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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
118
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.
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.
PAEC General Hospital, Islamabad
Islamabad, Islamabad, Pakistan
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.
Time frame: 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.
Time frame: From enrolment to 4, 8, and 12 weeks post-injection
Demographic data (name, age, gender)
Name, age, gender would be used to assess the effects of demographic data on post-injection outcomes in patients with temporomandibular myofascial pain.
Time frame: From enrolment to 12 weeks post-injection
Tenderness on palpation of masseter and temporalis muscles
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.
Time frame: From enrolment to 4, 8, and 12 weeks post-injection
Adverse reactions following intramuscular 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.
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Time frame: From enrolment to 12 weeks post-injection