Comparative Analysis of Dry Needling Techniques for Orofacial Myofascial Pain
Comparative Analysis of the Effectiveness and Comfort of Different Dry Needling Techniques in the Treatment of Orofacial Myofascial Pain: A Randomized Clinical 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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Flávio Magno Gonçalves, Professor
- Número de teléfono: 55 (42) 98816-7711
- Correo electrónico: flaviomagno93@yahoo.com.br
Ubicaciones de estudio
-
-
Paraná
-
Curitiba, Paraná, Brasil, 80430140
- Center for Diagnosis and Treatment of the Temporomandibular Joint, Universidade Tuiuti do Paraná (CDATM-UTP)
-
Contacto:
- Flávio Magno Gonçalves, Professor
- Número de teléfono: 55 42 98816-7711
- Correo electrónico: flaviomagno93@yahoo.com.br
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Dynamic 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.
|
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:
|
|
Comparador activo: Static 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.
|
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:
|
|
Comparador activo: Hybrid 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 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:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change from Baseline in Self-Reported Orofacial Pain Intensity
Periodo de tiempo: 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.
|
Baseline (T0) and 7 days post-intervention (T2). (This is the primary endpoint to identify mid-term clinical relevance).
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change from Baseline in Pressure Pain Threshold (PPT)
Periodo de tiempo: 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.
|
Baseline (T0), 7 days post-intervention (T2), and 15 days post-intervention (T3).
|
|
Change from Baseline in Mandibular Range of Motion
Periodo de tiempo: 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.
|
Baseline (T0), 7 days post-intervention (T2), and 15 days post-intervention (T3).
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- NEC 02
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .