Comparative Analysis of Dry Needling Techniques for Orofacial Myofascial Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorFlávio Magno Gonçalves
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Dry needling
Procedure/SurgeryDry 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.
Treatment groups
45 Participants
are divided into 3 treatment groupsGroup A: Dynamic Dry NeedlingActive comparator 1 intervention
Group B: Static Dry NeedlingActive comparator 1 intervention
Group C: Hybrid Dry NeedlingActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from Baseline in Self-Reported Orofacial Pain Intensity
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.
Time frame
Baseline (T0) and 7 days post-intervention (T2). (This is the primary endpoint to identify mid-term clinical relevance).Secondary outcomes
1
Change from Baseline in Pressure Pain Threshold (PPT)
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.
Time frame
Baseline (T0), 7 days post-intervention (T2), and 15 days post-intervention (T3).2
Change from Baseline in Mandibular Range of Motion
Functional assessment measuring maximum functional mouth opening, maximum assisted mouth opening, protrusion, and lateralities (all in millimeters) using a high-precision digital caliper.
Time frame
Baseline (T0), 7 days post-intervention (T2), and 15 days post-intervention (T3).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Flávio Magno Gonçalves
Lead sponsor
Tuiuti University of Paraná
Sponsor institution
Source ClinicalTrials.gov
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