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Magnesium Sulphate Injection in Treatment of Myofascial Trigger Points

Primary Purpose

Trigger Point Pain, Myofascial

Status

Completed

Phase

Phase 4

Locations

Egypt

Study Type

Interventional

Intervention

Magnesium sulfate

Saline

About this trial

This is an interventional treatment trial for Trigger Point Pain, Myofascial focused on measuring trigger point, masseter muscle, myofascial pain, magnesium sulphate

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Faculty of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

group I

group II

Arm Description

each patient injected 0.5ml in each TrPs of saline by the same operator

each patient injected 0.5ml in each TrPs of magnesium sulphate by the same operator

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)

Full Information

NCT ID

NCT04742140

First Posted

January 30, 2021

Last Updated

December 5, 2021

Sponsor

Fayoum University

1. Study Identification

Unique Protocol Identification Number

NCT04742140

Brief Title

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

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Completed

Study Start Date

February 20, 2021 (Actual)

Primary Completion Date

August 20, 2021 (Actual)

Study Completion Date

September 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fayoum University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Trigger Point Pain, Myofascial

Keywords

trigger point, masseter muscle, myofascial pain, magnesium sulphate

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

180 (Actual)

8. Arms, Groups, and Interventions

Arm Title

group I

Arm Type

Active Comparator

Arm Description

each patient injected 0.5ml in each TrPs of saline by the same operator

Arm Title

group II

Arm Type

Experimental

Arm Description

each patient injected 0.5ml in each TrPs of magnesium sulphate by the same operator

Intervention Type

Drug

Intervention Name(s)

Magnesium sulfate

Other Intervention Name(s)

Study

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Saline

Other Intervention Name(s)

Control

Intervention Description

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

Primary Outcome Measure Information:

Title

pain score

Description

pain score measured on a 10-point visual analogue scale (VAS), the 0 indicating no pain and 10 indicating the worst pain ever.

Time Frame

6 months postoperative

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

six months postoperative

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alshaimaa Mohamed, phd

Organizational Affiliation

Fayoum University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Faculty of Dentistry

City

Fayoum

ZIP/Postal Code

63514

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33045182

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.

Results Reference

background

PubMed Identifier

23384256

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.

Results Reference

background

PubMed Identifier

32271467

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.

Results Reference

background

PubMed Identifier

36123724

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.

Results Reference

derived

Learn more about this trial

Magnesium Sulphate Injection in Treatment of Myofascial Trigger Points

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