Evaluation of the Effect of Adding Sodium Bicarbonate to Lidocaine in the Treatment of Myofascial… (NCT07572994) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Evaluation of the Effect of Adding Sodium Bicarbonate to Lidocaine in the Treatment of Myofascial Pain Syndrome
Egypt30 participantsStarted 2026-05-01
Plain-language 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.
Who can participate
Age range
16 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Patients aged 16 to 70 years Clinical diagnosis of myofascial pain syndrome (MPS) Presence of active myofascial trigger points Pain duration ≥ 3 months Pain intensity ≥ 4 on the Visual Analog Scale (VAS) Trigger points located in accessible muscles No trigger point injection in the affected area within the past 3 months Ability and willingness to provide informed consent Willingness to comply with study procedures and follow-up visits
Exclusion Criteria:
Known allergy or hypersensitivity to lidocaine, sodium bicarbonate, or other amide-type local anesthetics Current use of anticoagulants or presence of bleeding disorders Local or systemic infection at or near the injection site History of fibromyalgia, cancer-related pain, or central pain syndromes Major psychiatric disorders (e.g., schizophrenia, severe depression) Recent trauma or surgery to the neck, shoulder, or back within the past 6 months Use of analgesics (e.g., NSAIDs, opioids) within 5 days prior to injection Severe systemic diseases (e.g., uncontrolled diabetes, liver failure, kidney failure, severe cardiovascular disease)
\-
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Reduction in Pain Intensity
Timeframe: Baseline, immediately after injection, and 2 weeks post-injection