Lidocaine Versus Magnesium Sulphate in Management of Myofascial Pain Dysfunction Syndrome

NCT06595017 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: 1
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Myofascial Pain Dysfunction Syndrome

Keywords

Myofascial pain dysfunction syndrome; Magnesium Sulphate; Lidocaine; Pain; Electromyography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The maximum mouth opening

  At interval pre-injection and 1, 3, and 6 months after injection.

• Electrical activity

  At interval pre-injection and 1, 3, and 6 months after injection.

• Quality of life

  At interval pre-injection and 1, 3, and 6 months after injection.

Study Arms (3)

Saline arm

PLACEBO COMPARATOR

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

Lidocaine arm

ACTIVE COMPARATOR

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)

Magnesium Sulphate arm

ACTIVE COMPARATOR

Drug: Magnesium sulphate

Interventions

Magnesium sulphate 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 points at a 30º angle to the skin. Negative aspiration was performed and each trigger point was injected with 2 ml of magnesium sulphate

Magnesium Sulphate arm

Lidocaine (drug) 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

Lidocaine arm

Saline 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 Saline

Saline arm

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Misr University for Science and Technology: lead

MeSH Terms

Conditions

Fibromyalgia; Pain

Interventions

Magnesium Sulfate; Lidocaine; Pharmaceutical Preparations; Sodium Chloride

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Sodium Compounds

Central Study Contacts

Maha Majied Demonstrator in Oral and Maxillofacial Surgery Department

CONTACT

00201024127018; maha.abdalmajied@must.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Demonstrator in Oral & Maxillofacial Surgery Department at Misr University for Science and Technology

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2024
• Primary Completion: September 30, 2025
• Study Completion: November 30, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09