Thus, hydrodilatation through the rotator cuff interval might be a better treatment option than that through the posterior glenohumeral recess for patients with adhesive capsulitis, considering its superior effect in alleviating pain during shoulder movement.For patients with adhesive capsulitis, hydrodilatation is typically performed using corticosteroids with ultrasound guidance via the posterior glenohumeral recess. Recently, a new intervention technique via the rotator cuff interval has been described. This study aimed to compare the efficacy of hydrodilatation with triamcinolone acetonide via the posterior glenohumeral recess and the rotator cuff interval in patients with adhesive capsulitis. This prospective randomized controlled trial was conducted in a tertiary care center with a follow-up period of 12 weeks. We enrolled 64 patients diagnosed with shoulder adhesive capsulitis. The subjects were randomly assigned to two groups that received hydrodilatation with corticosteroids either through the posterior glenohumeral recess or though the rotator cuff interval. The injection contained 4 ml of triamcinolone acetonide (40 mg) mixed with 4 ml of 2% lidocaine hydrochloride and 12 ml of normal saline. The shoulder pain and disability index, visual analog scale for pain, and range of motion were analyzed before and at 6 and 12 weeks after the treatment. Both groups experienced improvements in the visual analog scale scores, shoulder pain and disability index scores, and range of motion throughout the study period. A significant group-time interaction was observed in terms of the visual analog scale for pain during motion ( Adhesive capsulitis (AC), i.e., painful stiff shoulders, is characterized by progressive painful limitation of the shoulder motion, resulting in disability and impaired quality of life . The preAs AC is primarily considered an inflammatory disease , intra-aHydrodilatation is typically performed using ultrasound guidance via the posterior glenohumeral joint. Recently, a new injection technique via the rotator interval was described . The rotThis study aimed to compare the short-(6 weeks) and intermediate-term (12 weeks) effects of hydrodilatation with triamcinolone acetonide through the posterior glenohumeral recess and through the rotator cuff interval. We hypothesized that the rotator cuff interval approach would achieve greater reduction in pain and better improvement in function as compared to the posterior glenohumeral recess approach.ClinicalTrials.gov . All participants provided written informed consent and were randomly assigned to two groups undergoing hydrodilatation either though the posterior glenohumeral recess or though the rotator cuff interval, respectively. Randomization was performed by a computer using a random sequence generator in a block of four without stratification. The number of patients in each group was the same. Concealment of treatment assignment was maintained in sealed envelopes, which were opened only before the interventions. This study used an open-label design, because the participants would know their group allocation through the differences in the area of injection.This was a prospective randomized control trial in compliance with the Consolidated Standards of Reporting Trials statement. The study was approved by the Institutional Review Board of Taipei Veteran General Hospital, Taiwan, and was registered at Participants were recruited from the outpatient clinics of the Department of Physical Medicine and Rehabilitation at the Taipei Veterans General Hospital. The diagnosis of AC was based on clinical history, physical examination, and ultrasonography and radiography findings.The inclusion criteria were as follows: 1) age 35–65 years (to prevent the inclusion of patients with secondary AC), 2) onset of shoulder stiffness since over a month, and 3) limitation in the passive range of motion (ROM) over 30° when compared with the contralateral side in at least two of these three movements: forward flexion, abduction, or external rotation.The exclusion criteria were as follows: 1) ultrasound findings of rotator cuff tears, 2) plain radiography findings of significant glenohumeral joint arthritis, 3) accompanying cervical radiculopathy, 4) systemic inflammatory joint disease, 5) intra-articular injection into the glenohumeral joint within the past 3 months, 6) history of surgery on the affected shoulders, 7) regular use of systemic non-steroidal anti-inflammatory drugs or corticosteroids, and 8) allergy to corticosteroid or lidocaine.All patients received one shot of ultrasound-guided hydrodilatation by a single physiatrist, using an Acuson S2000 machine  with a linear 9–12 MHz probe. The injection fluid contained 4 ml of 40 mg (10 mg/ml) triamcinolone acetonide (Shincort) mixed with 4 ml of 2% lidocaine hydrochloride (xylocaine) and 12 ml of normal saline.In the group receiving hydrodilatation through the posterior glenohumeral recess, the patients were positioned side-lying with the injected shoulder on the top and the ipsilateral arm resting on a pillow . The proIn the group receiving hydrodilatation through the rotator cuff interval, the patients were placed in the supine position with the shoulder in slight abduction and extension to facilitate the visualization of the rotator cuff interval. The probe was placed lateral to the coracoid process on the deltopectoral groove. After sterile preparation, a 22-gauge, 1.75-inch needle was inserted using an in-plane approach from the lateral side of the probe. The needle was inserted deep into the coracohumeral ligament to reach the sheath of the long head of the biceps tendon . The injAll the injection procedures were conducted by the same physician, who had more than 8 years of experience in ultrasound-guided injection techniques. We prescribed acetaminophen for our enrolled patients after the injections. They were advised to take the medication within the dosage of allowance when the visual analogue scale (VAS) of pain exceeded 4/10. Before the injection, a leaflet describing the post-injection exercise program was handed to the participants and the program was instructed by the same instructor. The program consisted of Codman's exercise, wall climbing exercise, shoulder external and internal rotation exercise using the bar and towel stretching exercise behind the back. All patients started the home-based exercises at the first day after injections. They were advised to perform the exercises for a minimum of two sessions per day. During the study period (within 12 weeks after interventions), the participants were allowed to receive physical therapy at our outpatient clinics. The modalities used during physical therapy comprised hot packing, ultrasound diathermy and inferential current therapy.The primary outcome was the shoulder pain and disability index (SPADI) score. The secondary outcomes were the VAS score for pain and ROM of the shoulder. All assessments were performed by a research assistant, who was blinded to the treatment allocation, at baseline and at 6 and 12 weeks after the treatment.The SPADI was used to assess the severity of pain and disability. A previous study has shown that the Chinese version of the SPADI has high internal consistency and test-retest reliability . It consRegarding VAS, patients were asked to indicate the intensity of their average level of pain in the affected shoulder within the past 1 week using an 11-point scale, ranging from 0 (no pain) to 10 (worst pain imaginable).In terms of ROM, the degrees of shoulder flexion, abduction, external and internal rotation were measured by a goniometer in the supine position in a random sequence. External and internal rotation was measured with the shoulder in 90° of abduction and the elbow in flexion of 90°. If shoulder abduction was less than 90°, external and internal rotation was measured with the shoulder in the maximal degree of abduction. During follow-up, the shoulder was positioned at the same degree of abduction to measure the ROM of external and internal rotation. Each ROM was measured twice and the average values were used for analysis.Based on an antecedent randomized controlled trial comparing the effect of different injection methods for AC , our samThe Shapiro-Wilk test was used to determine whether the continuous variables were normally distributed. In the case of normal distribution, univariate analysis of the continuous variables was conducted using one-way analysis of variance, or else the Mann-Whitney U-test was used. The chi-square test was used for comparison of the categorical data. If data with small cell counts were encountered, the Fisher’s exact test was used. The effect size of the between-group difference was denoted by Cohen’s d, derived from the between-group mean difference divided by the pooled standard deviation.p-values <0.05 were considered statistically significant.Repeated measurement analysis of variance was employed to analyze the effect of group-time interaction, which was considered the outcome of interest. The within-subjects factor was the time points of outcome measurements (baseline and 6 and 12 weeks following interventions). The difference in the treatment approaches  was regarded as the between-subjects factor. Repeated measurement analysis of variance was also used to compare the continuous variables within the same group across different time points, using the Bonferroni test for post-hoc analysis. The intention-to-treat principle was used in this study. Regarding the missing data due to loss of follow-up, we handled this issue by using the method of last observation carried over . The lasn = 32) and that undergoing hydrodilatation through the rotator cuff interval (n = 32). Three patients did not visit the follow-up clinic in the 6th week, whereas four patients were lost to follow-up in the 12th week (p = 1.00). The baseline characteristics, including age, sex, body weight, body height, SPADI scores, VAS scores for pain , and shoulder ROM, were similar across both the groups . The F-ratio and p-value for all the repeated measurements are presented in A significant decrease in the SPADI scores   and in tThe procedure was well tolerated by the patients in both approaches, and no serious adverse events were observed. Two patients (one in each group) reported significant post-injection pain (VAS score >4) on the first day after the intervention, which resolved spontaneously without the need for additional treatments.The present randomized controlled trial aimed to compare the effectiveness of hydrodilatation with triamcinolone acetonide through the posterior glenohumeral recess and through the rotator cuff interval. Our results revealed that both the approaches contributed to significant improvement in the shoulder pain and function for at least 3 months in the patients with AC. A significant group-time interaction was observed in terms of VAS during motion, favoring hydrodilatation through the rotator cuff interval approach.To date, only one trial has investigated the influence of the injection sites of hydrodilatation on AC. AC is thought to begin with inflammatory hypervascular synovitis, which elicits a progressive fibroblastic change in the adjacent capsule . IncreasIn recent studies, the rotator cuff interval has been implicated as the key structure in the pathogenesis of AC . The firIn this study, hydrodilatation through the rotator cuff interval was more effective in improving the pain during motion as compared to hydrodilatation through the posterior glenohumeral recess. Compared with the measurements of pain at rest or at night, pain during motion is more sensitive in evaluating the progress of AC because the disease is characterized by motion limitation. These results are comparable with those reported by However, unlike the study by The optimal volume of distension during hydrodilatation remains unclear. The injection volume varied significantly among the prior studies . Two appHydrodilatation through the rotator cuff interval has several advantages over hydrodilatation through the posterior glenohumeral recess. First, parts of the injectate infiltrate into the subacromial bursa, which contributes to better pain control if the patients have concomitant subacromial impingement. Second, it is easier to assess the rotator cuff and subacromial bursa before the procedure to prevent unwanted corticosteroid injections in those who already have rotator cuff tendon tears. Third, in patients with a larger body size, the approach through the posterior glenohumeral recess would be more challenging than the method through the rotator cuff interval using the linear transducer.In our study, the primary outcome was the between-group difference of the changes in the total SPADI score. Based on our data, the change of the total SPADI score from baseline to the 12th week was −24.69 ± 10.80 in the group using the posterior-glenohumeral-recess approach and −28.41 ± 9.86 in the group using the rotator-cuff-interval approach. To recognize a mean difference of 3.72 with a standard deviation of 10.34 in the SPADI score, a total of 246 participants were required for reaching a power (β) of 0.8 and an alpha (α) level of 0.05. Therefore, even though the actual number of the enrolled participants exceeded the estimated sample size by around 14%, the small difference in the SPADI score was not able to be recognized. Furthermore, a previous study  suggesteOur study has some limitations. First, the follow-up period was only 12 weeks; therefore, the long-term effects of the treatment remain unknown. Further research should incorporate a longer study period to examine the long-term effects of hydrodilatation through the rotator cuff interval for treating AC. Second, we included subjects with AC at different stages. The disease duration recalled by the participants might not be accurate, and the precise stage of the AC could not be determined, which might have affected our results. Third, due to the design of the intervention, the participants could not be blinded to the intervention protocol. Fourth, the study did not include a placebo group; the improvement of the outcomes in both the groups might be partially attributed to the natural recovery of the disease. However, as the effectiveness of hydrodilatation with corticosteroid has been proven to be comparable to or even better than corticosteroid injection , the incDespite these limitations, this study has some strength. First, this was an adequately powered randomized-controlled study with a relatively low rate of loss to follow-up. Second, all patients were required to have a radiograph, ultrasound, and clinical assessment by the same physician to ensure the accuracy of AC diagnosis. Third, all injections were performed by a single experienced physician with sonographic guidance to ensure that the injectate was injected inside the target region.Ultrasound-guided hydrodilatation with triamcinolone acetonide achieved better pain relief during motion through injection in the rotator cuff interval than through the posterior glenohumeral recess in patients with AC. Nevertheless, there was no significant difference in the shoulder function and ROM recovery between the two intervention methods. Therefore, hydrodilatation through the rotator cuff interval might be a better treatment option for patients with AC, considering its superior effect on alleviating pain during movement when compared with the posterior glenohumeral recess approach.


