Comparison Between Botox and Magnesium Sulfate Effect in Treatment of Myofascial Pain Trigger Points Within the Masseter Muscle

Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age16-50
SponsorMisr University for Science and Technology

About this trial

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

Eligibility criteria

Qualifiers

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.)

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • MgSO4
  • BOTOX-A
  • Saline (NaCl 0,9 %) (placebo)

Treatment groups

60 Participants
are divided into 3 treatment groups