Evaluation of the Effect of Adding Magnesium Sulfate to Lidocaine in the Treatment of Myofascial Pain Dysfunction Syndrome Using Surface Electromyography (sEMG).(Randomized Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Pain reduction.
研究概览
简要总结
Two groups of patients diagnosed with Myofascial Pain Dysfunction Syndrome (MPDS) will be included in this study. One group will receive trigger point injections of lidocaine alone. The other group will receive trigger point injections of lidocaine combined with magnesium sulfate. The study aims to compare the effectiveness of both treatments in reducing pain and improving muscle function. Patients will be assessed using a pain scale (VAS) and surface electromyography (sEMG) to measure muscle activity.
详细描述
This randomized clinical trial aims to evaluate whether adding magnesium sulfate to lidocaine in trigger point injections provides better pain relief and muscle relaxation in patients with Myofascial Pain Dysfunction Syndrome (MPDS) compared to lidocaine alone.
Participants diagnosed with MPDS will be randomly assigned into one of two groups:
Group 1 (Control Group): Trigger point injection of lidocaine 2% Group 2 (Intervention Group): Trigger point injection of lidocaine 2% combined with magnesium sulfate 10% Each participant will receive injections in the identified myofascial trigger points. Pain during injection and after injection will be assessed using the Visual Analog Scale (VAS). Muscle activity will be measured using surface electromyography (sEMG) at specific time points during rest and muscle contraction.
The study will compare the changes in pain scores and EMG readings between the two groups to determine whether magnesium sulfate enhances the analgesic and muscle-relaxing effects of lidocaine. The results of this study may help improve treatment strategies for MPDS and provide evidence for using magnesium sulfate as an adjuvant to lidocaine in trigger point injections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
This is a randomized single-blinded trial. Participants and outcome assessors are blinded to the injection material. The clinician performing the injections is not blinded due to preparation and administration requirements.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 70 years.
- •Clinical diagnosis of Myofascial Pain Dysfunction Syndrome (MPDS).
- •Presence of active myofascial trigger points in accessible muscles (e.g., masseter, temporalis, upper trapezius).
- •Pain duration ≥ 3 months.
- •Pain intensity ≥ 4 on the Visual Analog Scale (VAS).
- •Noprior trigger point injection in the affected area within the past 3 months.
- •Ability and willingness to provide informed consent.
- •Compliance with study visits and procedures
排除标准
- •Known allergy or hypersensitivity to Lidocaine, Magnesium Sulfate, or related agents.
- •Current use of anticoagulants or history of bleeding disorders.
- •Systemic or local infection at or near the injection site.
- •History of fibromyalgia, central pain syndromes, or cancer-related pain.
- •Major psychiatric illnesses (e.g., schizophrenia, severe depression).
- •Recent surgery or trauma to the head, neck, or upper back (<6 months).
- •Use of analgesics (NSAIDs, opioids) within 5 days before intervention.
- •Severe systemic diseases:- Uncontrolled diabetes mellitus- Liver or kidney failure- Severe cardiovascular conditions.
研究组 & 干预措施
Lidocaine injection
2%preservative-free without vasocostrictor injectable solution, 1.8 ml per injection point.
干预措施: Lidocaine 2% (preservative-free, without vasoconstrictor) (Drug)
Injection of Magnesium sulfate with Lidocaine
10% injectable solution (100 mg/ml), from certified supplier. Approx. 3.8 ml per point (1.8 ml Lidocaine + 2 ml MgSO₄)
干预措施: Lidocaine 2% + Magnesium Sulfate 10% (combination) (Drug)
结局指标
主要结局
Pain reduction.
时间窗: Baseline, 1week, 2 weeks post-injection.
Pain intensity will be assessed using the Visual Analogue Scale (VAS) ranging from 0 to 10 cm, where 0 indicates no pain and 10 indicates worst imaginable pain.
Muscle activity improvement.
时间窗: Baseline, 1 week, 2 weeks post-injection
Muscle activity will be assessed using surface electromyography (sEMG) by measuring Maximum Voluntary Contraction (MVC) in microvolts (µV). Higher values indicate improved muscle activity.
次要结局
- Pain experienced during injection(Immediately after injection)
研究者
Maii Emad Abdelazeem
Principle investigator
Cairo University