Clinical Research Directory
Browse clinical research sites, groups, and studies.
Outcome of Treatment With Botulinum toxinA in Patients With Temporomandibular Myofascial Pain
Sponsor: PAEC General Hospital, Islamabad
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.
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
118
Start Date
2026-01-02
Completion Date
2026-04-01
Last Updated
2026-06-25
Healthy Volunteers
No
Interventions
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.
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.
Locations (1)
PAEC General Hospital, Islamabad
Islamabad, Islamabad, Pakistan