Magnesium Sulfate and Trigger Points

NCT06975813 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: 1111
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The patients will be randomly assigned to one of the two groups according to the treatment method: group I (masseter group) and group II (masseter \&sternocleidomastoid group) where each patient will be injected 0.5ml in each trigger point (TrPs) of magnesium sulphate according to the treatment group by the same operator. The treatment method for TrPs will be the primary predictor variable. Patients will be examined at the following intervals: during diagnosis, 1-month, 3-months, and 6-months post-injection. The participated patients will be assessed using pain score measured on a 10-point visual analogue scale (VAS), the 0 indicating no pain and 10 indicating the worst pain ever

Conditions

Myofascial Pain Syndrome

Outcome Measures

Primary Outcomes (1)

• muscle pain

  by visual analogue scal

  6 months

Study Arms (2)

masseter muscle

ACTIVE COMPARATOR

Drug: masseter muscle

masseter and sternocleidomastoid muscles

EXPERIMENTAL

Drug: masseter and sternocleidomastoid muscle

Interventions

masseter muscle DRUG

masseter muscle trigger points injection by magnesium sulphate

masseter muscle

masseter and sternocleidomastoid muscle DRUG

masseter and sternocleidomastoid muscle trigger points injection by magnesium sulphate

masseter and sternocleidomastoid muscles

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• definite diagnosis of myofascial pain
• presence of one or more unilateral or bilateral trigger points in the masseter muscle and sternocleidomastoid muscle;
• no history of any invasive procedures of the related masseter muscle.

You may not qualify if:

• any painful conditions (other than myofascial trigger points) affecting the orofacial region
• any systemic diseases that could masticatory function (e.g., rheumatoid arthritis and epilepsy);
• pregnancy and lactation

Sponsors & Collaborators

• Fayoum University: lead

MeSH Terms

Conditions

Myofascial Pain Syndromes

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: May 9, 2025
• First Posted: May 16, 2025
• Study Start: June 1, 2025
• Primary Completion: December 30, 2025
• Study Completion: January 27, 2026
• Last Updated: May 16, 2025

Record last verified: 2025-05