Magnesium Sulphate Injection in Treatment of Myofascial Trigger Points

Phase 4

Completed

• Conditions: Trigger Point Pain, Myofascial
• Interventions: Drug: Saline; Drug: Magnesium sulfate

• Registration Number: NCT04742140
• Lead Sponsor: Fayoum University

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.

Study Timeline

• Study First Submitted: 2021-01-30
• Study First Submitted QC: 2021-02-02
• Study First Posted: 2021-02-05
• Study Start: 2021-02-20
• Primary Completion: 2021-08-20
• Study Completion: 2021-09-01
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-05
• Last Update Posted: 2021-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group I	Saline	each patient injected 0.5ml in each TrPs of saline by the same operator
group II	Magnesium sulfate	each patient injected 0.5ml in each TrPs of magnesium sulphate by the same operator

Primary Outcome Measures

Name	Time	Method
pain score	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 Outcome Measures

Name	Time	Method
quality-of-life in an Oral Health Impact Profile questionnaire (OHIP-14)	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)

Trial Locations

Locations (1)

Faculty of Dentistry; 🇪🇬 Fayoum, Egypt