Clinical trial NCT04742140: Magnesium Sulphate Injection in Treatment of Myofascial Trigger Points
Official title: Magnesium Sulphate Injection in Treatment of Myofascial Trigger Points in Masseter Muscle
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Trigger Point Pain, Myofascial
Keywords: trigger point
masseter muscle
myofascial pain
magnesium sulphate
Lead sponsor: Fayoum University
Sponsor class: OTHER
First posted: 2021-02-05
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: pain score
timeFrame: 6 months postoperative
Secondary outcomes:
measure: quality-of-life in an Oral Health Impact Profile questionnaire (OHIP-14)
timeFrame: six months postoperative
Other outcomes:
Locations:
city: Fayoum
country: Egypt
facility: Faculty of Dentistry
Study officials:
affiliation: Fayoum University
name: Alshaimaa Mohamed, phd
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.
citation: Refahee SM, Mahrous AI, Shabaan AA. Clinical efficacy of magnesium sulfate injection in the treatment of masseter muscle trigger points: a randomized clinical study. BMC Oral Health. 2022 Sep 19;22(1):408. doi: 10.1186/s12903-022-02452-3.