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Outcome of Treatment With Botulinum toxinA in Patients With Temporomandibular Myofascial Pain

19. juni 2026 oppdatert av: Azhar Ahmed, PAEC General Hospital, Islamabad
Purpose: The aim of this study is to investigate the effectiveness and patient reported outcomes (interincisal distance and temporomandibular myofascial pain) of treatment with intramuscularly administered BTX-A vs N/S in patients with temporomandibular myofascial pain. OBJECTIVES: To determine the outcome of treatment with botulinum toxin-A vs N/S in patients with temporomandibular myofascial pain.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

OPERATIONAL DEFINITIONS:

Temporomandibular myofascial pain: Presence of any one or more of the following plus positives:

Pain in the Jaw Muscles: Persistent or recurrent pain located in the muscles of mastication (muscles that move the jaw).

Tenderness on Palpation: The pain is associated with tenderness that is identified during palpation of the affected muscles, particularly in the masseter, temporalis.

Limited Range of Motion: Patients often exhibit a reduced range of motion in the jaw.

OUTCOMES:

Temporomandibular myofascial pain score: Pain score will be assessed before and after 4, 8, and 12 weeks using visual analogue scale. It would determine subjective pain experience of patients. Visual Analogue Scale (VAS) represents continuous pain intensity, where the left end of the line indicates "no pain," while the right end denotes "worst pain imaginable." Patients indicates their level of pain (in cm), by marking a single point on the line.

Interincisal Distance: The interincisal distance refers to the measurement between the edges of the upper and lower central incisors when the jaw is fully opened using vernier caliper and it would be quantified in mm. Normal mouth opening ranges from 40-60 mm, mouth opening less than 40 mm would be consider as trismus.

HYPOTHESIS:

Botulinum toxin-A injection of 10-100 units would reduce the pain and increase the interincisal distance in patients with TMJ-MFP.

Studietype

Intervensjonell

Registrering (Faktiske)

118

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Pakistan
    • Islamabad
      • Islamabad, Islamabad, Pakistan, 44000
        • PAEC General Hospital, Islamabad

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • Patients presenting with temporomandibular myofascial pain (VAS ≥ 6) for more than one month will be included.
  • Both genders.
  • Age 18-70 years

Exclusion Criteria:

  • Patient with history of allergic reactions with botulinum toxin-A.
  • Medically compromised patients. Current pregnancy.
  • Use of medication by the patients that could interfere with the effect of botulinum toxin-A (gentamycin, baclofen, atropine, revastigmine, verapamil, succinylcholine)
  • Neuromuscular disorders.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Botulinum Toxin-A (BTX-A) Group
Intramuscular injection of Botulinum Toxin-A (BTX-A) would be used in this study to evaluate its outcome on pain reduction and improvement in interincisal mouth opening in patients with temporomandibular myofascial pain.
Legemiddel: Botulinum Toxin-A (Botulax - letibotulinumtoxinA)
In this study, intramuscular injection of Botulinum Toxin-A (50-100 units) would be administered to the patient using a 1 mL insulin syringe with a 26G needle at a dilution of 10 U/mL in normal saline. Injections would be given at 5 sites: 3 in the masseter muscle and 2 in the temporalis muscle, based on the patient's side of complaint (unilateral or bilateral). Topical lidocaine 5% cream would be applied before injection. The injection aims to reduce jaw muscle pain and increase interincisal mouth opening, allowing patients to resume normal daily activities without delay.
Legemiddel: Normal Saline
Intramuscular injection of normal saline (N/S) 1 mL would be administered at the same sites (masseter and temporalis muscles) as a placebo comparator. Normal saline injection would not be expected to significantly reduce pain intensity or increase interincisal mouth opening compared to BTX-A.
Placebo komparator: Normal Saline (Placebo Injection)
Out of 118 patients, 59 patients would be given intramuscular injection of normal saline as a placebo.
Legemiddel: Botulinum Toxin-A (Botulax - letibotulinumtoxinA)
In this study, intramuscular injection of Botulinum Toxin-A (50-100 units) would be administered to the patient using a 1 mL insulin syringe with a 26G needle at a dilution of 10 U/mL in normal saline. Injections would be given at 5 sites: 3 in the masseter muscle and 2 in the temporalis muscle, based on the patient's side of complaint (unilateral or bilateral). Topical lidocaine 5% cream would be applied before injection. The injection aims to reduce jaw muscle pain and increase interincisal mouth opening, allowing patients to resume normal daily activities without delay.
Legemiddel: Normal Saline
Intramuscular injection of normal saline (N/S) 1 mL would be administered at the same sites (masseter and temporalis muscles) as a placebo comparator. Normal saline injection would not be expected to significantly reduce pain intensity or increase interincisal mouth opening compared to BTX-A.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Measurement of post-injection pain in patients diagnosed with Temporomandibular Myofascial Pain
Tidsramme: From enrolment to 4, 8, and 12 weeks post-injection
Pain: Post-injection pain outcome when measured using Visual Analogue Scale (VAS) would determine the subjective pain experience of patients. VAS is a straight, 10 cm long horizontal line. VAS represents continuous pain intensity, where the left end of the line indicates "no pain," while the right end denotes "worst pain imaginable." Patients indicate their level of pain (in cm) by marking a single point on the line.
From enrolment to 4, 8, and 12 weeks post-injection
Measurement of Interincisal mouth opening in patients diagnosed with Temporomandibular Myofascial Pain.
Tidsramme: From enrolment to 4, 8, and 12 weeks post-injection
Interincisal Distance: Reduced mouth opening would be quantified in millimeters by measuring interincisal distance at maximum mouth opening using a Vernier caliper. Normal mouth opening ranges from 40 to 60 mm. Mouth opening less than 40 mm is considered trismus.
From enrolment to 4, 8, and 12 weeks post-injection

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Demographic data (name, age, gender)
Tidsramme: From enrolment to 12 weeks post-injection
Name, age, gender would be used to assess the effects of demographic data on post-injection outcomes in patients with temporomandibular myofascial pain.
From enrolment to 12 weeks post-injection
Tenderness on palpation of masseter and temporalis muscles
Tidsramme: From enrolment to 4, 8, and 12 weeks post-injection
Pain elicited upon digital palpation of the masseter and temporalis muscles would be assessed before and after injection to evaluate the effect of BTX-A on local muscle tenderness.
From enrolment to 4, 8, and 12 weeks post-injection
Adverse reactions following intramuscular injection
Tidsramme: From enrolment to 12 weeks post-injection
Any immediate or delayed adverse reactions following intramuscular injection of BTX-A or normal saline would be recorded and assessed to ensure patient safety.
From enrolment to 12 weeks post-injection

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

PAEC General Hospital, Islamabad

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

2. januar 2026

Primær fullføring (Faktiske)

1. april 2026

Studiet fullført (Faktiske)

1. april 2026

Datoer for studieregistrering

Først innsendt

19. juni 2026

Først innsendt som oppfylte QC-kriteriene

19. juni 2026

Først lagt ut (Faktiske)

25. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

25. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

19. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • PGHI-IRB(DME)-RCD-06-058

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

As the hospital where this study is being conducted does allow to share any collected data with other researchers due to patient confidentiality.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Ja

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