CompletedPhase 4

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

Pakistan118 participantsStarted 2026-01-02

Plain-language 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.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

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

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

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

Trial details

NCT IDNCT07668375

SponsorPAEC General Hospital, Islamabad

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04-01

View on ClinicalTrials.gov More Myofascial Pain - Dysfunction Syndrome of TMJ trials

Plain-language summary

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

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

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

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