Introduction
Materials and Methods
Study Design and Setting
Inclusion criteria
Exclusion criteria
Randomization and blinding
Interventions
Device information | Manufacturer | ASA (S.r.l., Vicenza, Italy) | |
Model identifier | MLS laser, Mphi | ||
Year produced | 2020 | ||
Number of emitters | 1 | ||
Emitter type | NIR laser with two synchronized laser diodes | ||
Irradiation parameters | Center wavelength | Laser diode 1 | Laser diode 2 |
905 nm | 808 nm | ||
Operating mode | Pulsed wave | Continuous wave | |
Power | 200 mW | 1000 mW | |
Peak radiant power | 75 W | 1.0 W | |
Frequency range | 1–2000 Hz | ||
Power level | 50% | ||
Target area diameter | ø 2 cm | ||
Beam profile | Two laser beams work simultaneously and synchronously with coincident propagation axes | ||
Application technique | Contact | ||
Irradiance or power density | 0.19 W/cm2 | ||
Number of points irradiated | 5 acupoints in the affected side. 7 acupoints applied bilaterally. A total of 19 acupoints | ||
Duration of each treatment session | 1140 s | ||
Dose of each point | 26.22 J | ||
Dose in the form of energy density | 8.35 J/cm2 | ||
Cumulative dose of each treatment session | 498.16 J | ||
Frequency of treatment | 3 times per weeks | ||
Total treatment session | 72 times |
Outcome Measure
Statistical Analyses
Results
Characteristic | LA group | Control group |
---|---|---|
Age, mean (SD), year | 45.43 (13.14) | 41.67 (13.81) |
Gender, No. (%) | ||
Female | 26 (61.90) | 31 (73.81) |
Male | 16 (38.10) | 11 (26.19) |
Body mass index, mean (SD) | 25.15 (5.36) | 26.49 (5.89) |
Affected side of facial paralysis, No. (%) | ||
Right | 21 (50.00) | 27 (64.29) |
Left | 21 (50.00) | 15 (35.71) |
Duration of facial paralysis, mean (SD), month | 14.05 (3.57) | 14.36 (3.35) |
Presence of hypertension, No. (%) | ||
Yes | 3 (7.14) | 6 (14.29) |
No | 39 (92.86) | 36 (85.71) |
Presence of diabetes, No. (%) | ||
Yes | 6 (14.29) | 0 (0) |
No | 36 (85.71) | 42 (100.00) |
Use of corticosteroid medications | ||
Yes | 28 (66.67) | 26 (61.90) |
No | 14 (33.33) | 16 (38.10) |
Use of Acupuncture | ||
Yes | 18 (42.86) | 22 (52.38) |
No | 24 (57.14) | 20 (47.62) |
Use of Exercise | ||
Yes | 18 (42.86) | 20 (47.62) |
No | 24 (57.14) | 22 (52.38) |
Primary Outcome
Baseline | Follow-up | |||||||
---|---|---|---|---|---|---|---|---|
LA group No./Total No. (%) | Control group No./Total No. (%) | P value | ORs (95% CI) | LA group No./Total No. (%) | Control group No./Total No. (%) | P value | ORs (95% CI) | |
HB 1 | 100(42/42) | 100(42/42) | > 0.99 | Not application | 26.19(11/42) ** | 76.19(32/42) ** | < .001 | 0.11 (0.04–0.30) |
ENoG2 | ||||||||
Orbicularis oculi | 100(42/42) | 100(42/42) | > 0.99 | Not application | 11.90(5/42) ** | 66.67(28/42) ** | < .001 | 0.08(0.02–0.21) |