Background: Burn patients experience major physiological and psychological stressors during treatment and rehabilitation, including elevated levels of pain, anxiety, stress, or depression. Music interventions inclusive of music therapy (MT) have been shown to improve such symptoms, but rigorous clinical trials investigating specific music therapy methods in adult burn patients are scarce.Methods: This is a single center Randomized Controlled Trial (RCT) protocol with two parallel arms. Participants are 81 adult burn patients admitted to the Intensive Care Unit (ICU) of the University Hospital Fundación Santa Fe de Bogotá in Colombia. The intervention consists of a Music Assisted Relaxation (MAR) protocol, a music therapy technique composed of entrained live music combined with a guided relaxation and/or the use of imagery. The effects of the MAR will be compared to a control group  over a period of maximum 2 weeks or six interventions. The primary outcome measure is perceived background pain, as measured with a Visual Analog Scale (VAS) before and after each intervention. Secondary outcomes are anxiety and depression levels; vital signs; and the use of pain medication. Additionally, some patients in the intervention group will be invited to participate in electroencephalography, electromyography, and electrocardiography recordings during the MAR.Discussion: This study protocol follows the SPIRIT guidelines for defining items of clinical trials and is the first study in Colombia to evaluate the effects of music therapy for adult burn patients. With this RCT it is hoped to gather new knowledge about the potential of music therapy to help critical care patients cope and recover from their injuries during the hospitalization in the ICU.Trial registration:www.clinicaltrials.gov, Identifier: NCT04571255.Protocol version: V1.0, May 24th 2021 Burn wounds are among the most painful and traumatic injuries that a person can experience and provide multiple challenges for both patients and health care professionals . EffectiFirst, the background pain resulting from the injuries and the destruction of skin tissue. Many times, this pain is of moderate or low intensity, but usually remains over time.Second, many patients experience intense procedural pain during medical and therapeutic procedures, such as wound debridement, dressing change, or during physical therapy, among others.Third, breakthrough pain, which can occur at any time.And fourth, the post-operative pain that is associated with wounds caused by skin extraction and grafting.It is widely recognized that pain perception is based on an individual experience that affects the patient's physiological, mental, emotional, and social aspects of life . The IntAdditionally, there are also psychological challenges that burn patients must face, such as elevated levels of anxiety, stress, depression, insomnia, and changes in body identity . This isThis study protocol aims at filling some of the current gaps in knowledge by measuring the effects of a live Music Assisted Relaxation (MAR) protocol—provided by a certified music therapist—on background pain, mental health, vital signs, and the use of pain medication in adult burn patients.The primary objective of this study is to evaluate the effect of a MAR protocol compared to treatment as usual on perceived background pain in adult burn patients admitted to the Intensive Care Unit of the University Hospital Fundación Santa Fe de Bogotá.Secondary objectives are:To examine the effects of the MAR on the patients' anxiety and depression levels.To examine the effects of the MAR on the patients' vital signs .To examine the effects of the MAR on the patients' medication usage (complementary or rescue doses).To examine medical and social factors, which might be associated with the effects of the MAR.To describe the effects of the MAR on neurophysiological parameters in a few patients in the intervention group (exploratory part of the study).We hypothesize that the MAR protocol plus treatment as usual—as compared to treatment as usual alone—will lead to lower levels of perceived background pain and will positively impact the patients' mental health, vital signs, and medication usage.This study protocol follows the SPIRIT guidelines for defining standard protocol items for clinical trials . This stInclusion criteria are burn patients of legal adult age admitted to the ICU of the University Hospital Fundación Santa Fe de Bogotá; and an estimated hospitalization of >7 days. Exclusion criteria are patients with known psychiatric disorders; patients with cognitive disabilities; and sedated and/or mechanically ventilated patients.p-value of 5%, the number of participants expected to have in the study is n = 81, which is similar to other studies in the field , Power = 1-β and Z(α/2) and Z(β) are taken from the z table. For this particular case, P1 corresponds to the expected outcome in the control group and P2 the expected outcome in the intervention group. The primary outcome measure is the Visual Analog Scale (VAS) that consists of 10 points (100%) and when considering a clinically significant decrease and difference of 2 points (20%), these values would correspond to 80 and 60%, respectively (P1: 80 and P2: 60). Replacing these values in the above equation, the sample size is:Where Randomization takes place in the form of assigning the participants according to a set of randomized numbers generated by a computer software . The randomization ratio is 1:1. Once randomization is executed, sealed envelopes are used for each participant and group allocation is performed accordingly.Due to the nature of the intervention, blinding participants to the result of the randomization is not feasible. However, data collection takes place by blinded research assistants and data analysis will also take place by researchers blinded to the outcomes of the randomization.Participants in the intervention group will take part in a Music Assisted Relaxation (MAR) protocol. MAR is a music therapy technique that includes listening to live music based on the principles of entrainment , 43, comParticipants in the control group receive treatment as usual (TAU) according to the attending physician. An environmental control will be imposed for the control group to equalize basic conditions during data collection including promoting a resting posture, interrupting care procedures unless absolutely necessary, and keeping the room doors closed.Basic socio-demographic and medical data will be collected from all participants, including age; gender; educational level; marital status; level of support by the patient's social system; medical diagnosis; type and location of the burns; and depth and surface % of the burns.Primary outcome measure is a Visual Analog Scale (VAS) of 0-10. 0 indicates a state without any pain and 10 indicates the most severe pain possible. Each number from 0 to 10 is distributed in a line 1 cm apart and the patient can mark the intensity of pain felt at the time of filling out the VAS. The VAS will be applied at baseline, and every time before, after, and at 3 h post-each intervention. Period of data collection: maximum 2 weeks from the point of study entry.The Colombian version of the Hospital Anxiety and Depression Scale (HADS)  will be Vital signs  will be measured via hospital monitors before the intervention, after the intervention, and at 3 h post-intervention. Period of data collection: maximum 2 weeks from the point of study entry.The use of pain medication refers to the frequency and dose of additional analgesic medications requested by the patient during the study period (complementary or rescue doses). The total amount of dosage and frequency will be calculated by summing up individual records. Period of data collection: maximum 2 weeks from the point of study entry.In about 20% of the patients in the intervention group (approx. eight participants), additional Electroencephalogram (EEG), Electrocardiogram (ECG) and Electromyography (EMG) recordings will be made. Since this is an exploratory feature of the study, participation in the EEG, ECG, and EMG measurements is voluntary and depends on the location of the burn wounds, the clinical stability of the patient, and is defined together with the attending physician. The sample size of 20% was chosen based on an estimation of potential participants without any head/face/neck burn injuries, in which the application of electrodes would not be feasible. As the aim of the MAR is to help patients achieve relaxation, the hypothesis for these measurements is that this will lead to (1) an increase in Alpha and Theta brain waves, both of which correspond to deep relaxation and inward-focused states of mind; (2) a reduction in muscular tone; and (3) changes in the high frequency (HF) and low frequency (LF) components and in the LF/HF ratio indicating a parasympathetic activation. All these physiological variables will be acquired simultaneously with a Micromed LTM64  acquisition system, with a sampling frequency of 512 Hz. The Micromed LTM64 is of clinical quality and has the due approval of the Colombian National Institute for Drug and Food Safety 20090486-2015). For the EEG recordings, the international 10-20 scalp system setup will be used, but the final number of electrodes will depend on medical approval for each patient. From these signals, we will assess power changes in the physiological Theta (4-8 Hz), Alpha (8-12 Hz) and Beta (12-30 Hz) frequency bands, associated with brain relaxation and engagement, respectively , 47. The6-2015. FThe schedule of enrolment, interventions and assessments is shown in the following Data collection and storing will be done manually and later transcribed to an electronic database. The accuracy of data transcription will be checked by randomly selecting 20% of the participants for whom a double-data entry procedure will be implemented as a means for control of potential errors while transcribing the results from the paper questionnaires to the electronic database. The original questionnaires will be stored in a locked shelf inside the ICU and digital data storing and processing follows the institutional guidelines for data security, including a password protected laptop, encrypted files, and using secure methods of file transfers.p-value test, and the Mann-Whitney U-test will be performed. When analyzing the data, a univariate analysis will be carried out in which the frequency (absolute and relative), percentages and confidence intervals of the different qualitative variables will be established. Subsequently, the association between the different variables will be evaluated through the Chi-square χ2 test. Additionally, the Shapiro Wilk test will be used to determine the distribution of the quantitative variables. Once this result is obtained, we will seek to determine the mean, standard deviation, central tendency, and dispersion for the variables of normal distribution, while the median and interquartile range will be sought for those of non-normal distribution. These variables will be evaluated using the Student's t-test or the Mann-Whitney U-test according to the distribution. The results will be considered statistically significant when observing a value of p < 0.05 (5%). Finally, a multivariate analysis will be carried out where logistic regression will be used to determine the contribution of each of the different quantitative variables in terms of the observed results.Data analysis will be performed by analysts blinded to the randomization outcomes and based on an intention-to-treat analysis (ITT) . Basic sThe study was approved by the hospital's ethics committee (CCEI-11234-2019/CCEI-11971-2020) and is registered in Clinicaltrials.gov (NCT04571255). All participants will sign an informed consent to participate in the study, including two additional witnesses. Dissemination of the study results will be realized locally, nationally and internationally through publications, posters sessions and oral presentations at conferences.This feasibility study investigates the effects of a live MAR