Trial Outcomes & Findings for Efficacy of Photobiomodulation Therapy Using 980nm Versus 635nm Diode Lasers for Treatment of Myofascial Pain (NCT NCT07069764)
NCT ID: NCT07069764
Last Updated: 2025-10-23
Results Overview
"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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
At baseline, after 10 treatment sessions (5 weeks), and at 1-month follow-up (approximately 2 months in total from baseline).
Results posted on
2025-10-23
Participant Flow
Participant milestones
| Measure |
Low-Level Laser Therapy at 635 nm for Arm 1
Participants will receive low-level laser therapy using a diode laser with 635 nm wavelength, applied 2 times per week for 5 weeks to treat myofascial pain syndrome in the temporomandibular joint.
Doctor 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.
|
Low-Level Laser Therapy at 980 nm for Arm 2
Participants will receive 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.
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|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy of Photobiomodulation Therapy Using 980nm Versus 635nm Diode Lasers for Treatment of Myofascial Pain
Baseline characteristics by cohort
| Measure |
Low-Level Laser Therapy at 635 nm for Arm 1
n=15 Participants
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.
|
Low-Level Laser Therapy at 980 nm for Arm 2
n=15 Participants
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.
|
Total
n=30 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
|
29.6 years
STANDARD_DEVIATION 6.5 • n=5 Participants
|
30.1 years
STANDARD_DEVIATION 7 • n=7 Participants
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29.9 years
STANDARD_DEVIATION 6.7 • n=5 Participants
|
|
Sex/Gender, Customized
male
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex/Gender, Customized
female
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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."
"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
Outcome measures
| Measure |
Low-Level Laser Therapy at 635 nm for Arm 1
n=15 Participants
Participants will receive low-level laser therapy using a diode laser with 635 nm wavelength, applied 2 times per week for 5 weeks to treat myofascial pain syndrome in the temporomandibular joint.
Doctor 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.
|
Low-Level Laser Therapy at 980 nm for Arm 2
n=15 Participants
Participants will receive 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.
|
|---|---|---|
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Pain Intensity Reduction
Baseline
|
7.6 "units on scale
Standard Deviation 1.2
|
7.8 "units on scale
Standard Deviation 1.1
|
|
Pain Intensity Reduction
Post-treatment(after 10 sessions)
|
3.2 "units on scale
Standard Deviation 1.1
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2.5 "units on scale
Standard Deviation 1.0
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Pain Intensity Reduction
AFTER one month
|
2.9 "units on scale
Standard Deviation 1.3
|
2.1 "units on scale
Standard Deviation 0.9
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SECONDARY outcome
Timeframe: 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."
"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."
Outcome measures
| Measure |
Low-Level Laser Therapy at 635 nm for Arm 1
n=15 Participants
Participants will receive low-level laser therapy using a diode laser with 635 nm wavelength, applied 2 times per week for 5 weeks to treat myofascial pain syndrome in the temporomandibular joint.
Doctor 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.
|
Low-Level Laser Therapy at 980 nm for Arm 2
n=15 Participants
Participants will receive 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.
|
|---|---|---|
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Maximum Mouth Opening (MMO)
baseline
|
34.5 millimeters
Standard Deviation 4.2
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34 millimeters
Standard Deviation 3.9
|
|
Maximum Mouth Opening (MMO)
after 10 sessions
|
41.3 millimeters
Standard Deviation 3.5
|
43.5 millimeters
Standard Deviation 3.2
|
|
Maximum Mouth Opening (MMO)
follow up after 1 month
|
42.1 millimeters
Standard Deviation 3.2
|
44.2 millimeters
Standard Deviation 2.9
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SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Low-Level Laser Therapy at 635 nm for Arm 1
n=15 Participants
Participants will receive low-level laser therapy using a diode laser with 635 nm wavelength, applied 2 times per week for 5 weeks to treat myofascial pain syndrome in the temporomandibular joint.
Doctor 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.
|
Low-Level Laser Therapy at 980 nm for Arm 2
n=15 Participants
Participants will receive 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.
|
|---|---|---|
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Lateral Jaw Movements
baseline
|
6.2 millimeters
Standard Deviation 0.9
|
6.0 millimeters
Standard Deviation 0.8
|
|
Lateral Jaw Movements
after 10 sessions
|
8.3 millimeters
Standard Deviation 1.0
|
8.7 millimeters
Standard Deviation 1.1
|
|
Lateral Jaw Movements
follow up after one month
|
8.5 millimeters
Standard Deviation 0.8
|
8.8 millimeters
Standard Deviation 1
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SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Low-Level Laser Therapy at 635 nm for Arm 1
n=15 Participants
Participants will receive low-level laser therapy using a diode laser with 635 nm wavelength, applied 2 times per week for 5 weeks to treat myofascial pain syndrome in the temporomandibular joint.
