After applying the inclusion and exclusion criteria, 55 subjects were enrolled; 18 subjects were assigned to group A and subjected to TENS and pharmaceutical therapy; 19 subjects were assigned to group B and received LLLT and pharmaceutical therapy, and 18 subjects were assigned to group C or the control group and underwent sham laser therapy and pharmaceutical therapy. Assignment of subjects to the groups was via block randomization; 20 blocks of three subjects each were used.
Subjects in all groups were evaluated in terms of demographic information (age and sex), history of MPS, the presence of parafunctional habits such as clenching and bruxism, and Angle’s class of malocclusion.
In group A (TENS and pharmaceutical therapy), patients (n=18) were subjected to TENS (Smart Series, Stimulator 710P, Novin Medical Engineering, Iran) in 10 sessions, each time for 20 minutes continuously with 100-μs pulse width and 10-Hz frequency in normal mode. (17,20)
In group B (LLLT and pharmaceutical therapy), patients (n=19) underwent LLLT with Gallium-Aluminum-Arsenide (GaAlAs) laser (Thor Co., London, UK) at 810-nm wavelength (808±5nm) and continuous-wave frequency three times a week for a total of 10 sessions. At each session, the laser was irradiated to the trigger points for 10 seconds. In case of absence of a specific trigger point, the laser was irradiated to several foci in the linear path of pain with the exposure settings of 200 mW/cm
2 average power, 10s duration, 2 J/cm
2 energy density, and 810-nm wavelength using a DD2 probe with an oval tip (1×1). (12) In terms of safety, this laser is classified as the 3B class with linear polarization (Thor Laser System, RN Medical, USA).
Eighteen controls received sham laser irradiation; however, patients were not aware whether they were receiving actual or sham laser irradiation. For the control group, the same laser handpiece was used but instead of the actual laser beam, only the guiding light was irradiated. A control group was included in this study to assess the psychological effect of treatment on the recovery of patients. (12)
All case and control groups received 500 mg of methocarbamol and 250 mg of naproxen t.i.d. for 10 days. (2,12)
To determine the level of pain of patients, a 10-point horizontal VAS was used before the treatment (baseline) and at one month after the treatment. Zero indicated no pain, while 10 indicated maximum pain. (2,12) The scores were recorded. The operator was blinded to the effects of treatment, and patients were also blinded to the phases of treatment. The person analyzing the results was also blinded to the effects of treatment.
In the examination of the major and minor muscles of mastication and the TMJ, right and left sides were separately examined. The side with higher VAS score was considered for data analysis. Kruskal-Wallis test was used to compare the three groups. In case of significant differences, pairwise comparisons were made by Dunn’s test.
Results
In this study, 55 patients with MPS were treated in three groups of TENS, LLLT, and sham laser. Patients were followed up after one month. At one month, 16 patients in TENS group, 18 patients in LLL group, and 15 patients in sham laser group showed up for the follow-up.
The VAS findings for tenderness of the muscles of mastication are as follows:
Table 1 shows the level of pain of the muscles of mastication in MPS patients at different time points. In the masseter muscle, the level of pain (VAS score) decreased in both TENS and LLLT groups after the treatment. The pain (VAS score) increased in sham laser group, and these changes in the three groups were statistically significant (P=0.001 for TENS, P=0.003 for LLLT, and P=0.028 for sham laser; Table 1). In the temporalis muscle, the level of pain decreased after treatment in TENS group but this reduction was not significant. In LLLT and sham laser groups, pain reduction was significant (P=0.843 for TENS, P=0.050 for LLLT, and P=0.001 for sham laser; Table 1). In the medial pterygoid muscle, pain severity decreased after treatment in TENS group but this reduction was not significant. Pain reduction in LLLT group was not significant either. Pain increased in sham laser group after treatment (P=0.160 for TENS, P=0.190 for LLLT, and P=0.001 for sham laser; Table 1). In the lateral pterygoid muscle, pain significantly decreased in TENS, LLLT, and sham laser groups (P=0.021 for TENS, P=0.006 for LLLT, and P=0.001 for sham laser; Table 1).
