Magnesium Sulphate Injection in Treatment of Myofascial Trigger Points

December 5, 2021 updated by: Alshaimaa Ahmed shabaan, Fayoum University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Fayoum, Egypt, 63514
        • Faculty of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: group I
each patient injected 0.5ml in each TrPs of saline by the same operator
Drug: Saline
each patient injected 0.5ml in each TrPs of saline according to the treatment group by the same operator
Other Names:
  • Control
Experimental: group II
each patient injected 0.5ml in each TrPs of magnesium sulphate by the same operator
Drug: Magnesium sulfate
each patient injected 0.5ml in each TrPs of magnesium sulphate according to the treatment group by the same operator
Other Names:
  • Study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain score
Time Frame: 6 months postoperative
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)
Time Frame: six months postoperative
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fayoum University

Investigators

  • Principal Investigator: Alshaimaa Mohamed, phd, Fayoum university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2021

Primary Completion (Actual)

August 20, 2021

Study Completion (Actual)

September 1, 2021

Study Registration Dates

First Submitted

January 30, 2021

First Submitted That Met QC Criteria

February 2, 2021

First Posted (Actual)

February 5, 2021

Study Record Updates

Last Update Posted (Actual)

December 7, 2021

Last Update Submitted That Met QC Criteria

December 5, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mg SO4 injections

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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