Placebo effects can be very effective in certain pain conditions, but their use is still highly controversial. Several studies show that patients would accept a placebo treatment under certain circumstances, particularly when they are informed prior to the treatment or when there are no effective treatment alternatives. This study examines the question, which factors influence the degree of acceptability of a hypothetical placebo application.Patients filled in a questionnaire dealing with placebo applications. Moreover general data, diagnosis, duration of pain, pain ratings and anxiety/depression/stress scores, sleep disorders and opioid intake were collected from the patients` charts. 129 patients  entered the study. All patients had chronic pain syndromes and were treated in an universitary academic interdisciplinary pain center. Mean duration of pain was 14.7 years.The study did not show significant differences in placebo acceptability among patients with different pain diagnoses or accompanying psychological diagnoses or disorders. Hidden placebo application was considered much more unacceptable for the patients than the enhanced placebo or the open placebo application. An improved condition was associated with less feeling of deception, more trust and less negative mood than an unchanged or worsened condition.Acceptance of placebo as pain therapy is much more dependent on the way of application (hidden or open) or on the resulting condition  than on factors inherent in the individual patients. There are also psychological or functional effects such as expectations ,2 and thnstrated . Even opnstrated , migrainnstrated  and in cnstrated  demonstrnstrated . In deprnstrated .Conditioning plays an important role in placebo application ,16. In pThe clinical use of placebo is still highly controversial . On the There are some studies in the medical literature concentrating on the acceptance of placebo treatments –27. ThesWe therefore sought to broaden the present knowledge on placebo acceptability also to severely affected patients with chronic pain. Further, the present study examines the question, which factors influence the degree of acceptability of a hypothetical placebo application. In particular, we wanted to elucidate whether sex, age, pain duration, pain levels, anxiety, depression, and stress scores or different pain diagnoses, beyond musculoskeletal pain alone, have an influence on the acceptability of a hypothetical placebo application. To this end, we used a modified version of the questionnaire used by Kisaalita et al.  and applAll patients with chronic pain who were treated at the Interdisciplinary Pain Center of the University Hospital Freiburg, either with an interdisciplinary assessment of their pain or with multimodal pain treatment were eligible for the study. In our institution, new patients infrequently receive monodisciplinary outpatients` appointments as first contact. Mostly, patients are diagnosed during an interdisciplinary assessment. This is followed by multimodal pain therapy in many cases. Data were collected during a three-month period (5/1/2016-7/31/2016). Patients were asked to fill in a questionnaire about placebo applications. Patients signed a written declaration of consent to the study.The study was approved by the Ethics Committee of the University Hospital Freiburg (IRB number: 121/16). The datasets generated and analysed during the current study are available as a supporting information file.A questionnaire was distributed to the patients during their stay in the hospital. Prior to filling in the questionnaire, the patients read a fact sheet about the study and signed a declaration of agreement to participation in the study. The questionnaire contained modified questions partially derived from the questionnaire used by Kisaalita et al. . The firThe second part contained questions regarding the patient’s ratings scale on how deceptive placebo treatment would be for them under certain circumstances, how much they would lose trust to the doctor and how much this would negatively impact their mood . The patGeneral data, diagnosis based on the ICD , duration of pain, the presence of a sleep disorder and opioid intake were derived from the patients’ charts. Patients at our institution routinely fill in the German pain questionnaire  prior toA computer software package  was used to conduct statistical analyses. Initially, descriptive statistics were applied to all measures. Data were tested for normal distribution by means of the D’Agostino-Pearson normality test. The Wilcoxon signed rank test was used to compare ranks in measures without normal distribution. The Mann Whitney test was used to calculate sex differences in placebo acceptability. A Friedman test with Dunn`s Multiple Comparison test was used to calculate the variance of ranks among the scores for distinct questions. The Kruskal-Wallis test was used to compare the variance of ranks in unmatched observations. Spearmans correlations were calculated to test the correlation between pain levels on the NRS, depression anxiety and stress levels and the acceptability data. P <0.05 was considered statistically significant. The sample size estimation was performed with G*Power . With α 129 patients (44 m/ 85 f) entered the study (mean age 51.5 years). Mean duration of pain was 14.7 years. Patients suffered from a variety of different pain diagnoses such as:cervical pain,widespread pain,facial pain,headache,low back pain andneuropathic pain, mostly of the lower limb.A chronic pain disease with somatic and psychological factors (ICD 10: F45.41)  was diagThe acceptability rate for hidden placebo use was on average rated median 8 (IQR 3–10), . Median acceptability values were 6 (IQR 2–10)  for open placebo application, 5 (IQR 1–8)  for enhanced placebo application, 7 (IQR 4–10) (mean 6.3 SD 3.4) for placebo use in spite of alternatives, 5 (IQR 2–9)  for placebo use with no alternatives and 8 (IQR 3–10)  for diagnostic placebo application . Thus, tThere was no correlation between placebo acceptability and duration of pain. No difference in placebo acceptability was detected between male and female participants. No statistically significant difference was found in placebo acceptability between the different diagnosis groups. Also no statistically significant difference was found between patients with and without the diagnosis of chronic pain disease with somatic and psychological factors (ICD 10: F 45.41), with and without opioid intake, with and without sleep disorder, with and without anxiety disorder, depression or the presence of distinct psychological factors contributing to pain maintenance . Only a The diagnostic placebo condition also showed a weak negative correlation with depression scores  and anxiety scores . Stress scores and the mean, maximal and tolerable NRS scores showed no correlation with placebo acceptability scores.Overall cumulated median values for deception, trust and negative mood were much higher in the hidden condition than in the open condition , Table 5Overall cumulated median values for deception, trust and negative mood were 4 (IQR 1–8)  in the improved condition, 7 (IQR 3–10)  in the constant condition and 8 (IQR 3.5–10)  in the worsened condition. The difference between these values was statistically significant (p < 0.0001). The influence of the condition on deception trust and negative mood is displayed in There was no correlation between deception, trust and negative mood and sex or duration of pain. No statistically significant difference was found among the values for deception, trust and negative mood, between the different diagnosis groups, between patients with and without the diagnosis of chronic pain disease with somatic and psychological factors (ICD 10: F 45.41), with and without opioid intake, sleep disorder, anxiety disorder or the presence of distinct psychological factors contributing to pain maintenance. Generally, depression seemed to have some influence on the feeling of deception, impacted trust and negative mood. Here, in a number of conditions a there was a tendency towards statistical significance. Statistically significant differences between patients with and without depression were found for mood in the hidden placebo improved condition (p = 0.0499), for mood in the open placebo improved condition (p = 0.0332), and for deception in the open placebo worsened condition (p = 0.0253).For some placebo paradigms, there were slight and moderate inverse correlations of the values for deception, impacted trust and negative mood towards age of the patient (data not shown). The condition of placebo application had a much higher net impact on deception, trust and mood .Pain scores showed weak inverse correlations in the open placebo improved condition with deception , trust  and mood . Weak inverse correlations with pain scores were also seen in the open placebo unchanged paradigm with deception  and trust  and in the open placebo worsened condition with deception  and trust . The maximal pain scores and the tolerable pain scores showed no correlation with deception trust or mood.The present study examined factors that might contribute to placebo acceptability by means of an adapted patient-centered systematic approach to study placebo acceptability –27. In mFurther, the change of resulting condition plays a role in placebo acceptability: an improved condition goes along with less feeling of deception, more trust and less negative mood, than an unchanged condition or a worsened condition.The range of the values for placebo acceptability regarding hidden placebo, open placebo, enhanced placebo, placebo with or without alternatives and diagnostic placebo also reflects the findings by Kisaalita et al. . While iIn the hidden placebo and the worsened hidden placebo paradigm, there was an inverse correlation with age for the values for deception, impacted trust and negative mood. Thus, younger patients were more likely to feel deception and react with impacted trust and negative mood than older patients.The present study was successful in broadening the current data basis on placebo acceptability, but it widely failed in detecting specific influencing factors. No differences were detected regarding sex, pain duration, different pain diagnoses, anxiety/stress scores, psychosocial co-factors, sleep disorder or opioid use. However, older age, at least in some instances seems to go along with higher placebo acceptability in the hidden condition and in the diagnostic condition as well as less feeling of deception, impacted trust and negative mood in the hidden placebo unchanged and worsened and the open placebo worsened condition. Moreover, depression seems to increase the feeling of deception and negative mood and to decrease trust in the physician.All in all, our data suggest that placebo acceptability is much more dependent on the context of placebo application than on factors inherent to the single patient. Up to now, apart from single physicians performing hidden placebo treatments , placeboOur data do not allow any conclusions on how or when to apply placebos in a clinical context. At best, the data might serve to give the clinician an idea of when to expect acceptance of a placebo application and when not. Anyway, due to ethical considerations, that is to say, to respect the patients`autonomy, it is crucial that the patient decides, whether to use a placebo or not. Thus, only open label applications may be considered ethical. Blease et al.  argue thSome limitations of the study have to be discussed: participation in the study was restricted to patients undergoing multimodal pain treatment or interdisciplinary assessments. These patients were present at the hospital for at least one day. We limited the study to these patients, excluding patients coming for a single ambulatory appointment, because we sought to have time to explain to the patients that participation in the study would in no way imply a potential placebo treatment for them and that the study was only a theoretical survey, which had nothing to do with their actual treatment. This inclusion criterion however limited the number of patients eligible. Moreover, it is likely that this led to a higher portion of patients with chronic pain included in the study, as the long mean duration of pain indicates. This however was also an intended effect, as we wanted to collect data on placebo acceptability in patients with chronic pain, beyond (mild) musculoskeletal pain. The sample size estimation was difficult, as we did not have clear data in the literature on the expectable standard deviation. In any case, the sample size is sufficient to detect clinically important differences.Another limitation is, that the study did not distinguish between open label placebo with and without rationale . As patiAdvantages of the study are the relatively large number of participants, the broad variation over several distinct pain diagnoses and the high participation rate.In conclusion, the present study shows that placebo acceptability in chronic pain patients, is not, or only to a negligible degree, dependent on the pain diagnoses, pain duration and accompanying psychological factors. The paradigm of placebo application  and the resulting individual condition  are much stronger predictors of placebo acceptability. As the individual effect of a placebo application can not be predicted, it still difficult to decide whether or not a patient should receive an open or an open conditioned placebo. Therefore, future research might also examine the question whether placebo acceptability has an impact on the magnitude of placebo responses.S1 Table(XLSX)Click here for additional data file.


