Lidocaine Versus Magnesium Sulphate in Management of Myofascial Pain Dysfunction Syndrome

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-55
SponsorMisr University for Science and Technology

About this 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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

75 Participants
are divided into 3 treatment groups
Group A: Saline armPlacebo comparator 1 intervention
Group B: Lidocaine armActive comparator 1 intervention
Group C: Magnesium Sulphate armActive comparator 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

The maximum mouth opening

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

Time frame
At interval pre-injection and 1, 3, and 6 months after injection.
2

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.

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

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

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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