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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Ceylan Güzel, Dr
- Telefonní číslo: +90 5364501650
- E-mail: ceylan.guzel@medipol.edu.tr
Studijní místa
-
-
-
Istanbul, Turecko (Türkiye), 34214
- Medipol Mega University Hospital
-
Kontakt:
- Ceylan Güzel, Dr.
- Telefonní číslo: +905364501650
- E-mail: ceylan.guzel@medipol.edu.tr
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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. |
|
Experimentální: 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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Between-Needle Difference in Palpation-Evoked Masseter Pain Reduction From Baseline to Day 14
Časové okno: Baseline and Day 14 (14 days after injection)
|
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)
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Between-Needle Difference in Palpation-Evoked Masseter Pain Reduction at Day 7
Časové okno: Baseline and Day 7
|
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
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Overall Procedural Pain During Masseter Trigger Point Injection
Časové okno: Day 0 (within 60 seconds after each injection)
|
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)
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- E-10840098-50.04-5377
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .