Lidocaine Versus Magnesium Sulphate in Management of Myofascial Pain Dysfunction Syndrome

Misr University for Science and Technology

Status and phase

Not yet enrolling

Phase 2

Conditions

Myofascial Pain Dysfunction Syndrome

Treatments

Drug: Magnesium sulphate

Drug: Saline

Drug: Lidocaine (drug)

Study type

Interventional

Funder types

Other

Identifiers

NCT06595017

Details and patient eligibility

About

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

Enrollment

75 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

75 participants in 3 patient groups, including a placebo group

Saline arm

Placebo Comparator group

Description:

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

Treatment:

Drug: Saline

Lidocaine arm

Active Comparator group

Description:

Treatment:

Drug: Lidocaine (drug)

Magnesium Sulphate arm

Active Comparator group

Treatment:

Drug: Magnesium sulphate