Evaluation of the Effect of Adding Sodium Bicarbonate to Lidocaine in the Treatment of Myofascial Pain Syndrome

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-70
SponsorCairo University

About this trial

This study is designed to evaluate a method to improve the treatment of myofascial pain syndrome (MPS), a common condition that causes muscle pain, tenderness, and reduced movement due to the presence of trigger points in muscles.

A commonly used treatment for this condition is the injection of a local anesthetic called lidocaine into these trigger points to relieve pain. However, the pain relief from lidocaine alone may be temporary.

In this study, we are investigating whether adding a small amount of sodium bicarbonate to lidocaine can improve its effectiveness. Sodium bicarbonate may reduce the pain during injection and help the anesthetic work faster and possibly last longer.

Participants in this study will be randomly assigned into one of two groups:

One group will receive lidocaine alone. The other group will receive lidocaine mixed with sodium bicarbonate.

The injection will be performed once into the painful muscle trigger points under sterile conditions.

Pain levels will be assessed using a simple pain scale, and muscle activity will be measured using a non-invasive technique called surface electromyography (sEMG), which records muscle electrical activity. These measurements will be taken before the injection, immediately after, and during follow-up visits.

Participants may experience mild discomfort during or after the injection, but all procedures are routinely used in clinical practice. Safety measures will be in place to manage any possible side effects.

The goal of this study is to determine whether the combined injection provides better pain relief, improves muscle function, and enhances patient comfort compared to lidocaine alone.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Lidocaine 2 %

    Drug

    2% lidocaine (preservative-free, without vasoconstrictor) will be administered via intramuscular injection into the identified trigger points. Approximately 1.8 mL will be injected per point using a sterile 25-27 gauge needle. The injection will be performed using a standardized "fast-in, fast-out" (peppering) technique.

  • Lidocaine + Sodium Bicarbonate

    Drug

    A buffered anesthetic solution will be prepared immediately before injection by mixing 2% lidocaine with 8.4% sodium bicarbonate in a ratio of 9:1 (1.8 mL lidocaine + 0.2 mL sodium bicarbonate per injection point). The solution will be administered via intramuscular injection into trigger points using a sterile 25-27 gauge needle and standardized injection technique.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Lidocaine 2% (control group)Active comparator 1 intervention
Group B: Lidocaine + Sodium Bicarbonate (buffered group)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Reduction in Pain Intensity

Pain intensity will be assessed using the Visual Analog Scale (VAS) (0-10). In addition, surface electromyography (sEMG) will be used to objectively evaluate muscle activity at rest (MVC%). A reduction in VAS scores and sEMG activity indicates improvement.

Time frame
Baseline, immediately after injection, and 2 weeks post-injection

Secondary outcomes

1

Pain During Injection

Pain experienced during the injection procedure will be measured using the Visual Analog Scale (VAS) (0-10), immediately after completion of the injection.

Time frame
Immediately after injection

Other outcomes

1

Change in Muscle Activation Pattern

Changes in muscle activation during voluntary contraction will be assessed using surface electromyography (sEMG) (MVC%). Improvement indicates better functional muscle recovery.

Time frame
Baseline and 2 weeks post-injection

Sponsors and contacts

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