Comparative Effectiveness of Standard and Modified Laser Therapy in Myofascial Pain Management: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pain Assessment
研究概览
简要总结
The goal of this clinical trial is to evaluate and compare the effectiveness of modified laser therapy versus conventional laser therapy in managing pain and mandibular function in patients with chronic myofascial pain syndrome involving the masseter muscles. The main questions it aims to answer are:
- Does high-intensity laser therapy (HILT) provide a greater reduction in pain intensity on a numerical rating scale (NRS) compared to low-level laser therapy (LLLT)?
- Does high-intensity laser therapy (HILT) provide greater improvement in functional outcomes, specifically maximal incisal opening, compared to low-level laser therapy (LLLT)?
Comparison Group:
Researchers will compare the experimental group receiving High-Intensity Laser Therapy (HLLT) to a comparator group receiving Low-Level Laser Therapy (LLLT) to see if the modified high-intensity approach provides superior pain relief and improved mandibular movement.
Participants will:
- Be randomly assigned to either the HILT or LLLT treatment group.
- Undergo 12 laser irradiation sessions delivered over one month.
- Have laser energy applied directly to the trigger points of the masseter muscles during 5-minute sessions.
- Attend follow-up assessments at each session, and at intervals of 1, 3, and 6 months.
- Provide pain ratings using a numerical scale and have their maximal mouth opening measured by a caliper.
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)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of myofascial temporomandibular disorder following the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD).
- •Participants eligible for inclusion in this study must not have received any previous laser therapy for the management of myofascial pain dysfunction syndrome or temporomandibular disorders like pharmacological therapy, physical therapy, manual techniques, and trigger point injections.
- •No previous laser therapy for last 3 months.
- •Pain localized to the masseter muscles.
- •Pain lasting at least 3 months with a self-reported pain level of 6 or higher on a numerical rating scale (NRS).
排除标准
- •1- Patients with TMJ pain, or those who had any previous treatment for TMD 2- Patients with any history of cervical or degenerative conditions, any surgery or trauma to the neck during last year 3- Previous treatment of MPDS during last year 4- Confirmed diagnosis of fibromyalgia or rheumatoid arthritis 5- Patients with dark skin tone or chubby face
研究组 & 干预措施
High intensity Laser Therapy (HLLT)
干预措施: High Level Laser Therapy (Device)
Low Level Laser Therapy (LLLT)
干预措施: Low Level Laser Therapy (Device)
结局指标
主要结局
Pain Assessment
时间窗: Pain will be assessed using a numerical rating scale (NRS) at rest and during mouth opening at the following follow up time points: at each session, 1, 3 months and 6 months.
次要结局
- Maximal incisal opening(Maximal incisal opening is measured at each session, 1, 3 months and 6 months.)
研究者
Ayman Mohamed Gouda
Assistant professor of Oral and Maxillofacial Surgery
Cairo University