Lidocaine Versus Magnesium Sulphate in Management of Myofascial Pain Dysfunction Syndrome

Evaluation of the Effect of Magnesium Sulfate Injection in Comparison to Lidocaine for Management of Myofascial Pain Dysfunction Syndrome: a Randomized Controlled Clinical Trial

The goal of this clinical trial is to investigate the effectiveness of Magnesium Sulphate in the management of myofascial pain dysfunction syndrome in comparison to Lidocaine and Saline.

A total of 75 patients suffering from myofascial pain dysfunction syndrome will be assigned into one of three groups, each with 25 patients.

Group A: (Saline) includes patients enrolled for Saline injection into the trigger points. Group B: (Magnesium Sulphate) includes patients enrolled for Magnesium Sulphate injection into the trigger points. Group C: (Lidocaine) includes patients who will be enrolled for Lidocaine injection into the trigger points The primary outcome that will be investigated is (pain with a visual analogue score), and secondary outcomes will be (maximum mouth opening between edges of upper and lower incisors with millimeters, electrical activity with Electromyography, and quality of life assessed using the Oral Health Impact Profile questionnaire) The outcomes will be assessed pre-injection, 1month after injection, 3months after injection, and 6 months after injection

Study Overview

• Status: Not yet recruiting
• Conditions: Myofascial Pain Dysfunction Syndrome
• Intervention / Treatment: Drug: Saline; Drug: Lidocaine (drug); Drug: Magnesium sulphate

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Maha Majied Demonstrator in Oral and Maxillofacial Surgery Department; Phone Number: 00201024127018; Email: maha.abdalmajied@must.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age Limitations: Participants must be between 18 and 55 years old.
• Chronic Pain Diagnosis: Individuals must have a diagnosis of chronic myofascial pain dysfunction syndrome (MPDS) affecting the face muscles, neck, shoulder, or upper back for a duration exceeding three months.
• Trigger Point Recognition: Patients must show awareness of their pain when pressure is applied to identified myofascial trigger points, in accordance with established diagnostic guidelines.
• Consent to Participate: Willingness to provide informed consent and engage in all aspects of the study.

Exclusion Criteria:

• Previous Treatments: A history of receiving dry needling or pulsed radiofrequency therapy, or currently participating in other pain management treatments.
• Recent Injury or Surgery: Any recent trauma, surgical procedures, or infections in the affected area within the past six months.
• Medication Interference: Current or recent use of moderate to strong analgesics (e.g., tramadol, morphine) that could influence pain assessment.
• Severe Health Conditions: Individuals with significant systemic illnesses (e.g., severe liver or kidney disease), blood clotting disorders, rheumatoid arthritis or epilepsy.
• Mental Health: Presence of current psychiatric disorders, cognitive impairments, or inability to comply with the study protocol.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Saline arm; After localization of the trigger points, the skin was disinfected with alcohol, the tight muscle band was grabbed between two fingers, and a 30-gage 3/4-inch needle was introduced 1-2 cm away from the trigger points at a 30º angle to the skin. Negative aspiration was performed and each trigger point was injected with 2 ml of saline	Drug: Saline; After localization of the trigger points, the skin was disinfected with alcohol, the tight muscle band was grabbed between two fingers, and a 30-gage 3/4-inch needle was introduced 1-2 cm away from the trigger point at a 30º angle to the skin. Negative aspiration was performed and each trigger point was injected with 2 ml of Saline
Active Comparator: Lidocaine arm; After localization of the trigger points, the skin was disinfected with alcohol, the tight muscle band was grabbed between two fingers, and a 30-gage 3/4-inch needle was introduced 1-2 cm away from the trigger points at a 30º angle to the skin. Negative aspiration was performed and each trigger point was injected with 2 ml of lidocaine	Drug: Lidocaine (drug); After localization of the trigger points, the skin was disinfected with alcohol, the tight muscle band was grabbed between two fingers, and a 30-gage 3/4-inch needle was introduced 1-2 cm away from the trigger point at a 30º angle to the skin. Negative aspiration was performed and each trigger point was injected with 2 ml of Lidocaine
Active Comparator: Magnesium Sulphate arm	Drug: Magnesium sulphate; After localization of the trigger points, the skin was disinfected with alcohol, the tight muscle band was grabbed between two fingers, and a 30-gage 3/4-inch needle was introduced 1-2 cm away from the trigger points at a 30º angle to the skin. Negative aspiration was performed and each trigger point was injected with 2 ml of magnesium sulphate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score	Pain intensity was assessed using a 10-cm line visual analog scale (VAS) that represents a continuum between "no pain" and "worst pain." with 0 cm representing no pain, and 10 cm representing the worst pain imaginable.	At interval pre-injection and 1, 3, and 6 months after injection.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The maximum mouth opening	The maximum mouth opening (MMO) was evaluated by measuring the interincisal distance between the upper and lower central incisors.	At interval pre-injection and 1, 3, and 6 months after injection.
Electrical activity	Measured using electromyography, EMG can provide valuable insights into altered muscle activity patterns and help in the diagnosis and management of myofascial pain dysfunction syndrome through readings.	At interval pre-injection and 1, 3, and 6 months after injection.
Quality of life	evaluated using the Oral Health Impact Profile questionnaire (OHIP-14), which consists of 14 items categorized into seven domains of oral health. Participants were instructed to score each item on a scale from 0 to 4, where 0 indicates never, 1 represents hardly ever, 2 signifies occasionally, 3 denotes fairly often, and 4 corresponds to very often. The total score was computed by summing the responses to all 14 items, with higher scores reflecting a greater negative impact on oral health-related quality of life	At interval pre-injection and 1, 3, and 6 months after injection.

Collaborators and Investigators

• Sponsor: Misr University for Science and Technology

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): November 30, 2025

Study Registration Dates

• First Submitted: September 10, 2024
• First Submitted That Met QC Criteria: September 10, 2024
• First Posted (Estimated): September 13, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 17, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Pain; Electromyography; Lidocaine; Magnesium Sulphate; Myofascial pain dysfunction syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Disease; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Stomatognathic Diseases; Jaw Diseases; Craniomandibular Disorders; Mandibular Diseases; Syndrome; Fibromyalgia; Myofascial Pain Syndromes; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anticonvulsants; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Calcium-Regulating Hormones and Agents; Reproductive Control Agents; Calcium Channel Blockers; Tocolytic Agents; Lidocaine; Magnesium Sulfate
• Other Study ID Numbers: 1 (Other Identifier: Mobile Health and Wellness Program)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No