Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07390851

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of oral and dental medicine, cairo university

Giza, Giza Governorate, 12613, Egypt

Location status: Recruiting

Location contact

Khaled A Elhayes, Phd

CONTACT

Maii E Abdelazeem, BSc

CONTACT

[email protected]

01013988933

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

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 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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Khaled A Elhayes, PhD

CONTACT

+20 1030000360

Maii E Abdelazeem, BSc

CONTACT

[email protected]

+20 1013988933

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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)

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 5, 2026
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.