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NCT04742140 Clinical Trial

Magnesium Sulphate Injection in Treatment of Myofascial Trigger Points

Trigger Point Pain, Myofascial Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04742140
Other study ID # Mg SO4 injections
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date February 20, 2021
Est. completion date September 1, 2021

Study information
Verified date December 2021
Source Fayoum University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 180
Est. completion date September 1, 2021
Est. primary completion date August 20, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Magnesium sulfate
each patient injected 0.5ml in each TrPs of magnesium sulphate according to the treatment group by the same operator
• Saline
each patient injected 0.5ml in each TrPs of saline according to the treatment group by the same operator

Locations
Country Name City State
Egypt Faculty of Dentistry Fayoum

Sponsors (1)
Lead Sponsor Collaborator
Fayoum University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

Sakalys D, Rokicki JP, Januzis G, Kubilius R. Plasma rich in growth factors injection effectiveness for myofascial pain treatment in masticatory muscles. Randomised controlled trial. J Oral Rehabil. 2020 Jul;47(7):796-801. doi: 10.1111/joor.12973. Epub 2020 Apr 21. — View Citation

Yilmaz O, Sivrikaya EC, Taskesen F, Pirpir C, Ciftci S. Comparison of the Efficacy of Botulinum Toxin, Local Anesthesia, and Platelet-Rich Plasma Injections in Patients With Myofascial Trigger Points in the Masseter Muscle. J Oral Maxillofac Surg. 2021 Jan;79(1):88.e1-88.e9. doi: 10.1016/j.joms.2020.09.013. Epub 2020 Sep 14. — View Citation

Yousef AA, Al-deeb AE. A double-blinded randomised controlled study of the value of sequential intravenous and oral magnesium therapy in patients with chronic low back pain with a neuropathic component. Anaesthesia. 2013 Mar;68(3):260-6. doi: 10.1111/anae.12107. Epub 2012 Dec 17. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
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