Evaluation Of The Effect Of Low-Level Laser Therapy On Masseter Muscle Versus Therapeutic Ultrasound On Patients With Myofascial Pain Disorder : A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 36
- 主要终点
- pain
研究概览
简要总结
Myofascial pain dysfunction (MPD) is one of the most common causes of chronic orofacial pain, primarily affecting the masticatory muscles such as the masseter and temporalis. It leads to facial pain, muscle tenderness, and restricted mouth opening, significantly impacting patients' quality of life and daily function.
Despite the wide range of conservative treatment modalities-such as medications, splint therapy, and physiotherapy-there is still no universally accepted approach that provides consistent and long-lasting relief.
Low-level laser therapy (LLLT) and therapeutic ultrasound (US) are two non-invasive physical modalities frequently used in dentistry for pain control and tissue healing. Each has shown promising outcomes individually.
Azizi et al. (2007) demonstrated that LLLT at 780 nm can significantly reduce pain and tenderness for up to three months, while Khairy (2018) reported notable pain relief and improved jaw function using pulsed ultrasound at 1.5 W/cm² for 5 minutes over 10 sessions.
However, direct comparative evidence between LLLT and therapeutic ultrasound in patients with myofascial pain dysfunction is still lacking.
This knowledge gap prevents clinicians from identifying which modality offers superior short- and long-term outcomes in terms of pain reduction, muscle function improvement, and patient satisfaction.
Therefore, this study aims to compare the efficacy of low-level laser therapy versus therapeutic ultrasound in the management of myofascial pain dysfunction, using standardized treatment parameters from the most evidence-based protocols in the literature.
详细描述
Myofascial pain dysfunction (MPD) is one of the most common causes of chronic orofacial pain, typically involving the masticatory muscles such as the masseter and temporalis. It is characterized by localized muscle tenderness, trigger points, and functional limitation of jaw movements. The condition affects a significant percentage of adults and can lead to persistent discomfort and impaired quality of life.
The etiology of MPD is multifactorial, including parafunctional habits such as bruxism, psychological stress, trauma, malocclusion, and muscle overuse. Because of this complex etiology, management often requires a multimodal approach combining behavioral, pharmacological, and physical therapies.
2. Myofascial Pain and Physical Modalities
Conservative physical modalities are widely used as first-line treatments for MPD because they are non-invasive, safe, and easily applicable. These modalities include ultrasound therapy, low-level laser therapy, transcutaneous electrical nerve stimulation (TENS), and thermotherapy. Among these, therapeutic ultrasound (US) and low-level laser therapy (LLLT) have gained increasing attention for their effectiveness in pain reduction and tissue healing without pharmacological side effects.
3. Low-Level Laser Therapy (LLLT)
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients should have one or more signs and symptoms of these
- •Symptoms: Patients who report typical symptoms of myofascial pain , such as pain, discomfort, especially when opening or closing the mouth.
- •Mouth Opening: Limited range of motion or difficulty with full mouth opening.
- •Pain: Pain or tenderness around the TMJ, often radiating to the ear, temple, or neck.
- •Patients who will be free from any systemic diseases that affect temporomandibular joint.
- •Patients who will be ready to give informed consent.
排除标准
- •Blood dyscrasias and systemtic diseases.
- •Previous surgery of the affected joint.
- •Infection
- •Patients with previous facial fracture.
- •Patients who will be under another type of treatment for TMD (e.g., occlusal splints, pharmacological drugs, or head and neck surgery).
- •Patients who will not attend the proposed treatment sessions or follow-up visits.
研究组 & 干预措施
Evaluation The Effect Of Low-Level Laser Therapy On Masseter Muscle On Patients With Myofascial Pain
Low-Level Laser Therapy (LLLT) utilizes light energy, typically in the red or near-infrared spectrum (630-830 nm), to stimulate photochemical reactions in the target tissues. The absorbed photons enhance mitochondrial activity, increase ATP production, improve local blood circulation, and reduce inflammatory mediators such as prostaglandins and bradykinin. These actions contribute to analgesia, relaxation of muscle fibers, and acceleration of tissue repair.
In the study by Azizi et al. (2007), LLLT at 780 nm with a total energy of 1200 mJ per treated region significantly reduced pain and muscle tenderness, and these imp
干预措施: Evaluation Of The Effect Of Low-Level Laser Therapy On Masseter Muscle Versus therapeutic Ultrasound On Patients With Myofascial Pain Disorder (Device)
Evaluation Of The Effect Of therapeutic Ultrasound On Patients With Myofascial Pain Disorder
Therapeutic Ultrasound (US), on the other hand, transmits mechanical acoustic energy through soft tissues, producing micro-vibration and mild thermal effects. These effects increase cellular permeability, stimulate fibroblast activity, enhance microcirculation, and facilitate the resorption of inflammatory exudates. The pulsed mode specifically provides a non-thermal biostimulatory effect, making it suitable for acute or painful conditions.
Khairy (2018) reported that pulsed ultrasound at 1.5 W/cm² for 5 minutes per session over ten sessions produced significant reductions in pain intensity and improvement in mouth opening in patients with myofascial pain dysfunction.
干预措施: Evaluation Of The Effect Of Low-Level Laser Therapy On Masseter Muscle Versus therapeutic Ultrasound On Patients With Myofascial Pain Disorder (Device)
结局指标
主要结局
pain
时间窗: measured at baseline ,1week, 2weeks, 3weeks, 4weeks, 1months,3months, 6months
pain severity will be assessed using Visual analogue scale 0-10
次要结局
- Maximum interincisal opening(baseline , 1week, 2weeks,3weeks, 4weeks, 1month,3months, 6months)