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Completed

NCT Number: NCT07069764

Efficacy of Photobiomodulation Therapy Using 980nm Versus 635nm Diode Lasers for Treatment of Myofascial Pain

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.

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Key information

Conditions

Myofascial Pain Syndrome Muscular Diseases Musculoskeletal Diseases Myofascial Pain Syndromes

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Institute for Laser Enhanced Sciences

Cairo, Cairo Governorate, 11562, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • - patients with myofascial pain due to stress, medically free, not to resort to self-medication during the study period with no chronic diseases.

Exclusion criteria

  • 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.

Treatment and study plan

Doctor smile 635nm For Arm 1

Device

Participants will receive low-level laser therapy using a diode laser with a wavelength of 635 nanometers. The treatment will be applied twice weekly for five weeks to the affected temporomandibular joint muscles to reduce myofascial pain and improve muscle function.

Other names: device_LLLT

Doctor smile 980 nm For Arm2

Device

Participants will receive low-level laser therapy using a diode laser with a wavelength of 980 nanometers. The treatment will be applied twice weekly for five weeks to the affected temporomandibular joint muscles to reduce myofascial pain and improve muscle function.

Other names: device _LLLT

Primary outcomes

  1. Pain Intensity Reduction

    Time frame: 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

Secondary outcomes

  1. Maximum Mouth Opening (MMO)

    Time frame: At baseline, after 10 treatment sessions (5 weeks), and at 1-month follow-up (approximately 2 months in total from baseline).

    "Maximum Mouth Opening (MMO) was assessed in millimeters at three time points: baseline, after 10 sessions of low-level laser therapy (5 weeks), and at 1-month follow-up. Data are reported as mean ± standard deviation in the tables below. No conclusions or comparisons are included in this description."

  2. Lateral Jaw Movements

    Time frame: At baseline, after 10 treatment sessions (5 weeks), and at 1-month follow-up (approximately 2 months in total from baseline).

    Lateral jaw movements (side-to-side excursion) were measured in millimeters to assess changes in temporomandibular joint function. Measurements were recorded at baseline, after 10 sessions of low-level laser therapy (5 weeks), and at 1-month follow-up. Higher values indicate a greater range of mandibular motion.

  3. Changes in Muscle Activity Measured by Surface Electromyography (sEMG)

    Time frame: At baseline and after 10 treatment sessions (5 weeks)

    Surface electromyography (sEMG) was used to assess the electrical activity of the masseter and anterior temporalis muscles during maximum voluntary clenching. Recordings were obtained at baseline and after 10 sessions of low-level laser therapy (5 weeks). Results are expressed as mean amplitude values in microvolts (µV). Lower values indicate reduced muscle activity, which reflects clinical improvement.

  4. Protrusive Movements

    Time frame: At baseline, after 10 treatment sessions (5 weeks), and at 1-month follow-up (approximately 2 months in total from baseline).

    Protrusive mandibular movements were measured in millimeters to evaluate the functional improvement of the temporomandibular joint. Measurements were taken at baseline, after 5 weeks of low-level laser therapy, and at 1-month follow-up. Higher values indicate greater range of mandibular protrusive motion.

Sponsors and collaborators

Lead sponsor

National Institute of Laser Enhanced Sciences

Other

Registry information

Acronym: LLLTsEMG

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 17, 2025
Registry last updated
Oct 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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