Abstract
BACKGROUND
Trigeminal neuralgia (TN) is defined as intense, abrupt, often unilateral, stabbing, short, repeated episodes of pain in one or more distributional branches of the trigeminal nerve.
AIM
To see how electromagnetic therapy (EMT) compared to low-level laser therapy (LLLT) affect TN in diabetes patients.
DESIGN
This is a randomized controlled trial.
SETTING
Physical therapy and Neurology Outpatients Clinics at Faculty of Physical Therapy.
POPULATION
One hundred and forty diabetic patients with TN were evaluated for eligibility. As a result, 126 diabetic patients with TN were included in this trial. They were randomly divided into three equal-sized groups using random allocation software. Due to travel to another country, two patients did not complete the treatment protocol, and four opted out of the post-therapy evaluation. So, 120 volunteer diabetic patients with TN of both sexes were diagnosed for the participation in this study by a neurologist (N.=40 in each group).
METHODS
For two months, participants in the control group A received the medication only (oral hypoglycemic drugs, Analgesics, vitamin B12), participants in the study group B received the medications as in group A in addition to LLLT, and participants in the study group C received medication as in group A in addition to electromagnetic therapy (EMT). The primary outcome was the amplitude of compound muscle action potentials of temporalis and masseter muscles by using NEXUS 10 (Mind media). The secondary outcome was pain intensity by using the Visual Analog Scale (VAS).
RESULTS
According to the results of this study, there is a statistically significant difference in visual analog scale scores and the amplitude of compound muscle action potentials of the temporalis and masseter muscles among groups in favor of group B.
CONCLUSIONS
After treatment, all groups improved significantly, with the laser group outperforming the electromagnetic group by a large margin. For irradiation, LLLT was more effective than EMT in reducing diabetic patients’ trigeminal pain, and increasing masseter and temporalis muscles compound action potential amplitude in diabetic patients with TN.
CLINICAL REHABILITATION IMPACT
LLLT was more effective than EMT at reducing diabetic patient’s trigeminal pain, and increasing masseter and temporalis muscles compound action potential amplitude in diabetic patients with TN patients after two months of interventions.
Key words: Trigeminal neuralgia, Low-level light therapy, Magnetic field therapy
Diabetes is a risk factor for classic trigeminal neuralgia (TN), and nerve damage caused by hyperglycemia may be the link between the two disorders. More research is needed to confirm the correlation and define the underlying mechanism for the positive association, which would provide fresh insight into the etiology of TN and may be led to new therapeutic options.1
Diabetic neuropathy, a lesion or disease of the central or peripheral somatosensory nervous system, is considered a common cause of neuropathic pain. Chronic diabetic neuropathic pain is a major contributor to the global burden of illness, causing significant misery, poor quality of life, and impairment in individuals.2
Intense, abrupt, often unilateral, stabbing, short, repeated episodes of pain in one or more distributional branches of the trigeminal nerve were characterized as TN. The normal TN incidence is 4 to 5 per 100,000.1 TN is a unilateral condition characterized by sudden start and termination, transient electric shock-like symptoms, and limited to one or more of the trigeminal nerve’s three divisions. Trigger factors such as (trivial stimuli, smoking, shaving, washing, and talking) are commonly evoked pain.3
Most of those affected are in their forties and fifties, and females are the most affected. TN is common in alcoholism, diabetes, and DS. The exact etiology is unknown, but several predisposing factors such as root compression by a tumor or blood vessels in the cerebello-pontine angle are present. Attacks are triggered by jaw movements, such as brushing one’s teeth, smiling, or mastication, and can persist for days or weeks. In between attacks, the patient is fully free.4
Low-level laser therapy (LLLT) is a treatment method that employs a mono wavelength of light. The effects of monochromatic light and laser radiation on cell and tissue function are unknown.4, 5 Many researchers have reported significant pain reduction as a result of laser therapy in various disorders, including headache, rheumatoid arthritis, fibromyalgia, nervous system diseases, post-operative pain, lumbago, chronic cervical pain, and myofascial pain syndrome.5 Low-intensity laser therapy improves the capacity for myelin synthesis and increases nerve function in injured nerves, according to clinical trials. Moreover, it promotes axonal growth in wounded nerves in animal models.6
Electromagnetic therapy (EMT) uses the electric charge of the magnets in treatment. EMT treatment usually comes through an electric pulse. Bioelectromagnetism and pulsed EMT are two types of EMT that are non-invasive and painless treatments for various injuries, bone-related diseases, and symptoms. The treatment works by simulating a pulsating, variable frequency, and intensity electromagnetic field generated by a solenoid positioned around the patient. Pulsed magnetic fields usage was examined and has been proven to help the body regain positive potential faster, assisting most wounds healing, tissue repair, and lowering swelling faster.7 As a result, the randomized trial’s study question was:
How does low-level laser therapy, compared to EMT, influence the intensity and amplitude of the temporalis and masseter muscles’ compound muscle action potentials in diabetic TN patients?
