Magnesium Sulphate Injection in Treatment of Myofascial Trigger Points

NCT04742140 | Completed Phase 4

• 1 other identifier: Mg SO4 injections
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Trigger Point Pain, Myofascial

Keywords

trigger point; masseter muscle; myofascial pain; magnesium sulphate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  six months postoperative

Study Arms (2)

group I

ACTIVE COMPARATOR

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

Drug: Saline

group II

EXPERIMENTAL

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

Drug: Magnesium sulfate

Interventions

Magnesium sulfate DRUG

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

Also known as: Study

group II

Saline DRUG

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

Also known as: Control

group I

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fayoum University: lead

Study Sites (1)

Faculty of Dentistry

Al Fayyum, 63514, Egypt

Location

Related Publications (4)

• 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.

  PMID: 33045182 BACKGROUND

• 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.

  PMID: 23384256 BACKGROUND

• 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.

  PMID: 32271467 BACKGROUND

• 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.

  PMID: 36123724 DERIVED

MeSH Terms

Conditions

Myofascial Pain Syndromes

Interventions

Magnesium Sulfate; Sodium Chloride

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Sodium Compounds

Study Officials

• Alshaimaa Mohamed, phd

  Fayoum University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor in oral & maxillofacial Surgery Department

Study Record Dates

• First Submitted: January 30, 2021
• First Posted: February 5, 2021
• Study Start: February 20, 2021
• Primary Completion: August 20, 2021
• Study Completion: September 1, 2021
• Last Updated: December 7, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)