protocol provided by a certified music therapist on background pain, anxiety and depression, vital signs, and medication intake in adult burn patients. Other outcome measures correspond to the exploratory feature of this study including EEG, EMG and ECG measurements in 20% of the participants in the intervention group. Pain and impaired mental health are frequent symptoms in burn patients and can negatively affect clinical trajectory and recovery during hospitalization in the ICU and beyond. Music therapy is a non-invasive and cost-effective therapy that has been shown to reduce pain and anxiety levels in several clinical populations, including burn patients , 31. MARThe current MAR protocol extends previously used interventions by explicitly using live music based on the principles of entrainment. Entrainment—the conscious synchronization and modification of musical elements in relation to biological rhythms of the patient—can further help to individualize the music and has been shown to improve well-being and reduce symptoms in palliative care , pediatrWhile it is known that music itself can release neurotransmitters and hormones related to pain and stress relief , the traAnother new feature of this study is the focus on background pain instead of procedural pain. While background pain is usually lower in intensity, it is of longer duration and may thus alter pain memory in the long-term . This isWe have also identified several potential limitations of this study protocol. First, background pain is influenced by many different factors, such as the medical condition of the patient, the number of procedures, mental health, and social support, among others. This means that a diversity of factors can potentially affect the pain perception of patients. This might be different during procedural pain, in which a more direct relationship between the procedure and the pain experience exists and thus immediate effects of music interventions might be observed more consistently. However, as mentioned at the end of the previous section, background pain in burn patients is an under-investigated topic and may be highly relevant for long-term well-being and health. While an accumulative effect of the MAR intervention over time may lead to an improved relaxation response and coping mechanisms and thus to reduced pain levels and improved mental health, little is known about the ideal dosage or frequency of music interventions. Formal moderator/mediator analyses in the fields of music therapy and music medicine may help in addressing such issues and are clearly needed –73.Another limitation might be the broad inclusion criteria, which could affect the statistical power of the study. This was chosen since recruitment during COVID pandemic might be slower than expected, as ICU beds usually are prioritized for COVID patients during each infection peak. Thus, to keep recruitment within a feasible time frame, this study does not focus on a specific patient group within the burn population.And third, other outcome measures including EEG, EMG, and ECG measurements are an exploratory feature of this study and due to the small sample size, the results can thus not be generalized. However, we consider them as important first steps in materializing the need for describing potential neurophysiological pathways and mechanisms of live MAR interventions based on the principles of entrainment.This is the first RCT on music therapy and pain management for adult burn patients in Colombia—and to our knowledge—also in South America. It is hoped that the results of this study will help gain new knowledge about complementary therapies for burn patients in ICU settings and provide new insights into the effectiveness and the underlying mechanisms of music in health care contexts.The studies involving human participants were reviewed and approved by Ethics Committee of the University Hospital Fundación Santa Fe de Bogotá, CCEI-11234-2019/CCEI-11971-2020. The patients/participants provided their written informed consent to participate in this study.ME, RM, AS-V, MV, and SP-G conceived the study and developed the study design. ME drafted the manuscript. MV provided expertise for conducting primary statistical analysis for EEG results. SM-D, WB-Z, NS-C, JM-S, and VG-O contributed to the study design. All authors approved the final manuscript.The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.


Background: Whiplash is a consequence of traumatic injuries, mostly related to road accidents, with variable clinical manifestations, also known as Whiplash Associated Disorders, such as neck, head and temporo-cranio-mandibular pain. Methods: The current study aims to evaluate the onset and evolution of temporomandibular joint pain in people with whiplash in a study group treated with the use of Zimmer Collars , as compared to a control group. This prospective study included 31 patients followed by the Dental Prosthesis Department of the University of Bari “Aldo Moro”: 20 patients with whiplash (age range: 20–39 years) treated with Zimmer collars and 11 patients with whiplash (age range: 20–33 years) who were not. Immediately after the whiplash occurred, a visual analogue scale (VAS) was used to describe the intensity of pain and to complete the chart of the European Academy of Craniomandibular Disorders. Five out of twenty patients, already treated with a Zimmer collar, wore an occlusal splint as well because of persistent pain reported at the 28-day and 60-day follow-up and were supported by pharmacological therapy with analgesics (paracetamol) and muscle relaxants (thiocolchicoside). Results: During the last follow-up (at six months), three out of five patients displayed a residual VAS score of 3, 4, and 5, respectively, while the remaining two displayed a VAS of 0. In the control group, four out of eleven patients needed to wear an occlusal splint but without muscle relaxants and analgesics pharmacological therapy; these four corresponded to the patients showing a residual painful symptomatology, with VAS reaching value of 2, and also were the oldest patients of the group. Data regarding VAS values and Zimmer collar use, both at the first visit and six months later, were statistically analyzed. Conclusion: Our prospective study highlights how whiplash-associated acute disorders are often self-limiting over a period of few months, thus reducing the possibility of symptom chronicity; the latter seems to be strictly related to lesion severity, pre-existence of a craniomandibular dysfunction and patient age, but appears to be independent from Zimmer collar use, as statistically confirmed. The current definition of whiplash as a transfer mechanism of collision energy towards the neck due to a sudden acceleration/deceleration was introduced in 1995 by the Quebec Task Force on Whiplash Associated Disorders (WADs) [Whiplash-related clinical manifestations can occur within different timeframes post-trauma: Whiplash Syndrome appears immediately or in the following 72 h, while Late Whiplash Syndrome appears at least 6 months later. The main symptom is neck and head pain but also temporo-mandibular joint (TMJ) or cranio-mandibular pain .Data emerging from the international literature on temporomandibular disorders in whiplash patients are quite contradictory. Salè et al.  reportedPérez del Palomar et al.  used a dNotably, it has been reported in the literature that victims of motor accidents in Lithuania did not report chronic symptomatology even after acute whiplash injury ; on the The current study aims to evaluate pain in the TMJ as a symptom in whiplash patients, both immediately after the trauma and six months post-injury, and to compare symptoms in patients needing to wear the Zimmer collar and those who do not.t-test, independent sample t-test, χ2 test) had a significance level of p < 0.05.We studied 31 patients  treated at the Dental Prosthesis Department of the University of Bari “Aldo Moro”. Precisely, 20 patients (age range 20–39 years) were treated using a Zimmer collar, and a control group of 11 patients (age range 20–33 years) did not receive a Zimmer collar, after whiplash. Patients received an occlusal splint  when persistent pain was reported at a 28 days follow-up, along with paracetamol and thiocolchicoside, when necessary. Patients were clinically examined immediately after whiplash trauma and VAS was used to describe the intensity of the referred pain . The samFive out of twenty patients, already treated with a Zimmer collar , receiveFifteen out of twenty patients (75%) of the study group reported pain absence at the last follow-up.Twenty patients of the study group (100%) presented myositis-affecting tendons of the masticatory muscles due to contracture after whiplash trauma. By forcing the condyle in a superolateral or posterior superolateral position, the collar fosters anteromedial dislocation of the meniscus and retro-discal tissue compression, with consequent posterior retro-discitis and capsulitis . Four oup < 0.001). A similar result was observed in the control group : mean VAS decreased from 6.55 ± 1.29 to 0.73 ± 1.01. Furthermore, the difference in mean six-month VAS score between groups was not significant (p = 0.958), thus meaning that Zimmer collar therapy did not improve the prognosis of patients and that whiplash acute disorders are mainly self-limiting over six months.With regard to the results of the statistical analysis, during the first visit, the mean VAS score was 6.45 ± 1.39 points; after six months, the mean score was significantly reduced to 0.70 ± 1.53 points , thus confirming that Zimmer collar therapy did not improve the prognosis of whiplash acute disorders, which self-limited over six months.During the first visit, eight patients (40.00%) had a single RCD symptom and 12 (60.00%) had two RCD symptoms in the group receiving the Zimmer collar, against seven (63.64%) and four (36.36) in the control group, respectively; in both groups, nobody was asymptomatic. During the six-month follow-up visit, in both groups there were no patients with two RCD symptoms, and the number of asymptomatic patients grew to 15 (75.00%) in the group that received the Zimmer collar and to eight (72.73%) in the control group, but this difference was not significant  had an RCD symptom and 16 (51.61%) had two RCD symptoms initially; after six months, only eight patients showed chronicity of symptoms.p = 0.001), confirming the authors’ observations. The same findings were observed for the correlation between symptom chronicity and the pre-existence of TMJ disorders . The correlation between age and chronicity of symptoms was positive, weak, and not significant ; three patients with a residual VAS score higher than 3 were older than 38 years.The correlation between these outcomes was positive, moderate in strength, and statistically significant  and/or physiotherapy tractions, may be potentially involved into the pathogenesis of craniomandibular disorders; the forcing of the condyle in a superolateral or posterior superolateral position allows for anteromedial dislocation of the meniscus with retro-discal tissue compression and consequent posterior retro-discitis and capsulitis.Although still controversial, authors generally agree that whiplash can cause more severe symptoms  in contrast to non-traumatized patients. Other authors ,19,20,21Generally, negative prognostic factors towards functional recovery and TMD onset are the following: high impact speed (>60 Km/h), elevated initial pain intensity, head position during impact, headrest absence, advanced age, female sex , cervical rachis deformity, and ongoing legal cases.Davis  claims t(A)Lesion severity: such as manifestation of a traumatic brain injury or craniocaudal joint dislocation. Indeed, a VAS of 4 remained in the patient that reported a traumatic brain injury and a VAS of 3 and 5 remained in those patients subject to very strong trauma.(B)Pre-existent craniomandibular dysfunction: Two patients out of three with a residual VAS higher than 3 showed signs of parafunction at the six-month follow-up period.(C)Patient age: three out of five patients with a residual VAS higher than 3 were older than 38 years; therefore, such patients were referred for longer therapy and gum shield use.(D)Control group: in the short term, Zimmer collar therapy promotes tendon myositis, with greater pain reported with respect to the control group (no Zimmer Collar); furthermore, chronic pain after six months was equal between the study and control group in terms of percentage, thus highlighting how pain persistence is due to a central sensitization phenomenon affecting the nervous system.The current study highlights that the acute phase immediately after whiplash usually improves and can resolve within a few months, with the reduced possibility of chronicization. The residual symptomatology can persist for various reasons, as follows:The pathophysiology of TMD development and its exacerbation as a sequela of whiplash injury can be distinguished from other TMDs , as individuals have both a variable intensity macro-trauma to muscles, ligaments, and tendons of the cervical area and an adjunctive involvement of the central nervous system because of diffuse axonal injury ,28 or reData from the literature on TMD amplification or exacerbation in whiplash injuries are quite discordant, as several factors may influence or complicate such an association as well its therapy, duration, and prognosis. Despite its limitations, especially regarding the low number of cases analyzed within, the current study demonstrates that whiplash-associated acute disorders are often self-limiting over a period of few months; symptom chronicity appears mostly related to lesion severity, possible pre-existence of craniomandibular dysfunction/disorder, and patient age, but on the whole is not related to Zimmer collar use.


