|Year : 2022 | Volume
| Issue : 2 | Page : 146-149
Efficacy of pulsed short wave therapy in symptomatic TMD patients: Randomized control trial
Sadhurya M Dhanasekaran, A Kannan, Krithika C Lakshmi, G Anuradha, K Yesoda Aniyan
Department of Oral Medicine and Radiology, SRM Dental College, Ramapuram, Chennai, India
|Date of Submission||30-Dec-2021|
|Date of Decision||28-Apr-2022|
|Date of Acceptance||29-Apr-2022|
|Date of Web Publication||22-Jun-2022|
Sadhurya M Dhanasekaran
Department of Oral Medicine and Radiology, SRM Dental College, Ramapuram, Chennai
Source of Support: None, Conflict of Interest: None
| Abstract|| |
Context: Temporomandibular joint (TMJ) is a ginglymoarthroidal joint of synovial variety. The joint's pathology includes those predominantly of musculoskeletal origin, which poses a complex problem in the clinical scenario. The management of temporomandibular joint disorders (TMD) remains a challenge due to the intricate anatomy of the joint and the multipart etiologies associated with it. Aims: This study aimed to compare the effectiveness of pulsed short wave therapy (PSWT) with pharmacotherapy in symptomatic TMD patients. Methods and Material: A total of 62 patients were included in this randomized control trial and were randomly allotted into two groups. Patients in Group I received PSWTand Group II received a combination of a muscle relaxant and a nonsteroidal anti-inflammatory drug (NSAID) for 5 consecutive days. Visual analog scale (VAS) scores were recorded during the follow-up. Statistical Analysis Used: The statistical analysis was performed using Stata/SE 17.0 statistical software. Results: There was a statistically significant difference in the groups for different periods. Kaplan–Meier function and extended survivor function tests showed better pain alleviation in the short wave therapy group. Conclusion: The current study shows that PSWT decreased pain without adverse effects. Therefore, it could be considered a safe and potentially effective adjuvant therapeutic modality for TMD.
Keywords: Pharmacotherapy, pulsed short wave device, temporomandibular disorders, temporomandibular joint, visual analog scale
|How to cite this article:|
Dhanasekaran SM, Kannan A, Lakshmi KC, Anuradha G, Aniyan K Y. Efficacy of pulsed short wave therapy in symptomatic TMD patients: Randomized control trial. J Indian Acad Oral Med Radiol 2022;34:146-9
|How to cite this URL:|
Dhanasekaran SM, Kannan A, Lakshmi KC, Anuradha G, Aniyan K Y. Efficacy of pulsed short wave therapy in symptomatic TMD patients: Randomized control trial. J Indian Acad Oral Med Radiol [serial online] 2022 [cited 2022 Jun 29];34:146-9. Available from: https://www.jiaomr.in/text.asp?2022/34/2/146/347927
| Introduction|| |
The temporomandibular joint is a bilateral, ginglymoarthroidal synovial joint of condylar variety, which helps articulate the mandible with the base of the skull. Literature reveals that temporomandibular joint disorders (TMD) affect approximately 5%–12% of the overall population. Irrespective of the numerous therapeutic modalities available for TMD management, there remains a substantial gap that requires newer studies to evaluate the efficacy of therapeutic interventions that are less invasive, potent, and do not cause obvious patient discomfort.
Pulsed short wave therapy (PSWT), or ActiPatch, is a low-power, nonthermal therapeutic aid that operates at 27.12 MHz and delivers a magnetic field in short pulses at 1000 pulses per second. PSWT brings about pain alleviation by sub-sensory stimulation of nerve fibers., This holds substantial potential in alleviating pain in patients suffering from TMD. This study attempts to assess the efficacy of PSWT in symptomatic TMD patients.
| Subjects and Methods|| |
This randomized clinical trial was carried out on patients reporting to the outpatient department of a dental college. Randomization was done using the computerized random table method. Simple random sampling was done to avoid selection bias. This study was approved by the institutional review board (SRMDC/IRB/2019/MDS/NO.901) date of approval: 04-12-2019, and informed consent was obtained from all the willing participants. The subjects were selected according to Axis I Research diagnostic criteria (RDC TMD criteria). A sample size of 62 was obtained, with each group receiving 31 samples. The sample size was calculated with 80% power and 5% alpha error.
- Subjects between 18 and 50 years of age of both genders
- Dull regional pain in the face persisting for more than 1 month in the temporomandibular region
- Patients with tenderness of the muscles of mastication.
- Patients with a history of neurologic or psychiatric disorders
- Patients with a history of dental pain, recent trauma, pathologies, dental treatment, or surgery
- Pregnant women
- Patients with a cardiac pacemaker.
Group I received PSWT for 60 min per day over 5 consecutive days [Figure 1]a and [Figure 1]b.
[PSWT or ActiPatch is a closed-loop system consisting of an antenna of about 30 cm2 with a low-energy signal generator circuit and a 3-V battery power supply. The frequency is about 27.12 MHz with a pulse rate of about 1000 Hz].