The null hypothesis was that LLLT versus EMT would not induce clinically significant improvements in the intensity and amplitude of the temporalis and masseter muscles’ compound muscle action potentials in diabetic TN patients.
Materials and methods
Design ad sitting
A randomized controlled trial was carried out at outpatient physical therapy and neurology clinics with an ethical code stated in Helsinki Declaration 1975. It was conducted between October 2021 and February 2022. Our study had registration number: NCT05075707, which was found on Clinicaltrials.gov.
Procedures
Ethical considerations
Our procedures had ethically approved number: P.T.REC/012/003392 by ethical committee board approval of Faculty of Physical Therapy, Cairo University before performing the study. A description of the procedure was explained to all participants, and they signed a consent form. Also, they understand that they have the right to withdraw their consent and stop participating in this study at any moment without causing harm to the authors.
Sample size calculation
Sample size calculation: G*Power (version 3.1.9.2; Germany) was used to compute the sample size a priori (F tests- MANOVA: Repeated measures, within-between interaction), using an effect size of 0.45, an 80% power analysis, and a two-sided 5% significant level. As a result, the total estimated sample size for TN patients was 76 patients, increasing by almost 40% to 120 patients, when the dropout rate from the time of randomization to the end of the treatment protocol was taken into account.
Subjects
One hundred and twenty volunteer diabetic patients with TN of both sexes were chosen randomly and diagnosed for the study by a neurologist using physical examination and magnetic resonance imaging (MRI) on the brain stem. They were followed up and treated by the same referring neurologist informed by the study idea and objectives. All patients were recruited from Alkasr Al Ainy teaching hospital, Cairo University, and different dental and neurology clinics in the Cairo governorate. They were chosen based on the following criteria.
All of the subjects were between the ages of 26 and 41, male and female, diabetic type-2 patients with persistent TN, (from 3 to 6 months). Patients were awake, cooperative, and free of psychological concerns (as evaluated by a psychologist), as well as problems caused by orthopedic or particular sensory deficiencies. The International Classification of Headache Disorders 2 Criteria were used to diagnose Classical TN, with symptoms lasting 3 to 6 months.1 With no good medical pain treatment in the last three months, discomfort during attacks should not be less than a six on a VAS.
Patients were excluded if they acquired TN due to a tumor, herpes zoster, or any other cause other than diabetes, such as severe coagulation malfunction, cardiac dysfunction, or prior invasive therapy (ethanol, radiofrequency, Gama-knife microvascular decompression, glycerinum injection). Patients were not allowed to participate if they had a previous disability in the facial region, any musculoskeletal disorder, including contracture deformity or limitation of facial joint motion prior to illness, or visual and auditory problems.
