Myofascial Pain Syndrome
Conditions
Keywords
Low-Level Laser Therapy
Brief summary
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.
Detailed description
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.
Interventions
DEVICEDoctor smile 635nm For Arm 1
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.
DEVICEDoctor smile 980 nm For Arm2
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.
Sponsors
National Institute of Laser Enhanced Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
This is an open-label study with no masking; both participants and investigators are aware of the treatment assignments.
Intervention model description
Randomized controlled trial with two parallel groups comparing the effect of low-level diode laser therapy at 980 nm and 635 nm wavelengths on myofascial pain in temporomandibular disorders. Participants receive treatment sessions over a defined period with outcomes measured by surface electromyography and pain scales.
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity Reduction | 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
| Measure | Time frame | Description |
|---|---|---|
| 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). | 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. |
| Lateral Jaw Movements | 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. |
| Changes in Muscle Activity Measured by Surface Electromyography (sEMG) | 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. |
| Protrusive Movements | 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. |
Countries
Egypt
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Low-Level Laser Therapy at 635 nm for Arm 1 Participants received low-level laser therapy using a diode laser with a 635 nm wavelength. Treatment was applied twice weekly for five weeks to the masticatory muscles affected by myofascial pain syndrome in the temporomandibular joint region, aiming to reduce pain and improve muscle function. | 15 |
| Low-Level Laser Therapy at 980 nm for Arm 2 Participants received 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.
Doctor smile 980 nm For Arm2: 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. | 15 |
| Total | 30 |
Baseline characteristics
| Characteristic | Low-Level Laser Therapy at 635 nm for Arm 1 | Low-Level Laser Therapy at 980 nm for Arm 2 | Total |
|---|---|---|---|
| Age, Continuous | 29.6 years STANDARD_DEVIATION 6.5 | 30.1 years STANDARD_DEVIATION 7 | 29.9 years STANDARD_DEVIATION 6.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 15 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 15 Participants | 15 Participants | 30 Participants |
| Sex/Gender, Customized female | 8 Participants | 7 Participants | 15 Participants |
| Sex/Gender, Customized male | 7 Participants | 8 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
Pain Intensity Reduction
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
Time frame: At baseline, after 10 treatment sessions (5 weeks), and at 1-month follow-up (approximately 2 months in total from baseline).
Population: All randomized participants in each arm (15 participants per group) were included in the analysis population. Analyses were conducted according to the intention-to-treat principle, including all participants who received at least one session of low-level laser therapy and had at least one post-baseline assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low-Level Laser Therapy at 635 nm for Arm 1 | Pain Intensity Reduction | Baseline | 7.6 units on scale | Standard Deviation 1.2 |
| Low-Level Laser Therapy at 635 nm for Arm 1 | Pain Intensity Reduction | Post-treatment(after 10 sessions) | 3.2 units on scale | Standard Deviation 1.1 |
| Low-Level Laser Therapy at 635 nm for Arm 1 | Pain Intensity Reduction | AFTER one month | 2.9 units on scale | Standard Deviation 1.3 |
| Low-Level Laser Therapy at 980 nm for Arm 2 | Pain Intensity Reduction | Baseline | 7.8 units on scale | Standard Deviation 1.1 |
| Low-Level Laser Therapy at 980 nm for Arm 2 | Pain Intensity Reduction | Post-treatment(after 10 sessions) | 2.5 units on scale | Standard Deviation 1 |
| Low-Level Laser Therapy at 980 nm for Arm 2 | Pain Intensity Reduction | AFTER one month | 2.1 units on scale | Standard Deviation 0.9 |
Comparison: The study was designed to compare the effects of 635 nm and 980 nm low-level laser therapy on pain and jaw function. Statistical analysis methods are described below.p-value: 0.0595% CI: [0.68, 0.79]Friedman test, Mann-Whitney U test
Secondary
Changes in Muscle Activity Measured by Surface Electromyography (sEMG)
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.