Group II received a combination of an NSAID and a muscle relaxant commercially available as Myospas TH [diclofenac – 50 mg and thiocolchicoside – 4 mg] twice a day for 5 consecutive days.
A visual analog scale (VAS) was used for recording pain scores both before and after the intervention (5th day) in both groups. The patients were recalled at a 2-week interval, and the VAS score was recorded at the end of the 2nd and 3rd weeks.
The statistical analysis was performed using Stata/SE 17.0 statistical software. The intragroup comparison was made using the Friedman test, and intergroup comparison of VAS scores between interventions and during follow-up visits was made using the Mann–Whitney U test. Kaplan–Meier function and exponentially extended survivor function were also done to grade the intervention.
| Results|| |
Of the 62 participants in the study, 27 males and 35 females were present with a mean age of 29.6 ± 5.8 in Group I and 31.5 ± 10.2 in Group II [Table 1].
|Table 1: Intragroup comparison of VAS scores between different time periods (5 days, 2 weeks, and 3 weeks) using Friedman test followed by Dunn's posthoc test|
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Intragroup comparison using the Friedman test showed a statistically significant difference in the groups for different periods [Day 5, 2 weeks, and 3 weeks]. (P < 0.001) [Table 1].
Intergroup comparison performed using Mann–Whitney U test showed no statistically significant difference in VAS scores between both the groups for day 5. A statistically significant difference was observed between the groups' VAS scores at the end of 2 weeks (P = 0.03) and 3 weeks (P = 0.03) [Table 2].
|Table 2: Intergroup comparison of VAS scores between interventions on day 5 and during follow-up visits using Mann–Whitney U test|
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The Kaplan–Meier function showed a rapid decrease in TMJ pain alleviation probability (0.91) in Group II during the second review visit at 2 weeks and a more rapid decline during the third review visit at 3 weeks (0.59). Group I showed a slight decline in the TMJ pain alleviation rate (0.96) only during the second review visit at 2 weeks and declined to 0.84 during the third 3 weeks review visit [Figure 2]. As depicted by the Kaplan–Meier curve, there was no difference in TMJ pain alleviation probability between both the groups on day 5.
Exponentially extended survivor function “emean” estimated the approximate overall meantime for TMJ pain alleviation, which was 109.32 days in Group I and 41.86 days in Group II [Figure 3].
|Figure 3: Exponentially extended survivor function for TMJ pain alleviation|
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| Discussion|| |
TMDs comprise pathologies involving both soft and hard tissues. Pain remains the most common debilitating symptom, invariably leading to disrupted psychological behavior. RDC/TMD is the most accepted and reliable diagnostic tool clinically with a sensitivity and specificity rate of 0.86 and 0.98.
The primary concern of intervention towards the management of TMDs is pain alleviation. Multimodality therapeutics involve physical therapy, pharmacotherapy, and surgical management. Transcutaneous electric nerve stimulation (TENS) and ultrasound (US) are emerging dual combinations. It is popular as it is noninvasive and effective in managing both acute and chronic cases. The pulsating effect of TENS seems to be a major drawback., Pharmacotherapy remains the primary modality easily accessible to the patients as over-the-counter medication. Numerous drugs are beneficial.
Many researchers have attempted to evaluate the variations in the prevalence of TMDs based on the age and gender being studied. Muthukrishnan and Sekar conducted a prevalence study on TMD subjects based on age among 3039 study subjects, and the results were 437 subjects in the age group 18–30 years, 846 subjects were in the age group 31–50 years, and 348 subjects in the age group above 50 years had TMD. In the current study, the mean age of the participants in the PSWT group was 29.6 ± 5.8 years with 13 males and 18 females and 31.5 ± 10.2 years in the medication group with 14 males ad 17 females.
ActiPatch (Bioelectronics corporation) belongs to contactless electroceuticals of PSWT, which emits a safe form of nonionizing electromagnetic radiation that induces sub-sensory stimulation of the nerve fibers. They work on the mechanism of gate control theory, which blocks the large nerve fibers and occludes the pain signals traveling to the brain. It provides pain relief through mitigation of central sensitization, which is accomplished through stochastic neuromodulation of afferent nerves. Staelin et al. found that it was effective in pain reduction in about 52% of the subjects with chronic back pain and concluded that it was an effective interventional modality in improving the quality of life. The device is portable, lightweight and sensation free, which the patients can easily handle without any professional guidance. It does not produce numbing, paresthesia, tingling, or tissue burning as seen in diathermy. Literature evidence with PSWT in TMD management is sparse. This is the first study investigating PSWT as an adjuvant treatment modality for TMD.
Fukuda et al. evaluated the effectiveness of PSWT among 128 female patients with knee osteoarthritis and assessed the pain score before, after the treatment, and follow-up after 12 months. The results demonstrated a significant reduction in pain and improvement in quality of life with long-term follow-up.
Fouda et al. compared low-level laser, dry needling, anesthesia, and pulsed electromagnetic field (PEMF) in 72 patients. After the intervention and follow-up, the ratio of pain score reduction was high in the PEMF group. In our study, the duration of the PSWT group was 60 min per day for 5 consecutive days. A statistically significant difference was found at the end of the intervention and at the end of 2 weeks (P = 0.0369) and 3 weeks (P = 0.0336).