Frontalis muscle | 97.62(41/42) | 100(42/42) | > 0.99 | 0.33(0.01–8.22) | 19.05(8/42) ** | 61.90(26/42) ** | < .001 | 0.14(0.05–0.39) |
Orbicularis oris | 100(42/42) | 100(42/42) | > 0.99 | Not application | 14.29(6/42) ** | 57.14(24/42) ** | < .001 | 0.13(0.04–0.36) |
Ala nasi muscle | 100(42/42) | 100(42/42) | > 0.99 | Not application | 14.29(6/42) ** | 75.61(31/42) * | < .001 | 0.06(0.02–0.18) |
Blink reflex 3 | ||||||||
R1 | 95.24(40/42) | 97.62(41/42) | > 0.99 | 0.49(0.04–5.59) | 4.76(2/42) ** | 59.52(25/42) ** | < .001 | 0.03(0.01–0.16) |
R2 | 100(42/42) | 100(42/42) | > 0.99 | Not application | 2.38(1/42) ** | 40.48(17/42) ** | < .001 | 0.04(0.004–0.29) |
R2 differences | 71.63(30/42) | 61.90(26/42) | 0.35 | 1.54(0.62–3.84) | 9.52(4/42) ** | 40.48(17/42) | < .001 | 0.15(0.05–0.51) |
Secondary Outcomes
Baseline | Follow-up | |||||||
---|---|---|---|---|---|---|---|---|
LA group | Control group | Mean difference | P value | LA group | Control group | Mean difference a | P value | |
SB Grading 1 | 27.29 (14.58) | 29.00 (16.47) | -1.71(-8.47 to 5.04) | 0.61 | 71.90 (11.98) | 51.64 (13.63) | 20.26 (14.69 to 25.83) | < .001 |
Latency (ms) of ENoG 2 | ||||||||
Orbicularis oculi | 3.30(0.26) | 3.45(0.62) | -0.15 (-0.36 to 0.05) | 0.14 | 2.47(0.52) | 3.08(0.32) | -0.61 (-0.43 to -0.09) | < .001 |
Frontalis muscle | 3.23 (0.37) | 3.14(0.29) | 0.09 (-0.05 to 0.24) | 0.21 | 2.63(0.25) | 2.75(0.17) | -0.12 (-0.21 to -0.03) | 0.01 |
Orbicularis oris | 2.84(0.46) | 2.83(0.51) | 0.01 (-0.21 to 0.22) | 0.96 | 2.36(0.34) | 2.65(0.21) | -0.28 (-0.41 to -0.16) | < .001 |
Ala nasi muscle | 3.32(0.40) | 3.29(0.36) | 0.02 (-0.14 to 0.19) | 0.74 | 2.77(0.27) | 3.04(0.24) | -0.26 (-0.38 to -0.16) | < .001 |
Amplitude of the MUAPs (mv) 2 | ||||||||
Frontalis muscle | 551.53(79.99) | 558.70(70.42) | -21.79 (-52.21 to 8.62) | 0.16 | 328.26(43.94) | 375.32(22.08) | -64.23 (-80.89 to -47.56) | < .001 |
Orbicularis oris | 544.11(68.77) | 565.90(50.07) | 14.02 (-16.55 to 44.59) | 0.36 | 325.30(32.13) | 389.54(43.76) | -29.82 (-55.03 to -4.62) | 0.02 |
Depressor angulli oris | 600.31(89.07) | 586.29(44.56) | -7.17 (-39.87 to 25.55) | 0.66 | 409.97(66.14) | 439.79(48.66) | -47.06 (-62.15 to -31.97) | < .001 |
Duration (ms) of EMG 2 | ||||||||
Frontalis muscle | 7.93 (0.85) | 7.89(0.73) | 0.05(-0.21 to 0.30) | 0.72 | 5.43(1.33) | 6.57(0.48) | -1.71(-8.47 to 5.04) | < .001 |
Orbicularis oris | 7.11 (0.37) | 7.30(0.71) | -0.19 (-0.44 to 0.05) | 0.12 | 5.08(0.57) | 5.96(0.81) | -2.16 (-2.58 to -1.74) | < .001 |
Depressor angulli oris | 8.17(0.55) | 8.13(0.62) | 0.04(-0.30 to 0.38) | 0.82 | 4.94(0.65) | 7.09(1.22) | -1.14 (-1.58 to 0.71) | < .001 |