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

February 1, 2026 updated by: Maii Emad Abdelazeem, Cairo University

Evaluation of the Effect of Adding Magnesium Sulfate to Lidocaine in the Treatment of Myofascial Pain Dysfunction Syndrome Using Surface Electromyography (sEMG).(Randomized Clinical Trial)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This randomized clinical trial aims to evaluate whether adding magnesium sulfate to lidocaine in trigger point injections provides better pain relief and muscle relaxation in patients with Myofascial Pain Dysfunction Syndrome (MPDS) compared to lidocaine alone.

Participants diagnosed with MPDS will be randomly assigned into one of two groups:

Group 1 (Control Group): Trigger point injection of lidocaine 2% Group 2 (Intervention Group): Trigger point injection of lidocaine 2% combined with magnesium sulfate 10% Each participant will receive injections in the identified myofascial trigger points. Pain during injection and after injection will be assessed using the Visual Analog Scale (VAS). Muscle activity will be measured using surface electromyography (sEMG) at specific time points during rest and muscle contraction.

The study will compare the changes in pain scores and EMG readings between the two groups to determine whether magnesium sulfate enhances the analgesic and muscle-relaxing effects of lidocaine. The results of this study may help improve treatment strategies for MPDS and provide evidence for using magnesium sulfate as an adjuvant to lidocaine in trigger point injections.

Study Type

Interventional

Enrollment (Estimated)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Khaled A Elhayes, PhD
  • Phone Number: +20 1030000360

Study Locations

  • Egypt
    • Giza Governorate
      • Giza, Giza Governorate, Egypt, 12613
        • Recruiting
        • faculty of oral and dental medicine, Cairo university
        • Contact:
        • Contact:
          • Khaled A Elhayes, Phd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Lidocaine injection
2%preservative-free without vasocostrictor injectable solution, 1.8 ml per injection point.
Drug: Lidocaine 2% (preservative-free, without vasoconstrictor)
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.
Experimental: Injection of Magnesium sulfate with Lidocaine
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)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain reduction.
Time Frame: Baseline, 1week, 2 weeks post-injection.
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.
Time Frame: Baseline, 1 week, 2 weeks post-injection
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain experienced during injection
Time Frame: Immediately after injection
Pain during injection will be assessed immediately after injection using the Visual Analogue Scale (VAS) ranging from 0 to 10 cm, where 0 indicates no pain and 10 indicates worst imaginable pain.
Immediately after injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Maii E Abdelazeem, Bsc, Faculty of Oral & Dental Medicine, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 26, 2025

Primary Completion (Estimated)

November 26, 2026

Study Completion (Estimated)

November 26, 2026

Study Registration Dates

First Submitted

January 23, 2026

First Submitted That Met QC Criteria

February 1, 2026

First Posted (Actual)

February 5, 2026

Study Record Updates

Last Update Posted (Actual)

February 5, 2026

Last Update Submitted That Met QC Criteria

February 1, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CU-OMFS-MPDS-TP-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared. This is an academic thesis-based study, and the data contain sensitive personal and clinical information. Data access is restricted by institutional policies and ethical approval requirements. De-identified aggregate results will be reported in publications.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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