Magnesium Sulphate Injection in Treatment of Myofascial Trigger Points

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-20

Study Completion Date

2021-09-01

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.

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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.

Conditions

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Trigger Point Pain, Myofascial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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group I

each patient injected 0.5ml in each TrPs of saline by the same operator

Group Type ACTIVE_COMPARATOR

Saline

Intervention Type DRUG

each patient injected 0.5ml in each TrPs of saline according to the treatment group by the same operator

group II

each patient injected 0.5ml in each TrPs of magnesium sulphate by the same operator

Group Type EXPERIMENTAL

Magnesium sulfate

Intervention Type DRUG

each patient injected 0.5ml in each TrPs of magnesium sulphate according to the treatment group by the same operator

Interventions

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Magnesium sulfate

each patient injected 0.5ml in each TrPs of magnesium sulphate according to the treatment group by the same operator

Intervention Type DRUG

Saline

each patient injected 0.5ml in each TrPs of saline according to the treatment group by the same operator

Intervention Type DRUG

Other Intervention Names

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Study Control

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No