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

19. juni 2026 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

118

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: 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.
Medicin: 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.
Medicin: 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.
Medicin: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

PAEC General Hospital, Islamabad

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

2. januar 2026

Primær færdiggørelse (Faktiske)

1. april 2026

Studieafslutning (Faktiske)

1. april 2026

Datoer for studieregistrering

Først indsendt

19. juni 2026

Først indsendt, der opfyldte QC-kriterier

19. juni 2026

Først opslået (Faktiske)

25. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

25. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PGHI-IRB(DME)-RCD-06-058

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ja

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Kliniske forsøg med Myofascial smerte - Dysfunktionssyndrom af TMJ

Kliniske forsøg med Botulinum Toxin-A (Botulax - letibotulinumtoxinA)

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Saudi Arabia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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