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

NCT06676475 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-11-12

No results posted yet for this study

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

Conditions

  • Myofacial Pain
  • Trigger Points, Myofascial

Interventions

DRUG

MgSO4

2ml MgSo4 (Magnesium sulfate sterile ampoule 10 ml, 100 mg/ml = 0.41 mMol/ml. Egyptian Int. Pharmaceutical Industries Co., Egypt).

DRUG

BOTOX-A

2ml of BTX

DRUG

Saline (NaCl 0,9 %) (placebo)

2 ml of saline

Sponsors & Collaborators

  • Misr University for Science and Technology

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-01
Primary Completion
2025-02-28
Completion
2025-08-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06676475 on ClinicalTrials.gov