Evaluation of the Effect of Adding Sodium Bicarbonate to Lidocaine in the Treatment of Myofascial Pain Syndrome Using Surface Electromyography (sEMG)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Cairo University
- Enrollment
- 30
- Locations
- 1
Study Overview
Brief 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.
Detailed Description
Study Overview
This study is a randomized, parallel-group, single-blind clinical trial designed to evaluate the clinical effectiveness of adding sodium bicarbonate to lidocaine in the treatment of myofascial pain syndrome (MPS). The study compares outcomes between lidocaine alone and buffered lidocaine using surface electromyography (sEMG) and pain assessment tools.
Background
Myofascial pain syndrome is a prevalent musculoskeletal disorder characterized by the presence of myofascial trigger points, leading to localized or referred pain, functional limitation, and reduced quality of life. Although trigger point injections with lidocaine are widely used and provide rapid pain relief, their effects are often temporary and may require repeated administration.
Buffered lidocaine, achieved by adding sodium bicarbonate, has been proposed to enhance anesthetic performance by increasing the pH of the solution. This increases the proportion of the non-ionized form of lidocaine, facilitating faster onset of action, improved tissue penetration, and reduced pain during injection. However, its role in managing MPS has not been sufficiently established.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
This is a single-blind study in which participants are unaware of their group allocation. The operator administering the injection and the outcome assessor are not blinded due to the nature of the intervention and preparation of the buffered solution. Participants are not informed whether they receive lidocaine alone or lidocaine combined with sodium bicarbonate.
Eligibility Criteria
- Ages
- 16 Years to 70 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Investigators
Ola mohamed abdelfatah
"Postgraduate Researcher (Master's Candidate), Oral and Maxillofacial Surgery, Faculty of Dentistry, Cairo University"
Cairo University