Usually discomfort and pain are associated with dental work, especially for young patients. Pain control can be achieved by using anesthesia. Sight of injection can terrify any patient and if the patient is a child it is really difficult to convince them for injections. Alternatives to injections have been explored. Pediatric dentists are using anesthesia in the form of jelly and patch. Recently, the concept of mucosal vibration has been put forward to enhance the effectiveness of local anesthesia.The aim of the present study was to compare and evaluate the effectiveness of lignocaine jelly and mucosal vibration in reducing pain during administration of local anesthesia in pediatric dental patients.Thirty children in the age group 6 to 11 years who required bilateral anesthesia for dental treatment in mandible were selected for this study. Pain was compared using Wilcoxon signed-rank test at the time of injection using Sound, Eye, Motor (SEM) scale as objective criteria and facial pain rating (FPR) scale as subjective criteria after administration of injection by a trained assistant who was blinded to the procedure.Local anesthetic injection along with mucosal vibration resulted in significantly less pain (p = 0.001) in comparison with the injections without the use of mucosal vibration.The result shows that mucosal vibration can be used as an effective means to reduce the intensity of pain during local anesthetic injection in dentistry.How to cite this article: Tandon S, Kalia G, Sharma M, Mathur R, Rathore K, Gandhi M. Comparative Evaluation of Mucosal Vibrator with Topical Anesthetic Gel to reduce Pain during Administration of Local Anesthesia in Pediatric Patients: An in vivo Study. Int J Clin Pediatr Dent 2018;11(4):261-265. Ointments, anesthetic sprays, gels, or adhesive patch are topical application of local anesthetic which are utilized to reduce pain of local anesthetic injections, but these methods have their own limitations.3Pain is defined as an unpleasant sensory and emotional experience arising from actual or potential tissue damage or described in terms of such damage.4 They proposed that the pain sensation can be reduced by activating nerve fibers that conduct touch, pressure, and temperature stimuli. The spinal cord is believed to have a neurological “gate” that either blocks or permits pain signals to travel up the spinothalamic tract to the brain. Stimulation of the larger diameter fibers through touch signal mechanoreceptors  causes activation of inhibitory neurons, which prevent the activation of projection neurons at the synaptic junction in the dorsal horn of the spinal cord. This results in a closure of the gate causing pain sensation.5 A decrease in pain intensity during vibratory stimulation was observed in patients suffering from acute or chronic musculoskel-etal pain of various origins in the study conducted by Lundeberg et al.5 Earlier use of Vibraject, attached to a traditional syringe to transfer a vibrating stimulus to the needle, did not result in a significant reduction of pain scores during needle insertion.67 Recently, Dr Steven Goldberg introduced Dental vibe® , which delivers vibration as a counterstimulation and in a sustained frequency onto the site of injection.3 Implementing the same concept of vibration, we have used Colgate 360° Total Advanced sonic-powered toothbrush for mucosal vibration. Bristles of the brush were covered with soft sponge with a frequency of 20,000 strokes/minute vibrations and named it as Rajasthan University of Health Science (RUHS) mucosal vibrator  and group II . The inclusion criteria were patients with a mean age of 8.5 ± 1.88 (6-11) years with Frankel’s behavior rating scale positive or definitely positive and who required bilateral local anesthetic injections in lower jaw for dental treatment whether restoration, pulpotomy, pulpectomy or extraction. Patients with Frankel’s behavior rating scale as negative or definitely negative and medically compromised patients were excluded from the study. Parents of the patients were explained about the study. An informed consent was obtained. The protocol of the study was reviewed and approved by the Medical Research Ethical Committee of Rajasthan College of Dental Sciences, Jaipur. In the first appointment, the injection site was isolated using cotton roll and the topical Precaine (8% lignocaine and 0.8% dibucaine)  anesthetic gel was applied using sterile cotton dipped applicator for 30 seconds to the injection site  and leftAs it is extremely difficult to quantify pain in children, two different objective and subjective scales were used:89 The SEM scale , an obje1011 Video recording of the whole procedure was done for further future evaluation. The second scale was Wong-Baker FPR scale , a subjeWilcoxon signed-rank test was used for statistical analysis. All analysis was conducted using Statistical Package for the Social Sciences software .There was a statistically significant difference between the mucosal vibration and the topical gel group (p < 0.001). 2 The pain due to injection of local anesthetic can be decreased by a number of methods which include reducing the speed of injection, application of counterirritation, varying the rates of infiltration, distraction techniques, buffering and warming the local anesthesia, use of fine needles with improved syringes, precooling the injection site, application of topical analgesics, and use of vibration.7 The present study was conducted to compare and evaluate the efficacy of mucosal vibration with topical local anesthetic Precaine gel  in pain reduction during injection of local anesthesia. A random crossover design was planned. In the study, patients with Frankel’s behavior rating scale as positive and definitely positive were included to rule out the emotional factors, such as tension, anxiety, depression, worries, and previous eventful dental experiences from affecting the results of study, as these may open the pain gate, thus reducing the threshold of pain.1112Management of pain during dental treatment is the most critical subject. Pain sensation is initiated by condition stimuli as sound of the drill or touch of the needle during local anesthetic injections and is not necessarily dependent on tissue damage.7 Minasian and Yagiela13 in a study concluded that topical anesthesia is more effective if charged ions of an anesthetic agent were driven by tissue through iontophoresis before insertion of needle.In this study, topical anesthetic gel was selected for comparison with the mucosal vibration because it is frequently used to reduce pain during an injection pro-cedure.7 Also, the additional time required to apply topical anesthesia may increase the child’s apprehension concerning the approaching procedure.14 Due to such problems, a predictable means of pain control along with local anesthetic administration is desirable.Toxic sequel may be associated with topical anesthetic because some of the topical agents are relatively toxic and amount of drug absorbed through the mucosa. Furthermore, the taste of the sprays and gels can make the child uncooperative. The effectiveness of the topical anesthetic gel also gets reduced due to dissolution of the agents with the saliva at the site. This was supported in a study conducted by Shilpapriya et al.15 studied 77 dental patients and found that a topical anesthetic (unspecified), when applied for 3 minutes, was no more efficient in reducing the pain of injection than was placebo.Kincheloe et al4 serves as a basis for explaining the analgesic effect of mucosal vibration. According to the theory, A-β nerve fibers, which transmit signal from vibration and touch receptors in the skin, stimulate inhibitory interneurons of the spinal cord. These neurons decrease the pain signal transmitted by A-δ and C fibers from the skin to second-order neurons that ascend to the brain.16The gate control theory of pain given by Melzack and Wall7 Nasehi et al,16 and DiFelice et al17 have reported decrease in pain when vibrating stimuli were applied during local anesthetic injection.Studies conducted by Shilpapriya et al,18 in pain perception when comparison was done between VibraJect® and a conventional syringe along with anaject.No statistically significant difference was found in the study conducted by Saijo et alThe present study showed that the use of mucosal vibrator during local anesthetic injection reduces patient discomfort and the soft sponge covering of the bristles of tooth brush used as mucosal vibrator in the study can have a massaging effect which helps in the dissolution of solution faster and a soothing effect.19Mucosal vibration can be an effective alternative for reduction in pain due to injection. The vibration might also be more effective if a more efficient vibration device compared with foam swab was employed. The level of dental anxiety may have a strong influence on an individual’s reaction, and knowledge of each patient’s level of dental anxiety may help tailor treatment to the patient’s needs.The present study included limited number of patients. Similar study involving larger sample size is required. Future studies can be conducted to compare the effectiveness of RUHS mucosal vibrator with similar devices to reduce pain perception during local anesthetic injection.Mucosal vibrator is an effective device during local anesthetic injection administration to alleviate pain and stress of injection. This device contributes both physiological and psychological aspect of patient management based on gate control theory of pain, audible distraction, and massaging effect of the device. As very few studies have been conducted related to this and since the sample size taken in this study was small, therefore, further research is warranted with a large sample size.


