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

NCT07572994 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-05-07

No results posted yet for this study

Summary

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.

Conditions

  • Myofacial Pain
  • Myofacial Pain Syndrome
  • Myofacial Pain Syndromes
  • Trigger Point Pain, Myofascial
  • Myofascial Pain Dysfunction Syndrome

Interventions

DRUG

Lidocaine 2 %

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.

DRUG

Lidocaine + Sodium Bicarbonate

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.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Khalid elhayes, professor · cairo university oral and maxillofacial surgery department

  • Abdelmoez Mohamed El-Sharkawy, Associate professor · cairo University -oral and maxillofacial surgery department

  • Adham Yehia Zakaria, Lecturer · cairo university oral and maxillofacial surgery department

  • Eman hassan Elzamarany, lecturer · Department of Neurology and Clinical Physiology Faculty of Medicine, Cairo University

  • ola mohamed Abdelfath · cairo university oral and maxillofacial surgery department

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2026-09-01
Completion
2026-10-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07572994 on ClinicalTrials.gov