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NCT Number: NCT06595017

Lidocaine Versus Magnesium Sulphate in Management of Myofascial Pain Dysfunction Syndrome

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

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Key information

Conditions

Myofascial Pain Dysfunction Syndrome Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

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

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

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

Primary outcomes

  1. Pain score

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

    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.

Secondary outcomes

  1. The maximum mouth opening

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

    The maximum mouth opening (MMO) was evaluated by measuring the interincisal distance between the upper and lower central incisors.

  2. Electrical activity

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

    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.

  3. Quality of life

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

    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

Study contacts

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

Maha Majied Demonstrator in Oral and Maxillofacial Surgery Department

CONTACT

[email protected]

00201024127018

Sponsors and collaborators

Lead sponsor

Misr University for Science and Technology

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

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.

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