Efficacy of Photobiomodulation Therapy Using 980nm Versus 635nm Diode Lasers for Treatment of Myofascial Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pain Intensity Reduction
研究概览
简要总结
This randomized controlled clinical trial aims to evaluate the efficacy of low-level laser therapy (LLLT) using two different diode laser wavelengths (980 nm and 635 nm) in the treatment of myofascial pain associated with temporomandibular disorders (TMD). The study compares pain reduction and muscle activity improvement using surface electromyography (sEMG) before and after laser application. Participants are randomly assigned to receive either 980 nm or 635 nm laser treatment twice per week for five weeks. The primary outcomes include pain intensity and functional mandibular movements, while secondary outcomes assess changes in sEMG recordings.
详细描述
This randomized controlled clinical trial investigates the effectiveness of low-level laser therapy (LLLT) using two diode laser wavelengths-980 nm and 635 nm-for the treatment of myofascial pain syndrome (MPS) in patients with temporomandibular disorders (TMD). The study is conducted at the National Institute of Laser Enhanced Sciences (NILES), Cairo University.
Participants who meet the inclusion criteria are randomly assigned to two intervention groups. Group 1 receives LLLT using a 635 nm diode laser, while Group 2 receives LLLT using a 980 nm diode laser. Both groups undergo treatment twice per week for a total of five weeks, following a standardized protocol.
The primary outcomes include pain intensity assessed using a visual analog scale (VAS), and evaluation of mandibular range of motion including lateral and protrusive movements. Secondary outcomes involve the assessment of masseter and temporalis muscle activity using surface electromyography (sEMG) before and after the treatment period.
The study aims to provide evidence-based comparison between the two wavelengths in terms of pain reduction and neuromuscular improvement, contributing to the optimization of non-invasive laser protocols for TMD-related myofascial pain.
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
- None
盲法说明
"This is an open-label study with no masking; both participants and investigators are aware of the treatment assignments."
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- patients with myofascial pain due to stress, medically free, not to resort to self-medication during the study period with no chronic diseases.
排除标准
- •Patients with TMJ disorders either due to bony degeneration changes or soft tissue changes.
- •Patients with pain of dental etiology were excluded, pregnancy, lactation, cardiac arrhythmia, diabetic patients, erosions and medically free.
- •Patient with history of malignancy or a history of previous surgery of neck and/ shoulder within the past year of the study were excluded.
- •Any patients had treatment that can affect muscles will be excluded, either pharmacological treatment (e.g, opioids, morphine, muscles relaxants or anti-depressants), physiotherapy management and occlusal splints.
研究组 & 干预措施
Low-Level Laser Therapy at 635 nm for Arm 1
Participants will receive low-level laser therapy using a diode laser with 635 nm wavelength, applied 2 times per week for 5 weeks to treat myofascial pain syndrome in the temporomandibular joint.
干预措施: Doctor smile 635nm For Arm 1 (Device)
Low-Level Laser Therapy at 980 nm for Arm 2
Participants will receive low-level laser therapy using a diode laser with 980 nm wavelength, applied 2 times per week for 5 weeks to treat myofascial pain syndrome in the temporomandibular joint.
干预措施: Doctor smile 980 nm For Arm2 (Device)
结局指标
主要结局
Pain Intensity Reduction
时间窗: At baseline, after 10 treatment sessions (5 weeks), and at 1-month follow-up (approximately 2 months in total from baseline).
"Pain intensity was assessed in patients with myofascial pain syndrome of the temporomandibular joint using the Visual Analog Scale (VAS), a 10-point scale ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity. Measurements were recorded at baseline, after 10 sessions of low-level laser therapy (5 weeks), and at 1-month follow-up. Data are reported in the tables below. Lower scores reflect reduced pain intensity
次要结局
- Changes in Muscle Activity Measured by Surface Electromyography (sEMG)(At baseline and after 10 treatment sessions (5 weeks))
- Maximum Mouth Opening (MMO)(At baseline, after 10 treatment sessions (5 weeks), and at 1-month follow-up (approximately 2 months in total from baseline).)
- Lateral Jaw Movements(At baseline, after 10 treatment sessions (5 weeks), and at 1-month follow-up (approximately 2 months in total from baseline).)
- Protrusive Movements(At baseline, after 10 treatment sessions (5 weeks), and at 1-month follow-up (approximately 2 months in total from baseline).)
研究者
Dr. Hala Shaaban
Dentist
National Institute of Laser Enhanced Sciences