Randomization
One hundred and forty diabetic patients with TN were evaluated for eligibility; six participants were omitted from the trial because they did not meet the inclusion criteria, and eight patients refused to participate. As a result, 126 diabetic patients with TN were included in this trial. They were randomly divided into three equal-sized groups using random allocation software to reduce selection bias.8 Due to travel to another country, two patients did not complete the treatment protocol, and four opted out of the post-therapy evaluation.
The patients were sorted into three equal groups at random through the Graph Pad Quick Calcs website9 (N.=40 in each group); group A (Control Group), which received medication only; group B, which received medication in addition to LLLT; and group C, which received medication in addition to EMT. Figure 1 shows a representation showing patient retention and randomization throughout the research.
Figure 1.
—CONSORT flow diagram.
Outcome measures
Primary outcome
The amplitude of compound muscle action potential of temporalis and masseter muscles was performed using NEXUS 10 (Mind media). This electromyography feedback application is a reliable research method for assessing and modifying brain activity.10 Before and after therapy, the compound motor action potential amplitudes in all patients’ masseter and temporalis muscles were measured. During the recordings, the participants were asked to sit comfortably upright and not move their heads. The electrodes were positioned two centimeters apart on the masseter muscle belly, parallel to muscular fibers, three millimeters above and anterior to the mandibular angle. This electrode location has been proven to be the most effective in reducing facial muscle cross-talk. The electrode over the anterior temporalis was positioned just in front of the hairline, and the reference electrode was placed just below the hairline over the lower neck. The signals were amplified and filtered using the Nexus 10 EMG device (Figure 2, 3).
Figure 2.
—Bilateral temporalis, active black, reference red, ground grey.
Figure 3.
—Rt masseter, active black, reference red, ground grey.
Secondary outcome
The VAS is a measurement technique that examines a characteristic or attitude that is difficult to measure directly, and it is assumed to run throughout a continuum of values.8 Frequently, the severity or frequencies of certain symptoms in epidemiologic and clinical studies were assessed by VAS.11 For example, a patient’s level of discomfort might range from none to a large deal. The patient perceives this range as continuous; their pain does not appear to leap in and out as a classification of none, mild, moderate, and severe would imply. The VAS was successful in capturing the underlying consistency. All participants were told to express their distress by VAS before and after therapy.
Intervention
Therapeutic equipment includes
1 - LASER SCANNER PAGANI, model 2014.LP1 Italy, 2014.
2 - EMT device (Electronica Pagani, class 1 type B, Italy, 2014.
Three groups received the following treatment: Control Group (A): all patients received the following medication only: oral hypoglycemic drugs, e.g., gliclazide, glibenclamide, or metformin. Carbamazepine (tegretol) 600-1200mg/day (pain clear and antiepileptic) Analgesics: Acupan (pain clear) Vitamin B12: Milga.12
Study group B: received medications as in group A in addition to low-level laser therapy, in the form of 2 months sessions (3 days/week), and 20 min/session laser scanner. Position of the patient was sitting and putting on glasses. The therapist’s position was sitting in front of the patient and putting on glasses. The laser group received irradiation from a low-power 15 mill watt helium-neon laser with a wavelength of 830 nm and a beam density of 150-170 mw/cm2. The treatment lasted 20 minutes and was delivered extra-orally on the tenderest spots, following the path of the nerve branches. The scanning laser technique was utilized on the skin overlying the four delicate spots of the face while seated.13
Study group C: patients in the electromagnetic group received medication as in group A in addition to EMT (Figure 4).
Figure 4.
—Application of EMT device.
In the supine position, with all metal objects removed, EMT was administered using electromagnetic electrodes for two monthly sessions (3 days/week) 20 min/session. Continuous magnetic field magnetic induction for 30 Gauss and frequency was 50 Hz. The position of the patient was supine. Both electrodes were placed on the affected side of the patient’s face, and the therapist was sitting on a chair.14 During the application of laser and electromagnetic modalities, no observable adverse effects were noticed. Each patient was asked to report any problems while the pain level was being monitored during the sessions.
