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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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07800338
Enrollment
36
Registered
2026-09-02
Start date
2026-09-01
Completion date
2027-02-01
Last updated
2026-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

TMJ

Brief summary

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.

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.

Interventions

DEVICEEvaluation Of The Effect Of Low-Level Laser Therapy On Masseter Muscle Versus therapeutic Ultrasound On Patients With Myofascial Pain Disorder

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.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
painmeasured at baseline ,1week, 2weeks, 3weeks, 4weeks, 1months,3months, 6monthspain severity will be assessed using Visual analogue scale 0-10

Secondary

MeasureTime frameDescription
Maximum interincisal openingbaseline , 1week, 2weeks,3weeks, 4weeks, 1month,3months, 6monthsMaximum interincisal opening will be measeured in millimeters using digital caliper

Contacts

CONTACTmohamed mostafa dentist, bachelor's degree
Mohamed-elsebaie@dentistry.cu.edu.eg01060249544

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 3, 2026