Patients with cognitive deficits are 3 times more likely to suffer a hip fracture than geriatric patients of the same age group without cognitive deficits. The persistence of perioperative pain following hip fracture is a risk factor for the occurrence of delirium, poor functional prognosis, and the development of secondary chronic pain. Patients with cognitive deficits receive 20 to 60% less analgesics than those without cognitive deficits. Our retrospective descriptive monocentric study was performed in an orthogeriatric unit on a cohort of elderly patients hospitalized for hip fracture. The aim of the study was to compare the quantity of strong opioids delivered in a morphine sulfate equivalent daily during the preoperative period after a hip fracture between cognitively intact patients and those with cognitive deficits.p = 0.38)). Patients with moderate to severe cognitive deficits more often experienced delirium during their hospitalization (p < 0.01) and received more psychotropic drugs in the first 3 postoperative days (p = 0.025).Our total population of 69 patients had a median age of 90 years old, and 46% of these patients had moderate or severe cognitive deficits. During the preoperative period, the same quantity of strong opioids was administered to both groups of patients (13.1 mg/d versus 10.8 mg/d (We reported that with standardized pain management in an orthogeriatric unit, patients aged 75 years and older received the same daily average quantity of strong opioids during the preoperative period regardless of the presence of cognitive deficits. Hip fracture is one of the most serious consequences of falls in elderly subjects . The hipOlder subjects with multimorbid conditions also suffer acute postfracture pain in addition to existing chronic pain . Acute pFrequent atypical clinical presentations in older subjects may explain why the evaluation of pain for elderly patients may be more complicated compared with that for young adults. Furthermore, patients with cognitive deficits can present communication disorders that make evaluation of pain even more difficult –24. SeveThis was a retrospective descriptive monocentric study. Our consecutive patient cohort consisted of subjects aged 75 years old and older hospitalized for hip fracture in the orthogeriatric units of the Grenoble Alpes University Hospital (France) located in the orthopaedic and traumatology surgery department. The inclusion period was from 09 october 2018 to 13 may 2019. The study followed CNIL  and RGPD  recommendations. Study registration within the internal register for processing activities of the Data Protection Officer (DPO) controller was performed prior to Clinical Research and Innovation Delegation (DRCI) approval. Patients and their families were informed about the study and could refuse to participate.The exclusion criteria were surgery prior to admission to the unit, functional management of hip fracture, and preoperative death. To avoid interpretation bias, we excluded patients with multiple concomitant fractures and patients who previously had strong opioid treatment  Fig. .Fig. 1FThe aim of our study was to compare preoperative analgesic management of hip fracture in patients 75 years old and older with or without moderate to severe cognitive deficits. The main critical criterion was the average quantity of strong opioids delivered in a morphine sulfate equivalent in milligrams per day (mg/d). Equivalence calculations for strong opioids were performed according to the equianalgesic Table .Our secondary aims were to compare the 2 groups of patients over various time periods based on the following criteria: 1) pain assessment using numerical scales and the quantity of acetaminophen delivered in grams per day (g/d) in the preoperative period and the first 3 postoperative days; 2) the quantity of strong opioids delivered in a morphine sulfate equivalent in mg/d in the first 3 postoperative days; 3) the occurrence of delirium during hospitalization according to the scale of the Confusion Assessment Method (CAM) ; and 4) The following data were collected: gender, age, type of fracture and of surgery, preoperative delay in hours, length of stay in days, living place, pre-fracture functional status according to Katz’s Activities of Daily Living scale (ADL)  and LawtIn order to distinguish our two groups according the cognitive status, we considered the MMSE less than 6 months old previous the hip fracture to determine if the patient were in one or the other group. Geriatric patients with moderate or severe cognitive deficits (group I) were defined according to the known MMSE with a score below 20/30 regardless of the aetiology of the disorder. If the MMSE score was greater than 21/30 or not available, the patient was included in group II. Patients with MMSE scores between 21 and 25/30 were not considered patients with moderate or severe cognitive deficits because their verbalization, understanding, and participation in pain self-assessment would be less affected within this population , 24.The orthogeriatric unit employs a set of protocols and standardized pain management (SPM) that consists of the following: 1) pain assessment through a numerical scale performed systematically 3 times a day and then repeated as many times as necessary. The numerical scale is a self-assessment scale with a maximum score of 10 where 0 indicates no pain and 10 indicates unbearable pain; the algoplus scale was performed in addition in case of severe cognitive deficits 2) non-pharmacological pain management included during the preoperative period: the limitation of the movements of the traumatized limb by positioning in alignment of the limb, blocking rotations by avoiding muscular contractions of the traumatized limb, mobilization in the block by trained paramedical teams, and ice during the peri-operative period; 3) systematic prescription of 1 g of acetaminophen 3 times a day and 5 mg per os of oxycodone  systematically delivered in the morning before the nursing and mobilization procedures; 4) conditional prescription of strong opioids based on pain intensity all day. A pain intensity level greater than 6 induces opioid use. Data tracking of the numerical scale of prescriptions and analgesics given was performed by nursing staff.p-value less than 0.05 indicated a significant result.Study data were collected through patient electronic records using Cristalnet and Easily software. Descriptive analysis was conducted on all of the variables collected, on the total population collected, and in each group according to the categorical variable defined as the presence or absence of cognitive deficits. Qualitative parameters were expressed in numbers and percentages. Quantitative parameters were described by the mean ± standard deviation and by median with the 25th and 75th percentiles. Descriptive analysis of the different variables according to the categorical variable was analysed by univariate tests. Quantitative data were compared using the Mann-Whitney test or Welch test, and qualitative data were compared using the Chi-2 test or nonparametric Fisher test. No multivariate analysis was performed due to the low number of patients involved in our study. Analysis was performed using data processed in Excel 2019 for PC, and statistics were performed on Pvalue.io. A Among the 117 patients admitted for hip fracture within orthogeriatric units, 69 patients were included in our panel after applying our exclusion criteria  and an average IADL score of 0.48/8 versus 3.65/8 (p < 0.001). Patients in this group also lived more frequently in nursing homes (p < 0.001). The weight and presence of severe renal failure were comparable in both groups (Table The population characteristics are presented in Table p = 0.38)  mg/d in the preoperative period. Patients in group I received an average of 13.1 +/− 9.20) mg/d, and patients in group II received 10.8 (+/− 11.9) mg/d. No significant difference between these groups was identified . In the preoperative period, the quantity of acetaminophen delivered daily was equivalent for both groups with an average of 1.78 g/d for group I and 1.73 g/d for group II (p = 0.83). During the first 3 postoperative days, no differences were noted between the 2 groups regarding pain assessment (p = 0.89), quantity of acetaminophen delivered (p = 0.84), or the quantity of strong opioids delivered (p = 0.19) (Table p < 0.01). Regarding patients’ usual treatments, prescription for patients with moderate or severe cognitive deficits included more psychotropic drugs than patients with no or mild cognitive deficits (p = 0.026). In the preoperative period, psychotropic drugs were delivered in a comparable manner . During the first 3 postoperative days, psychotropic drugs were delivered more frequently to patients with moderate or severe cognitive deficits (59%) compared with patients with no or mild cognitive deficits (32%) (p = 0.025)  and during the first 3 postoperative days (p = 0.57)  , 37. StaCognitive comorbidity is often undiagnosed by community players, and patients could have physiological cognitive dysfunctions associated with their age . When foDelirium is one of the most frequent perioperative complications of hip fracture, and its incidence is 2 to 3 times higher for patients with dementia , 41. In A link was established between untreated or inadequately treated perioperative pain and the occurrence of confusion , 44. ThiOur study had several limitations. This study was retrospective and monocentric. However, our study included patients who were older than those previously included the literature with a median age of 90 years . The chaOur study demonstrated that regardless of the presence of cognitive deficits and delirium, patients 75 years old and over hospitalized in the orthogeriatric unit for a hip fracture received the same daily average quantity of strong opioids during the preoperative period. Standard pain management in an orthogeriatric unit can avoid the undertreatment of pain in patients with moderate to strong cognitive deficits. The expertise and the quality of multidisciplinary care in our perioperative orthogeriatric unit could explain the homogeneity of care. Indeed, orthogeriatric care pathways are recommended to improve the prognosis of these patients when hospitalized for hip fracture , 37.