Statistical analysis
The statistical analyses were calculated by SPSS 19. The mean value and standard deviation for each variable assessed throughout the research were calculated for both groups. The mean values of each parameter in each group were compared using the paired t-test. It was considered significant if the P value was less than 0.05. Analysis of Variance (ANOVA) was used to compare the findings after treatment across the three research groups. After ending the treatment, a comparison of clinical features between patients of the three groups revealed a significant difference using multivariate Analysis of Variance (MANOVA). P value was used to indicate the significance level (P<0.001).
Results
Subject characteristics
In the pre-treatment, there is no significant variation in age (years) across the groups, duration of illness (months), and clinical features among the three groups (GA, GB, and GC) (P>0.05) (Table I).
Table I. —Characteristics of patients in various categories before starting the treatment.
| Item | Control (GA) Mean±SD |
Study (GB) Mean±SD |
Study (GC) Mean±SD |
F | P | |
|---|---|---|---|---|---|---|
| Age (years) | 38.67±5.59 | 38.4±5.08 | 37.4±4.23 | 0.21 | 0.809 | |
| Duration of illness/ (Month) | 5.45±1.23 | 5.50±1.19 | 5.25± 1.16 | 0.24 | 0.784 | |
| Clinical features | 1- Temporalis muscle CMAP | 72.4±14.5 | 76.07±9.72 | 70.0±12.77 | 0.89 | 0.42 |
| 2- Masseter muscle CMAP | 132.67±20.53 | 126.8±29.47 | 129.7±28.2 | 0.19 | 0.83 | |
| 3- Visual Analogue Scale | 7.733±1.033 | 7.667±1.047 | 7.533±0.915 | 0.16 | 0.85 | |
SD: standard deviation; P>0.05: non-significant; *P≤0.05: significant, **P≤0.01: highly significant.
LLLT compared to EMT influenced the intensity and amplitude of the temporalis and masseter muscles’ compound muscle action potentials in diabetic TN patients.
A non-significant difference was discovered in the mean values of the temporalis muscle CMAP between pre- and post-treatment in the control group (GA), as the paired t-test results for the control group (GA) of (1.87), and the P value of (0.082). When the mean values of the temporalis muscle CMAP were compared before and after treatment for the study (GB), a highly significant difference was found, as demonstrated by the paired t-test result (4.32), and the P value is (0.001). The paired t-test result for the temporalis muscle CMAP between pre- and post-treatment for study (GC) reveals a significant change, with a P value of (0.026), and a paired t-test result of (2.49) (Table II, Figure 5).
Table II. —Comparison of the mean values of the amplitude of Temporalis muscle CMAP pre and post-treatment in three groups.
| Item | Control (GA) | Study (GB) | Study (GC) | |||
|---|---|---|---|---|---|---|
| Pre-test | Post-test | Pre-test | Post-test | Pre-test | Post-test | |
| Mean±SD | 72.4±14.5 | 77.47±14.13 | 76.07± 9.72 | 96.8±16.67 | 70.0±12.77 | 77.0±14.73 |
| t-value | 1.87 | 4.32 | 2.49 | |||
| P value | 0.082 | 0.001** | 0.026* | |||
*Significant; **highly significant.
Figure 5.
—The mean values of the amplitude of Temporalis muscle CMAP pre and post-treatment in all groups.
A significant difference was discovered in the mean values of the masseter muscle CMAP between pre- and post-treatment in the control group (GA), as demonstrated by the paired t-test findings of (2.23), before and post-treatment of the control group (GA), and P value of (0.043). When the mean values of the masseter muscle CMAP were compared before and after therapy for study (GB), a very significant difference was found, with a paired t-test result of (7.62), and a P value of (0.001). When the mean values of the masseter muscle CMAP were compared before and after treatment of study (GC), a significant difference was found, as evidenced by the paired t-test result of (2.82), and P value of (0.014) (Table III, Figure 6).
