulation (fast-in and fast-out).

Dry needling (Procedure): 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.

+Outcome measures

Primary outcomes

Change from Baseline in Self-Reported Orofacial Pain Intensity [Baseline (T0) and 7 days post-intervention (T2). (This is the primary endpoint to identify mid-term clinical relevance).]: Evaluated using a 100 mm Visual Analog Scale (VAS), where 0 mm indicates "no pain" and 100 mm indicates the "worst imaginable pain". The individual marks their current pain perception on the scale. The score is determined by measuring the distance from the left anchor to the individual's mark.

Secondary outcomes

Change from Baseline in Pressure Pain Threshold (PPT) [Baseline (T0), 7 days post-intervention (T2), and 15 days post-intervention (T3).]: Measured using a calibrated digital pressure algometer equipped with a 1 cm² rubber tip applied perpendicularly over the active trigger point. Pressure increases constantly at a rate of 1.5 kg/cm²/second until the individual reports that the pressure sensation turns into pain. Higher values (in kg/cm²) indicate lower mechanical pain sensitivity.
Change from Baseline in Mandibular Range of Motion [Baseline (T0), 7 days post-intervention (T2), and 15 days post-intervention (T3).]: Functional assessment measuring maximum functional mouth opening, maximum assisted mouth opening, protrusion, and lateralities (all in millimeters) using a high-precision digital caliper.

+Eligibility

Sex: All, ages: 18 Years to 80 Years, accepts healthy volunteers

Inclusion Criteria:

* Clinical diagnosis of Myofascial Pain (with or without referred pain) in the masseter and/or temporalis muscles according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) Axis I
* Presence of at least one active trigger point in a taut band reproducing the chief complaint
* Baseline pain intensity ≥ 2 on the VAS in the last two weeks
* Confirmed pressure pain threshold (PPT ≤ 1.5 kg/cm²)
* Signed informed consent form

Exclusion Criteria:

* TMD treatment in the last 3 months (physical therapy, needling, laser therapy) or Botulinum Toxin injection in the orofacial region within 12 months
* Continuous systemic use of analgesics, anti-inflammatories, or muscle relaxants
* Diagnosis of fibromyalgia, systemic rheumatic diseases, neurological disorders, or neuropathic pain
* Needle phobia (belonephobia), coagulation disorders, or use of anticoagulant drugs
* Active skin or odontogenic infections in the application area
* History of recent facial trauma or orthognathic/joint surgery
* Pregnancy

+Locations (1)

Facility	City	Country	Status
Center for Diagnosis and Treatment of the Temporomandibular Joint, Universidade Tuiuti do Paraná (CDATM-UTP)	Curitiba, Paraná	Brazil