Comparison Between Botox and Magnesium Sulfate Effect in Treatment of Myofascial Pain Trigger Poi… (NCT06676475) | Clinical Trial Compass
Not Yet RecruitingPhase 2/3
Comparison Between Botox and Magnesium Sulfate Effect in Treatment of Myofascial Pain Trigger Points Within the Masseter Muscle
Egypt60 participantsStarted 2024-12-01
Plain-language summary
The goal of this randomized clinical trial is to compare the effectiveness of Botulinum toxin type A, magnesium sulfate and saline injections in treatment of the masseter muscle trigger points, in patients between 16 - 50 years old with myofascial pain with masseter muscle trigger points. The main questions it aims to answer are:
* which treatment has longer effect of pain release with the least possible side effects and recurrence rate?
* Which treatment has greater impact on improving patient's quality of life? Researchers will compare Botulinum toxin type A, magnesium sulfate to a placebo saline injections in treatment of the masseter muscle trigger points Participants will attend to the clinic 4 times
* 1st visit will include taking preoperative records and treatment injection
* 2nd visit will be follow up and taking records after 1 month
* 3rd visit will be follow up and taking records after 3 months
* 4th visit will be follow up and taking records after 6 months
Who can participate
Age range
16 Years – 50 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 diagnosed with orofacial pain and trigger points in the masseter muscle unilaterally or bilaterally for at least period 6 months other criteria
* Definite diagnosis of myofascial pain based on the DC/TMD criteria with a referral
* Presence of one or more unilateral or bilateral trigger points in the masseter muscle
* No history of any invasive procedures of the related masseter muscle (Taşkesen, Cezairli, 2023.)
Exclusion Criteria:
* Any painful conditions (other than myofascial trigger points) affecting the orofacial region
* Any systemic diseases that could affect masticatory function (e.g., rheumatoid arthritis and epilepsy
* Pregnancy and lactation. (Refahee, Mahrous, Shabaan,2022)
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
1
Evaluating pain
Timeframe: preoperative - post operative - 1 , 3 ,6 months follow up