Table III. —Comparison of the mean values of Masseter muscle CMAP pre and post treatment in three groups.
| Item | Control (GA) | Study (GB) | Study (GC) | |||
|---|---|---|---|---|---|---|
| Pre-test | Post-test | Pre-test | Post-test | Pre-test | Post-test | |
| Mean±SD | 132.6±20.53 | 136.8±24.03 | 126.8±29.47 | 195.7±23.8 | 129.7±28.2 | 131.4±28.16 |
| t-value | 2.23 | 7.62 | 2.82 | |||
| P value | 0.043* | 0.000** | 0.014* | |||
*Significant; **highly significant.
Figure 6.
—The mean values of Masseter muscle CMAP pre and post-treatment in all groups.
When the mean VAS values in the control group (GA) were compared pre and post-treatment, a significant difference was discovered, as the paired t-test results for the control group (GA) are (2.93) and the P value is (0.011). When the mean VAS values for study (GB) were compared before and after treatment, a highly significant difference was found, with a paired t-test result of (6.20) and a P value of (0.00). When the mean VAS values for the study (GC) were compared before and after treatment, a significant difference was found, as evidenced by the paired t-test result of (4.96) and P value of (0.015) (Table IV, Figure 7).
Table IV. —Comparison between the mean values of VAS pre and post-treatment in all groups.
| Item | Control (GA) | Study (GB) | Study (GC) | |||
|---|---|---|---|---|---|---|
| Pre-test | Post-test | Pre-test | Post-test | Pre-test | Post-test | |
| Mean±SD | 7.73±1.03 | 6.66±1.54 | 7.66±1.04 | 4.00±1.89 | 7.53±0.91 | 5.66±2.02 |
| Median | 8 | 7 | 7.7 | 4.0 | 7.53 | 5.667 |
| Mode | 7 | 5 | 7 | 3 | 7 | 4 |
| Statistical z-value | 2.93 | 6.20 | 4.96 | |||
| Statistical P value | 0.011* | 0.000** | 0.015* | |||
*Significant; **highly significant.
Figure 7.
—Comparison between the mean values of VAS pre and post-treatment in all groups.
After ending the treatment, comparing clinical features among patients in the three groups reveals a significant difference using MANOVA (Table V).
Table V. —Comparison of clinical features of the Patients in all groups after ending the treatment.
| Item | Study (G A) Mean±SD |
Study (GB) Mean±SD |
Control (GC) Mean±SD |
F | P |
|---|---|---|---|---|---|
| 1- Temporalis muscle CMAP | 77.47±14.13 | 96.8±16.67 | 77.0±14.73 | 8.27 | 0.001** |
| 2- Masseter muscle CMAP | 136.8±24.03 | 195.7±23.8 | 131.4±28.16 | 29.58 | 0.000** |
| 3- Visual Analogue Scale | 6.66±1.54 | 4.0±1.89 | 5.66±2.02 | 8.13 | 0.001** |
*Significant; **highly significant.
Discussion
Diabetic mononeuropathy affecting the third, fourth, or sixth cranial nerves is frequently described in people with diabetes mellitus. However, the fifth cranial nerve (the trigeminal nerve) appears to be extremely seldom implicated. Acute painful neuropathy is an uncommon but distinct condition frequently associated with poor glycemic control. Rapid onset of intense pain, primarily in the thighs and lower limbs, characterizes it.15
Only 20-50% of diabetic people and 60% of Diabetic polyneuropathy dPNP patients develop neuropathic pain NP. It is unclear why some patients get NP and others do not. However, evidence of risk factors (demographic, metabolic, sensory, and genetic) for the development of NP in dPNP is emerging. Despite the fact that many studies have gone into understanding the processes of painful diabetic neuropathy (pDN) and neuropathic pain (NP), there are still no therapy options for the fundamental causes.16
TN is the most disabling condition causing severe pain known to humanity. Many surgical procedures and drugs have been used and failed for treatment. Despite the multiple approaches available, the results are unsatisfactory. In actual practice, treating pain in diabetic patients with TN is difficult.15
This study aimed to distinguish and compare the effects of LLLT and EMT on diabetic individuals with TN. Clinical EMG was used to scientifically quantify diabetic TN, while VAS was used to assess it subjectively. The current study’s major findings proved that LLLT and/or EMT combined with medication for two months sessions positively affect the level of pain, temporalis muscle action potential, and masseter muscle action potential in diabetic TN patients.
