Comparison of 26G and 30G Needles for Masseter Trigger Point Injections in Patients With Myofascial Pain Syndrome (MASS-NEEDLE)
Comparison of Two Needle Gauges (26G and 30G) for Masseter Muscle Trigger Point Injection in Myofascial Pain Syndrome: A Randomized Split-Face Controlled Trial
This randomized split-face study aims to compare the effects of 26G and 30G needles used for masseter trigger point injections with lidocaine in patients with myofascial pain syndrome. Both needle sizes are routinely used in clinical practice. Pain reduction from baseline to day 14 will be compared between the two sides of the face. Secondary outcomes include pain reduction at day 7, procedural pain, injection-site tenderness at 48 hours, bruising, and patient preference. The split-face design allows both needle sizes to be evaluated in the same patient, minimizing individual differences.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Both 26G and 30G needles were routinely used for masseter trigger point injection in our clinic. Comparing these gauges under otherwise standardized conditions may help clarify whether needle selection affects short-term pain reduction, procedural pain, and patient preference. A randomized split-face design permits this comparison within the same patient, reducing the influence of differences between individuals.
The primary objective of this study was to compare the within-patient reduction in palpation-evoked masseter pain between sides treated with 26G and 30G needles from baseline to day 14 following lidocaine injection. Secondary objectives were to compare pain reduction at day 7, overall procedural pain, injection-site tenderness at 48 hours, ecchymosis, and patient preference.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Ceylan Güzel, Dr
- Número de teléfono: +90 5364501650
- Correo electrónico: ceylan.guzel@medipol.edu.tr
Ubicaciones de estudio
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Istanbul, Turquía (Türkiye), 34214
- Medipol Mega University Hospital
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Contacto:
- Ceylan Güzel, Dr.
- Número de teléfono: +905364501650
- Correo electrónico: ceylan.guzel@medipol.edu.tr
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
Adults aged 18-65 years.
Bilateral masseter myofascial pain persisting for at least 8 weeks.
Baseline palpation-evoked pain score of ≥6 on an 11-point Numerical Rating Scale (NRS) on each side.
Presence of at least one active myofascial trigger point within a palpable taut band in each masseter muscle, reproducing the patient's familiar pain.
Diagnosis established according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD).
No previous treatment for masseter myofascial pain.
Exclusion Criteria:
- Concomitant temporomandibular joint arthralgia.
Known allergy to local anesthetics.
Pregnancy or lactation.
Active infection, open lesion, or malignancy at the injection site.
Bleeding diathesis or use of anticoagulant or antiplatelet medications.
Inability to cooperate with study procedures.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Bilateral Masseter Trigger Point Injection 26 G
All participants received bilateral masseter trigger point injections in a single session. A 26-gauge (26G) needle was randomly assigned to one masseter muscle and a 30-gauge (30G) needle to the contralateral masseter muscle using a computer-generated randomization sequence. Each masseter received 0.3 mL of 2% lidocaine without vasoconstrictor using a standardized injection technique. The right masseter was injected first in all participants. Participants and the outcome assessor were blinded to needle-gauge allocation, whereas the injecting clinician was not blinded. |
A 26-gauge (0.45 × 13 mm) needle was used for masseter trigger point injection. A total of 0.3 mL of 2% lidocaine without vasoconstrictor was administered using a standardized injection technique. |
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Experimental: Bilateral Masseter Trigger Point Injection 30 G
All participants received bilateral masseter trigger point injections in a single session. A 26-gauge (26G) needle was randomly assigned to one masseter muscle and a 30-gauge (30G) needle to the contralateral masseter muscle using a computer-generated randomization sequence. Each masseter received 0.3 mL of 2% lidocaine without vasoconstrictor using a standardized injection technique. The right masseter was injected first in all participants. Participants and the outcome assessor were blinded to needle-gauge allocation, whereas the injecting clinician was not blinded. |
A 30-gauge (0.45 × 13 mm) needle was used for masseter trigger point injection. A total of 0.3 mL of 2% lidocaine without vasoconstrictor was administered using a standardized injection technique. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Between-Needle Difference in Palpation-Evoked Masseter Pain Reduction From Baseline to Day 14
Periodo de tiempo: Baseline and Day 14 (14 days after injection)
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Palpation-evoked masseter pain was assessed separately on each side using an 11-point Numerical Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst possible pain). At baseline and day 14, pain was recorded at the most painful trigger point identified during each assessment. Pain reduction was calculated as baseline NRS minus day 14 NRS for each side. The primary outcome was the within-participant difference in pain reduction between the 30G and 26G needle interventions (30G minus 26G). Positive values indicated greater pain reduction with 30G. |
Baseline and Day 14 (14 days after injection)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Between-Needle Difference in Palpation-Evoked Masseter Pain Reduction at Day 7
Periodo de tiempo: Baseline and Day 7
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Palpation-evoked masseter pain was assessed separately on each side using an 11-point Numerical Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst possible pain). Pain reduction was calculated as baseline NRS minus day 7 NRS for each side. The within-participant difference in pain reduction between the 30G and 26G needle interventions was calculated as 30G minus 26G. Positive values indicated greater pain reduction with 30G. |
Baseline and Day 7
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Overall Procedural Pain During Masseter Trigger Point Injection
Periodo de tiempo: Day 0 (within 60 seconds after each injection)
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Overall procedural pain was assessed separately for the 26G and 30G needle interventions using an 11-point Numerical Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst possible pain). Participants rated the entire injection procedure, including skin penetration, intramuscular needle manipulation, and lidocaine administration. Pain was recorded within 60 seconds after each injection. Within-participant pain scores were compared between needle gauges. |
Day 0 (within 60 seconds after each injection)
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Colaboradores e Investigadores
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Otros números de identificación del estudio
- E-10840098-50.04-5377
Información sobre medicamentos y dispositivos, documentos del estudio
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Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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