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Completed

NCT Number: NCT07668375

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

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.

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Key information

Conditions

Myofascial Pain - Dysfunction Syndrome of TMJ Craniomandibular Disorders Jaw Diseases Joint Diseases Mandibular Diseases Muscular Diseases Musculoskeletal Diseases Stomatognathic Diseases Temporomandibular Joint Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

PAEC General Hospital, Islamabad

Islamabad, 44000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Botulinum Toxin-A (Botulax - letibotulinumtoxinA)

Drug

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.

normal saline

Drug

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.

Primary outcomes

  1. Measurement of post-injection pain in patients diagnosed with Temporomandibular Myofascial Pain

    Time frame: 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.

  2. Measurement of Interincisal mouth opening in patients diagnosed with Temporomandibular Myofascial Pain.

    Time frame: 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.

Secondary outcomes

  1. Demographic data (name, age, gender)

    Time frame: 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.

  2. Tenderness on palpation of masseter and temporalis muscles

    Time frame: 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.

  3. Adverse reactions following intramuscular injection

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

PAEC General Hospital, Islamabad

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 25, 2026
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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