Magnesium Sulphate Injection in Treatment of Myofascial Trigger Points

Study Overview
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Brief Summary
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This is a prospective, single- center, randomized (1:1) clinical trial comparing the effectiveness of magnesium sulphate injections in treatment of myofascial trigger points in the masseter muscle versus the saline injection.

Detailed Description
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The proposal presents the magnesium sulphate (MgSO4) as a possible injection treatment for TrPs. The MgSO4 prevents the release of pre-synaptic acetylcholine from neuromuscular and sympathetic junctions that could explain the ability of the MgSO4 to relax the muscle and reduce pain Specific aim: evaluate the effectiveness of magnesium sulphate injections in treatment of myofascial trigger points in the masseter muscle versus the saline injection. Hypothesis: the injection of masseter muscle trigger points with magnesium sulphate is more effective than saline injection in pain relief.

Official Title
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Magnesium Sulphate Injection in Treatment of Myofascial Trigger Points in Masseter Muscle

Conditions
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Trigger Point Pain, Myofascial

Intervention / Treatment
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* Drug: Magnesium sulfate
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Definite diagnosis of myofascial pain with a referral, based on the DC/TMD criteria the presence of one or more trigger points in the unilateral or bilateral masseter muscle no history of any invasive procedures in the related masseter muscle. Exclusion Criteria: Factors that can cause pain in the orofacial region other than MTPs (decayed tooth, TMJ internal disorder). Any systemic disease that possibly affects the masticatory system such as rheumatoid arthritis and epilepsy pregnancy and lactation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group I<br>each patient injected 0.5ml in each TrPs of saline by the same operator | Drug: Saline<br>* each patient injected 0.5ml in each TrPs of saline according to the treatment group by the same operator<br>* Other names: Control;|
| Experimental: group II<br>each patient injected 0.5ml in each TrPs of magnesium sulphate by the same operator | Drug: Magnesium sulfate<br>* each patient injected 0.5ml in each TrPs of magnesium sulphate according to the treatment group by the same operator<br>* Other names: Study;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain score | pain score measured on a 10-point visual analogue scale (VAS), the 0 indicating no pain and 10 indicating the worst pain ever. | 6 months postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality-of-life in an Oral Health Impact Profile questionnaire (OHIP-14) | OHIP-14 is used to measure patients' self-reported discomfort, disability, and functional limitation due to oral conditions with scores ranging from 0 to 56 (with 56 representing a subject answering ''very often'' to all 14 items) | six months postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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trigger point, masseter muscle, myofascial pain, magnesium sulphate