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NCT Number: NCT04742140

Magnesium Sulphate Injection in Treatment of Myofascial Trigger Points

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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Key information

Conditions

Trigger Point Pain, Myofascial Muscular Diseases Musculoskeletal Diseases Myofascial Pain Syndromes

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of Dentistry

Al Fayyum, 63514, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Magnesium sulfate

Drug

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

Other names: Study

Saline

Drug

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

Other names: Control

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Fayoum University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 5, 2021
Registry last updated
Dec 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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