Pain management is one of the most important responsibilities of nurses in an intensive care unit (ICU). It is difficult to perform pain assessment appropriately in patients who are unable to report their pain. This study is aimed to determine the impact of implementing the critical care pain observation tool (CPOT) on the amount and frequency of analgesics' administration in ICUs.p values less than 0.05 were considered significant.This interventional study was conducted in 2014. Sixty nurses and 240 patients were studied. This study was carried out in three phases: first the data about amount and frequency of analgesic administration were extracted from patients' medical files. Then the CPOT was implemented into the nursing assessment process and finally, nurses' performance regarding the amount and frequency of analgesic administration was recorded. This data obtained before and after intervention were analyzed using chi-square and independent t-test p = 0.937, gender p = 0.996, and the cause of admission p = 0.996). We found that after implementing the CPOT into the nursing assessment process, the amount of analgesics administered  and the frequency of administration  increased significantly. Moreover, there was a significant increase in the frequency of pain assessment per patient per day in nursing practice after implementation of CPOT as compared to the practice before . The mean pain scores before and after the intervention (5.5 ± 1.08 vs.2.2 ± 0.48) were also significantly different.In this interventional study, we found that there was no difference in the demography and cause of ICU admission before and after implementation of CPOT :165-169.Modanloo M, Mohsenpour A,  Accordingly, accurate pain measurement depends on the patient's overt communication, both verbal and behavioral. Precise estimation and appropriate intervention for pain management pose a communication-related challenge between patients and healthcare providers.9 The American Society for Pain Management Nursing recommends its use in all ICU patients.8 This tool has been suggested to be used for assessing pain in adult patients with and without endotracheal tube; who are not able to communicate verbally. Use of this tool leads to a precise estimation of pain severity and consequently choosing an appropriate intervention for pain management.15Behavioral pain scales such as CPOT have been suggested by experts, and CPOT has been validated for use in adult patients in the ICU.17 Research finding reveals that caregivers frequently underestimate or overestimate pain intensity in more than 50% of their patients.18 However, a study has demonstrated that nurses often use invalid and biased methods to assess pain in patients19 and therefore, the majority of nurses (35-55%) underestimate the pain intensity.20 Furthermore, studies have shown that 64% of ICU patients, before and during painful medical care, do not receive care in order to relieve pain.20 Inadequate pain relief causes restlessness, myocardial ischemia, and lack of coordination with mechanical ventilation.21 On the other hand, the overuse of analgesics can also result in hypotension, respiratory depression, prolongation of mechanical ventilation, prolonged hospitalization, and respiratory infection associated with mechanical ventilation in the ICU.6Accurate pain assessment is required to ensure optimal pain management.19 The purpose of this study was to determine the impact of implementing the CPOT on the amount and frequency of analgesics' administration in ICU patients.Studies have shown that training nurses on the method of pain assessment and relief alone, is not enough to alter their performance in patients' pain management, but it is necessary to have guidelines and implement observation tools to assess pain and pain management nursing practices.This prospective interventional study with the before-and-after design was conducted in 2014. This study was undertaken to determine the effect of pain management program on nurses' performance and patients' clinical outcomes in ICU. The educational program consisted of two components-implementation of suggested objective tool, CPOT, as a part of the assessment process, and pain management.The sample consisted of all ICU nurses (n = 60) and 240 eligible patients. The eligible patients were intubated and had a low level of consciousness (GCS 5-10). They did not have neuromuscular disorders, delirium, and addiction to alcohol or drugs; and were not receiving continuous infusions of hypnotics, painkillers, and neuromuscular-blocking drugs. Four eligible patients were chosen randomly for each nurse who took care of them, two patients before and two patients after implementation of the CPOT.7 Each domain is scored from 0 to 2, and the total score can range from 0 to 8, a score >2 is interpreted as the presence of pain.8The instruments were organized to gather three types of data-nurses' information, patients' general and medical information, and data related to pain assessment and analgesics administration. In the first part, demographic variable of nurses including age and gender; and in second part, age, gender, and diagnosis of patients were collected; and in last part, the audit chart which was created for this study, was used to collect any information on pain assessment and relief such as amount and frequency of analgesics' administration, and some physiological parameters . The CPOT was used to measure pain score in last part. CPOT includes four sections. Each section includes a specific behavioral indicator: facial expression, body movement, muscle tension, and compliance with the ventilator for mechanically ventilated patients or extubated patients .7 Each dThis study was carried out in 5th of Azar Medical Center after approval of Ethics Committee of Golestan University of Medical Sciences (code: 364392121122). This implementation study included three phases. In preimplementation phase, data were extracted from medical records of 120 patients during the first 24 hours of admission in the ICU. In the implementation phase, all ICU nurses (n = 60) attended a one-day educational workshop, in which they were trained to document patients' pain management step by step, by focusing on CPOT. The CPOT and its instructions were attached in each ICU unit and included in ICU flow sheet. In the post-implementation phase, data were extracted from 120 ICU patients' medical files once more, which were matching the age and gender of patients in the preimplementation phase.Data were analyzed using SPSS version 16. Descriptive statistics were used to describe patients' and nurses' demographic characteristics and Chi-square and independent t-test were used to analyze data. The level of statistical significance was considered at less than 0.05.According to the findings, the majority of nurses participating in this study were female (88.3%), married (68.3%), and with a bachelor's degree (95%). The mean and standard deviation of their age, work experience in clinical setting, and ICUs were 31.43 ± 5.31, 2.74 ± 3.7, and 4.72 ± 3.67 years, respectively.p = 0.937), gender (p = 0.996), and the cause of hospitalization (p = 0.997)  were matched and there was no significant difference in terms of their age (= 0.997) .Also, comparison of the patients' physiological parameters  before implementing the CPOT did not show statistically significant difference among them . This dap <0.001) and nurses used this tool to measure the severity of pain in three stages; before and after the treatment of pain and at peak effect time of analgesics, which were 1.6 ± 0.75, 5.5 ± 1.08, and 2.02 ± 0.48, respectively.However, after implementing the CPOT, there was a significant increase in total score of nursing practice in pain assessment per patient per day compared with before  between the mean amount of analgesic administration before (7.95 ± 8.77) and after implementing the CPOT (11.01 ± 11.04). In addition, the frequency of analgesic administration after intervention (4.16 ± 0.99) was significantly (p <0.001) more than before intervention (2.91 ± 1.38). (p >0.05) . . Howeverp >0.05) .22Based on the findings, implementing the CPOT can lead to a significant difference in the amount and frequency of administered analgesics. It means using CPOT had led to a more accurate assessment of pain among hospitalized patients in the ICU. Gallo et al. reported a 33% increase in pain assessment times after training nurses about the use of neonatal and infant pain scale.23 Safari et al. showed that the use of BPS was effective in the ability to detect and monitor pain in patients with decreased level of consciousness, who are not able to express their pain. This enables the healthcare providers to diagnose and manage pain based on the behavioral symptoms. In addition, they concluded that the use of objective indicators by ICU nurses in the process of pain assessment is necessary.24Findings of Hirsch et al. also indicated that the behavior pain scale (BPS) training resulted in up to 76.1% increase in pain assessment by nurses.The comparison of the amount and frequency of analgesic administration during the first 24 hours of ICU admission showed a statistically significant difference before and after implementing the CPOT.25 Similarly, Rose et al. reported the use of CPOT increases the administration of analgesics in the ICU.26 However, Gélinas et al. and Arbour et al. reported that use of CPOT decreases the use of analgesics and sedatives.15According to the results, the amount and frequency of analgesic administration after the intervention was significantly higher than before. These results are consistent with the results of Williams et al. which showed that the use of pain behavioral tool increases administration of analgesics in ICU patients. They claimed that this was due to increased ability of nurses to evaluate the pain.19It is thus clear that the use of objective tools leads to a more accurate estimation of pain intensity. This is of great importance since the type and amount of analgesics for each patient should be based on assessing the severity and cause of his/her pain.Applying CPOT as an objective mean of pain assessment was effective in improving the performance of ICU nurses in assessment and management of patients' pain. It increased the amount and frequency of analgesic administration. We can recommend that COPT is a useful tool for assessment and management of pain in ICU patients and should be implemented in all ICUs.


