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
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.
Study Overview
Status
Conditions
Detailed Description
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)
Low-level laser therapy, also referred to as photobiomodulation therapy, uses light energy at specific wavelengths to produce photochemical and photothermal effects in tissues. These effects lead to enhanced cellular metabolism, increased microcirculation, improved oxygen supply, and stimulation of ATP production, which collectively accelerate healing and reduce inflammation.
Several studies have explored the role of LLLT in treating myofascial pain dysfunction.
Azizi et al. (2007) evaluated the effect of LLLT (780 nm, 10 mW) applied to the masseter, temporalis, medial, and lateral pterygoid muscles. Each region received 1200 mJ of energy per session, with twelve sessions performed over four weeks. The study demonstrated a significant reduction in pain and muscle tenderness and an improvement in mandibular function. Importantly, these therapeutic effects persisted up to three months after the completion of treatment, indicating both short-term and long-term efficacy.
Other research supports these findings, confirming that LLLT promotes analgesia by modulating nerve conduction velocity, reducing bradykinin and histamine release, and stimulating mitochondrial cytochrome oxidase activity. The cumulative evidence suggests that LLLT provides a safe, effective, and sustainable method for managing myofascial pain.
4. Therapeutic Ultrasound (US)
Therapeutic ultrasound is a commonly used modality in physiotherapy and dentistry. It transmits acoustic energy through tissues, producing both thermal and mechanical effects. These effects enhance blood flow, increase cell membrane permeability, and promote tissue repair while reducing muscle spasm and pain.
Khairy (2018) conducted a randomized clinical study comparing phonophoresis and ultrasound therapy in myofascial pain dysfunction syndrome. The study applied pulsed ultrasound at 1.5 W/cm² for 5 minutes per session, over ten sessions spanning three weeks. The ultrasound head was moved in circular motions across the affected masseter muscle using coupling gel.
Results showed significant improvements in pain intensity (VAS), maximum mouth opening (MMO), and muscle tenderness compared with baseline values. This confirms the beneficial role of pulsed ultrasound in decreasing pain and improving masticatory muscle function.
The therapeutic benefits of ultrasound are attributed to its mechanical micro-massage effect, which enhances cellular exchange, reduces edema, and improves local metabolism. The pulsed mode, in particular, minimizes thermal buildup and focuses on non-thermal biostimulation, making it suitable for inflamed or tender tissues such as the masseter.
5. Comparison between LLLT and Ultrasound Therapy
Both LLLT and ultrasound therapy share common goals-reducing pain, decreasing muscle stiffness, and improving jaw function-but act through different biophysical mechanisms. LLLT works primarily through photochemical cellular activation, while ultrasound acts via mechanical micro-vibration and mild thermal stimulation.
Although both modalities have been proven individually effective, few studies have directly compared their outcomes in myofascial pain dysfunction.
Combining evidence from Azizi (2007) and Khairy (2018) indicates that both approaches are effective within short treatment durations (3-4 weeks) and produce measurable improvements in pain and muscle performance. However, the relative superiority of one modality over the other remains undetermined, justifying the need for a direct head-to-head comparison using standardized settings.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: mohamed mostafa dentist, bachelor's degree
- Phone Number: 01060249544
- Email: Mohamed-elsebaie@dentistry.cu.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion criteria:
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.
Exclusion criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: 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 |
Given that both modalities promote pain relief and muscle recovery through distinct biological pathways-LLLT via photobiomodulation and US via mechanical and thermal stimulation-a direct comparison between them can determine which produces superior clinical outcomes in terms of pain reduction, functional improvement, and duration of therapeutic effect.
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Experimental: 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. |
Given that both modalities promote pain relief and muscle recovery through distinct biological pathways-LLLT via photobiomodulation and US via mechanical and thermal stimulation-a direct comparison between them can determine which produces superior clinical outcomes in terms of pain reduction, functional improvement, and duration of therapeutic effect.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pain
Time Frame: measured at baseline ,1week, 2weeks, 3weeks, 4weeks, 1months,3months, 6months
|
pain severity will be assessed using Visual analogue scale 0-10
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measured at baseline ,1week, 2weeks, 3weeks, 4weeks, 1months,3months, 6months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maximum interincisal opening
Time Frame: baseline , 1week, 2weeks,3weeks, 4weeks, 1month,3months, 6months
|
Maximum interincisal opening will be measeured in millimeters using digital caliper
|
baseline , 1week, 2weeks,3weeks, 4weeks, 1month,3months, 6months
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Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- tmj Myofascial Pain Disorder
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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