Based on conventional drug treatment, patients were treated with either a single nerve root pulsed radiofrequency therapy or a single local subcutaneous injection of BoNT-A in the lesion area. All the patients were followed up for 24 weeks on pain scores, sleep quality, anxiety, and depression scores, etc. In the last follow-up at the end of 24 weeks postoperation, the pain scores of patients in both groups were significantly lower than those before the operation (P < 0.05), indicating that both treatments were effective against PHN; however, there was no significant difference between these two groups (P > 0.05). It is noteworthy that the subcutaneous injection of BoNT-A is relatively easy to administer and less expensive compared to RF. Therefore, we believe that the subcutaneous injection of BoNT-A is an effective and safe method for the treatment of PHN.This study evaluated the effectiveness and safety of botulinum toxin type A (BoNT-A) and pulsed radiofrequency (RF) in the clinical treatment of postherpetic neuralgia (PHN). A total of 100 patients with PHN were randomly divided into two groups ( Shingles is caused by the reactivation of latent varicella-zoster virus (VZV) infection in the primary sensory neurons of the human body. Once reactivated, the VZV spreads along the sensory nerves and causes herpes in the corresponding cutaneous segment, which is often accompanied by severe pain . In mostSince Sluijter first proposed pulsed radiofrequency technology at the second Annual Conference of the European Federation of International Pain Societies in 1997, pulsed radiofrequency technology has been widely used in pain treatment due to its advantages of convenient operation, safety and effectiveness, minimally invasive, and fewer complications. The mechanism of pulsed radiofrequency technology for pain relief is mainly electric field effect; that is, pulsed radiofrequency technology generates voltage fluctuation between tissues requiring treatment through high-frequency current, thus generating periodic electric field activity and regulating synapses to achieve pain relief . EvidencBotulinum toxin type A (BoNT-A) is one of the natural toxins produced by Clostridium botulinum. Clinically, it is mainly used for the treatment of cosmetology and spasmodic diseases, including hemifacial spasm, spasmodic torticollis, and neurogenic bladder. –12. HoweThrough a randomized, single-blind, parallel-controlled clinical research, we compared the clinical efficacy and safety of pulsed radiofrequency (RF) and subcutaneous injection of BoNT-A in the treatment of PHN, observed the sensitivity of different characteristics of PHN to these two treatments, and further optimized the clinical strategy for the treatment of PHN.This study was registered in the Chinese Clinical Trial Registry. The registration number is ChiCTR1900020798. The research content was approved by the Ethics Committee of the Affiliated Hospital of Xuzhou Medical University (protocol code: XYFY2019-KL046-02) and strictly followed the Declaration of Helsinki. The whole process was completed in the Affiliated Hospital of Xuzhou Medical University. The study started on December 9, 2019, and the last patient completed the last follow-up on February 24, 2021.The inclusion criteria for this study were as follows: (1) pain lasted for more than one month after the herpes zoster was completely healed, (2) ID-Pain scale ≥2, (3) age ≥18 years, and (4) NRS ≥4.The exclusion criteria were as follows: (1) there was a history or family history of neuromuscular junction disease; (2) drugs acting on the neuromuscular junction or aminoglycoside antibiotics had been used in the past 2 weeks; (3) there was a personal or family history of coagulation dysfunction; (4) BoNT-A was used in the recent 6 months; (5) there were severe systemic diseases ; (6) women who were preparing for pregnancy, in the pregnancy or lactation period; (7) there were other conditions that would affect pain assessment ; (8) allergy to botulinum toxin A, lidocaine, gabapentin, tramadol, or oxycodone; (9) patients were unable to communicate, or with severe mental disorder, alcohol addiction, or drug abuse; and (10) patients refused the treatments. The study flow diagram is shown in https://random-allocation-software.software.informer.com/2.0/) was used to conform to the condition that 100 patients were randomly assigned according to 1 : 1. Patients and surgeons knew about the grouping, but the follow-up personnel and statisticians did not. Follow-up did not involve the specific situation of grouping.The computer software  was inserted into the plane along the lateral edge of the ultrasound probe and stopped when the tip reached the paravertebral space. The needle core was removed, and the radiofrequency electrode  was inserted. Then, the radiofrequency pain therapy instrument  was connected to give sensory stimulation of 0.1–0.3 mV at 50 Hz, which could induce the presence of abnormal sensation in the corresponding nerve distribution area. Subsequently, standard pulsed radiofrequency treatment was given: temperature 42 °C, frequency 2 Hz, pulse width 20 ms, voltage 37–41 V, and time 360 s.The main outcome measure of this study was the NRS of the two groups before and after surgery .Secondary outcome measures included the following: (1) sleep quality scores (SQSs) before and after surgery ; (2) GAD-7 and PHQ-9 scores before and 24 weeks after surgery; (3) proportion of different pain characteristics based on the ID-Pain scale before and 24 weeks after surgery; (4) oral analgesics at 24 weeks after surgery; (5) costs associated with treatments; and (6) occurrence of adverse events.δ, that was, 0.6. Assuming that the standard deviation between the two sets of data was approximately equal, we selected α = 0.025 (one-sided) and 1 − β = 0.8. N1 = N2 = 45 was calculated by the PASS 11. Taking into account the 10% dropout rate, 50 patients were proposed for each group.According to the method of estimating the sample size of the noninferiority test and the results of previous research studies , 20, thet-test was used for comparison between groups, and repeated measures ANOVA was used at different time points within the groups. The Mann–Whitney U test was used for non-normally distributed data. The chi-square test or Fisher's exact probability test was used for count data, and the rank sum test was used for rank data. Two-factor repeated measures ANOVA or generalized estimating equation (GEE) was used for comparison between two groups at multiple time points. P < 0.05 was considered to be statistically significant.Statistical software IBM SPSS 24.0 was used for statistical analysis of the data. The MICE program package in R software was used for multiple data filling. GraphPad Prism 5.0 was used for mapping. The Shapiro–Wilk test was used to determine the normality of the data distribution, and the Levene method was used to test the homogeneity of variance. The measurement data satisfying the normal distribution were represented by mean ± standard deviation n = 50): RF group and BoNT-A group. The basic information of the two groups is shown in According to the inclusion and exclusion criteria, 100 patients voluntarily participated in this study that started on December 10, 2019, and the last patient completed the last follow-up on May 19, 2021. All patients were randomized into two groups  was used to score the pain of all patients at baseline and 1 week, 4 weeks, 12 weeks, and 24 weeks postoperation. 0 represents no pain, and 10 represents the most severe pain. The subjects selected one number from the 11 numbers ranging from 0 to 10 to represent the degree of pain based on their personal subjective pain perception. The larger the number, the more severe the pain; the smaller the number, the less the pain.P > 0.05). The NRS at 1 week, 4 weeks, 12 weeks, and 24 weeks postoperation were significantly lower than the baseline value (P < 0.05). However, at the same point in time, there was no significant difference in NRS between the two groups (P > 0.05), as shown in There was no statistical difference in the baseline NRS between the two groups (A score sheet containing five questionnaires  was usedP > 0.05). The SQS at 1 week, 4 weeks, 12 weeks, and 24 weeks postoperation were significantly lower than the baseline value (P < 0.05). However, at the same point in time, there was no significant difference in the scores between the two groups (P > 0.05), as shown in There was no statistical difference in the baseline sleep quality scores (SQS) between the two groups . At 24 weeks postoperation, GAD-7 scores in the RF group were significantly lower than those at baseline (P < 0.05). Although the GAD-7 scores in the BoNT-A group were also lower than that at baseline, the difference was not statistically significant (P > 0.05). The postoperative GAD-7 scores in the BoNT-A group were lower than that in the RF group, and the difference was statistically significant (P < 0.05), as shown in There was no statistical difference in GAD-7 scores between the two groups at baseline (P > 0.05). At 24 weeks postoperation, PHQ-9 scores of the two groups were lower than those at baseline (P < 0.05), but there was no significant difference between the two groups (P > 0.05), as shown in There was no statistical difference in PHQ-9 scores between the two groups at baseline , while the incidence of burning pain postoperation in the BoNT-A group was significantly lower than that in the RF group (P < 0.05), as shown in There was no difference in the incidence of different pain characteristics between the two groups at baseline, as shown in In this study, the oral analgesics included anticonvulsants (gabapentin), antidepressants (duloxetine), and opioids (tramadol or oxycodone). However, most patients resist taking antidepressants for long periods. Therefore, at the end of 24 weeks postoperation, we mainly observed two indicators: (1) the dose of gabapentin and (2) whether to take tramadol or oxycodone.P > 0.05), and there was no difference in the proportion of patients taking tramadol or oxycodone (P > 0.05), as shown in At 24 weeks after surgery, there was no difference in the dose of gabapentin between the two groups (P < 0.05), as shown in According to the national charging standard, the expenses of patients in the RF group  were much higher than those in the BoNT-A group   is the most common and disturbing clinical symptom of herpes zoster. The current clinical guidelines recommend pregabalin, gabapentin, tricyclic antidepressants, and 5% lidocaine patch as the first choice for the treatment of PHN , 22, 23.Considering the clinical efficacy, cost, and ease of use, the most commonly used adjuvant therapy for PHN is spinal nerve pulsed radiofrequency. Most patients with PHN experienced a significant reduction in pain after pulsed radiofrequency , 25. HowAlthough there are many drugs and methods to treat PHN clinically, there are still some refractory PHN, which does not respond well to various treatments, seriously affect the sleep quality