Similarity of pharmacokinetics of intranasal ketorolac to the intravenous form and other advantages have promoted its application. This study compared the analgesic effects of intravenous and intranasal ketorolac in patients undergoing mandibular fracture surgery.In this clinical trial study, Sixty-four patients with unilateral mandibular fracture were divided randomly into two groups. In group 1, 30 mg of intravenous (IV) ketorolac was injected every 8 hours and in group 2, intranasal (IN) ketorolac spray was used as a 100-µL puff in each nostril (31.5 mg) every 6 hours. After each patient regained consciousness, pain intensity was measured based on visual analogue scale for 48 hours. Finally, the total dose of the opioid analgesic agent (pethidine) and the time for the first request for an analgesic agent were recorded for each patient, and their means were compared in each group with proper statistical tests.P<0.001). Furthermore, 2, 4, 6 and 8 hours after surgery, mean pain intensity in the IN group was significantly lower than that in the IV group (P<0.05). In the IN group, dose of antinociceptive medicine was slightly higher and the time to request it was shorter than the other group, but it was not statistically significant (P >0.05).Mean pain intensity of patients at baseline was significantly higher than that at other intervals and then, it decreased significantly (Application of intranasal ketorolac spray decreased pain after mandibular fracture surgery, especially at 8-hour interval after surgery, decreasing the need for opioids. Key words:Ketorolac, intranasal, intravenous, mandibular fracture. Pain which is an unpleasant feeling caused by destruction of a tissue disrupts the daily life even in its lowest rate. One of the most agonizing pains for patients is postoperative pain which is caused by inflammation and release of chemical mediators ,2. Lack Antinociceptive drugs typically consist of opioids which might have side effects like postoperative ileus, urinary retention, itching, dizziness, dependence, tolerance, addiction, vomiting and nausea. Based on the report of the Commission of Healthcare Accreditation Organization (CAHO), use of opioids in the postoperative period leads to patient dissatisfaction. On the other hand, use of partial agonists like tramadol has side effects like nausea, vomiting and ileus -5. ThereCurrently, use of NSAIDs, in combination with opioids or alone, is a part of multimodal antinociceptive treatments in controlling mild-to-moderate pains such as pain after maxillofacial, orthopedic and outpatient surgeries ,6,7.Ketorolac is an injectable NSAID drug with antinociceptive and antiinflammatory properties. This drug belongs to heterocyclic acetic acid family and has high antinociceptive effects and moderate antiinflammatory properties. The effect of this medicine occurs through blocking the formation of prostaglandins by blocking cyclooxygenase enzyme. Ketorolac, like other NSAIDs, is a non-selective COX inhibitor. Ketorolac is used to manage short-term moderate-to-severe postoperative pains. Maximum allowed time to use this medicine in oral form is 5 days, with 2 days for the injection form (intravenous or intramuscular) ,8-10.Intranasal spray (31.5 mg every 6–8 hours for 5 days) is another form of ketorolac, which has been introduced in recent years. Pharmacokinetics and half-life of intranasal spray are similar to the intravenous form. Its application have been promoted by its other advantages like ease of use, lack of pain during its intravenous or intramuscular injection and its use in patients with lockout oral feeding .et al.  Consent and intention to participate in the study2) Patients with unilateral maxillofacial fracture in the body, angle and parasymphysis, with fracture occurring not more than two weeks ago3) Patients in an age range of 20–60 years  4) ASA I  and ASA II patients  A VAS of ≥4 immediately after regaining consciousness (moderate to severe pain) -Exclusion criteria 1) Surgery lasting for >2 hours (due to complicated operation)2) Drug abuse by the patient 3) Psychopathic patients 4) Drug allergy 5) Systemic diseases that might be exacerbated due to drug side effects6) A history of seizures (due to anticonvulsive drug effects)7) More than one incision site 8) Use of more than two plates9) Edentulous patients (due to the difference in surgery procedure like circum wire)-Description of study groups The patients were divided randomly into two groups by a person not aware of the study objectives by using RandList software. In group 1, a 30-mg dose of intravenous ketorolac every 8 hours was prescribed and in group 2, a 15.75-mg dose of intranasal ketorolac  was prescribed as a 100-µL puff in each nostril (31.5 mg) every 6 hours.-Evaluation of the study outcomes The primary outcome of this study was the relief of postoperative pain. After regaining consciousness, the pain intensity was measured based on VAS for 48 hours at baseline and at 2-, 4-, 6-, 12-, 24-, 36- and 48-hour intervals. For this purpose, the patients were asked to express their pain intensity as a number from 0 (without pain) to 10 (severe and unbearable pain). Mean pain score for each patient in the study groups and at different time intervals were recorded and compared. The physician prescribed pethidine (25 mg) intravenously by the request of patient (PRN). Finally, total opioid dose (pethidine) was recorded for each patient in mg during the first 48 hours and the time of request for antinociceptive in minutes and the means of the groups were compared.Before initiating the study, each nurse was given the necessary instructions by the researcher about how to fill the checklist. The study process and pain scoring system were explained to the patients. All the patients completed the study and none left the study or was excluded. In this study, the surgeon and nurses in the ward, who recorded the prescribed doses of opioids and the first request for antinociceptives by the patient, were blinded to the study procedures. All the surgeries were carried out by a maxillofacial surgeon.All the patients underwent the general diagnostic procedures and treatment planning and none was deprived of care. All the ethical aspects of this study were approved by the Ethics Committee of Tabriz University of Medical Sciences (IR.TBZMED.REC.1396.1270). The study was registered in Iranian Clinical Trials Registration Center under the code IRCT2015062802295NB. At the beginning of the study, informed consent forms were signed by the subjects after proper explanations were provided by the researcher and explained to the patients in order to solve the problem of illiterate patients.-Analysis of data P<0.05.Data were analyzed with descriptive statistical methods , one-way ANOVA and repeated measures ANOVA using SPSS 19. Data normality was evaluated by Kolmogorov-Smirnov test. Statistical significance was set at In this study, 64 patients (48 men and 16 women) were evaluated with a mean age of 14.7±33.7 years  P>0.05). In other words, patients in both groups were the same regarding mean age and fracture type.The results of chi-squared test in terms of the gender of participants and the fracture site, and independent t-test in terms of mean age of patients showed no significant differences between the study groups (P<0.001). Sidak test was used for pairwise comparisons of different time intervals and mean pain intensity of patients. The results are presented in P<0.001).Based on Sidak test results, mean pain intensity of patients immediately after regaining consciousness was significantly higher than the means at other intervals and it was at the highest level (P<0.001). This process continued 12 hours after prescribing drug such that at each time interval of the study, pain intensity was higher compared to the following time intervals (P<0.001). In comparison of mean pain intensity in patients at 24-, 36- and 48-hour intervals after receiving drug, although slight clinical reduction in pain intensity of patients was observed, this decrease was not significant statistically (P>0.05). Therefore, mean pain intensity of patients 24 hours after receiving medicine up to 48 hours later was the same and in a very low level.Patients’ pain intensity 2 hours after receiving the first antinociceptive dose was the highest compared to 4-, 6-, 8-, 12-, 24-, 36- and 48-hour intervals (P<0.05). In contrast, immediately after regaining consciousness and 12, 24, 36 and 48 hours after surgery, means of pain intensity were not significantly different between the two groups (P>0.05).Independent-samples t-test was used to study the effect of antinociceptive drug on mean pain intensity at each study interval. The results of this test showed that 2, 4, 6 and 8 hours after surgery, mean pain intensity in the ketorolac spray group was significantly lower than that in the injection group. In addition, mean 48-hour mean pain intensity in the ketorolac spray group was significantly lower than that in the other group (P>0.05).The prescribed dose of antinociceptive agent during the 48-hour period after surgery and the first request for antinociceptive were recorded separately for each group . The resUse of opioid antinociceptives results in patients’ dissatisfaction due to their various side effects. Therefore, clinicians are not much interested in using them -5. On thNSAID drugs have been reported to be effective as a part of antinociceptive multimodal treatments in controlling mild to moderate pains, like maxillofacial postoperative pain, small orthopedic surgeries and outpatient surgeries ,7. KetorThe results of this study, which was designed and implemented to compare palliative effect of intravenous and intranasal ketorolac in mandible fracture surgeries, indicated that mean pain intensity of patients in both groups immediately after regaining consciousness was highest but it significantly decreased in 48 hours. Patients in the ketorolac spray group exhibited lower pain during the first 2 to 8 hours after regaining consciousness compared to the other group. Since patients in the intranasal ketorolac group received spray every 6 hours and every 8 hours in the injection group, in the first 8 hours, two doses (63 mg) and 1 dose (30 mg) were prescribed in spray and injection groups, respectively. Therefore, receiving a higher dose in the spray group can be effective in the lower pain intensity of patients in this group. Different studies indicated that pharmacokinetics and half-life of intranasal ketorolac (5.24 hours) is similar to its intravenous form (5–6 hours), explaining its considerable antinociceptive effects of intranasal ketorolac ,21.In this study, 12 to 48 hours after surgery, pain intensity was the same in both groups but its intensity decreased compared to the first 8 hours. The results also showed that the mean time of first opioid drug request and its dose were the same in both groups.et al. (et al. (Brown et al.  studied  (et al. , patient (et al. . This diet al. (He et al.  reportedet al. (Singla et al.  showed tet al. (Grant et al.  evaluateet al. (Bockow et al.  showed tThese results are consistent with our results that prescribing ketorolac, especially in the intranasal form, had antinociceptive effects 6 to 8 hours after surgery. Of course, in all these studies, the effect of placebo was compared with ketorolac spray. In this study, for the first time, the effects of ketorolac injection and spray were compared.Previous studies reported side effects for intranasal ketorolac. Approximately 24% of patients who used intranasal ketorolac exhibited transient nasal passage which was removed a few minutes after consuming the drug . HeadachThe use of intranasal ketorolac in patients with inter-maxillary fixation and limited oral antinociceptive agents can be useful. The similarity of pharmacokinetics and half-life of intranasal spray in its injected form and other advantages, like ease of use and not imposing intravenous or intramuscular injection pain, have increased the interest in its use. Of course, ketorolac spray is recommended only for 5 days because it has some side effects .-Limitations and suggestions There was no control group in this study. Therefore, the accurate and comprehensive comparison of opioid dose and painless time based on antinociceptive medicine was challenged. Although one maxillofacial surgeon conducted all the surgeries, creating the same accurate condition for all the patients, including surgery duration, trauma imposed on the surgery site, fracture type and other psychological factors, was not possible, which might have influenced the results of the study.On the other hand, it was not possible to blind the patients to the study because some of them received spray and some received injection. Another limitation of this study was the small sample size. It is suggested that larger sample sizes be used in future studies. Simultaneous use of oral or injected acetaminophen with intranasal ketorolac to manage acute pain in the first 6 hours after surgery is another suggestion that can be considered in future studies. In addition, in this study, only intravenous injection was used while other studies believe that intramuscular injection is more effective.


