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

NCT07668375 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: PGHI-IRB(DME)-RCD-06-058
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Myofascial Pain - Dysfunction Syndrome of TMJ

Keywords

Temporomandibular Myofascial Pain; TMJ Pain; Interincisor Mouth Opening; Intramuscular Botulinum Toxin Injections

Outcome Measures

Primary Outcomes (2)

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

  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.

  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

Secondary Outcomes (3)

• Demographic data (name, age, gender)

  From enrolment to 12 weeks post-injection

• Tenderness on palpation of masseter and temporalis muscles

  From enrolment to 4, 8, and 12 weeks post-injection

• Adverse reactions following intramuscular injection

  From enrolment to 12 weeks post-injection

Study Arms (2)

Botulinum Toxin-A (BTX-A) Group

EXPERIMENTAL

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.

Drug: Botulinum Toxin-A (Botulax - letibotulinumtoxinA); Drug: Normal Saline

Normal Saline (Placebo Injection)

PLACEBO COMPARATOR

Out of 118 patients, 59 patients would be given intramuscular injection of normal saline as a placebo.

Drug: Botulinum Toxin-A (Botulax - letibotulinumtoxinA); Drug: Normal Saline

Interventions

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.

Botulinum Toxin-A (BTX-A) Group; Normal Saline (Placebo Injection)

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.

Botulinum Toxin-A (BTX-A) Group; Normal Saline (Placebo Injection)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• PAEC General Hospital, Islamabad: lead

Study Sites (1)

PAEC General Hospital, Islamabad

Islamabad, Islamabad, 44000, Pakistan

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Botulinum Toxins, Type A; Saline Solution

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Outcome of treatment with botulinum toxinA in patients with temporomandibular myofascial pain

Model Details: Parallel Assignment Study design: Randomized controlled trial (RCT). Study setting: Department of Oral \& Maxillofacial Surgery, Pakistan Atomic Energy Commission General Hospital, Islamabad. Duration of study: 06 months (after the approval of synopsis by CPSP)

Study Record Dates

• First Submitted: June 19, 2026
• First Posted: June 25, 2026
• Study Start: January 2, 2026
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: June 25, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)