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

Cairo University (CU)

Status: Enrolling

Conditions: Myofascial Pain Dysfunction Syndrome

Treatments: Drug: Lidocaine 2% (preservative-free, without vasoconstrictor); Drug: Lidocaine 2% + Magnesium Sulfate 10% (combination)

Study type: Interventional

Funder types: Other

Identifiers

NCT07390851

CU-OMFS-MPDS-TP-2025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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28 participants in 2 patient groups

Lidocaine injection

Active Comparator group

Description:

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

Treatment:

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

Injection of Magnesium sulfate with Lidocaine

Experimental group

Description:

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

Treatment:

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