We evaluated the improvement of pain and the increase in mouth opening after temporomandibular joint arthrocentesis and the possible association with various factors such as previous splint treatment, medication, and diagnosis.We studied 57 temporomandibular joint disorder patients who underwent arthrocentesis at Korea University Anam Hospital. These patients  underwent arthrocentesis that was performed by one surgeon. The degree of mouth opening (assessed using the maximum mouth opening: MMO) and pain  were assessed pre- and post-arthrocentesis. The study also investigated whether treatment modalities other than arthrocentesis (medication and appliance therapy) were performed. Statistical analysis revealed that there was a significant difference in mouth opening and pain after temporomandibular joint arthrocentesis. Preoperative appliance therapy affected the results of arthrocentesis, but it was not statistically significant. With regard to pain relief, preoperative diagnosis did not show a significant difference. However, with regard to maximum mouth opening, patients with disc displacement without reduction with limited mouth opening (closed lock) showed the highest recovery (11.13 mm).The average of MMO increase after arthrocentesis was 9.10 mm, and patients with disc displacement without reduction with locking (closed lock) showed most recovery in maximum mouth opening and it was statistically significant. The average pain relief of patients after arthrocentesis was 3.03 in the VAS scale, and patients using anterior repositioning splint (ARS) preoperatively showed the most pain relief. Temporomandibular joint (TMJ) disorder (TMD) is a term used to define disorders occurring in the masticatory muscles, TMJ, and surrounding tissues . RegardlPatients with intra-articular TMDs present with various symptoms. An imbalance in the physiological relationship between the articular disc and condylar head causes various symptoms . Intra-aP < 0.001). Before the procedure, they showed a mean mouth opening of 24.1 ± 5.6 mm that increased to 42.7 ± 4 mm after arthrocentesis. The mean preoperative VAS  score was 8.75 ± 2.82, within the scale of 0 to 15, and it decreased significantly (P < 0.001) to 2.31 ± 2.55 after the procedure [TMJ arthrocentesis and lavage originated from the successful results of TMJ arthroscopy. Since the first publication on arthrocentesis by Nitzan and Dolwick in 1991 , TMJ artAppliance therapy was revealed effective in TMD patients with arthrogenous pain, with the purpose of reducing inflammation and joint load . Zhang eA muscle relaxant affects skeletal muscle function and decreases muscle tones. The decreased muscle tone can prevent the unnecessary forces that affect the TMJ, thus reducing the pain and giving stability to surrounding tissues. The muscle relaxants are believed to action by treating either spasticity secondary to upper motor neuron syndromes or muscular pain and spasms secondary to peripheral musculoskeletal conditions . There aIn this article, we evaluated the relationship between the decrease in pain and increase in mouth opening after TMJ arthrocentesis and the various factors such as previous splint treatment, medication, and diagnosis.This study was conducted on patients who visited Korea University Anam Hospital between January 2016 and June 2018 and were diagnosed with degenerative joint disease and disc displacement with and without reduction on radiographic and clinical evaluation. TMJ arthrocentesis was performed by one surgeon, and mouth opening and the degree of pain before and after the operation were examined. We also investigated whether other treatments  were performed before arthrocentesis. This study was approved by Korea University Anam Hospital in Seoul, South Korea: IRB number 2018AN0427, and informed consent was exempted because this study was a retrospective study.The sample was composed of individuals of both genders older than 15 years. Patients with signs and symptoms of intra-articular TMDs and degenerative joint disease and refractory to conservative treatment were included. They were diagnosed by the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD). Patients with previous surgery, hypoplasia and/or malignant neoplasm of the mandibular condyle, bone ankylosis, drug allergy, history of psychosomatic illness, or pregnant and lactating patients were excluded.The mouth opening and degree of pain were measured before TMJ lavage. The first step of TMJ arthrocentesis was extensive disinfection of the surgical site; a line was then drawn connecting the middle portion of the tragus and the outer canthus of the eye.Articular fossa and eminence were marked at 10 mm and 20 mm respectively, in front of the tragus, along the canthal-tragus line, and vertically bellow at 2 mm and 10 mm respectively. Through palpation of the two reference points, the condyle and articular eminence were marked with methylene blue solution.To reduce pain when inserting the needle, subcutaneous infiltration anesthesia was performed with 0.5 ml of 2% lidocaine using a dental anesthesia syringe.After opening the mouth of the patient, a 2-mL saline syringe was inserted with a 26G needle into the upper joint space, and saline was inserted with a gentle force. When 2 mL saline was aspirated again, it indicates that the needle is inserted into the proper place. The second needle was inserted in the same way in the same direction. After the needle was inserted, irrigation was performed for 30 min with 500 mL saline. At this time, the fluid was located at 1.5 m above the patient who is in supine position.Immediately after surgery, the surgeon injected hyaluronic acid into the operative site of the patient, and the distance between the maxillary and mandibular central incisors was measured to determine the MMO. Pain was recorded using the VAS, which is a subjective assessment. Postoperative MMO and VAS was measured 4 days after the procedure when patients came to the clinic for follow-up. The splint therapy was continued after 4-day follow-up.CRS and ARS were used to some patients in this study. CRS was used to reduce the bite force and joint load. ARS was used in patients with disc displacement, patients whose symptom persists after physical therapy or joint inflammation, and patients with severe inflammation to reduce the occlusal load. Splints were used prior to arthrocentesis. The period and duration of the appliance use varied depending on each patient’s symptom. Patients with severe symptoms wore the splint for 24 h (less than 1 week), and when the symptoms subsided, they were told to wear the splint during nighttime only.Muscle relaxant was prescribed to patients with muscle tenderness or pain. Thiosina Tab.  was used to patients three times a day. The medicine was prescribed more than 7 days depending on the symptom of the patients. Muscle relaxant was prescribed with painkiller  for the same days.®  was used for statistical analysis. To evaluate the result of arthrocentesis, paired t test was conducted. To compare the result of arthrocentesis categorized by various factors, t test and ANOVA were used. P < 0.05 was considered statistically significant in this study.SPSS for WindowsThe 57 patients with TMD met the eligibility criteria and underwent arthrocentesis . Of the 57 cases with TMJ lavage, 6 cases were performed on both sides and 51 cases were unilateral; 27 cases were of the right side and 24 were left.P < 0.05) (Table P < 0.05) (Table The average age of the patients was 38.65 ± 17.59 years old (Table 5) Table . The MMO5) Table . Patient5) Table .Table 1P = 0.400). With regard to MMO, the patients who were treated by both ARS and CRS showed more improvement (10.53 ± 5.94) than other groups (treated without appliance and treated with ARS) (Table P = 0.599). One patient was excluded in statistics because only one patient was treated with CRS.Patients treated with ARS showed most pain relief (3.67 ± 2.50) after arthrocentesis (Table P < 0.05) than those with degenerative joint disease and those with disc displacement without limited mouth opening , disc displacement without locking group , and degenerative joint disease group. There was no statistically significant association between preoperative diagnosis and pain relief Table . Howeverng Table .Forty-six out of 57 patients took a muscle relaxant to reduce the TMJ symptoms before arthrocentesis Tables  and 4. TPatients were also classified by the locking period. Locking was defined as subjective mouth opening limitation that patients say. To evaluate the efficacy of arthrocentesis on acute and chronic locking state, patients were divided into two groups depending on the locking period. Twenty-three out of 57 patients suffered from TMJ locking for more than 6 months Tables  and 4. PTMDs originate from the joint itself or arise due to any pathology of the muscles . The TMJArthrocentesis has been demonstrated to be effective in treating disc displacement without reduction . ArthrocTMJ splints such as ARS and CRS are most widely used conservative treatment that relieve the joint and muscle pain based on TMD education . It was There were studies about arthrocentesis that prescribed muscle relaxant after the procedure , 27. HowLocking period was one of the factors that were analyzed in this study. The result was that patient with locking more than 6 months showed slightly better results, but it was not statistically significant Tables  and 4. HWe investigated the MMO to evaluate the function of the TMJ. However, this study lacks information about the lateral movements of the jaws and TMJ. Hence, further study is needed to evaluate the improvement in TMJ function after arthrocentesis. The study was conducted to short-term follow-up, so it could not evaluate the long-term results.In this study, there were no complications such as facial nerve injury, pre-auricular hematoma, superficial temporal artery injury, and needle breakage in the joint  after TMThe average MMO increase after arthrocentesis was 9.10 mm, and patients with disc displacement without reduction with locking (closed lock) showed most recovery in MMO and showed statistically significant results. Among other factors, patients who used ARS and CRS preoperatively showed the second-best results in MMO.The average pain relief of patients after arthrocentesis was 3.03 in VAS scale, and patients using ARS preoperatively showed the most pain relief.