and emotional state of patients, and may even cause anxiety and depression in patients. Pulsed radiofrequency technology by the needle will be intermittent (pulse frequency of 2 Hz), short-term (current role duration of 20 ms), frequency of 500 kHz high-frequency alternating current (ac) on the dorsal root ganglion, by adjusting the nerve function to achieve pain relief, with minimally invasive, safe, quick effect, less adverse reaction, etc. But its ability to relieve pain is limited. Kim et al.  applied Based on this, we found through the literature review that BoNT-A has certain therapeutic effects on PHN and can improve the quality of life of patients , 13. ItsThrough the noninferiority study design, we found that BoNT-A was as effective in treating PHN as pulsed radiofrequency. Meanwhile, the patients in both groups were accompanied by a reduction in pain, a simultaneous improvement in sleep quality, and a significant reduction in anxiety and depression scores. Notably, the anxiety scores of the BoNT-A group were lower than that of the RF group at the 24 weeks postoperation. Overall, from the perspective of the three secondary outcome indicators of sleep quality, anxiety, and depression scores, the efficacy of BoNT-A is not inferior to that of pulsed radiofrequency.In this study, we also noted that patients with PHN often complained of different pain characteristics. Therefore, we applied the five pain characteristics in the ID-Pain scale—stabbing pain, burning pain, numbness, electric shock pain, and allodynia, and then added the spontaneous pain to observe whether there were differences in efficacy for different pain characteristics between the two treatments. By comparison, the incidence of burning pain in the BoNT-A group was significantly lower than that in the RF group at the end of 24 weeks postoperation, while the incidence of stabbing pain in the RF group was significantly lower than that in the BoNT-A group. At the same time, except for numbness, the incidence of other pain characteristics in both groups was significantly lower than that at baseline. These results also indicate that BoNT-A can effectively treat PHN from another aspect.ɑ2 − δ subunit and sodium channel, the decreased function of inhibitory neurons, and the necrosis of supporting cell [Previous studies have suggested that different pain characteristics may implicate different mechanisms, including peripheral sensitization, central sensitization, inflammatory response, deafferentation, and ectopic pacemaker. , 36, 37.ing cell . The maiing cell . With thing cell .Limited by the small sample size, this study cannot precisely explain which treatment is more suitable for patients with specific types of painful PHN. To select more targeted treatments according to the pain characteristics of patients, future studies are required to understand the precise mechanisms underlying different pain characteristics.Subcutaneous injection of BoNT-A can treat PHN and improve the quality of sleep and life effectively, with clinical efficacy comparable to pulsed radiofrequency. Although pulsed radiofrequency also showed excellent efficacy, it was more suitable for the treatment of large area PHN due to problems such as precise guidance and residual pain. For PHN patients with burning pain, BoNT-A can better improve the clinical symptoms of patients. In addition, the overall cost of subcutaneous injection of BoNT-A is relatively low, which is a relatively safe, effective, easy, and inexpensive method for the treatment of PHN.


Poor sleepers were significantly more prevalent in the mixed temporomandibular disorder pain group (76.8%) and myalgia group (71.7%) than in the arthralgia group (54.8%) (p=0.006). The presence of psychological distress in the myalgia group , global severity index of the Symptom Checklist-90-Revised in the arthralgia group , and presence of headache  and self-reported sleep problems  in the mixed temporomandibular disorder pain group were associated with an increase in the Pittsburgh Sleep Quality Index score. Ultimately, as the source of pain in painful temporomandibular disorder can affect and determine sleep quality and contributing factors, and as the complex interplay between sleep and pain can vary, a comprehensive treatment approach is necessary because good sleep is required by patients.Chronic pain conditions, including temporomandibular disorders, are closely related to poor sleep quality. This study investigated whether sleep deterioration in patients with painful temporomandibular disorder differed depending on the origin of pain, and also analyzed which clinical disease characteristics and whether psychological distress affected sleep quality. A total of 337 consecutive patients  with painful temporomandibular disorder , who were assessed and classified based on the diagnostic criteria for temporomandibular disorder (DC/TMD), were enrolled. They completed a battery of standardized reports on clinical sign and symptoms, and answered questions on sleep quality, excessive daytime sleepiness, and patients’ psychological status. The mean global Pittsburgh Sleep Quality Index scores were significantly higher in the mixed temporomandibular disorder pain group (6.97 ± 3.38) and myalgia group (6.40 ± 3.22) than in the arthralgia group (5.16 ± 2.94) ( Therefore, good sleep quality is a key factor underlying good daytime performance, emotional well-being, physical health, and pain control. Vice versa, poorer sleep quality is predicted by higher pain severity, poorer brain functioning, and greater psychologic distress2. Sleep deterioration, pain, and psychological distress are interlinked and inseparable.Humans sleep for a quarter to a third of their lifetime. Although human activity decreases during sleep, sleep is essential for health and pain control. Humans engage in certain productive activities while awake but obtain crucial health benefits during sleep, such as energy conservation, immune function regulation, homeostasis maintenance, memory consolidation, growth and recovery of the body, and psychological relaxation during sleep3. TMD has a multifactorial etiology. TMD is caused by the accumulation of daily microtraumas in the TMJ area due to parafunctional oral habits, such as bruxism and clenching. However, macrotrauma, psychological distress, and sleep problems also contribute to its development4. TMD is best understood within a biopsychosocial framework5. Following the publication of the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) in 1992, the Diagnostic Criteria for TMD (DC/TMD), a revised version that can be used for practical diagnosis in the clinical field, was published in 20146. In TMD diagnosis based on the DC/TMD Axis I, myalgia and arthralgia of the TMJ are the two main sub-diagnoses of TMD. In general, arthralgia is described as a well-defined inflammatory process, and the number of painful joints is related to poor sleep quality7. In contrast, chronic myalgia is caused by enigmatic pathophysiological mechanisms considered to be a pain syndrome and which interferes with both the quantity and quality of sleep9.Temporomandibular disorder (TMD) is an umbrella term for heterogeneous pain and dysfunction in the temporomandibular joint (TMJ) and masticatory muscle regions. Approximately 39% of the population has at least one sign or symptom of a TMD, and 25% have pain related to a TMD10. Yatani et al. reported that up to 90% of patients with TMD diagnosed by RDC/TMD had low sleep quality with high global PSQI11. Although the exact mechanism of the complex interaction between TMD pain and poor sleep remains under investigation, some researchers have suggested that painful TMD diagnoses and poor sleep quality are closely related10. However, a newly developed DC/TMD-based study on sleep quality in patients with painful TMD and sleep surveys according to the TMD subgroup of DC/TMD has not been conducted so far.The Pittsburgh Sleep Quality Index (PSQI) is an internationally widely used instrument for assessing self-perceived sleep quality and is well validated and reliable. According to previous RDC/TMD- and PSQI-based study, poor sleep quality is found in 60.3% of patients with TMD, and the global PSQI score in painful TMD cases was statistically higher than that in non-painful TMD cases12. Thus, chronic pain should be understood following a biopsychosocial model. Sleep problems cause musculoskeletal hypersensitivity, and TMD is a representative form of musculoskeletal pain in the orofacial area, which is prone to experiencing chronic pain. Considering the source of TMD pain or TMD subgroups, sleep quality was significantly worse in patients with TMD with myofascial pain than in patients with TMJ intracapsular pain13. In addition to poor sleep, psychosocial aspects are related to the experience of pain in cases of painful TMD14. Moreover, patients with myogenous TMD had more comorbid disorders including severe headache, fainting, anxiety, depression, and frequent sore throats, and more severe pain than patients with arthrogenous TMD15. Unfortunately, few studies have documented whether sleep quality differs according to the chronicity of symptoms, the number of DC/TMD sub-diagnoses, as well as the origin of TMD pain in patients, so novel clinical approaches and scientific evidence addressing these relationships are needed.When pain becomes chronic, there is a stronger relationship between sleep deterioration and pain aggravation. Chronic pain has an underlying mechanism that involves a more complex relationship between physical, psychological, and social factors than acute painTaken together, we hypothesized that sleep quality differs in patients with painful TMD depending on the origin of TMD pain , and sleep may be worse when there are multiple origins of pain. Furthermore, we first analyzed the association between poor sleep quality and clinical disease characteristics, excessive daytime sleepiness, and psychological distress in patients with painful TMD, which has not been previously reported. Controlling the risk factors for TMD is the first step in reducing healthcare costs and preventing TMD from becoming chronic. Therefore, it is worth analyzing the factors that contribute to poor sleep quality in patients with painful TMD.A total of 337 consecutive patients  who visited the Department of Orofacial Pain and Oral Medicine of Kyung Hee University Dental Hospital  over a 6-month period from October 2020 and March 2021 for the management of painful TMD were included in this study. All patients were examined by two TMD specialists with more than 7 years of experience and were carefully examined and diagnosed using the DC/TMD examination. Patients also completed comprehensive questionnaires, including the DC/TMD symptom questionnaire, DC/TMD demographics, oral behavior checklist, and TMD pain screener.Exclusion criteria were as follows: (1) patients who were under 18 years of age, (2) patients who had other systemic muscular disorders , (3) patients who had neurologic impairment or diseases , (4) patients