In the SCM muscle, pain significantly decreased in TENS group but this reduction was not significant in LLLT group. In sham laser group, tenderness significantly increased after treatment (P=0.049 for TENS, P=0.185 for LLLT, and P=0.001 for sham laser group; Table 1). In the trapezius muscle, pain significantly decreased in TENS and LLLT groups. In sham laser group, pain severity significantly increased (P=0.048 for TENS, P=0.027 for LLLT, and P=0.001 for sham laser; Table 1).
The amount of mouth opening in MPS patients at different time points is shown in Table 2. Mouth opening significantly increased in TENS group, while it significantly decreased in LLLT group after the treatment. The reduction in mouth opening was significant in sham laser group (P=0.051 for TENS, P=0.001 for LLLT, and P=0.001 for sham laser; Table 2).
Jaw deviation in MPS patients at different time points is presented in Table 3. Deflection and deviation were evaluated with respect to midline deviation when opening the mouth. Deflection increased in TENS and decreased in LLLT and sham laser groups; however, none of these changes were statistically significant (P=0.785 for TENS, P=0.063 for LLLT, and P=0.414 for sham laser; Table 3). Deviation increased in the three groups after the intervention but the increases were not statistically significant (P=0.180 for TENS, P=1 for LLLT, and P=1 for sham laser; Table 3).
Table 4 presents the level of TMJ pain in MPS patients. Regarding TMJ pain when opening/closing the mouth, pain significantly decreased in TENS group but this reduction was not significant in LLLT group. In sham laser group, TMJ pain significantly increased; the difference of sham laser group with LLLT and TENS was statistically significant in this respect (P=0.004 for TENS, P=0.157 for LLL, and P=0.001 for sham laser; Table 4).
The level of neck pain, earache, and headache in MPS patients at different time points is presented in Table 5. With regard to pain in the minor muscles of mastication, neck pain significantly decreased in TENS and LLLT groups, while it significantly increased in sham laser group (P=0.015 for TENS, P=0.056 for LLLT, and P=0.001 for sham laser; Table 5). Earache significantly decreased in TENS group but the reduction in pain in LLLT group was not statistically significant. Pain significantly increased in sham laser group after the intervention (P=0.013 for TENS, P=0.159 for LLLT, and P=0.013 for sham laser; Table 5). Headache decreased in TENS and LLLT groups after the intervention but not significantly. Headache significantly increased in sham laser group after the intervention (P=0.302 for TENS, P=0.099 for LLLT, and P=0.001 for sham laser; Table 5).
Comparison of TENS and LLLT for pain in the masseter and medial pterygoid muscles revealed that TENS was more efficient than LLLT in significantly decreasing the pain. For pain in the lateral pterygoid muscle, LLLT was more efficient than TENS. No significant difference was noted between TENS and LLLT for the other muscles.
Table 1. Pain scores of the muscles of mastication in MPS patients in the three groups at different time points
Table 2. Amount of mouth opening (mm) in MPS patients in the three groups at different time points
Table 3. Jaw deviation (mm) in MPS patients in the three groups at different time points
Table 4. TMJ pain score in MPS patients in the three groups at different time points
Table 5. The severity (VAS score) of headache, neck pain, and earache in MPS patients in the three groups at different time points
Discussion
MPS is a chronic disease with a relatively high prevalence. It affects the quality of life and can impair daily activities. (2) It is responsible for many lost work days. Thus, it is important to find non-invasive methods for treatment of MPS. In this study, we assessed non-invasive treatment methods for MPS, namely electro-physiotherapy by TENS and LLLT, in comparison with a sham laser control group to find the most efficient technique. New treatment modalities can decrease the dose and duration of pharmaceutical therapy for pain control. Comparison of VAS scores in TENS and LLLT groups before and after the intervention revealed that both modalities could be used for treatment of myofascial pain. The relationship of TMD with psychological disorders has been confirmed. Since it is believed that laser has psychological effects in addition to its somatic effects, we included a sham laser control group in our study; but apparently, this psychological effect cannot treat MPS alone, and the somatic effect of laser is dominant.