In this study, we aimed to evaluate the efficiency of the myorelaxant effect of CBD after the transdermal application in patients with myofascial pain. (2) Methods: The Polish version of the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD Ia and Ib) was used. A total of 60 patients were enrolled in the study and were randomly divided into two groups: Group1 and Group2. The average age in Group1 was 23.2 years (SD) = 1.6 years) and in Group2, it was 22.6 years (SD = 1.86). This was a parallel and double-blind trial. Group1 received CBD formulation, whereas Group2 received placebo formulation for topical use. The masseter muscle activity was measured on days 0 and 14, with surface electromyography (sEMG) . Pain intensity in VAS  was measured on days 0 and 14. (3) Results: in Group1, the sEMG masseter activity significantly decreased (11% in the right and 12.6% in the left masseter muscles). In Group2, the sEMG masseter activity was recorded as 0.23% in the right and 3.3% in the left masseter muscles. Pain intensity in VAS scale was significantly decreased in Group1: 70.2% compared to Group2: 9.81% reduction. Patients were asked to apply formulation twice a day for a period of 14 days. (4) Conclusion: The application of CBD formulation over masseter muscle reduced the activity of masseter muscles and improved the condition of masticatory muscles in patients with myofascial pain. Nowadays, dental practitioners are more obliged to treat patients suffering from myofascial pain (MFP). The main syndrome, which forces patients to search for medical help, is face and neck pain, headache and pain in the ear. Bruxism, the common sleep disorder and parafunctional activity of the masticatory system, may be considered one of the major causes of tooth wear and masticatory muscles MFP. Bruxism—determined by an increased activity of the limbic system, together with the modification of excitability of the neuromuscular spindles, leading to an increase in muscle contraction strength, which persists despite the end of motor function—constitutes a risk factor for the development of temporomadibular disorders (TMD). Bruxism is a common phenomenon that can affect from 8 to even 31% of the population without significant differences in relation to sex. Depending on the time of occurrence, we can distinguish awake bruxism (AB) and sleep bruxism (SB) . SB is aMyofascial pain (MFP) within masseter muscles is a common disorder. Excessive muscle effort in bruxers may develop muscle pain. The main syndrome of myofascial pain is a trigger point: a hard, painful on compression, palpable, localized nodule. Myofascial pain is a symptom of muscle damage. Energy crisis is the reason for the initial sarcomere contracture, that leads to increased metabolism and local hypoxia, muscle damage and inflammatory mediators release. Contraction knots are formed, as an effect of local injury, ischemia and fiber lock. The blood flow around and within the trigger point is reduced. Current approaches for trigger point management are needling, injections and deep massage.Cannabis sativa L. is known to contain more than 565 chemical compounds that belong to different groups, such as flavonoids, dihydrostilbens, phenanthrenes and the most characteristic for this plant—cannabinoids, mainly psychoactive THC, cannabidiol (CBD), and cannabinol (CBN) [Recently, there has been a heated debate regarding the controversial issue on the legalization of marijuana for medical purposes. The leaves of marijuana along with the blossoms and the fruiting tips of hemp are rich in tetrahydrocannabinol (THC). ol (CBN) ,5. The aol (CBN) . PsychoaC. sativa L. Within which we can distinguish three varieties: C. sativa, C. indica and C. ruderalis  [Cannabis sativa L. [Kingdom: Plantae (plants)Subkingdom: Tracheobionta (vascular plants)Superdivision: Spermatophyta (seed plants)Division: Magnoliophyta (flowering plants)Class: Magnoliopsida (dicotyledons)Subclass: HamamelididaeOrder: UrticalesFamily: CannabaceaeGenus: CannabisSpecies: sativaDespite the multi-character nature, cannabis is widely regarded as constituting only one very diverse species, ctively) . Botanicativa L. :Kingdom:Cannabis sativa L. is an annual plant belonging to the order Urticales, family Cannabaceae, and genus Cannabis (hemp) [s (hemp) . The higs (hemp) . Among ts (hemp) . Polyunss (hemp) . Varietis (hemp) ,12.CBD is an organic chemical compound belonging to the group of cannabinoids, which is present in hemp . Unlike According to a publication in 2017 by the National Academies of Sciences, Engineering and Medicine Waschington DC, cannabis might be used to treat chronic pain in adult patients . In a sy1—found primarily in the central nervous system and CB2—which occurs circumferentially and mainly in the immune system [1 receptors are activated by THC and CBD and are responsible for the local analgesic effect [In the human body, cannabinoids show their effect via two types of cannabinoid receptors: CBe system . CB recee system . Both CBc effect . The chec effect . CBD wasc effect  and in ac effect . The effc effect .®, Valeant Pharmaceuticals Inc., Laval, Canada, CB1 cannabinoid receptor agonist, and Nabiksimole , an extract containing delta-9-THC and CBD. Another cannabinoid-based drug available in the US is dronabinol , a synthetic delta-9-tetrahydrocannabinol. Nabilone is an oral drug approved by Health Canada for the treatment of severe chemotherapy-induced nausea and vomiting. Dronabinol, also in oral form, has also been approved for the treatment of severe chemotherapy-induced nausea and vomiting, as well as weight loss associated with acquired immunodeficiency syndrome. Nabiksimole is in the form of an aerosol for use on the oral mucosa, as an adjunct treatment to spasticity or neuropathic pain in adult patients with multiple sclerosis and incurable cancer pain [For the first time, cannabinoids are being used in medicine to treat pain . The procer pain .The activity of cannabinoids is associated with the modulation of adenylate cyclase and the operation of ion channels—by blocking N-type calcium channels, THC decreases the release of acetylcholine in the hippocampus and norepinephrine from sympathetic nerve terminals . Thus, aThis is a parallel-group, double-arm, randomized, double-blind clinical trial conducted to assess the myorelaxantand antinociceptive effect of CBD. A total of 60 patients were enrolled in this study and were provided with CBD formulation for dermal application. The enrolled patients were referred to the Department of Temporomandibular Disorders at the Medical University of Silesia in Katowice, Poland.n = 60) were randomly divided into two groups by allowing them to pick up a number (even or odd) from the container with formulation  and control group   . The ave5 males) . PatientPatients who agree to participate in the studyPatient’s age must be within ≥18 and ≤60 yearsGood general healthTemporomandibular disorder–positive as per the Polish version of the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) for group Ia and Ib .Presence of all teeth (with the exception of third molars)The inclusion criteria were as follows:Cannabis formulation/placebo formulation allergyHypersensitivity to substances to be used in the studySkin wounds with skin surface discontinuationAddiction to cannabisPatients being treated with analgesic drugs and/or drugs that affect muscle function Fixed or removable dental prosthesis Disease or autoimmune disorder associated with generalized muscular tensionThe exclusion criteria were as follows:ClinicalTrials.gov (NCT03994640). This study was performed in accordance with the Declaration of Helsinki and the International Conference on Harmonization: Guidelines for Good Clinical Practice. Patients received verbal and written information describing the trial and gave their consent to participate in the study.This study was approved by the Bioethical Committee of the Silesian Medical Chamber in Katowice, Poland (number KNW/0022/KB1/7/19) and is retrospectively registered at This study followed the consolidated standards of reporting trials (CONSORT) statement and was performed between 01.01.2018 and 01.01.2019 in the Department of Temporomandibular Disorders at the Medical University of Silesia in Katowice, Poland.(1)Screening visit for study participation and inclusion.(2)Baseline visit for sEMG test  and random allocation to the group, receiving a packaging with formulation (CBD or placebo) along with the instructions on how to use it.(3)First follow-up visit after 14 days of application .The trial consisted of two main visits, preceded by screening:Patients were examined by experienced dentists . Randomization was performed by ANB, a dentist, who was not involved in follow-up visits. The sEMG tests were performed by KWD on Day 0 and Day 14. KWD used the same paper templates to place electrodes in exactly the same position on follow-up visits on Day 0 and Day 14, to achieve comparable results. She was not aware of the patient’s group.Masseter muscle tension (μV) at rest and in maximal contraction was measured in previously determined points, with four-channel Neurobit Optima 4.0 . Points were repeatably marked on patients’ skin on baseline visit (EMG I) and on follow-up visit (EMG II) in the region of masseter with a special paper template. Two dischargeable electrodes with a diameter of 10 mm were placed with conductor gel on each of the masseter muscle: near the origin, under the zygomatic arch, and on the angle of the mandible, approximately 10 mm from each other. The location of the electrodes was based on anatomical landmarks, palpated by the dental practitioner during the examination of stomatognathic system. Patients were asked to perform an isometric contraction of the masseter muscles to find the best place to fix the electrode.www.seniam.org). Four Ag/AgCl adhesive electrodes, diameter 30 mm , were applied bilaterally, directly on both the masseter muscles (under the zygomatic arch and on the angle of the mandible) with an interelectrode distance of 10 mm. Patients remained in a silent and calm room and were made to sit in an upright position with feet on the floor and looking forward. The occlusal plane was parallel to the floor. Reference electrodes were placed on the neck. The sEMG signal was amplified and digitized.The placement of the electrodes, as well as preparation of the skin, was consistent with SENIAM guidelines: facial hair was shaved if necessary and cleaned with alcohol  of the mandible were recorded. It was done without the teeth contact and the position of the mandible was maintained only by the force of gravity and viscoelasticity of the stomatognathic system tissues. Patients were asked to slightly open the mouth until the teeth of the upper and lower jaw were out of contact. Then, the sEMG records of RP from right and left masseter muscles were recorded during a maximal voluntary isometric contraction (MVIC) and was established as the reference value: the tests were repeated thrice for each muscle on each side. The tests were separated by at least 1 min of rest. The mean values of sEMG (μV) of the masticatory muscles in mandible’s RP and in MVIC, obtained from Bioexplorer Neurobit .Normalization of the data collected allows for the assessment of the level of activity of the masseter muscle during RP as compared to the maximal activation capacity of the masseter muscle ,32. The Patients in Group1 were given CBD formulation, which was prepared according to the individual recipes for testing purposes. Many different vehicles were tested in order to obtain the best features of the CBD formulation. Cannabis oil and Charlotte’s Web Hemp Extract Oil Formula Olive Oil 30 mL  with 20% CBD oil was prepared. The approximate content of CBD  in this formulation was 1.46%.Cholesterol 3.0 gSolid paraffin 15.0 gLiquid paraffin 64.0 gWhite vaseline 18.0 gThe composition of cholesterol ointment (per 100 g) according to Polish Pharmacopoeia XI, on the basis of which a formulation with CBD oil was prepared:It was decided to develop a formulation based on cholesterol ointment due to the lack of pharmaceutical incompatibility with the test hemp oil containing CBD. Cholesterol ointment is a type of official pharmacopoeial medium used in pharmacy as an absorption medium, i.e., an emulsifying active substance dissolved in a solvent, which is most often water. Cholesterol ointment can be used to make various formulations as a vehicle, it can be also an independent preparation in an unprocessed form. A large “amount of water”, defined as the amount of water in grams that 100 g of substrate permanently binds at 20 °C of 120 for the substrate used, allows to emulsify a large amount of water and aqueous solutions. The presence of water in the formulation will reduce the feeling of greasiness—the preparation will have a lighter consistency and will allow the introduction of any additional active substances or water-soluble preservatives into the drug. The discussed medium can be applied to thermally and mechanically damaged skin, in atopic dermatitis and after long-term treatment with steroid ointments, so any pathological changes at the application site will not be a restriction on the use of the preparation. All ingredients are safe for the skin and do not cause irritation. There are also no specific contraindications for the use of this ointment base.Oleum CBD 2.0 g (20% CBD oil)Aqua purificata 3.0 gUng. Cholesterol 5.0 gPatients in Group2 were given control formulation, based on cholesterol as the vehicle but without CBD oil. The following is the composition of control formulation:Aqua purificata 3.0 gUng. Cholesterol 5.0 gThe ointments had the same consistency and color, they were packed in the same containers, which made it impossible to distinguish the formulation with CBD oil from placebo.In both groups, the formulation was intended for topical use to be applied on the skin surface of the masseter muscle, at the right and left side. Containers with CBD formulation were marked with even and odd digits for the appropriate group to allocate patient in one of the two groups. In addition to patients, doctors did not know the identity of the formulation. First, patients were asked to perform an allergy test by applying a small amount of the formulation (placebo or CBD) on the skin of the forearm 24 h before therapy. In the case of swelling, itching, or redness on skin, the patients were asked to quit therapy.Each patient had been taught on the procedure to apply the formulation in equal amounts (the size of peas) on both sides. Patients were informed that the formulation should be applied and rubbed gently into the skin surface (approximately 4 × 4 cm) and were supposed to apply it twice a day for up to a period of 14 days before the follow-up visit.t-tests for dependent samples, assuming the target values of test power equal to 95% (0.95) and 99% (0.99) and the significance level of the test α = 0.05. The values were generated using the STATISTICA software package, version 13.1. The results are presented in the table below , with an interval of 14 days. In statistical analysis, to demonstrate the effectiveness of CBD formulation, the following statistical tests for dependent samples were used:t-test, since the group sizes were rather small (n = 30), we performed the Shapiro–Wilk normality test. According to the Student’s t-test. The significance level of 0.05 was assumed.α = 0.05.The null hypothesis t-test. For the patients treated with CBD formulation, there was a significant improvement in masseter sEMG activity .We obtained results similar to that of Student’s An alternative to the Wilcoxon signed-rank test is the Sign test. Sign test provided the following results in As it was shown in the sign test, a significant decrease in electromyographic activity of masseter muscles was noted in patients treated with CBD formulation. The results of sign test match Wilcoxon signed-rank test results. t-test and Mann–Whitney U-test, the effect of the treatment with CBD formulation is clearly visible. In the case of Wald–Wolfowitz test, there is no basis to reject the null hypothesis; however, in the case of comparison of p-values, the significance level is close to 0.05.Based on the results of Student’s p-values) of the statistical analysis.ith population, t-student tests are given in We verify the null hypothesis: p-value is approximately 0). In the case of Group2, patients treated with placebo, however the hypothesis is rejected for significance level 0.05.As one can observe, for the Group1 of patients treated with CBD formulation the difference between means on Day0 and Day14 is very large and the null hypothesis will be rejected at any level of significance  presents A conclusion similar to that formulated for t-Student test can be obtained. For the patients treated with CBD formulation in Group1, the zero hypothesis will be rejected at any level of significance. In the case of the Group2 (patients treated with placebo) the result depends on the level of significance. Such a situation shows the essential influence of the treatment with CBD formulation for the average pain level .p-values) of the statistical analysis.The sign test gives the following results (the decision is taken for significance level 0.05): As one can observe from the sign test follows a significant impact of the treatment CBD formulation in Group1 for the decreasing of the average pain level (the conclusion the same as in the case of the Wilcoxon signed-ranks test).In t-test for independent samples means (the null hypothesis is that means are the same in two Groups)Student’s Wald-Wolfowitz runs test and U Mann- Whitney test (the null hypothesis is that probability distributions are the same in Group1 and Group2)In comparing the results between Group1 and Group2 after 14 days of therapy, we use the following tests:p-values) are shown in The results , the null hypothesis will be rejected according to all considered tests, so the impact of the treatment with CBD formulation in Group1 is visibly essential. p > 0.05). In the case of Group1 after 14 day, there was a significant effect of CBD on the average level of the rest sEMG activity of masseter muscles. In the case of Group2 after 14 days, there was no effect of using the formulation on the average level of masseter muscle sEMG activity.According to our results, there were no statistically significant differences between the two groups in terms of age or gender (The sEMG masseter muscle activity was significantly decreased in Group1 (CBD formulation) (11% in the right masseter muscle and 12.6% in the left masseter muscle) compared to Group2 (placebo formulation) (0.23% in the right masseter muscle and 3.3% in the left masseter muscle). The reduction in the mean values of sEMG after normalization of rest masseter was statistically significant in Group1 and was not significant in Group2 .In the case of Group1, there was a significant effect of CBD on the average pain level of masseter muscles. In the case of Group2, there was no effect of using the formulation on the average pain level of masseter muscle. It was observed in the study that pain intensity in VAS scale after 14 days of application of CBD formulation over masseter muscles was significantly decreased in Group1 (CBD) from the average VASI = 5.6 (SD = 1.38) on Day 0, to VAII = 1.67 (SD = 1.44). Comparing to Group2: placebo formulation application from the average VASI = 5.10 (SD = 1.26) on Day 0 to VASII = 4.60 (SD = 1.58) on Day 14. The pain intensity in VAS scale was significantly decreased in Group1 (CBD formulation): 70.2% reduction comparing to Group2 (placebo formulation): 9.81% reduction. The reduction was statistically significant in Group1 and was not significant in Group2 .There were no adverse effects recorded in this study.CBD is a non-psychoactive substance that can affect the treatment of many disease states, including pain and inflammation , which iInhalations are the most popular way of administering the active substances contained in cannabis . The sysTransdermal cannabinoids are effective in reducing pain and inflammatory symptoms ,39. PoteAccording to Lucas, CBD transdermal administration is 10 times higher than administration of THC in humans . Among aCannabinoids are used, inter alia, in treatment of nausea and vomiting in patients after chemotherapy  to incre2 skin surface, 3.8 ng/mL (SD = 1.4 ng/mL) CBD was found in blood plasma [Wong has found that intramuscular injection of THC reversed the mechanical sensitization, induced in masseter muscle of rats . Authorsd plasma . CBD forL SD = 1. ng/mL CBAccording to Stinchcomb expected therapeutic plasma level of CBD is 10 ng/mL in therapy of nausea vomiting, but also in pain therapy . The strNo psycho-active side effects were observed in patients attending control visits, because there was no THC in the cannabis oil, and there were no cases of hypothermia or hypomobility induced by THC.The surface electromyography (sEMG) recordings were performed at mandibular rest position from the masseter region and results were compared intra-session and inter-sessions after 7 and 14 days. A frequent complaint against studies comparing EMG values is the lack of reproducibility of sEMG measurements. However, according to a study published by Castroflorio in 2005, the analysis of the masseter muscle activity was considered repeatable, both between visits and during one study . AuthorsDysregulation of the balance between sympathetic and parasympathetic part within the autonomous nervous system is probably a very important factor in the induction of bruxism and myofascial pain. The autonomic nervous system regulates the body’s unconscious actions, for example sleep bruxism. Innovative methods to reduce muscle tonus and allow masticatory muscles to recover form myofascial pain are in demand . CBD as The application of CBD formulation on the masseter muscle reduces sEMG activity and pain intensity of masseter muscles during RP and improves the condition of the muscle in patients with MFP. Further research is needed in this field, but CBD, as an alternative for THC, should be taken into consideration in the therapy of masticatory muscles in patients with TMD.