who were pregnant, (5) patients who had a history of psychiatric disorders, and (6) patients unable to provide informed consent.The inclusion criteria were diagnosis of painful TMD according to the DC/TMD Axis I classification, and report of pain at the TMJ and/or masticatory muscles for at least 3 months. A total of 382 patients diagnosed with painful TMD were included, and 45 patients were excluded because they lacked medical documentation. Finally, 337 patients with painful TMD were then divided into three groups as follows: pain of muscle origin , pain of joint origin , and muscle–joint mixed TMD pain .All participants provided written consent for the study, which was approved by the Ethical Committee of Kyung Hee University Dental Hospital (KHD IRB no. 1804-2). The study was conducted in accordance with the principles of the Declaration of Helsinki.Experienced orofacial pain specialists conducted comprehensive clinical and radiographic examinations. TMD pain, sleep quality, psychological profile, and excessive daytime sleepiness were assessed using standard, validated, and reliable self-reported instruments administered at the initial evaluation.The duration of pain derived from the TMJ and/or masticatory muscles is reported in days. Temporomandibular pain was scored by the patients subjectively, ranging from 0  to 10 (worst pain imaginable) using a visual analog scale (VAS).16.We investigated self-reported parafunctional activities using the Oral Behavior Checklist, which includes jaw-related behaviors, such as teeth clenching and bruxism. The presence of headache was evaluated using the dichotomous question, “Do you have any headache in the temporal region and headache affected by jaw movement, function, or parafunction?” The presence of self-assessed tinnitus, psychological distress, and sleep problems was also reported with a binary answer. That is, each variable was recorded as a binary answer (yes/no) in all patients, as described in our previous study17. The PSQI was used to measure sleep quality. According to the recommended cutoff point of the PSQI (>5), the patients in this study were categorized as good sleepers (score ≤5) and poor sleepers (score ≥6).Using the 19-item PSQI, a well-validated self-report questionnaire, sleep quality in the past month was assessed. The PSQI has seven components: subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Each subscale is weighted equally, scored from 0 (good sleep/no problems) to 3 (poor sleep/severe problems), summing to a global PSQI score , with higher scores denoting worse sleep quality18. It contains 90 items, and patients rated each item on a 5-point scale  for how much each problem had distressed or bothered them during the past 7 days. It yielded nine subscale scores, including somatization, obsessive-compulsive, interpersonal sensitivity, anxiety, depression, hostility, phobic anxiety, paranoid ideation, and psychoticism, along with three global indices of distress . Higher T-scores of the nine subscales and three global indices on the SCL-90R indicate a greater propensity to experience psychological distress.The Symptom Checklist-90-Revision (SCL-90R), a validated brief self-report psychometric inventory, has been used to evaluate psychological profiles19. The ESS is an eight-item, self-administered questionnaire designed to measure the subject’s propensity to fall asleep in a variety of situations. The participant was instructed to answer how likely it is that they would fall asleep in different situations by giving a score on a 4-point scale (0–3). Thus, the total score (the sum of scores of the eight items) of the ESS ranges from to 0–24. Higher scores represent a greater possibility that the individual will fall asleep during the daytime. Unlike other scales that measure sleepiness at a single time point, the ESS is designed to evaluate the general level of sleepiness. The ESS total scores were dichotomized into scores ≤10 and >10; the latter was considered to represent clinically significant EDS. We used a score >10 on the ESS to measure excessive sleepiness.The Epworth sleepiness scale (ESS) is a validated clinical tool for evaluating excessive daytime sleepiness (EDS)The data were analyzed using SPSS Statistics for Windows, Version 26.0, . Continuous variables are presented as means and standard deviations (SD), and categorical variables are presented as frequencies and percentages. The inter-rater reliability between the two experts in the diagnosis of painful TMD was assessed using Cohen’s kappa coefficient and was 0.91 for myalgia, 0.94 for arthralgia, and 0.92 for mixed TMD pain groups. If the same diagnosis was not given by the two experts, the patient was finally assigned to one TMD group following in-depth discussion. Differences between the three painful TMD groups were examined using the chi-squared test for categorical variables and t-test and one-way analysis of variance (ANOVA) with Tukey’s post-hoc test for numeric variables. The chi-squared test with Bonferroni adjusted post hoc analysis was used to determine the equality of proportions. Spearman’s correlation coefficients (r) for global PSQI scores with demographics, TMD pain severity, and psychological profiles were calculated, ranging from −1 to +1, with −1 indicating a perfectly linear negative correlation and +1 indicating a perfectly linear positive correlation. Subsequently, assuming that the factors showing a significant correlation with the global PSQI score are predictors, multiple linear regression analysis with a stepwise method was conducted to explore significant predictors for increasing PSQI scores in patients with painful TMD. The estimated β was calculated using multiple linear regression analyses after adjusting for age. For all analyses, a two-tailed p-value of less than 0.05 was considered statistically significant.The research protocol was reviewed in compliance with the Helsinki Declaration and approved by the Institutional Review Board of the Kyung Hee University Dental Hospital (KHD IRB no. 1804-2).Informed consent was obtained from all subjects involved in the study.20. The age distribution was not significantly different between the three groups.Table p<0.001). There was no significant difference in the frequency of mouth opening limitation between groups. The mean symptom duration was significantly longer in the myalgia (524.35 ± 2010.22 days) and mixed TMD pain groups (620.59 ± 1171.99 days) than in the arthralgia group (272.94 ± 469.26 days) (p=0.044). Considering the contributing factors, the prevalence of tinnitus and headache were significantly higher in the myalgia and mixed TMD pain groups than in the arthralgia group (p<0.05). The prevalence of bruxism, clenching, macrotrauma history, and psychological distress did not differ significantly between the TMD groups. There was no significant difference in the presence of self-reported sleep problems between the myalgia (35.0%), arthralgia (30.6%), and mixed TMD groups (36.8%) (p=0.694). Psychological distress was observed in 55.4% of patients with painful TMD and was the most frequently observed contributing factor in all three groups, whereas a history of macrotrauma was only present in 6.5% and the least observed factor in all three groups.The VAS score was significantly higher in patients with mixed TMD pain (5.71 ± 1.93) than in those with arthralgia (4.97 ± 2.54) and myalgia (4.49 ± 2.77) .Based on the PSQI, poor sleep quality was more pronounced in patients with painful TMD with pain of both joint and muscle origin than in those with only one pain origin. Overall, the PSQI global score was significantly higher in the myalgia (6.40 ± 3.22), and mixed TMD pain (6.97 ± 3.38) groups than in the arthralgia group (5.16 ± 2.94), and the frequency of poor sleepers was significantly higher in the myalgia and mixed TMD groups than in the arthralgia group  of patients with painful TMD were poor sleepers, and the proportion of poor sleepers was significantly higher among patients with myalgia (71.7%) and mixed TMD pain (76.8%) than among patients with arthralgia (54.8%). The factors affecting sleep quality differed between the three TMD groups. Sleep disturbance occurred more frequently in patients with myalgia than in those with arthralgia, and sleep deterioration was more severe in patients with both diagnoses.p<0.05).Table p=0.01), whereas the proportion of patients experiencing EDS (ESS >10) did not differ significantly between the three groups .The total ESS score was significantly higher in the mixed TMD pain group (8.04 ± 3.82) than in the myalgia (6.56 ± 3.56) and arthralgia groups (6.55 ± 3.50)  strongly correlated with PSQI global score. In the mixed TMD pain group, tinnitus  and headache  significantly correlated with PSQI global score. Self-reported sleep problems investigated using dichotomous questions positively correlated with the PSQI global score in all three groups .Figure p=0.017).The correlation between the PSQI global score and psychological profiles was remarkable. The psychological profiles of the three groups significantly correlated with sleep quality. Regarding the nine subscales of the SCL-90R, all nine subscales correlated with an increase in PSQI global scores, and all subscales excluding hostility significantly positively correlated with PSQI global scores in the mixed TMD pain group. Total ESS scores significantly positively correlated with PSQI global scores only in the arthralgia group  and self-reported sleep problems  in the myalgia group, and headache  and self-reported sleep problems  in the mixed TMD pain group. The existence of self-reported sleep problems expressed as a dichotomy (yes or no) was strongly associated with the PSQI global score. In arthralgia, the global severity index of the SCL-90R was a predictor of the PSQI global score only in the arthralgia group .Following the Spearman’s correlation analysis, multiple linear regression analysis was performed on 17 predictor variables that significantly correlated with the PSQI global score Fig. . Regardi21. Poor sleepers accounted for 70.9% of patients with painful TMD, and the proportion of poor sleepers was significantly higher in the myalgia (71.7%) and mixed TMD pain groups (76.8%) than in the arthralgia group (54.8%). The proportion of poor sleepers was previously reported to be 60.3% among patients with TMD, regardless of the presence of pain10.Clinical characteristics differed according to TMD diagnosis based on DC/TMD, and their effect on sleep quality also differed according to the origin of TMD pain. TMD is an umbrella term, and the signs and symptoms of patients with TMD are diverse. As mentioned above, painful TMD is not only observed in patients with myalgia, arthralgia, and mixed TMD pain, but also in patients with aggravated psychological pain as determined by DC/TMD Axis II10, which may be due to differences in the subjects’ ethnicity, study area, and study methods. In addition, the mixed TMD pain group had the highest VAS score and highest PSQI global score. According to Zamani et