In 2013, de Godoy et al used a laser in the case group and had a placebo control group; their results were in accordance with our findings in the LLLT group. In our study, the laser was extra-orally irradiated on the painful muscles. Their results showed that laser decreased muscle pain and enhanced the quality of life of patients. (16) However, they only evaluated temporalis and masseter muscles, while we compared the level of pain and tenderness of the four muscles of mastication and the neck muscles.
In 2010, Mortazavi et al evaluated the factors related to MPS and found results similar to ours. Moreover, in their study, the number of females was higher than males, which was the same as in our study. This dominance may be due to the fact that female patients are more likely to seek treatment and show up for the follow-ups. (19) In 2005, Kato et al assessed tenderness of temporalis and masseter muscles but they did not examine medial and lateral pterygoids. (17) The level of pain was not significantly different between the two groups of TENS and LLLT but pain in each group significantly decreased after the intervention. Their results regarding the masseter muscle were similar to ours. However, no significant change occurred in the level of pain of the temporalis muscle in TENS group, and we only noted a significant reduction in pain in LLLT group. This difference may be due to the methodology of the two studies and to the method of using the tools at the trigger points; for instance, in TENS group, we used the handpiece extra-orally at the site of the muscle with maximum pain (which was mainly the masseter muscle). (8) Kato et al did not assess the psychological effect of laser but we had a sham laser group despite the self-limiting nature of muscle problems in TMD and thus, we can state with more certainty that both TENS and LLLT were efficient for pain relief, and partial recovery of patients cannot be exclusively attributed to time lapse because the results in the control group were not satisfactory.
In 2013, Amanat et al evaluated the efficacy of laser therapy along with pharmaceutical therapy for treatment of MPD. (12) In their study, GaAs laser at 980-nm wavelength was used, while we used GaAlAs laser at 810-nm wavelength; this may explain some differences in the results of the two studies. In contrast to our study, Amanat et al did not find a significant difference in pain intensity between the case and control groups. (12) In our study, significant pain reduction after treatment only occurred in the lateral pterygoid and temporalis muscles of the sham group while pain increased in their medial pterygoid and masseter muscles; therefore, the psychological effect of laser on muscle pain reduction was not confirmed in our study.
The mechanism of the analgesic (somatic) effect of the laser can partly be related to the release of endogenous endorphins, which has been confirmed in vitro. (25) This effect of laser depends on its intensity and specific wavelength. On the other hand, laser has an anti-inflammatory effect and not only increases the activity of macrophages and neutrophils but also enhances the secretion of specific inflammatory mediators. (10,26,27)
In 2007, Azizi et al evaluated the efficacy of laser for treatment of MPS and found a significant reduction in pain in the masseter, lateral pterygoid, and temporalis muscles, (1) which is similar to our findings; for the medial pterygoid, we found no significant change in LLLT group. In our study, the laser was used extra-orally on the skin; some previous studies have reported laser penetration depth of 2 to 5 cm in this position. (21,28,29) Thus, it is logical to assume that lower effect of LLLT on the medial pterygoid muscle in our study may be due to the deeper position of this muscle (in comparison with other muscles) and the consequently lower dose of laser absorbed by this muscle. Azizi et al only evaluated the somatic effect of the laser and had no control group to assess its psychological effect; (1) this was a limitation of their study.
In the current study, we evaluated the therapeutic effect of TENS on MPS. Evidence shows that TENS has both local and central analgesic effects. (20,22) Some studies have concluded that if a muscle is painful, treatment of its counterpart with TENS would decrease the intensity of pain in the primarily painful muscle. (20,22) As described earlier, TENS decreases pain via both peripheral and central mechanisms. Chronic muscle pain may be the result of the production and progressive accumulation of metabolic oxidation products in the muscle, stimulating the peripheral pain receptors. (24) Thus, pain control tools should act both centrally and peripherally. Both TENS and LLLT are capable of inhibiting pain via central and peripheral mechanisms. Thus, further studies on their pain control mechanisms can result in their more extensive and targeted use for pain relief.
Conclusion
Application of LLL can be successful for treatment of MPS. TENS is also an efficient modality for treatment of these patients.