Magnesium Sulfate as an Adjuvant to Lidocaine in MPDS Trigger Point Injections Assessed by VAS and sEMG.

NCT07390851 | Recruiting DMC

• 1 other identifier: CU-OMFS-MPDS-TP-2025
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Two groups of patients diagnosed with Myofascial Pain Dysfunction Syndrome (MPDS) will be included in this study. One group will receive trigger point injections of lidocaine alone. The other group will receive trigger point injections of lidocaine combined with magnesium sulfate. The study aims to compare the effectiveness of both treatments in reducing pain and improving muscle function. Patients will be assessed using a pain scale (VAS) and surface electromyography (sEMG) to measure muscle activity.

Conditions

Myofascial Pain Dysfunction Syndrome

Keywords

Trigger points injection; Myofascial Pain Dysfunction Syndrome (MPDS); Magnesium Sulfate; Surface Electromyography; Visual Analog Scale

Outcome Measures

Primary Outcomes (2)

• Pain reduction.

  Pain intensity will be assessed using the Visual Analogue Scale (VAS) ranging from 0 to 10 cm, where 0 indicates no pain and 10 indicates worst imaginable pain.

  Baseline, 1week, 2 weeks post-injection.

• Muscle activity improvement.

  Muscle activity will be assessed using surface electromyography (sEMG) by measuring Maximum Voluntary Contraction (MVC) in microvolts (µV). Higher values indicate improved muscle activity.

  Baseline, 1 week, 2 weeks post-injection

Secondary Outcomes (1)

• Pain experienced during injection

  Immediately after injection

Study Arms (2)

Lidocaine injection

ACTIVE COMPARATOR

2%preservative-free without vasocostrictor injectable solution, 1.8 ml per injection point.

Drug: Lidocaine 2% (preservative-free, without vasoconstrictor)

Injection of Magnesium sulfate with Lidocaine

EXPERIMENTAL

10% injectable solution (100 mg/ml), from certified supplier. Approx. 3.8 ml per point (1.8 ml Lidocaine + 2 ml MgSO₄)

Drug: Lidocaine 2% + Magnesium Sulfate 10% (combination)

Interventions

Lidocaine 2% (preservative-free, without vasoconstrictor) DRUG

Using 25-27G sterile disposable needle, intramuscular injection of 2%preservative-free solution of lidocaine without vasocostrictor, 1.8 ml at the most painful trigger points with "Fast-in, fast out" or "peppering" method and inject the solution slowly.

Lidocaine injection

Lidocaine 2% + Magnesium Sulfate 10% (combination) DRUG

Using 25-27G sterile disposable needle, intramuscular injection of 2%preservative-free solution of lidocaine without vasocostrictor mixed with 10%magnesium sulphate , Approx. 3.8 ml per point (1.8 ml Lidocaine + 2 ml MgSO₄) at the most painful trigger points with "Fast-in, fast out" or "peppering" method and inject the solution slowly.

Injection of Magnesium sulfate with Lidocaine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 70 years.
• Clinical diagnosis of Myofascial Pain Dysfunction Syndrome (MPDS).
• Presence of active myofascial trigger points in accessible muscles (e.g., masseter, temporalis, upper trapezius).
• Pain duration ≥ 3 months.
• Pain intensity ≥ 4 on the Visual Analog Scale (VAS).
• Noprior trigger point injection in the affected area within the past 3 months.
• Ability and willingness to provide informed consent.
• Compliance with study visits and procedures

You may not qualify if:

• Known allergy or hypersensitivity to Lidocaine, Magnesium Sulfate, or related agents.
• Current use of anticoagulants or history of bleeding disorders.
• Systemic or local infection at or near the injection site.
• History of fibromyalgia, central pain syndromes, or cancer-related pain.
• Major psychiatric illnesses (e.g., schizophrenia, severe depression).
• Recent surgery or trauma to the head, neck, or upper back (\<6 months).
• Use of analgesics (NSAIDs, opioids) within 5 days before intervention.
• Severe systemic diseases:- Uncontrolled diabetes mellitus- Liver or kidney failure- Severe cardiovascular conditions.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of oral and dental medicine, cairo university

Giza, Giza Governorate, 12613, Egypt

RECRUITING

Related Publications (2)

• Leitch J, Webb A, Pudwell J, Chamberlain S, Henry R, Nitsch R. Magnesium-Based Trigger Point Infiltrations Versus Local Anaesthetic Infiltrations in Chronic Pelvic Myofascial Pain: A Randomized, Double-Blind, Controlled Study. J Obstet Gynaecol Can. 2022 Aug;44(8):877-885. doi: 10.1016/j.jogc.2022.02.129. Epub 2022 Mar 24.

  PMID: 35339694 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 BACKGROUND

MeSH Terms

Conditions

Fibromyalgia

Interventions

Lidocaine; Magnesium Sulfate

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Maii E Abdelazeem, Bsc

  Faculty of Oral & Dental Medicine, Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maii E Abdelazeem, BSc

CONTACT

+20 1013988933; Maii.emad@dentistry.cu.edu.eg

Khaled A Elhayes, PhD

CONTACT

+20 1030000360

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: This is a randomized single-blinded trial. Participants and outcome assessors are blinded to the injection material. The clinician performing the injections is not blinded due to preparation and administration requirements.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Model Details: Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups. Group 1 will receive lidocaine trigger point injections, while Group 2 will receive lidocaine combined with magnesium sulfate. Outcomes will be assessed at predefined follow-up visits using VAS and surface EMG.

Study Record Dates

• First Submitted: January 23, 2026
• First Posted: February 5, 2026
• Study Start: November 26, 2025
• Primary Completion (Estimated): November 26, 2026
• Study Completion (Estimated): November 26, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)