Chronic low back pain is one of the major conditions causing serious personal and social difficulties in modern society. There are several noninvasive therapies for chronic low back pain; however, the effects of electromagnetic acupuncture have not been studied. Here, we describe the protocol for a study that will investigate the efficacy and safety of electromagnetic acupuncture for patients with chronic low back pain.The study has been designed as a double-blind, single-center, parallel-arm, sham-controlled, randomized clinical trial. A total of 104 patients with chronic low back pain who meet the criteria for selection and exclusion will be enrolled in a 1:1 ratio in an electromagnetic acupuncture group or a sham group. Sterilized disposable needles will be inserted at 6 acupoints, following which stimulation via an electromagnetic (Whata153) or a placebo (sham) stimulator will be applied. The 2 groups will receive a total of 6 treatment sessions over 3 weeks, with 1 follow-up visit within 3 days after the final treatment. The primary outcome will be the change in the visual analog scale (VAS) score for pain from baseline  to the follow-up visit . The secondary outcomes will be as follows: changes in the VAS score for pain from baseline (visit 1) to visits 3 (third session) and 5 (fifth session); changes in the VAS score for pain at all assessment points from baseline (visit 1) to the follow-up visit (visit 7); changes in the Oswestry Disability Index (ODI) from visit 1 to visits 3, 5, and 7; and the change in ODI at all assessment points from visit 1 to visit 7.The results of this trial are expected to provide important clinical information on the efficacy and safety of electromagnetic acupuncture for patients with chronic low back pain. Nonspecific chronic low back pain refers to pain that lasts for at least 3 months without a pathological anatomical abnormality.The Guidelines for Chronic Back Pain of the American College of Medicine, published in 2017, emphasize the importance of nonpharmacological treatment. According to these guidelines, nonsteroidal anti-inflammatory drugs (NSAIDs) and muscle relaxants can be considered if symptoms do not improve after nonpharmacological treatment, such as acupuncture and physiotherapy. Tramadol or duloxeine can be considered if NSAIDs and muscle relaxants are ineffective. Therefore, the demand for oriental medicine treatment for chronic low back pain has been increasing of late.According to the Survey on the Use of Oriental Medicine by the Korean Ministry of Health and Welfare in 2017, 73.8% of Koreans overall use oriental medicine. Low back pain was the most common symptom, accounting for 52.7% of cases. More specifically, acupuncture, cupping, moxibustion, and oriental physiotherapy were used for 90.2%, 53.0%, 49.1%, and 40.2% cases, respectively.–7 Some studies have also evaluated electromagnetic acupuncture, a less-commonly used modality, for muscle fatigue recovery, meridian potential changes, and activation of the autonomic nervous system.,9Low-frequency electroacupuncture is used to control pain and muscle tension. Many studies have shown that electroacupuncture has a better effect on low back pain than does conventional acupuncture. Because the intensity of stimulation required to produce the same effect is lower with electromagnetic stimulation than with electrical stimulation, patients experience less discomfort and pain and may experience more positive effects with the former than with the latter.Electromagnetic stimulation is based on the following principle. When a magnetic field is applied to a human body, a new electric field and electric current are generated, and the ions electrically stimulate the surrounding nerves. The intensity of the electric field decreases as it penetrates the skin. The advantage of electromagnetic stimulation is that the loss of the electric field in the skin is much less than that associated with electrical stimulation. For example, using the same intensity of stimulation of the skin, electromagnetic stimulation induces an electric field that is 10 times higher than that induced by electrical stimulation in a nerve located within 40 mm of the skin.Electromagnetic acupuncture may therefore also be effective in relieving chronic back pain; however, few studies have validated this. When an electric current is applied to a coil that is wound into a cylindrical shape, a magnetic field is produced. When an acupuncture needle, which is a magnetic substance, is inserted into the coil, an electromagnet is formed and a stronger magnetic field is achieved.We aim to investigate the efficacy and safety of electromagnetic acupuncture in patients with chronic low back pain and to collect the relevant data. Here, we describe the protocol for a parallel-arm, sham-controlled, randomized clinical trial for evaluating the efficacy and safety of electromagnetic acupuncture for patients with chronic low back pain. We intend to use the Whata153 , a device that converts electric energy into magnetic energy, for electromagnetic stimulation.22.1This study has been designed as a double-blind, single-center, parallel-arm, sham-controlled, randomized clinical trial for investigating the efficacy and safety of electromagnetic acupuncture for treatment of patients with chronic low back pain.A total of 104 patients with chronic low back pain who meet the criteria for selection and exclusion will be enrolled in a 1:1 ratio, with 52 patients included in an electromagnetic acupuncture group (EMA group) and 52 in a sham group.2.2The study protocol has been approved by the Institutional Review Board of Cheonan Korean Medicine Hospital, Daejeon University (protocol number: M2015-01-1). The protocol was registered with Korean National Clinical Trial Registry CRIS (KCT0002915). The protocol accords with the Declaration of Helsinki.2.32.3.1The inclusion criteria are as follows: age, 19 to 70 years; presence of chronic low back pain for >3 months; a minimum pain intensity score of 40 mm on a 100-mm visual analog scale (VAS); ability of the participant to fully understand the trial procedure and the risks involved, communicate with the examiner, and comply with the protocol; and provision of written informed consent for participation.2.3.2The exclusion criteria are as follows: a history of spinal surgery; progressive neurological deficit or severe psychiatric or psychological disorders; serious spinal disorders, such as metastatic cancer, vertebral fracture, spinal infection, and inflammatory spondylitis; other contraindications for treatment, such as clotting disorders, use of anticoagulants, and seizure disorders; presence of a device that could be affected by electromagnetic fields, such as a pacemaker or a hearing aid; use of medications that could affect the trial results, such as corticosteroids and anticonvulsants, within the last week; pregnancy, lactation, or plans for conception; participation in other clinical trials; and ineligibility judged by a physician.2.4Patients with chronic low back pain will be recruited through advertisements on hospital bulletin boards and websites. Individuals interested in participating will be provided an explanation of the study until they have completely understood the risks and benefits. If they agree to participate, they will be asked to sign a consent form and undergo screening for eligibility. If they are found to be eligible, a study researcher will randomly allocate them to either the treatment or the sham group. The treatment procedure will be scheduled after randomization. The study flow chart is presented in Fig. 2.5The block randomization method will be used for randomization, at a 1:1 ratio, to ensure balanced distribution. The random assignment code will be calculated using a computer software program, and statisticians will assign codes according to the randomized lists. The randomization code will be sealed in an opaque envelope and stored at the hospital.The patients and researchers performing treatment or assessing outcomes will be blinded to the treatment. To ensure blinding, needles for both groups will be manufactured in the same size and package. The Whata153 will be used for electromagnetic stimulation in the EMA group. In the sham group, a placebo stimulator with the same shape, sound, and machine motion will be used. The patients will not be able to identify the treatment, because the skin receives almost no sensory stimulus with electromagnetic stimulation.Randomization and blinding are not disclosed to the investigator until the end of the clinical trial, except for disclosure to individual patients in an emergency.2.6Both the EMA and sham groups will receive a total of 6 treatment sessions over 3 weeks, with 1 follow-up visit within 3 days after the last treatment . The trial will be conducted under the same conditions for all participants, and the same practitioners will treat all participants. Other therapies and treatments associated with chronic low back pain will be excluded during the trial period. Use of medications other than those specified in the exclusion criteria  will be maintained. The acupuncture protocol to be used is based on the Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) and is presented in Table 2.7,12  to 100 (worst pain imaginable). ODI was developed as a patient-oriented assessment tool and includes various questions that are answered by the patients themselves. The score is calculated as the total score/(number of questions provided by the author ∗ 5) ∗ 100.The primary and secondary outcomes will be based on the VAS score for pain and the Oswestry Disability Index (ODI). The VAS has been shown to be a reliable tool for evaluating chronic pain.2.10.1The change in the VAS score for pain from baseline  to the follow-up visit after treatment completion (visit 7) will be assessed as the primary outcome.2.10.2The following will be assessed as secondary outcomes: changes in the VAS score for pain from baseline (visit 1) to visits 3 (third session) and 5 (fifth session); changes in the VAS score for pain at all assessment points from baseline (visit 1) to the follow-up visit (visit 7); changes in the ODI from visit 1 to visits 3, 5, and 7; and the change in ODI at all assessment points from visit 1 to visit 7.2.11The occurrence of any adverse events will be evaluated at each visit. Patients will be monitored for undesirable, unintended signs, symptoms, and illnesses. The number and percentage of participants who experience at least 1 adverse event will be calculated.2.12Participants will be withdrawn from the trial if they do not meet the selection/exclusion criteria, withdraw consent, or conceive. The trial will be stopped if significant adverse events occur or if the patient is considered to be at risk upon further participation.2.13 The alpha level is 5% for both sides, and the study power is maintained at 80%. A total of 52 participants will thus be required in each group after considering an attrition rate of 10%.The sample size will be calculated as per the results of previous trials on electroacupuncture therapy for chronic low back pain, because there are no available studies on electromagnetic acupuncture therapy. We assume that the effect of electromagnetic acupuncture would at least be equivalent to those of electroacupuncture; therefore, we will refer to the effect size of electroacupuncture therapy as conservative treatment for low back pain. In a previous study, the mean difference in the follow-up VAS score for pain was 0.87 between groups, with an estimated standard deviation of 1.48.2.14P < .05, and the confidence interval at 95%. All statistical analyses will be performed using SPSS Statistics for Windows Version 20.0 . There is no intermediate analysis of this study, and the final decision on end of trial is with principal investigator.Statistical analysis will be primarily based on the intent-to-treat principle, although per-protocol principles will also be checked. The missing values will be analyzed by the last observation carried forward method. The significance level will be set at t test or the Wilcoxon rank sum test will be performed. For categorical data, the Chi-square test or Fisher exact test will be used.Differences in sociodemographic and baseline characteristics between the EMA and sham groups will be evaluated. For continuous data, Student t test or the Wilcoxon rank sum test, while those at all evaluation points from baseline to the follow-up visit will be assessed using repeated measures analysis of variance (RM-ANOVA). The incidence of adverse events will be investigated using the Chi-square test or Fisher exact test.Changes in VAS and ODI scores from baseline to each assessment point will be assessed using Student 3Of late, nonpharmacological therapies for chronic low back pain have gained popularity as replacements for medication or surgery. In the field of oriental medicine, various treatments, such as acupuncture, electroacupuncture, pharmacopuncture, and acupotomy, are used for chronic low back pain. Use of electromagnetic stimulation therapy has been reported for inducing muscle relaxation, treating Bell palsy as well as musculoskeletal pain.,21 To the best of our knowledge, this will be the first study on the use of electromagnetic acupuncture for the treatment of chronic low back pain.Magnetic fields are used to treat various diseases.This study design is expected to have some advantages. In order to verify the efficacy of electromagnetic acupuncture for chronic low back pain, the acupoints and procedure have been standardized. In addition, the placebo device will appear and sound, and be used, in the same way as the Whata153, ensuring a double-blind protocol. Moreover, RM-ANOVA will be used to assess not only the reduction in pain at a certain point in time but also differences in the amount of pain reduction over time.The results of this trial will provide important clinical information about the efficacy and safety of electromagnetic acupuncture, which is expected to cause less discomfort and provide better results than electroacupuncture, for chronic low back pain. We believe that this treatment will relieve pain and improve the quality of life for many patients experiencing chronic low back pain. Because this is a pilot trial, we will analyze the data from various aspects and use statistical methods that will help in providing a foundation for the final clinical trial. If this study is successful, we expect that further studies on electromagnetic acupuncture for other clinical diseases will be designed and performed.JHK designed, administrated and supervised the study protocol and critically revised the manuscript. SYO developed the protocol, drafted the manuscript. Both authors have read and approved the final manuscript.Conceptualization: Jae Hui Kang.Data curation: Seo Young OH.Formal analysis: Seo Young OH.Funding acquisition: Jae Hui Kang.Investigation: Seo Young OH, Jae Hui Kang.Methodology: Seo Young OH, Jae Hui Kang.Project administration: Jae Hui Kang.Resources: Seo Young OH.Software: Seo Young OH.Supervision: Jae Hui Kang.Validation: Seo Young OH.Visualization: Seo Young OH.Writing – original draft: Seo Young OH.Writing – review & editing: Jae Hui Kang.