Andrade et al. gave guidelines for pharmacological management of TMDs. He suggested muscle relaxants and NSAIDs orally twice daily, for 5 to 7 days. In the current study, the patients recruited in the pharmacotherapy group received a combination of a muscle relaxant and an NSAID. There was a significant reduction in pain (VAS score) at the end of the intervention (5th day), but there was no significant VAS score during follow-up.
Time to event analysis was performed to determine the probability of TMJ pain alleviation at different periods using the Kaplan–Meier function. It was concluded that almost half of the enrolled patients in the medication group reported a return of pain similar to the pretreatment at the end of 3 weeks. Whereas in the PSWT group, even at the end of 3 weeks a major proportion of the enrolled patients about 84% had retained the same level of VAS score. Exponentially extended survivor function “emean” revealed that the PSWT group showed an extended period of about 109.32 days during which TMJ pain remained alleviated. At the same time, Group II patients remained asymptomatic only for 41.86 days.
The ActiPatch group showed promising results toward pain alleviation in patients with TMD without any adverse effects. Time series analysis was performed, which showed better efficacy and which seemed to be a major strength of the study. Our study has certain limitations including shorter interventional duration and a smaller sample size. Long-term follow-up and blinding could have yielded better results. The pain intensity was the only parameter evaluated, whereas the functional outcome was not evaluated, which is a major drawback.
| Conclusion|| |
The current study demonstrates the efficacy of PSWT in symptomatic TMD patients. It serves as a safe, effective, and user-friendly treatment modality without any adverse effects. Further studies should be carried out with different populations and a longer duration of treatment. PSWT can serve as the treatment modality of choice in managing temporomandibular disorders.
Declaration of patient consent
The authors certify that they have obtained all appropriate patient consent forms. In the form, the patients have given their consent for their images and other clinical information to be reported in the journal. The patients understand that their names and initials will not be published, and due efforts will be made to conceal their identity, but anonymity cannot be guaranteed.
PSWT proves to be a better noninvasive alternative for TMD, as it brings about pain alleviation without any adverse effects
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |
Greene CS. “The Ball on the Hill”: A new perspective on TMJ functional anatomy. Orth Cranio Res 2018;21:170-4.
Valesan LF, Da-Cas CD, Réus JC, Denardin AC, Garanhani RR, Bonotto D, et al
. Prevalence of temporomandibular joint disorders: A systematic review and meta-analysis. Clin Oral Invest 2021;6:1-3.
Markov MS. Pulsed electromagnetic field therapy history, state of the art and future. Environmentalist 2007;27:465-75.
Koneru SN, Staelin R, Rawe IM. Chronic pain intervention using pulsed shortwave therapy: The relationship between pain demographics and central sensitization inventory. Pain Manag 2019;9:283-96.
Greene CS. Critical commentary 2: Validity of the research diagnostic criteria for temporomandibular disorders axis I in clinical and research settings. J Oral Facial Pain Headache 2009;23:20-3.
Chandra Veni AM, Kannan A, Krithika CL. To compare the effectiveness of transcutaneous electric nerve stimulation with ultrasound therapy in management of temperomandibular disorders. Int J Med Sci Innovat Res 2020;5:52-60.
Handa R, Sunil MK, Gupta C, Raina A, Khan T, Gulzar A. Efficacy of ultrasound massage therapy as an adjuvant pain control modality in TMDs: A clinical study. J Indian Acad Oral Med Radiol 2018;30:107. [Full text]
Wu M, Cai J, Yu Y, Hu S, Wang Y, Wu M. Therapeutic agents for the treatment of temporomandibular joint disorders: Progress and perspective. Front Pharm 2021;11:596099.
Muthukrishnan A, Sekar GS. Prevalence of temporomandibular disorders in Chennai population. J Indian Acad Oral Med Radiol 2015;27:508. [Full text]
Staelin R, Koneru SN, Rawe IM. An over-the-counter central sensitization therapy: A chronic back pain registry study of pain relief, medication use and their adverse effects. Pain Manag 2017;7:99-111.
Nair A, Sahoo R. ActiPatch: Can it be a tool to empower chronic pain patients? Indian J Palliat Care 2020;26:392-3. [Full text]
Fukuda TY, Alves da Cunha R, Fukuda VO, Rienzo FA, Cazarini C Jr, Carvalho ND, et al
. Pulsed shortwave treatment in women with knee osteoarthritis: A multicenter, randomized, placebo-controlled clinical trial. Phys Ther 2011;91:1009-17.
Fouda A. Comparison between four treatment modalities for active myofascial trigger points. Plast Aesth Res 2014;1:21-8.
Andrade EDD, Barbosa CMR, Pinheiro MLP. Pharmacological guidelines for managing temporomandibular disorders. Braz J Oral Sci 2004;3:503-5.
[Figure 1], [Figure 2], [Figure 3]
[Table 1], [Table 2]