Trial group B, which received LLLT in addition to medicine, exhibited the greatest improvement and highest significant improvement in temporalis muscle action potential and masseter muscle action potential, and level of pain. The study group (GC), which received EMT EMT and medicine for two monthly sessions, showed significant improvement in temporalis muscle action potential, masseter muscle action potential, and pain level.
The control group A, which was treated by medication only, showed non-significant improvement in temporalis and significant improvement in masseter muscle action potential, and level of pain only showed significant improvement.
The masseter muscle was chosen as a model for investigating the therapeutic effects in this study because it is a superficial muscle with taut bands that are more superficial, making it simpler to discern those taut bands and thus more responsive to the external effect of LASER or EMT activity. Surgical treatments include nerve block, peripheral nerve transection, and radiofrequency ablation of the trigeminal nerve.10, 17, 18
Although surgical treatments have better efficacy than conservative treatments with drugs, they have many complications, such as higher treatment cost, higher recurrence rate, and greater trauma, that hold the patients back. Recently, LLLT is a therapeutic technique in which physical therapists use a mono wavelength light amplifier.12
Monochromatic light and laser radiation may change tissue and cell function. However, in many studies, laser therapy was accompanied by a significant reduction in pain intensity and frequency compared to other treatment strategies. However, in a few studies, there was no significant difference in the analgesic effect between the placebo group and the laser group. In treating diabetic TN, LLLT could be considered without any side effects.12, 16
Supporting the current study results, magnetotherapy is a safer form of healing than using medicines, according to the outcomes of key reasons for utilizing it. This is because magnetotherapy has had very few known negative effects yet. Furthermore, some previously published clinical research corroborates the validity that magnetotherapy is useful in pain alleviation.19, 20 This may explain improved CMAP and improvement of facial pain parallel with the current study’s findings.
The results of Gnitrov et al.21 and Berish et al.22 supported the current study results in the improvement of diabetic TN as they hypothesized that because magnetotherapy promotes blood circulation, it could help with recovery. Increased blood flow to the nerve or painful area means more nutrients are delivered to the affected area, and waste items are removed quickly. The intracellular signal transudation mechanisms for activating nitric oxide synthase (NOS) have been linked to oxidative stress. Free radicals’ lifespan is thought to be lengthened by electromagnetic fields (EMF).23
On the one hand, nitric oxide (NO) is produced continuously in the live organism and serves as an important physiological mediator; on the other hand, oxidative stress has been linked to the stimulation of nitric oxide synthase (iNOS). When various stimuli are imposed, such as bacterial lipopolysaccharide (LPS) exposure, iNOS is induced.
NO works in both directions, protecting and injuring cells, and its overproduction causes hypotension or shock. The presence of an electromagnetic field (EMF) is thought to extend the lives of free radicals and alter the activity of specific enzymes.21 In the liver of mice, EMF did not influence NO production. However, EMF increased the amount of NO produced by LPS, and this impact was dependent on the LPS dose.24
Conclusions
LLLT and EMT, as measured by the parameters in this study, can be utilized to treat TN in diabetes patients. However, laser therapy is more effective in reducing pain and improving CMAP. Both techniques relieve pain without causing any negative side effects. It could be beneficial, especially in patients with diabetic neuralgia who have tolerated medication therapy. It is worth noting that identifying neuralgia from other persistent pains, such as atypical face pain, is critical to treatment success. It is also thought to be a more effective and safe treatment option than medications for various orofacial dysfunctions.
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