Time frame: At baseline and after 10 treatment sessions (5 weeks)
Population: sEMG analysis includes participants with valid baseline and post-treatment data. Differences in numbers are due to technical issues, poor signal quality, or withdrawals. Variations in sample size reflect missing data for some muscles or time points
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low-Level Laser Therapy at 635 nm for Arm 1 | Changes in Muscle Activity Measured by Surface Electromyography (sEMG) | Right temporalis M before treatment | 15.8 microvolts | Standard Deviation 2.9 |
| Low-Level Laser Therapy at 635 nm for Arm 1 | Changes in Muscle Activity Measured by Surface Electromyography (sEMG) | Right temporalis M after 10 sessions | 8.9 microvolts | Standard Deviation 2.3 |
| Low-Level Laser Therapy at 635 nm for Arm 1 | Changes in Muscle Activity Measured by Surface Electromyography (sEMG) | Left temporalis M before treatment | 16.1 microvolts | Standard Deviation 3 |
| Low-Level Laser Therapy at 635 nm for Arm 1 | Changes in Muscle Activity Measured by Surface Electromyography (sEMG) | Left temporalis M after 10 sessions | 9.2 microvolts | Standard Deviation 2.4 |
| Low-Level Laser Therapy at 635 nm for Arm 1 | Changes in Muscle Activity Measured by Surface Electromyography (sEMG) | Right masster M before treatment | 16.8 microvolts | Standard Deviation 2.9 |
| Low-Level Laser Therapy at 635 nm for Arm 1 | Changes in Muscle Activity Measured by Surface Electromyography (sEMG) | Right masseter M after 10 sessions | 8.9 microvolts | Standard Deviation 2.3 |
| Low-Level Laser Therapy at 635 nm for Arm 1 | Changes in Muscle Activity Measured by Surface Electromyography (sEMG) | Left masseter M before treatment | 17.2 microvolts | Standard Deviation 3.3 |
| Low-Level Laser Therapy at 635 nm for Arm 1 | Changes in Muscle Activity Measured by Surface Electromyography (sEMG) | Left masseter M after 10 sessions | 8.5 microvolts | Standard Deviation 2.2 |
| Low-Level Laser Therapy at 980 nm for Arm 2 | Changes in Muscle Activity Measured by Surface Electromyography (sEMG) | Left masseter M after 10 sessions | 10.2 microvolts | Standard Deviation 2.7 |
| Low-Level Laser Therapy at 980 nm for Arm 2 | Changes in Muscle Activity Measured by Surface Electromyography (sEMG) | Right temporalis M before treatment | 15.5 microvolts | Standard Deviation 3.1 |
| Low-Level Laser Therapy at 980 nm for Arm 2 | Changes in Muscle Activity Measured by Surface Electromyography (sEMG) | Right masster M before treatment | 16.5 microvolts | Standard Deviation 3.1 |
| Low-Level Laser Therapy at 980 nm for Arm 2 | Changes in Muscle Activity Measured by Surface Electromyography (sEMG) | Right temporalis M after 10 sessions | 9.9 microvolts | Standard Deviation 2.9 |
| Low-Level Laser Therapy at 980 nm for Arm 2 | Changes in Muscle Activity Measured by Surface Electromyography (sEMG) | Left masseter M before treatment | 16.8 microvolts | Standard Deviation 3.2 |
| Low-Level Laser Therapy at 980 nm for Arm 2 | Changes in Muscle Activity Measured by Surface Electromyography (sEMG) | Left temporalis M before treatment | 15.9 microvolts | Standard Deviation 3 |
| Low-Level Laser Therapy at 980 nm for Arm 2 | Changes in Muscle Activity Measured by Surface Electromyography (sEMG) | Right masseter M after 10 sessions | 9.9 microvolts | Standard Deviation 2.9 |
| Low-Level Laser Therapy at 980 nm for Arm 2 | Changes in Muscle Activity Measured by Surface Electromyography (sEMG) | Left temporalis M after 10 sessions | 10.1 microvolts | Standard Deviation 2.8 |
Secondary
Lateral Jaw Movements
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.
