Magnesium Sulphate Injection in Treatment of Myofascial Trigger Points

Sponsor
Fayoum University (Other)
Overall Status
Completed
CT.gov ID
NCT04742140
Collaborator
(none)
180
1
2
6.3
28.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
180 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Treatment
Official Title:
Magnesium Sulphate Injection in Treatment of Myofascial Trigger Points in Masseter Muscle
Actual Study Start Date :
Feb 20, 2021
Actual Primary Completion Date :
Aug 20, 2021
Actual Study Completion Date :
Sep 1, 2021

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of Dentistry Fayoum Egypt 63514

    Sponsors and Collaborators

    • Fayoum University

    Investigators

    • Principal Investigator: Alshaimaa Mohamed, phd, Fayoum University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Alshaimaa Ahmed shabaan, associate professor in oral & maxillofacial Surgery Department, Fayoum University
    ClinicalTrials.gov Identifier:
    NCT04742140
    Other Study ID Numbers:
    • Mg SO4 injections
    First Posted:
    Feb 5, 2021
    Last Update Posted:
    Dec 7, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Alshaimaa Ahmed shabaan, associate professor in oral & maxillofacial Surgery Department, Fayoum University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 7, 2021