Doctor 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.
|
Low-Level Laser Therapy at 980 nm for Arm 2
n=15 Participants
Participants will receive 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.
|
|---|---|---|
|
Changes in Muscle Activity Measured by Surface Electromyography (sEMG)
Left temporalis M after 10 sessions
|
9.2 microvolts
Standard Deviation 2.4
|
10.1 microvolts
Standard Deviation 2.8
|
|
Changes in Muscle Activity Measured by Surface Electromyography (sEMG)
Right masster M before treatment
|
16.8 microvolts
Standard Deviation 2.9
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16.5 microvolts
Standard Deviation 3.1
|
|
Changes in Muscle Activity Measured by Surface Electromyography (sEMG)
Right temporalis M before treatment
|
15.8 microvolts
Standard Deviation 2.9
|
15.5 microvolts
Standard Deviation 3.1
|
|
Changes in Muscle Activity Measured by Surface Electromyography (sEMG)
Right temporalis M after 10 sessions
|
8.9 microvolts
Standard Deviation 2.3
|
9.9 microvolts
Standard Deviation 2.9
|
|
Changes in Muscle Activity Measured by Surface Electromyography (sEMG)
Left temporalis M before treatment
|
16.1 microvolts
Standard Deviation 3.0
|
15.9 microvolts
Standard Deviation 3
|
|
Changes in Muscle Activity Measured by Surface Electromyography (sEMG)
Right masseter M after 10 sessions
|
8.9 microvolts
Standard Deviation 2.3
|
9.9 microvolts
Standard Deviation 2.9
|
|
Changes in Muscle Activity Measured by Surface Electromyography (sEMG)
Left masseter M before treatment
|
17.2 microvolts
Standard Deviation 3.3
|
16.8 microvolts
Standard Deviation 3.2
|
|
Changes in Muscle Activity Measured by Surface Electromyography (sEMG)
Left masseter M after 10 sessions
|
8.5 microvolts
Standard Deviation 2.2
|
10.2 microvolts
Standard Deviation 2.7
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SECONDARY outcome
Timeframe: 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."
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.
Outcome measures
| Measure |
Low-Level Laser Therapy at 635 nm for Arm 1
n=15 Participants
Participants will receive low-level laser therapy using a diode laser with 635 nm wavelength, applied 2 times per week for 5 weeks to treat myofascial pain syndrome in the temporomandibular joint.
Doctor 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.
|
Low-Level Laser Therapy at 980 nm for Arm 2
n=15 Participants
Participants will receive 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.
|
|---|---|---|
|
Protrusive Movements
baseline
|
5.8 millimeters
Standard Deviation 0.7
|
5.9 millimeters
Standard Deviation 0.6
|
|
Protrusive Movements
after 10 sessions
|
7.4 millimeters
Standard Deviation 0.8
|
7.8 millimeters
Standard Deviation 0.7
|
|
Protrusive Movements
follow up after one month
|
7.5 millimeters
Standard Deviation 0.7
|
8.0 millimeters
Standard Deviation 0.6
|
Adverse Events
Low-Level Laser Therapy at 635 nm for Arm 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Low-Level Laser Therapy at 980 nm for Arm 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Low-Level Laser Therapy at 635 nm for Arm 1
n=15 participants at risk
Participants received photobiomodulation therapy using a diode laser at a wavelength of 635 nm. Treatment was applied twice per week for 5 weeks to the masseter and temporalis muscles associated with temporomandibular disorder. The goal was to reduce myofascial pain and improve mandibular function.
|
Low-Level Laser Therapy at 980 nm for Arm 2
n=15 participants at risk
Participants received photobiomodulation therapy using a diode laser at a wavelength of 980 nm. Treatment was applied twice per week for 5 weeks to the masseter and temporalis muscles associated with temporomandibular disorder. The goal was to reduce myofascial pain and improve mandibular function.
|
|---|---|---|
|
Eye disorders
No adverse events reported
|
0.00%
0/15 • "Adverse event data were collected from baseline, throughout the 5-week treatment period, and at the 1-month follow-up visit."
"The standard definitions of adverse events and serious adverse events, as provided by ClinicalTrials.gov, were used. Data were collected systematically through patient self-reports and clinical observations during treatment sessions and at the follow-up visit."
|
0.00%
0/15 • "Adverse event data were collected from baseline, throughout the 5-week treatment period, and at the 1-month follow-up visit."
"The standard definitions of adverse events and serious adverse events, as provided by ClinicalTrials.gov, were used. Data were collected systematically through patient self-reports and clinical observations during treatment sessions and at the follow-up visit."
|
Other adverse events
| Measure |
Low-Level Laser Therapy at 635 nm for Arm 1
n=15 participants at risk
Participants received photobiomodulation therapy using a diode laser at a wavelength of 635 nm. Treatment was applied twice per week for 5 weeks to the masseter and temporalis muscles associated with temporomandibular disorder. The goal was to reduce myofascial pain and improve mandibular function.
|
Low-Level Laser Therapy at 980 nm for Arm 2
n=15 participants at risk
Participants received photobiomodulation therapy using a diode laser at a wavelength of 980 nm. Treatment was applied twice per week for 5 weeks to the masseter and temporalis muscles associated with temporomandibular disorder. The goal was to reduce myofascial pain and improve mandibular function.
|
|---|---|---|
|
General disorders
None reported
|
0.00%
0/15 • "Adverse event data were collected from baseline, throughout the 5-week treatment period, and at the 1-month follow-up visit."
"The standard definitions of adverse events and serious adverse events, as provided by ClinicalTrials.gov, were used. Data were collected systematically through patient self-reports and clinical observations during treatment sessions and at the follow-up visit."
|
0.00%
0/15 • "Adverse event data were collected from baseline, throughout the 5-week treatment period, and at the 1-month follow-up visit."
"The standard definitions of adverse events and serious adverse events, as provided by ClinicalTrials.gov, were used. Data were collected systematically through patient self-reports and clinical observations during treatment sessions and at the follow-up visit."
|
Additional Information
DR.hala shaaban attiyah
National Institute of Laser Enhanced Sciences (NILES), Cairo University
Phone: 01012894478
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place