Time frame: At baseline, after 10 treatment sessions (5 weeks), and at 1-month follow-up (approximately 2 months in total from baseline).
Population: All randomized participants completed the study and were included in the analysis for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low-Level Laser Therapy at 635 nm for Arm 1 | Lateral Jaw Movements | baseline | 6.2 millimeters | Standard Deviation 0.9 |
| Low-Level Laser Therapy at 635 nm for Arm 1 | Lateral Jaw Movements | after 10 sessions | 8.3 millimeters | Standard Deviation 1 |
| Low-Level Laser Therapy at 635 nm for Arm 1 | Lateral Jaw Movements | follow up after one month | 8.5 millimeters | Standard Deviation 0.8 |
| Low-Level Laser Therapy at 980 nm for Arm 2 | Lateral Jaw Movements | baseline | 6.0 millimeters | Standard Deviation 0.8 |
| Low-Level Laser Therapy at 980 nm for Arm 2 | Lateral Jaw Movements | after 10 sessions | 8.7 millimeters | Standard Deviation 1.1 |
| Low-Level Laser Therapy at 980 nm for Arm 2 | Lateral Jaw Movements | follow up after one month | 8.8 millimeters | Standard Deviation 1 |
Secondary
Maximum Mouth Opening (MMO)
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.
Time frame: At baseline, after 10 treatment sessions (5 weeks), and at 1-month follow-up (approximately 2 months in total from baseline).
Population: All randomized participants in each arm (15 participants per group) were included in the analysis population. Analyses were conducted according to the intention-to-treat principle, including all participants who received at least one session of low-level laser therapy and had at least one post-baseline assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low-Level Laser Therapy at 635 nm for Arm 1 | Maximum Mouth Opening (MMO) | baseline | 34.5 millimeters | Standard Deviation 4.2 |
| Low-Level Laser Therapy at 635 nm for Arm 1 | Maximum Mouth Opening (MMO) | after 10 sessions | 41.3 millimeters | Standard Deviation 3.5 |
| Low-Level Laser Therapy at 635 nm for Arm 1 | Maximum Mouth Opening (MMO) | follow up after 1 month | 42.1 millimeters | Standard Deviation 3.2 |
| Low-Level Laser Therapy at 980 nm for Arm 2 | Maximum Mouth Opening (MMO) | baseline | 34 millimeters | Standard Deviation 3.9 |
| Low-Level Laser Therapy at 980 nm for Arm 2 | Maximum Mouth Opening (MMO) | after 10 sessions | 43.5 millimeters | Standard Deviation 3.2 |
| Low-Level Laser Therapy at 980 nm for Arm 2 | Maximum Mouth Opening (MMO) | follow up after 1 month | 44.2 millimeters | Standard Deviation 2.9 |
Secondary
Protrusive Movements
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.
Time frame: At baseline, after 10 treatment sessions (5 weeks), and at 1-month follow-up (approximately 2 months in total from baseline).
Population: randomized participants who completed the study protocol were included in the analysis. No participants were excluded from the outcome measure analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low-Level Laser Therapy at 635 nm for Arm 1 | Protrusive Movements | baseline | 5.8 millimeters | Standard Deviation 0.7 |
| Low-Level Laser Therapy at 635 nm for Arm 1 | Protrusive Movements | after 10 sessions | 7.4 millimeters | Standard Deviation 0.8 |
| Low-Level Laser Therapy at 635 nm for Arm 1 | Protrusive Movements | follow up after one month | 7.5 millimeters | Standard Deviation 0.7 |
| Low-Level Laser Therapy at 980 nm for Arm 2 | Protrusive Movements | baseline | 5.9 millimeters | Standard Deviation 0.6 |
| Low-Level Laser Therapy at 980 nm for Arm 2 | Protrusive Movements | after 10 sessions | 7.8 millimeters | Standard Deviation 0.7 |
| Low-Level Laser Therapy at 980 nm for Arm 2 | Protrusive Movements | follow up after one month | 8.0 millimeters | Standard Deviation 0.6 |