Comparative Analysis of Dry Needling Techniques for Orofacial Myofascial Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dry needling.
- Who it may be relevant to
- Registry conditions: Myofascial Pain Syndromes, Facial Pain, Trigger Points. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
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 l
Primary outcome measures
- Change from Baseline in Self-Reported Orofacial Pain Intensity [Time frame: Baseline (T0) and 7 days post-intervention (T2). (This is the primary endpoint to identify mid-term clinical relevance).]
Secondary outcome measures (2)
- Change from Baseline in Pressure Pain Threshold (PPT) [Time frame: Baseline (T0), 7 days post-intervention (T2), and 15 days post-intervention (T3).]
- Change from Baseline in Mandibular Range of Motion [Time frame: Baseline (T0), 7 days post-intervention (T2), and 15 days post-intervention (T3).]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Brazil · 1 center
- Center for Diagnosis and Treatment of the Temporomandibular Joint, Universidade Tuiuti do — Curitiba
Identifiers
NCT: NCT07706153 · NEC 02