al., the sleep quality measured using PSQI deteriorates as the symptom severity of TMD increases22. In a recent study, compared to TMD-free controls, painful TMD caused a 3.2 times increase in the frequency of poor sleep as measured using PSQI, which was higher than the 1.91 times in intra-articular TMDs23. We hypothesized that sleep quality might differ with painful TMD sub-diagnosis according to the DC/TMD, and our results suggest that sleep and related clinical factors are dependent on the source of TMD pain and symptom severity.The PSQI global score was also significantly higher in the myalgia (6.40 ± 3.22) and mixed TMD pain (6.97 ± 3.38) groups than in the arthralgia group (5.16 ± 2.94). The PSQI mean score of patients with painful TMD reported by Rener-Sitar et al. was 7.5, somewhat higher than our result26. In contrast, muscle pain is poorly localized and has a pressing quality, marked tendency towards referral of pain, and more affective aspect; arthralgia is well-localized and has a stabbing quality, no tendency toward referral of pain, and less affective aspect. In general, psychosocial factors, such as depression and tension personality, are more frequently observed in patients with myogenous TMD27. Unlike arthralgia, myalgia is often accompanied by changes in psychological state29. Anxiety and stress-related bruxism activity are positively associated with myogenous TMD pain27. In particular, psychosocial forces can shape individual vulnerability to pain-related outcomes over time30. Therefore, analgesic and anti-inflammatory drugs are prescribed for arthrogenous pain; however, antidepressants, anticonvulsants, and muscle relaxants are commonly prescribed for myogenous pain31. Although some patients with advanced osteoarthritis develop central sensitization, central sensitization and neuropathic features have been reported in patients with muscle pain32.An in-depth discussion on the reason for the difference in sleep quality according to the origin of TMD pain is needed. Among TMD sub-diagnoses, arthralgia is accompanied by a well-defined inflammatory process mediated by inflammatory cytokines, whereas chronic myalgia presents with an enigmatic pathophysiological mechanism33. As a next step, increased muscle tension can be a local trauma, physiological dysfunction, and lead to a defensive response to psychological burden34. A central mechanism in the development of muscle pain due to prolonged overactivity is primarily concerned with the muscles that tense when experiencing psychological discomfort, anxiety, or stress35. Specifically, the masseter muscle, temporal muscle, sternocleidomastoid muscle, and trapezius muscle are typical examples mentioned when discussing the central mechanism. These muscles tend to respond to changes in mental state that can cause muscle pain associated with mental disorders or chronic stress36. Poor sleep is most likely a comorbidity or a contributing factor that continues their vicious cycle9. The disparity between the ability to control muscle pain, good sleep, and mental health can affect the chronicity of symptoms.The exact etiology of the central mechanism of muscle pain and its relationship with psychological distress remain unclear. Starting with a peripheral mechanism of myalgia excitability, the outlasting sensitization of peripheral nociceptors may result in persistent hypersensitivity of peripheral nociceptors, which are involved in excitation and/or dysfunction of central neurons37. When there are multiple causes of TMD pain, the psychological aspects can be more complex. Patients with multiple TMD diagnoses have higher rates of depression and somatization38. Manfredini et al. reported a tendency to have higher SCL-90-R scores in patients with myofascial pain combined with TMJ pain than in those with TMJ pain alone39. However, Reissmann et al. reported that the location of pain in TMD patients was not a major factor when predicting psychosocial profiles and current pain severity40. The discrepancy between our results and those of Reissmann et al. might be explained by the fact that they did not consider symptom duration and pain chronicity as the study’s main variables.As hypothesized, sleep was more disturbed in the mixed TMD pain group with both joint- and muscle-derived pain than in those with pain from a single origin. This suggests that when symptoms are complex with multiple origins of pain, sleep and psychosocial aspects are more vulnerable. According to Trivedi et al., as the number of physical symptoms a patient has increases, the morbidity of depression also increases41, which is similar to the prevalence of sleep disorders (10–36%)42. Sleep disorders have been found to affect 88% of patients with chronic pain43. Conversely, more than 40% of patients with sleep disorders report chronic pain44. In addition, chronic pain and sleep problems commonly have psychological comorbidities, especially depression45. As acute pain progresses to the chronic phase, the central pain control system and psychosocial factors can also be more impaired30. Regarding changes in the brain, dysregulation of neurotransmitters in the brain is linked to both chronic pain and depression, and this linkage makes pain patterns more complex and exacerbates pain46. Chronic pain is also related to anatomical alterations in brain regions involved in cognitive and emotional modulation of pain47. There may be a brain circuit that responds differently to noxious stimuli in patients with chronic painful TMD compared to those with acute TMD or non-painful TMD. These complex interactions may explain why patients with TMD pain of mixed origin develop psychological distress and are at increased risk of sleep problems and central amplification of pain. However, studies on the etiopathology and underlying mechanisms of mixed TMD pain based on DC/TMD are extremely limited, and more detailed studies are needed.In the present study, the mixed TMD pain group had the longest symptom duration and the highest PSQI global score among the three painful TMD groups. The chronicity of TMD pain can be closely linked to poor sleep quality in patients with painful TMD. In general, the prevalence of chronic pain ranges from 10 to 40%12. In a previous study using the SCL-90R in TMD patients, depression and somatization scales were higher in women than in men48. In addition, there is a tendency for increased prevalence of tinnitus in patients with chronic pain49. In the present study, the prevalence of tinnitus and headache was highest in the mixed TMD pain group. Chronic pain and tinnitus have several similarities and are frequently associated with hypersensitivity to sensory stimuli. Both are abnormal and variable subjective sensations, often not fully explained by initial peripheral lesions; thus, they are referred to as phantom sensations. Moreover, patients suffering from these two conditions often share the same psychological traits with an increased propensity for anxiety and depression51. Although research on the exact mechanism is needed, the overlap of pain and psychological distress is particularly pronounced in patients with chronic pain and headache52.Female sex is a major risk factor for both chronic pain and poor sleep quality. In the myalgia and mixed TMD pain groups, the proportion of women was higher than that in the arthralgia group. Women are more exposed to chronic pain than men and are more prone to co-occurrence of chronic pain with depression and anxiety9. Furthermore, as pain becomes chronic, central neural plasticity and central sensitization increase, and psychological factors may become vulnerable53. Specific psychosocial characteristics place individuals at elevated or reduced risk for the transition from an acute to a persistent pain state54. Of course, psychosocial processes exist within an individual as a pre-existing vulnerability factor. Sleep problems considering the chronicity of TMD pain should be further studied in patients with painful TMD.Both chronic pain and sleep disturbances share an array of psychological health issues. Although the degree of correlation varied between the painful TMD groups, the T-score of the nine parameters of the SCL-90R positively correlated with the PSQI global score. The relationships between pain, poor sleep phenomena, and psychological distress should be considered “reciprocal” in painful TMD. Disturbed sleep affects pain perception by lowering the pain threshold, and patients with pain have poor sleep in terms of sleep efficiency, sleep latency, and awakenings after sleep onsetOur study has several limitations. We did not use investigations such as polysomnography (PSG) or actinography, which are considered the gold standard for sleep evaluation. Especially, PSG presents the results of objectively measuring various aspects of sleep. However, as in many countries around the world, it was not possible to conduct PSG because of the lack of sleep labs, insurance coverage, high cost, and lack of suitability for large-scale studies. PSG has a weakness in that it cannot be performed in a comfortable environment, such as at home, where the patient sleeps every day. Thus, it only reflects the results obtained in the laboratory for just a few days. In addition, there are physical and time limitations for PSG-based research in many patients. Our study was designed as a retrospective study to investigate the conditions under which sleep quality deteriorates in patients with painful TMD; therefore, the causal relationship cannot be clarified. It merely suggests statistically related factors. However, we assessed the sleep of 337 patients with painful TMD using the PSQI, a sophisticated and reliable questionnaire. Although TMD pain was classified according to the DC/TMD criteria, not all subgroups of DC/TMD were analyzed, and the new questionnaire included in DC/TMD AXIS II was not accompanied, so there may be limitations in the interpretation of the results. Subsequent large-scale longitudinal studies and prospective study designs with all subgroups of DC/TMD AXIS I and questionnaires from AXIS II are needed to clarify our findings.Successful TMD treatment is possible by considering sleep quality in patients with painful TMD. As sleep problems can be the underlying factors for the onset, development, and prolonging of TMD along with psychosocial profiles, these factors should be examined along with clinical symptoms in patients with painful TMD. In this study, sleep quality differed according to the chronicity of symptoms, number of DC/TMD sub-diagnoses, and origin of TMD pain in patients. In particular, chronic symptom duration, multiple origins of pain, myogenous TMD pain, and psychological distress were associated with worsening sleep quality. Therefore, these sleep and pain-related phenomena must be considered when diagnosing and treating patients with painful TMDs. Global efforts are needed to present treatment guidelines regarding sleep for each subgroup according to the DC/TMD in addition to efforts to increase the accuracy of subgroup diagnosis.