Clinical trial NCT06595017: Lidocaine Versus Magnesium Sulphate in Management of Myofascial Pain Dysfunction Syndrome
Official 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Myofascial Pain Dysfunction Syndrome
Keywords: Myofascial pain dysfunction syndrome
Magnesium Sulphate
Lidocaine
Pain
Electromyography
Lead sponsor: Misr University for Science and Technology
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Pain score
timeFrame: At interval pre-injection and 1, 3, and 6 months after injection.
Secondary outcomes:
measure: The maximum mouth opening
timeFrame: At interval pre-injection and 1, 3, and 6 months after injection.
measure: Electrical activity
timeFrame: At interval pre-injection and 1, 3, and 6 months after injection.
measure: Quality of life
timeFrame: At interval pre-injection and 1, 3, and 6 months after injection.
Other outcomes:
Locations:
Study officials:
References: