Methods. Fifty-four TMD patients  with an average age of 40.7 (age range: 29–54 yr.) were randomly subdivided into two groups. The study group (AG) received 1 week of at-home LVT treatment with the NOVAFON Pro Sk2/2 : 50/100 Hz, bilaterally applied to the pain area for 16 minutes daily. The placebo group (IG) followed the same protocol using inactive devices. Temporomandibular joint pain (TMJ), muscular pain (MM), and headache (HA) were assessed. Pain was evaluated using the visual analogue scale (VAS) before (T0) and after therapy (T1). Statistical analysis and Student's t-tests were applied . Results. AG patients reported decreased average values for all types of pain considered between T0 and T1, with a statistically significant difference for TMJ pain (P < 0.05), MM pain, and HA (P < 0.001). IG patients reported a no statistically significant decrease in the average values of MM pain and an increase in the average values of TMJ pain and HA. Conclusion. The study supports the use of local vibration therapy in the control of TMD-related TMJ pain, local muscular pain, and headache.Several methods are currently used to manage pain related to temporomandibular disorder (TMD). Vibratory stimulation is applied as a pain treatment for several musculoskeletal disorders, but it has not yet been studied in-depth for TMD symptoms. The aim of this study is to analyse the effectiveness of at-home local vibration therapy (LVT) for the management of TMDs-related myofascial pain.  Temporomandibular disorders (TMD) comprise a large number of pathologies related to the masticatory muscles and/or temporomandibular joint (TMJ) and constitute a part of the musculoskeletal disorder group . CurrentOne of the most recently proposed physical therapy treatments is local vibration therapy. Local vibration therapy produces vibrations that reach up to 6 centimetres of tissue depth; it is used to regulate muscle tone, relieve localized pain, and stimulate an increase in blood and lymphatic circulation –9. This The aim of this study is to evaluate the effectiveness and efficiency of local vibration therapy in the treatment of craniomandibular pain by comparing the application of an active vibratory device with the application of an inactive placebo device on two samples of dysfunctional patients.A randomized, double-blind, placebo-controlled clinical study was conducted at the Clinical Gnathology Unit of the Department of Oral and Maxillofacial Sciences at the “Sapienza” University of Rome. The study was approved by the Institutional Ethics Committee (N. 93/2017-0001385); all patients signed an informed consent document before participating in the study.The patient enrollment process followed the CONSORT  criteria .During the period of February 2018–July 2019, 317 subjects under observation in our department were assessed for eligibility. All patients were screened for temporomandibular disorders (TMD) by specialists in the field using the DC/TMD diagnostic criteria . Criteri256 patients were excluded according to these criteria. The resulting study sample consisted of 61 patients, 16 male (26.2%) and 45 female (73.8%), with an average age of 38.39 years (range 29–54 years).The study involved the administration to all patients of a local vibration device (NOVAFON Pro (Sk2)) for professional/home mixed use. Patients were treated with both active, functioning devices and placebo devices identical to the functioning ones but therapeutically inactive. The therapeutic protocol involved 7 applications of vibration therapy: the first and last applications were performed by a specially trained operator (G.S.) at the clinical gnathology department; the remaining 5 were carried out at home by the patient.A single operator (G.S.), blinded to the diagnosis and symptoms of patients, carried out the distribution of the devices and provided patient instruction on correct methods of use; all patients were given the same instructions for home use following the indications provided by the manufacturer. Patients used the active or placebo device for 5 days for 16 minutes a day.T0 : before treatmentT1 : after the last application (7 days after T0)The symptoms evaluated for all patients were joint pain, muscular pain (masticatory muscle pain), and headache (attributed to TMD). Each type of pain was measured at the following times:The 0–100 visual analogue scale (VAS) was used to measure pain self-assessment, with 0 indicating “no pain” and 100 “the worst imaginable pain.”At the end of treatment (T1), all patients were given a questionnaire regarding their impression of the treatment's effectiveness: Patients' Global Impression of Improvement (PGI-I) Scale .In order to perform a comparative data analysis of the active and inactive devices, all participants were subsequently divided into two groups: a study group (AG) that received active devices and a placebo group (IG) that received inactive devices.The primary outcome of the study was to evaluate the change in perceived pain levels after one week of local vibration therapy in the group that received active devices (AG) and in the group that received placebo devices (IG).The device used was the NOVAFON Pro Sk2/2 .This direct current electromedical device consists of a switch with two levels to adjust the intensity of the vibration produced (50/100 Hz); a handpiece to modify the power of the vibration; spherical and disc-shaped extra oral heads (means of stimulating the skin and mucous membranes); and an extension clamp .Use of the disc head on button 2 (50 Hz) for 4 minutes/side. The device was used with moderate pressure and rotational movements along the masseter and temporal muscles. The disc surface allows for greater dispersion of vibratory stimulation, with the aim of relaxing the musculature.Use of the spherical head on button 1 (100 Hz) for 4 minutes/side. The device was used with moderate pressure and punctual movements localized on patients' most painful areas along the masseter and temporal muscles and temporomandibular joint. The spherical surface concentrates vibratory stimulation on a smaller surface, with the aim of resolving muscle contractures and reducing myalgia.Two different application modalities were applied on both sides of the face to the masseter  and temporal  muscles and to the TMJ , for a tSince there were no data available from other clinical studies about the application of this kind of vibratory stimulation for TMD-related pain, patients were recruited using convenience sampling.All local vibration devices (active and inactive) were randomly assigned to the study population using a random number generator (Research Randomizer©).We used a total of 10 devices received from the manufacturer, 5 active and 5 inactive. These devices were delivered to patients by a single operator (G.S.); 34 active and 27 inactive devices were assigned over the course of the study. The devices showed the same exterior and functional characteristics. Neither the patients nor the operator knew which devices were active.t-test was performed .Data analysis was performed with SPSS (version 23) statistical processing software. To assess whether there were significant differences in the pain levels  of AG and IG patients at T0 and T1, a paired samples From the expected sample of 61 suitable patients, 7 were excluded for not carrying out the therapy according to the planned treatment modalities .The resulting study sample therefore consisted of 54 patients; the characteristics of all study subjects are shown in t-test was not significant for TMJ pain and muscular pain  show a decrease between T0 and T1 in average values of all types of pain considered, with a statistically significant difference for TMJ pain, muscle pain, and headache. Results for the group that performed the therapy with inactive devices (IG) show a decrease in average values of muscular pain and an increase in the average values of TMJ pain and headache. In comparing data between the start (T0) and end of therapy (T1), Student's lar pain .t-test analysis of the decrease in relative average pain values between patients who performed active and inactive therapy at T1 did not show significant results for TMJ pain, muscular pain, or headache (P > 0.05).The Student's The results of patients' self-evaluations of treatment effectiveness using the PGI-I Scale are shown in This is the first study involving application of a local vibration device directly at the level of the joint area and masticatory muscles  in order to evaluate the effectiveness of local vibration therapy for reducing TMD-related joint/muscular pain and headache.The subjects of the group who underwent active local vibration therapy (AG) reported a significant decrease in average values of TMJ pain, muscular pain, and headache. Furthermore, there were no significant decreases in average pain values for patients in the study group that received placebo therapy with inactive devices (IG); these patients reported an increase in TMJ pain and headache that was statistically significant for the latter with respect to the initial pain level.The choice to use vibratory stimulation in dysfunctional patients was based on evidence from previous studies showing the effectiveness of local vibration therapy in reducing chronic musculoskeletal pain and in delaying the onset of muscular pain , 11. SevThe pain symptomatology afflicting temporomandibular disorder patients is very complex and often invalidating, and it demonstrates a tendency to become chronic when there is no timely therapeutic intervention. There are several therapeutic strategies for relieving TMD-related pain, but only two studies evaluated the possible application of vibratory stimulation, and both report results in line with those obtained by our research.Roy et al.  investigIn light of this evidence, the type of the device we used is particularly versatile, since it allows for daily home use for short periods and the possibility of extraoral application near the location of the pain. Patients who underwent therapy with an active device mostly reported an improvement in their pain condition and had no notable difficulty in following the home prescription. The extraoral application of the therapy also presents the additional advantage of being able to be applied in concomitance with the conventional therapy of occlusal splints, for patients needing mechanical support. Our study results reinforce the evidence that local vibration therapy is most effective for muscular and tension pain, such as local myalgia and headache. Our results regarding decrease in TMJ pain, however, also suggest that this therapy is able to resolve strictly articular problems. From this perspective, local vibration therapy could be a valuable addition to complement other conservative therapies.P value of 0.08 and 0.06, respectively. To address this limitation and obtain more reliable results, the study sample is currently being expanded.This study also presents several limitations. First, despite the positive results obtained, the patient sample examined is still too limited to represent reliable and significant results regarding the efficacy of NOVAFON Pro Sk2/2 in reducing TMD-related symptoms. We see evidence of this limitation in the statistical nonsignificance, despite the encouraging clinical decrease of symptoms, of the compared average pain values between AG and IG at the end of therapy (T1) (with significance threshold set at 5%). Having noticed values close to the aforementioned significance threshold and in light of the limited sample size, the same test was carried out with an increased significance threshold of 10%. The results obtained from the second test show a significant difference regarding TMJ pain and headache with a Second, the results obtained correspond to a single week of therapy, while prolonged evaluation, extending beyond the completion of therapy (follow-up), is necessary. Finally, pain assessment in this study was limited to patient self-assessment, but the importance of using multiple methods of pain assessment, given the complexity of changes this symptom can undergo during experimental procedures, has been well documented , 21.Local vibration therapy is a valid support tool in the control of TMD-related familiar muscular pain. The extraoral application method is versatile, easy to apply, and integrates well with other conservative therapies; it is also useful for increasing patient compliance with other rehabilitation treatments. Moreover, this therapy offers the advantage of being performed at home by the patient, in different therapeutic moments, allowing the clinician greater possibility for treatment individualization.Further studies are needed, however, to confirm the results obtained with larger samples and to include the short/long-term follow-up.


Pain; forearm and arm circumference; range of motion; disabilities of the arm, shoulder, and hand score; and touch sensation were evaluated on the day of the plaster cast dressing and 3 and 6 weeks after. In comparison to the control group, the pulsed electromagnetic field group reported significant changes after 3 and 6 weeks of treatment: lower pain levels , greater mobility of upper-limb joints, improvement in exteroceptive sensation, and reduction in disability of the upper limb  . Our results suggest that early addition of pulsed electromagnetic field treatment, during cast immobilization of distal radius fractures, has beneficial effects on the pain, exteroceptive sensation, range of motion, and daily functioning of patients.To assess whether pulsed electromagnetic field therapy during cast immobilization of distal radius fractures has beneficial effects on pain and limb function, the study included 52 patients (mean age 60.8 ± 15.0 years) with distal radius fractures treated with cast immobilization. Patients were allocated to a pulsed electromagnetic field group ( A distal radius fracture (DRF), also known as Colles' fracture, is one of the most common fractures  in peoplThe therapeutic procedure for DRFs consists of the repositioning of the fracture and cast immobilization. In some cases, surgery is performed. An important element of treatment is the rehabilitation intervention aimed at restoring the strength and function of the limb and helping prevent complications. However, a meta-analysis indicated that insufficient evidence is available to determine the best form of rehabilitation .Early introduction of treatment in patients with DRFs aims to decrease pain and improve hand function. Collins  emphasizPulsed electromagnetic fields (PEMF) have been used for many years to support fracture healing . A meta-In addition, PEMF therapy has shown other beneficial effects, including reduction of acute and chronic pain associated with connective tissue  injury as well as edema and inflammation control and wound healing .Various strategies for the use of PEMF can be found in the literature. The studies mainly involve patients with tibia fractures –14. MostTherefore, this study aimed to determine the effect of PEMF therapy, started a day after injury and cast immobilization, on pain, edema, limb range of motion, exteroceptive sensation, and daily functioning in patients with DRFs.The study included 52 consecutive patients  who were admitted to the casualty department after a distal radius fracture based on the AO classification (Arbeitsgemeinschaft für Osteosynthesefragen) developed by Müller et al. , type A The inclusion criteria for the study were as follows: distal end radius fracture type A or B according to the AO classification, cast immobilization treatment, no limitation of wrist and hand function before injury, no contraindication to PEMF, and patient's consent. The exclusion criteria were multiple-organ injury; reports of previous DRF; and concurrent diseases influencing DRF recovery, such as diabetes, hyperthyroidism, psychiatric illness, and inflammatory osteoarthritis.This study was approved by the Research Ethics Committee at Poznań University of Medical Sciences (protocol number: 957/11). All procedures performed in the study were in accordance with the principles of the 1964 Declaration of Helsinki. Each participant was informed about the study and signed the informed consent statement.The study participants were allocated to one of the two groups: the PEMF group, consisting of 27 patients, and the control non-PEMF group, consisting of 25 patients.The PEMF therapy device was produced by ASTAR ABR . The patient's hand, wrist, and distal forearm were placed inside a concentric coil applicator 345 mm in diameter and 440 mm in height generating a magnetic field intensity of 6–10 mT and a frequency of 25–30 Hz. Each treatment lasted 30 min. The magnetic field applied was initially generated for 1 s with a break. The length of the break in the first treatment was 3 s and was reduced by 0.5 s in each consecutive application. As from the seventh treatment, the magnetic field applied was generated with a constant amplitude throughout the treatment. For 10 days, the patients received the treatment once a day at the same time in the morning, with a break over the weekend, and then three times a week. Altogether, the patients received 22 treatments over six weeks .On the day following the injury and cast immobilization, both the PEMF and control groups started rehabilitation that consisted of active shoulder, elbow, and finger mobilization exercises three times a day . All participants were given instructions for home exercises to be performed under the supervision of a physiotherapist.All patients participating in the study underwent conservative treatment without the need for surgery and the need for extension of the period of plaster immobilization beyond 6 weeks.The visual Analogue Scale (VAS) was used to assess pain severity. The results were obtained by measuring the distance (0 to 100 mm) from the beginning of the scale to the position selected by the patient, where “0” is “no pain” and “100” is “the worst possible pain” .Shoulder and forearm circumferences of both injured and uninjured limbs were measured with a tape measure. To assess edema, the measurement was taken at the proximal end of the radius (above the cast) and mid-shaft of the humeral bone at the deltoid tuberosity. The mean of the measurements of both limbs formed the outcome.The range of joint motion was measured using a goniometric method according to the rules of the International Standard Orthopaedic Measurement using the Sagittal Frontal Transverse Rotation system to an accuracy of 1°. The ranGrip strength was measured using a Jamar dynamometer (Poland), and the results are expressed in kilograms (kg). The participant was seated comfortably in a chair, the shoulder was adducted and neutrally rotated, and the elbow was flexed at 90°, with the forearm and wrist in neutral positions. The participant was instructed to grip the dynamometer handle as hard as possible for 5 s . Global Two-point discrimination sense perception was measured using a standardized Dellon's discriminator (two-point discrimination test) with a preset distance between individual filaments as measurement points. The shortest distance was estimated at which two-point discrimination occurred  . At the The WEST hand monofilament test (Weinstein Enhanced Sensory Test)  was performed to assess the skin's sensitivity to touch, with the use of five individual fibers of standardized diameter, rigidity, and weight and with pressures of 0.07 g, 0.2 g, 4 g, and 200 g. The patient was sitting with eyes closed. Thumb and fingers II and V were examined, starting with the heaviest monofilament. The examination consisted of touching the given spot three times. It was considered successful when the patient could feel the touch at least one time . Data anThe DASH  questionnaire was used to assess the disability of the upper limb. In this questionnaire, the upper limb is considered a functional unity. Partial dysfunction of a limb impaired general function of a limb as well as everyday life and social activity of the patient. The basic version of the thirty-point questionnaire was used in this examination , 28.The measurements were evaluated on the day of immobilization, then after 3 weeks, and on the day of the cast removal. All evaluations were carried out by the same researcher.U test was used. To assess the differences in the examination dates, the ANOVA Friedman's test was employed with the post-hoc comparison. The calculations were performed using StatSoft STATISTICA 10.0 software. A p value < 0.05 was considered significant.Descriptive data were presented as median values and standard deviations. The normality distribution was tested using the Shapiro–Wilk test. Most variables in both groups were not distributed normally. To assess differences between the two groups, the Mann–Whitney Patient demographics  were comBefore the therapy, no significant difference was observed between the groups with regard to age, pain (VAS), circumference of the forearm and shoulder, and the range of motion  Tables  and 2.p < 0.01) and circumference of the forearm (p < 0.01) were reduced, whereas the range of motion significantly increased (shoulder flexion (p < 0.01), extension (p < 0.01), abduction (p < 0.01), and elbow flexion (p < 0.01)) in both groups.Three and six weeks after the zero examination, significant pain . No significant difference was noted between the two groups with regard to the circumference of the forearm and shoulder. The range of motion was significantly higher in the PEMF group in comparison to that in the control group: shoulder flexion , extension , and abduction  (Pain reduction was significantly higher during examination in the PEMF group in comparison to that in the control group (three weeks =0.0002) .p=0.003 and p=0.001, respectively) and higher grip strength in the fractured and unfractured hand   .Prior to therapy, no significant difference was found between the two groups with regard to the exteroceptive sensation measured with the WEST hand monofilaments and Dellon's discriminator.p=0.0098). After six weeks, the exteroceptive sensation measured with the monofilaments and Dellon's discriminator was significantly better in the PEMF group in comparison to that in the control group   .p=0.0499). A significantly greater decrease in limb disability was recorded in the PEMF group in comparison to that in the control group after three (p < 0.0001) and six weeks of therapy (p < 0.0001)  showed significant differences between the two groups in the first examination ( 0.0001) .In comparison to the control group, the PEMF group showed a significantly higher reduction in pain, increased mobility of the upper-limb joint, improvement in exteroceptive sensation, and reduction in the upper-limb disability, assessed by the DASH questionnaire, after 3 and 6 weeks of treatment. In this study, the duration of casting was six weeks, and prolonging this duration was not necessary in any patient.The study originally aimed to investigate the effects of the PEMF treatment, applied immediately after the fracture diagnosis and casting, on pain and limb function. In most published studies, except one , PEMF thIn a prospective randomized controlled study of long-bone fractures, Shi et al.  demonstrSimilarly, Hannemann et al.  concludeIt should be noted that a DRF can lead to pain, edema, movement restrictions in joints, and functional impairment. Exercise and other physical interventions  are used to prevent complications and speed up recovery .Several studies reported that the PEMF therapy has beneficial effects on both acute and chronic pain , 30.The results of the present study confirmed the pain relief effect of magnetotherapy. Significantly lower pain levels were reported in PEMF patients after three and six weeks of therapy, referring to the initial examination, in comparison to the patients who were not exposed to magnetic field therapy. Our research results are in agreement with the observations reported by Lazović et al.  Their raIn their systematic review of randomized studies, Andrade et al.  confirmeIn our research, significant edema reduction was reported in both groups, which is believed to be of primary importance in obtaining hand function . ContrarIn our research, the beneficial effect of alternating magnetic fields on the increase in shoulder and elbow range of motion was observed. This can be explained by greater pain reduction in PEMF patients. Pain leads to increased muscular tension. Moreover, severe pain may have a negative impact on patients' psyche and, consequently, discourage them from participating in rehabilitation. The beneficial effect of PEMF on pain and function in musculoskeletal disorders has been confirmed in other studies .Taking into consideration the wrist joint range of motion, the mean values for palmar and dorsal wrist flexion after fraction were significantly higher in the PEMF group in comparison to that in the control group. Significant differences were also noted in grip strength, which was measured after the period of cast immobilization.Cheing et al.  noted a Evaluation of exteroceptive sensation is vital for the assessment of hand function. Melchior et al.  demonstrIn our own research, a significant increase in exteroceptive sensation, evaluated with Dellon's discriminator and monofilaments, was observed after six weeks in both groups. However, it was more significant in the PEMF group than in the control group. Notably, the weakening in touch sensation may have been as a result of soft tissue injury and pain that accompanied the fraction.The authors of other studies point out further consequences of the fracture: functional impairment and loss of independence . TherefoThe DASH questionnaire was used for assessment of upper-limb disability. It is considered one of the best clinical measures of the upper-limb disability assessment . Its useThe limitation of this study was the small number of patients included. However, 52 patients were examined three times by the same researcher, and all of them completed the examination. Our research did not only focus on the monitoring of symptoms associated with the pathology, but, more importantly, it evaluated the effect of the therapy on patients' daily functioning. The effect of PEMF treatment on fracture healing has not been studied.In conclusion, this finding suggests that the early addition of PEMF treatment during cast immobilization for DRFs has some beneficial effect, particularly on the pain and function of the broken limb, and improves daily functioning. Final conclusions, however, await further well-conducted randomized controlled trials, in line with the principles of evidence-based medicine in this field.


Several studies reported short-term analgesic efficacy of obturator nerve block (ONB), as in comparison with the femoral nerve block (FNB) in the treatment of postoperative pain after the total knee replacement (TKR). The optimal method remains under debate. The purpose of our current work is to compare the safety and efficacy of FNB and ONB for postoperative analgesia after TKR.This prospective, randomized, and controlled study was performed from January 2018 to December 2019. It was authorized via the Institutional Review Committee in NO.971 Hospital of the People's Liberation Army Navy (2019-PLAN-132).Two hundred patients were divided randomly into 2 groups, the control group (n = 100) and study group (n = 100). The experimental group received FNB and control groups received ONB. Primary outcome included pain at different time point . The Visual Analogue Scale scores were marked by patients themselves on a paper with a graduated line starting at 0 (no pain) and ending at 10 (the most painful). Opioid consumption was converted to equivalents of oral morphine uniformly for statistical analysis. Secondary outcomes included the knee range of motion, the hospital stay length as well as the postoperative complications such as pulmonary embolism and deep vein thrombosis.Table 1 will show the clinical outcomes between the 2 groups.This trial would provide an evidence for the use of different types of peripheral nerve blocks in TKR. The reported incidence of severe postoperative knee pain after TKR ranges from 10.3% to 36.8%.,6 Opioid is frequently used for postoperative pain management. However, it may be associated with many adverse effects, including headache, nausea, vomiting, respiratory depression, retention of urine, and constipation.–9 Specific medical diseases related to the inadequate pain control involved myocardial infarction, coronary ischemia, venous thrombosis, and pneumonia. Effective postoperative analgesia can reduce opioid consumption and promote rehabilitation.The total knee replacement (TKR) is regarded as a successful method option for treating the end-stage knee osteoarthritis, with satisfactory functional recovery, significant deformity correction effect, and outstanding postoperative pain relief.–13 The optimal method remains under debate. Femoral nerve block (FNB) was reported to reduce postoperative pain and has increased in popularity because of its opioid sparing effects, and consistency with anticoagulatory therapy. However, some articles reported that FNB may decrease the strength of quadriceps femoris, which causes risk of fall. Recently, several studies reported short-term analgesic efficacy of obturator nerve block (ONB), as in comparison with the FNB in the treatment of postoperative pain after TKR. Bergeron et al reported that there was no significant difference between FNB and ONB in terms of functional outcomes. Currently, there is no reliable evidence to support the clinical application for pain control. The purpose of our current work is to compare the safety and efficacy of FNB and ONB for postoperative analgesia after TKR.Several methods have been applied to reduce postoperative pain after TKR including the peripheral nerve block and the local infiltration anesthesia, intravenous analgesics as well as the epidural anesthesia.22.1This controlled, randomized, and prospective research was performed from January 2018 to December 2019 which was performed in accordance with the SPIRIT Checklist for randomized studies. It was authorized via the Institutional Review Committee in NO.971 Hospital of the People's Liberation Army Navy (2019-PLAN-132) and then was registered in research registry (researchregistry5849).2.2All patients participating in the TKR will be treated in our orthopedic outpatient department. The surgeon will explain the details of trial, afterward, patiently answer all the patient's questions. The patient is then presented with the written information of our trial. Each of patient received a written informed consent. Since all patients participated voluntarily, they could withdraw at any time during the trial.2.3The subjects in this research were 200 primary TKR patients from our Hospital. The inclusion criteria were:(1)patients prepared for primary unilateral TKR;(2)the age were above 50 years.The exclusion criteria were as follows:(1)2;the body mass index of the patients was more than 40 kg/m(2)allergies or contraindications to the opioid analgesics;(3)a history of deep vein thrombosis or pulmonary embolism 3 months before the operation.2.4Two hundred patients were divided randomly into 2 groups, namely, control group (n = 100) and the study group (n = 100), respectively. A table of random numbers hidden in the 1:1 ratio was computer-formed. A researcher who did not take part in the trial used the website Randomization.com to generate a random distribution sequence, which was hidden in sealed opaque sequence numbered envelopes that were allocated to investigators. The surgeons, investigator, anesthetist, and nurses were all kept blinded to allocation results.2.5All patients were given the spinal anesthesia. The surgical procedures were performed by the senior surgeon. In the process of operation, pneumatic tourniquet was utilized. An incision was made in the center of the knee and then extended to the medial side of patella. A posterior stabilized prosthesis  was implanted. The experimental group received FNB and control groups received ONB. Other procedures were the same: removing excess peri-patella synovium and osteophytes, trimming the patella with a narrow oscillating saw and circumferential electrocautery of the patella. Multimodal postoperative pain management of our center were administered to all the patients. Analgesic protocol: after admission, patients were given 200 mg celecoxib orally every 12 hours for preemptive analgesia until the morning of the operation day. Intraoperatively, patients were given 20 mg ropivacaine diluted with 60 mL normal saline by topical injection to the joint capsule and collateral ligaments. Intravenous patient-controlled analgesia was given after TKR.2.6Post-operative clinical data were assessed by an independent senior surgeon blinded to the patient's randomization. Primary outcome included pain at different time point . The Visual Analogue Scale scores were marked by patients themselves on a paper with a graduated line starting at 0 (no pain) and ending at 10 (the most painful). Opioid consumption was converted to equivalents of oral morphine uniformly for statistical analysis. Secondary outcomes included the knee range of motion, the hospital stay length as well as the postoperative complications such as pulmonary embolism and deep vein thrombosis.2.7U test or the independent samples t-test were used to analyze the inter-group comparison. Chi-square detection was utilized to compare the categorical variables among the groups. The analysis of repeated measurement of the variance was applied to analyze the repeated data. A P < .05 was regarded the significant in statistics.The calculations of sample size are conducted utilizing the software of PASS 2011 . All the needed analyses are implemented through utilizing SPSS for Windows Version 20.0. All the data are represented with proper characteristics as median, mean, percentage as well as standard deviation. Mann–Whitney 3Table 4 The postoperative pain is caused by inflammation resulted from direct nerve injury or the tissue injury. Patients can perceive the pain through afferent pain pathway, this is the target of a variety of drugs. Direct anesthetics or the drugs that reduce the response of local hormones to injury  can be utilized to block the activity of pain receptors, thereby reducing the activity of pain receptors. The various management programs of postoperative pain and the lack of a definitive “gold standard” indicate that there is room for improving the standard of care.Pain management after the TKR is still challenging, but is important due to good pain management can improve the outcomes of patient. About half of patients who undergo the TKR experience moderate to serious postoperative pain.,19 Despite muscle weakness after surgery, there is evidence that the patients receiving the peripheral nerve block can recover faster than the patients receiving patient-controlled analgesia. Thus, we performed this protocol to compare the efficacy of FNB and ONB for pain management in patients undergoing TKR.Peripheral nerve block with continuous or single infusion of local anesthetics has been extensively utilized in TKR field. The more familiar forms of peripheral nerve block in the TKA are the sciatic nerve, obturator nerve, and the FNBs.5This trial would provide an evidence for the use of different types of peripheral nerve blocks in TKR.Data curation: Peng Lin.Investigation: Fuheng Zhang.Methodology: Fuheng Zhang.Writing – original draft: Wei Zhang.


Objective: The burden of comorbidity among young patients with hemorrhagic stroke is high. This study examines the effect of comorbidity on the length of stay (LoS) and mortality among immobile hemorrhagic stroke patients younger than 50 years.Materials and Methods: A retrospective post-hoc analysis study design was used. A total of 767 younger adults (mean age 41.64 ± 8.16 years) hospitalized for hemorrhagic stroke between November 2015 and July 2017 were evaluated. All-cause mortality was recorded for 90 days after admission regardless of whether death occurred before or after discharge. Comorbidity was assessed using the Charlson Comorbidity Index (CCI), categorized as low (0–1) and high (≥2). A multiple linear regression model was applied to examine the association between CCI and LoS. Survival was evaluated with Kaplan–Meier and Cox regression analyses.Results: The mean CCI of all patients was 1.25 (SD ± 0.79) and median was 1.0 . The average LoS for patients with a low CCI was 17.73 (± 11.59) days compared with 19.49 (± 15.21) days in those with a high CCI (p = 0.142). The mortality rate was 6.0% . After controlling for confounders, high CCI was not associated with longer LoS , whereas high CCI was associated with greater likelihood of death than a low CCI .Conclusions: High global comorbidity was associated with increased short-term mortality but not with LoS. Measures to manage comorbidities aimed at reducing negative clinical impacts of stroke among younger adults are warranted. Stroke is a major cause of death worldwide . In ChinPrevious studies have suggested an upward trend of stroke in younger people and a declining incidence of stroke in older adults –9. StrokIn addition, China has 7.5 million stroke survivors who suffer greatly through comorbidity . It was This study was derived from a research project from the National Health and Family Planning Commission of the People's Republic of China, which aimed to develop a standardized nursing intervention model (SNIM) among immobile stroke patients. As one of the main gauges of this study, the Charlson Comorbidity Index (CCI) addresses multiple comorbidities by creating a weighted total score based on the presence of various conditions, and is commonly used in outcome and mortality studies , 22, 24.Study subjects enrolled were the participants of the SNIM, a prospective study conducted in 25 general hospitals covering five provinces and one municipality city in China . Further information about the SNIM study is published elsewhere , acute ischemic stroke , and transient ischemic attack   . AccordiAll participants in SNIM, except for those who died or relinquished medical treatment, underwent a 90-day follow-up after enrollment in the study. All-cause mortality was recorded for 90 days including in-hospital deaths. Survival time was regarded as the duration from the date of admission to the date of death. Dates of death were collected from death certificates.Comorbidity was assessed using the CCI. The index contained 19 comorbid conditions and was adjusted specifically for stroke evaluation , 23, 27.N = 767) because our aim was to evaluate young immobile hemorrhagic stroke patients with comorbidities, with the study outcomes focusing on mortality and LoS. Immobility was defined as when the patient's basic physiological needs were carried out in bed, except for active or passive bedside sitting/standing/wheelchair use for examination. LoS was defined as the period from the date of admission to the date of discharge or date of death. All-cause mortality was recorded for 90 days after the date of admission regardless of whether death occurred before or after discharge. Therefore, we opted to exclude participants in accordance with the following criteria: older than 50 years , AIS  cases (n = 623), TIA cases (n = 57), and discharged within 24 h of admission (n = 14).In this study we considered a sample of participants with hemorrhagic stroke who were younger than 50 years , experience of surgery, duration of immobility, level of hospital, payment type, and complications that occurred during hospital stay including pressure injuries, pneumonia, deep vein thrombosis (DVT), and urinary tract infections.We assessed 19 diagnoses for each patient according to the CCI: “history of myocardial infarction (weight = 1),” “congestive heart failure (weight = 1),” “cerebrovascular disease ,” “peripheral disease ,” “chronic pulmonary disease (weight = 1),” “connective tissue disease (weight = 1),” “peptic ulcer disease (weight = 1),” “dementia (weight = 1),” “mild liver disease ,” “diabetes without end-organ damage ,” “moderate or severe renal disease (weight = 2),” “diabetes with end-organ damage ,” “hemiplegia (weight = 2),” “tumor without metastasis ,” “leukemia ,” “lymphoma (weight = 2),” “moderate or severe liver disease (weight = 3),” “metastatic solid tumor (weight = 6),” and “AIDS ” , 28.2 test for proportions and Student's t-test for means. We used Kaplan–Meier survival curves and the log-rank test to compare mortality between the two groups. Sociodemographic and clinical parameters were adjusted by a Cox proportional hazards model. A multiple linear regression model was applied to evaluate the relationship between CCI and LoS while controlling for the above covariates listed. In all analyses, CCI was categorized as low (0–1) and high (≥2) comorbidity .We employed descriptive statistics to summarize patients' characteristics. Variables were compared across patients in the two CCI categories using the χorbidity . A p < 0A total of 767 immobile hemorrhagic stroke patients younger than 50 years were hospitalized between November 2015 and July 2017. The mean age of the patients was 41.64 (standard deviation [SD] ± 8.16) years. The mean CCI of the patients was 1.25 (SD ± 0.79) and the median was 1.0 . The percentage of patients with high CCI score (≥2) was 16.17%. Forty-six patients died, and the average LoS was 18.01 (SD ± 12.26) days. p = 0.142). As shown in p = 0.413).p = 0.002)  (p = 0.002) in the crude estimate analysis. In the Cox proportional hazards model, a high CCI score (≥2) was associated with an even greater likelihood of death compared with a low CCI score (0–1) after adjusting for confounders .Overall, death occurred in 6.0% of the study population. The number of patients with a low (0–1) and a high (≥2) CCI score who died were 31 (4.82%) and 15 (12.10%), respectively (= 0.002) . Patient 0.0016) . As showTo our knowledge, this is the first study from China to focus on the effect of comorbidity on LoS and short-term mortality among immobile patients younger than 50 years of age with hemorrhagic stroke. The results indicated that a high CCI score (≥2) could be an effective predictor for higher risk of death compared with a low CCI score, although the present study did not show a significant association between increased LoS and a high CCI score. These findings highlight the essential clinical impact of comorbid conditions among a diverse population of younger patients from a developing country with a universal healthcare system.No significant associations were found between LoS and comorbidities in this study, suggesting that this predictor of clinical outcome has less influence on LoS among the younger hemorrhagic stroke population. Contrary to our results, Richard et al.  analyzedIn the present study we found a low mortality rate of 6.0%, which is lower than the previous studies reporting case fatality rates ranging from 7.7 to 9.9% among younger hemorrhagic and ischemic stroke patients , 31. HowPrevious studies have reported an association between comorbidity and an increased rate of adverse clinical outcomes, particularly regarding mortality , 35, 36.Comorbidities can hinder the young patient's recovery from a stroke . TherefoOur study has some strengths. This study firstly demonstrated the prognostic value of comorbidity using the CCI for short-term survival among immobile hemorrhagic stroke patients younger than 50 years in China, whereby our findings reinforce the importance of monitoring chronic comorbidities. Besides this, in the future we will address long-term mortality, allowing us to better delineate a stroke-management scenario that to date has been lacking in the developing world.post-hoc analysis, whereby the data were prospectively collected for the SNIM research project and later were used retrospectively as part of our study design. Secondly, there is a lack of other relevant clinical data, including clinical severity of stroke (NIHSS), premorbid Rankin scale, volume of intracerebral bleeding, laboratory data, and the details of causes of death, because these features were not recorded in the first place, which is an inherent drawback of a retrospective analysis of a prospectively collected database. The data about the etiologic classification of patients with intracerebral hemorrhage, such as hypertension, and oral anticoagulants is limited. In addition, no affirmative criteria were available to determine the severity of comorbidities, which may potentially influence the clinical outcome of the participants. Prospective studies with more sophisticated evaluations are required to confirm our findings.As for limitations, firstly this study is a retrospective Among hemorrhagic stroke patients younger than 50 years of age, patients in the high-CCI group (CCI ≥2) were associated with increased short-term mortality but not with LoS. More emphasis should be placed on comorbidities as part of wider strategies to reduce the negative clinical impact in young hemorrhagic stroke patients.The datasets used and analyzed during the current study are available from the corresponding author on reasonable request.The studies involving human participants were reviewed and approved by the ethics committee of Peking Union Medical College Hospital. Patients' records and information were anonymized and de-identified prior to the analysis. The patients/participants provided their written informed consent to participate in this study.XWu: study concept and design. XWu and HL: analysis and interpretation of data. HL: edited the manuscript and drafted the tables. JC and JJia: critical review of the manuscript for important intellectual content. CZ, BS, JJin, YL, XWe, and SC: recruited patients, collected data, and edited the manuscript. All authors critically reviewed and approved the manuscript before it was submitted.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.


The aim of the present study was to assess the potential role of some biological, psychological, and social factors to predict the presence of painful temporomandibular disorders (TMDs) in a TMD-patient population. The study sample consisted of 109 consecutive adult patients  who were split into two groups based on Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) diagnoses: painful TMD and non-painful TMD. The presence of pain was adopted as the depended variable to be identified by the following independent variables : age, gender, bruxism, tooth wear, chewing gum, nail biting, perceived stress level, chronic pain-related impairment (GCPS), depression (DEP), and somatization (SOM). Single-variable logistic regression analysis showed a significant relationship between TMD pain and DEP with an odds ratio of 2.9. Building up a multiple variable model did not contribute to increase the predictive value of a TMD pain model related to the presence of depression. Findings from the present study supported the existence of a relationship between pain and depression in painful TMD patients. In the future, study designs should be improved by the adoption of the best available assessment approaches for each factor. Temporomandibular disorders (TMDs) are a heterogeneous group of conditions characterized by the presence of signs and symptoms such as pain in the masticatory muscles and/or the temporomandibular joint (TMJ), limited jaw movements, and TMJ sounds  during function . The ResThe protocol of (R)DC/TMD includes a dual axis evaluation, providing diagnoses based on both the physical data and the psychosocial data. The Axis I protocol is based on guidelines for oral history taking and clinical assessment, while the Axis II protocol encompasses an evaluation of several psychological factors  that are considered key factors for TMD onset, clinical manifestation, and treatment outcome ,5,6. AddThere are several biological, psychological, and social factors that may be associated with TMDs . AmongstWithin these premises, given the heterogeneity of the conditions grouped under the umbrella term “temporomandibular disorders”, a possible improvement to current knowledge is to gain information on the separate painful and non-painful TMD diagnoses. Hence, the aim of the present study was to assess the potential role of the above factors to predict the presence of painful TMDs in a TMD-patient population, the null hypothesis being that they are not related to painful TMDs.The study sample consisted of 109 consecutive adult patients , 22 men (mean age 27.0 ± 7.5) and 87 women (mean age 34.6 ± 15.6), who sought for TMD treatment at the University Dental Clinic in Krakow, Poland and agreed to take part in the study. Criteria for inclusion in the study were: 1) the presence of one or multiple TMD diagnoses according to RDC/TMD; 2) the absence of signs and/or symptoms of systemic or local diseases possibly mimicking TMDs , as excluded by relevant consultants; and 3) the absence of other orofacial disorders possibly mimicking TMD-like signs and/or symptoms , as excluded based on the patients’ history and relevant consultants’ reports.The study was conducted in accordance with the principles of the Helsinki Declaration and approved by the Bioethics Committee of the Jagiellonian University (No. KBET/90/B/2010). All patients signed a written consent document.All patients were examined by an investigator who had taken a specific training on RDC/TMD evaluation as well as on tooth wear assessment from a gold-standard examiner within the framework of a three-year specialty program in Orofacial Pain and Dysfunction . All parCollected data were managed as either outcome  or predictor  variables to fit the study aim.The study sample was split into two groups based on RDC/TMD diagnoses:1) Painful TMD group included patients with a diagnosis of myofascial pain/myofascial pain with limited opening (IA/IB) and/or arthralgia/osteoarthritis (IIIA/IIIB), independent of the presence of concurrent disc disorders diagnoses.2) Non-painful TMD group included patients with disc displacement with reduction (IIA), disc displacement without reduction with limited opening/disc displacement without reduction without limited opening (IIB/IIC), and osteoarthrosis (IIIC), without any axis I group I or any other axis I group III diagnosis.1) Age (years) and gender were taken from each patient’s medical history provided before the visit.2) The presence of bruxism was assessed using two questions from RDC/TMD questionnaire. Sleep bruxism was thus addressed with the question: “Have you been told, or did you notice yourself, that you grind your teeth or clench your jaws when you are asleep?” The presence of awake bruxism was assessed using the question: “Do you grind your teeth or clench your jaws during the day?”. As per suggestions from the consensus expert panel, at least one positive answer was considered indicative of possible bruxism (7).3) Assessment of tooth wear was performed using the 5-point ordinal scale for the quantification of occlusal and incisal tooth wear proposed by Lobbezoo and Naeije : 0 = no 4) Oral habits, such as chewing gum and nail biting, were assessed on the basis of a Yes/No answer.1) The perceived stress level was assessed during the clinical investigation with the use of a 100 mm visual analog scale (VAS), where 0 mm = no stress and 100 mm = maximal stress.2) The psychological status was assessed by means of the RDC/TMD Axis II, which comprises a psychosocial assessment based on three instruments. Chronic pain-related impairment was assessed based on Graded Chronic Pain Scale (GCPS) scores   might beThe categorization into pain vs. non-pain was adopted as the dependent variable to be identified by the following independent variables : age, gender, bruxism, tooth wear, chewing gum, nail biting, perceived stress level, chronic pain-related impairment (GCPS), DEP, and somatization (SOM). All the independent variables were dichotomized. Dichotomization was based on the presence or the absence  for GCPS, DEP, SOM, and bruxism. This was based on scores over or under the median value for numerical variables .Single-variable logistic regression analyses were performed to assess the association between the various predictors and the TMD group . To build a multi-variable regression model, an arbitrary threshold was set to include in the initial model all those factors that were significant at p<0.20 in the single-variable logistic regression analysis. Then, the variable with the weakest association was removed from the model until all the variables that were retained in the model showed a p<0.05. The odds ratios (OR) were assessed for each variable. OR values higher than 2 are commonly considered significant from a clinical viewpoint. Nagelkerke’s R-square was obtained as an estimation of the total variance explained by the predictor factors included in the model. All statistical procedures were elaborated with the R software, version 3.6.0 .Regarding the marital status of the patients of the study group, 55.9% of them were never married while 37.6% were married. In total, 4.9% had been divorced, and 2% had been widowed. As far as the patients’ education is concerned, 67.9% were university graduates, 27.5% of the respondents had completed various secondary schools, and 4.6% had received only primary school education.In total, 67.9% of the participants were diagnosed with at least one of the conditions belonging to the pain group, and the remaining 32.1% represented the non-pain group.Single-variable logistic regression analysis showed a significant relationship between TMD pain and DEP with an odds ratio of 2.9 . The oth2 = 0.121). Stepwise elimination of variables led to a final model including just one significant variable . Among the other variables included in the primary multiple variable model , none remained in the final model. Thus, building up a multiple variable model did not contribute to increase the predictive value of a TMD pain model related to the presence of depression. The primary multiple logistic regression model including all the above-selected independent variables had DEP as the only significant variable . None of the other variables were significant, hence the model was not strong : age, gender, bruxism, tooth wear, chewing gum, nail biting, perceived stress level, chronic pain-related impairment, depression, and somatization. Based on the present study, the null hypothesis that none of the above factors are related to painful TMDs could be rejected. Despite the weakness of a significant relationship that prevented us from building predictable multiple variable models for TMD pain, single variable analysis gave some interesting suggestions. On one hand, it showed only a significant relationship between TMD pain and DEP, but on the other hand, it also showed chronic pain-related impairment and SOM scores; female gender and bruxism increased the chance, whilst male sex decreased the chance of belonging to the painful TMD group by approximately two times. Moreover, this investigation is the one of the first to assess risk factors in a population of TMD patients based on the presence of pain and not its location, in accordance with what was suggested for the evaluation of psychological factors in a previous paper . Many stBased on literature studies, it is not surprising that depression is associated with TMD pain, since TMD-pain patients have been reported to have higher psychosocial impairment than TMD-free individuals ,32. AccoTMD pain is known as a complex disease being impacted by many disease-related variables in multiple domains, including biological, psychosocial, and pain processing variables . TherefoThere are several factors that might have affected the outcomes of this investigation. The main problem was that the regression model included factors that were not assessed based on the best available methods. For instance, awake and sleep bruxism were screened with the questions included in the history-taking questionnaire of the RDC/ TMD. Future studies should assess awake bruxism by means of an Ecological Momentary Assessment and sleep bruxism by means of instrumental measurement strategies such as electromyography ,36. SecoFindings from the present study supported the existence of a relationship between pain and depression in painful TMD patients. Such kind of analysis has never been performed in any previous studies, and it supports a need of considering both psychological factors and TMD signs and symptoms. In the future, study designs should be improved by the adoption of the best available assessment approaches for each factor.


Neuropathic pain occurs in 1% of the population and is difficult to manage. This chronic pain causes psychological distress and impacts patient's quality of life, especially in cancer patients. The aim of this study was to show and compare the efficacy of pregabalin and duloxetine, which are reported in the group of first‐line treatment at European Federation of Neurological Societies (EFNS) guidelines on the pharmacological treatment of neuropathic pain (2010 revision) in lung cancer patients by using visual analogue scale (VAS) and Leeds Assessment of Neuropathic Symptoms and Sign (LANSS).A prospective, randomized, open label, 3 month of study was conducted. A total of 44 patients that were diagnosed with neuropathic pain (14 women and 30 men) were included in the study. Patient's LANSS and VAS values were recorded before treatment. Then, 22 patients undergo pregabalin and 22 patients undergo duloxetine therapy. But due to side effects , two patients had stopped to use pregabalin. Their LANSS and VAS values were recorded after 1 and 3 months of therapy.p < .01). Duloxetine is superior to pregabalin in reducing the LANSS scores when we compare two groups.When we compare LANSS and VAS scores before treatment, after 1 and 3 months of treatment with pregabalin and duloxetine, a significant decrease was observed in both groups at the 1 and 3 months (Both duloxetine and pregabalin are effective in the treatment of neuropathic pain of lung cancer patients. And as far as we know, this is the first study comparing the efficacy of duloxetine and pregabalin in the neuropathic pain of lung cancer patients. There are a few number of comparative studies between duloxetine and pregabalin in the treatment of neuropathic pain from Turkey and as well as we know this is the first study comparing these treatments in lung cancer patients. Our aim is to show the efficacy of duloxetine and pregabalin and compare their efficacy in neuropathic pain of lung cancer patients. Also, it is common in cancer patients. Neuropathic pain (NeP) has been defined by the International Association for the Study of Pain as pain that is initiated or caused by a primary lesion or dysfunction in the nervous system Merskey, . NeP oftAccording to the clinical view, neuropathic pain is related to the etiology of various diseases like cancer or diabetes and it is often associated with comorbid conditions  and a lowered quality of life  and stimulus‐dependent (“evoked”) pain and other symptoms such as tingling (paresthesia) and also for the “negative” signs and symptoms that may be observed which include numbness, weakness, and loss of deep tendon reflexes in the involved nerve territory. So that clinical neurophysiology examines large fibers but is generally not useful in determining the possible involvement of small nerve fibers in neuropathic pain conditions, our neurologist did not perform standard nerve conduction studies to these patients and diagnose was made by the history and neurological examination. A total of 44 patients that were diagnosed as neuropathic pain (14 women and 30 men) were included in the study. Patient's Leeds Assessment of Neuropathic Symptoms and Sign (LANSS) and visual analogue scale (VAS) values were recorded before starting neuropathic pain treatment.The physicians were asked to fill out the LANSS questionnaire (characterization of the pain true five questions), as well as to perform the two included items for sensory testing: allodynia and altered pin‐prick threshold Bennett, . AllodynLeeds Assessment of Neuropathic Symptoms and Sign scores were recorded before the treatment and at the 1 and 3 months of treatment. For the patients who had a LANSS scale pain score ≥12 means NeP is most probably present. Neuropathic pain was also assessed in a quantitative way by using a visual analogue scale for pain (VAS) offering a score between 0 (no pain) and 100 (very severe pain) to measure pain intensity  and 22 patients undergo duloxetine (group 2) therapy. pregabalin was used twice a day with a total dose of 300 mg (2 × 150 mg), and duloxetine was used once a day with a dose of 60 mg. Randomization was made due to the admission of the patients to our clinic . The study protocol was approved by the ethics committee and made in accordance with the principles of the Helsinki Declaration.Patients were followed up closely, and their LANSS and VAS values were recorded at the 1 and 3 months of therapy.p < .05 were considered as statistically significant.Data analysis was made by using SPSS 16.0 for Windows. Descriptive statistics for continuous variables were showed as mean ± standard deviation. Wilcoxon signed rank test was used to evaluate pre‐ and post‐treatment. 3A total of 44 patients that were diagnosed with neuropathic pain (14 women and 30 men) were included in the study. Two patients (men) in pregabalin group were excluded from the study due to side effects  at the first week of treatment. Demographic variables are summarized in Table p < .001; Figure p < .001; Figure Group 1 had a mean VAS score of 74.25 before the treatment, 59.25 at the first month of treatment, and 45 at the third month of treatment which are statistically significant , European Federation of Neurological Societies (EFNS), Neuropathic Pain Special Interest Group (NeuPSIG), National Institute for Health and Care Excellence (NICE) have all included and recommend pregabalin and duloxetine as the first‐line therapy for neuropathic pain , and noncancerous pain  and increase the quality of life.5.1For future trials, we recommend to assess comorbidities , quality of life, symptoms, and signs with standardized tools and attempt to better define responder profiles to specific drug treatments.We state that there is no conflict of interest regarding the publication of this paper. Click here for additional data file. Click here for additional data file. Click here for additional data file.


Background: Trigeminal neuralgia (TN) is a recognized pain condition the treatment of which can be very challenging. Various surgical interventions can be applied in cases of therapy-resistance to drug treatments. The central lateral thalamotomy (CLT) against neurogenic (or neuropathic) pain is based on multiarchitectonic histological as well as physiopathological studies, and integrates the nucleus in a large thalamocortical (TC) and corticocortical network responsible for the sensory, cognitive and affective/emotional components of pain. The advent of the magnetic resonance imaging guided high intensity focused ultrasound (MRgFUS) brought a strong reduction in morbidity and increase in accuracy compared to penetration techniques.Objective: This study was aimed at analyzing the outcome of bilateral MRgFUS CLT for chronic therapy-resistant trigeminal pain, all performed in one single center.Methods: Patients were categorized in Classical, Idiopathic and Secondary TN. By definition, paroxysms lasted for seconds up to 2 min. All patients were screened for trigeminal neurovascular conflict. In case of classical TN, microvascular decompression was proposed. Therapy-resistance and thus indication for MRgFUS CLT was based on the lack of efficacy and/or side effects of antiepileptic and antidepressant drugs. Good outcome was defined by a pain relief ≥50%.Results: Eight patients suffering from chronic therapy-resistant trigeminal neuralgia were treated. All suffered from pain with paroxysmal character. Six patients reported additionally continuous pain. Mean follow-up was 53 months . The mean pain relief assessed by patients was 51%  at 3 months, 71%  at 1 year and 78%  at their longest follow-up. This represents 63% good outcomes at 3 months, 88% at 1 year and 100% at last follow-up. Frequency of the mean pain paroxysms decreased from 84 per day preoperative to 3.9 at 1 year postoperatively. There were no serious adverse events in this series.Conclusion: Our study provides preliminary support for the safety and efficacy of MRgFUS CLT, a histologically and pathophysiologically based medial thalamotomy against chronic therapy-resistant trigeminal neuralgia. At the beginning of the 20th century, Head and Holmes postulated the presence of an “essential medial thalamic center,” anatomically located medially to a pain-generating lesion in the thalamic ventral posterior complex (VP) and responsible for the pathogenesis of central pain . Sano prThe results obtained years ago in the medial thalamus by a few neurosurgical groups tend to support the primacy and possible exclusivity of CLp as a regulatory medial thalamic target: Sano , as an eSince the first clinical experience with the MRgFUS  and a seThis case series analyze the clinical results of consecutive MRgFUS treatments performed for chronic therapy-resistant trigeminal neuralgia with a mean follow-up of 4 years. This report reflects our current practice of treating chronic therapy-resistant neurogenic pain regardless of which body part is involved.All patients treated with this protocol signed an informed consent form after having been fully informed about the treatment, its results and risks. No additional ethical approval was sought because MRgFUS CLT has been approved by the Federal Office of Public Health (FOPH) of Switzerland and is covered by swiss social insurances.Patients were categorized according to Cruccu et al.  in ClassThe surgical procedure using the MRgFUS to perform CLT , 28, tarTen mg domperidone  were given prior starting sonications. The last patient of this series, received in accordance to our actual routine operation protocol 20 mg intravenous methylprednisolone in the hour following the end of the operation, 20 mg after 12 h and dexamethasone 2 mg three times daily for 3–4 days in order to control/limit the perifocal edema of the lesion. Control MR was performed 2 days postoperatively. Accuracy determination and target reconstruction were performed according to Moser et al. , 31.Detailed pain assessments with a full neurological examination including assessment of esthesia and algesia were performed preoperatively and postoperatively after two days, 3 months and 1 year. Later follow-up assessments were mostly performed through e-mail and phone conversations. Pre- and postoperative assessments included the items of the McGill Pain Questionnaire. Pain intensity was noted on a visual analog scale (VAS) for the least, the worst and mean pain intensities on a scale between 0 and 100. Patients were asked for a percentage value of postoperative pain relief as compared with their preoperative state. Mini-mental test and later Montreal Cognitive Assessments were performed preoperatively and after 2 days and 1 year follow-up. Good outcome was defined by a pain relief ≥50%. A recurrence was defined as initial good outcome (pain relief ≥ 50%) and later decrease of pain relief <50% and/or recurrence of pain attacks.post hoc analysis with Bonferroni-Holm testing .Statistical analysis of quantitative scores compared with baseline was carried out by repeated ANOVA measures and multiple comparisons were applied using a Patient's characteristics are summarized in Eight consecutive trigeminal neuralgia patients treated between 06/2011 and 11/2017 were analyzed here. All patients suffered from pain with paroxysmal character. 6 patients reported additionally continuous pain. Three patients were classified as Idiopathic TN, 3 as Classical TN and 2 as Secondary TN. Secondary causes for TN were multiple sclerosis (1) and 1 trigeminal schwannoma operated 20 years prior to MRgFUS intervention. There has been no sign of recurrence The patient with multiple sclerosis did not present MR signs of active demyelination, i.e., plaques accounting for a new potential source of pain in addition to the known causal brainstem plaque. All patients showed at least mild somatosensory deficits at detailed clinical examination. Nine surgical interventions for pain were performed in 5 patients previously . Two patients with classical TN refused microvascular decompression (MVD) prior to this study time.All patients had unilateral pain syndromes, 5 of them on the right side. Distribution of the pain in the trigeminal territories is given in Bilateral CLT in one session was performed in 6 patients. In Patient 4 previously treated with bilateral CLT RF, unilateral CLT complement as well as 1 centrum medianum (CM) target were performed. Patient 6 received a complementation on the right side of his bilateral MRgFUS CLT performed 14 months previously. The complement of the CLT target was offered because of symptom recurrence due to partial target coverage.3 (51–247 mm3). All patients were discharged after one night hospital stay.Average number of sonications was 15 ± 8 (5–31) and their duration was between 20 and 31 s. The average power of final sonications was 1020 ± 236 [W] (650–1300). Final temperatures were between 54 and 58°C. Mean lesion volume measured on MR T2 axial and sagittal images 2 days after treatment was 153 ± 85 mmThe mean pain relief assessed by patients was 51%  at 3 months, 71%  at 1 year and 78%  at their longest follow-up see . This reAt last follow-up, pain paroxysms were still present in 5 patients (63%) but their mean intensity was 27 ± 30/100 compared to 70 ± 20 preoperatively on VAS. Of the 6 patients reporting continuous pain preoperatively, 2 still reported continuous pain at last follow-up. Their mean continuous pain level was 16 ± 27/100 at last follow-up, compared with 50 ± 12/100 preoperatively. At last follow-up, statistical significance was reached for pain paroxysms but not for continuous pain. Pain qualities of both  pain components as well as frequency of spontaneous pain paroxysms are detailed in p = 0.03) and 7.6 ± 4.1 (2–16)  at 1 year follow-up. They were no cognitive changes, as assessed with MMST (n = 3) or MoCA (n = 5). Mean MMST scores were 29.3 ± 0.6 preoperatively, 29.7 ± 0.6 at 2 days, 3 months and 1 year follow-up. Mean MoCA scores were 26.8 ± 4.1 (20–30) preoperatively, 28.0 ± 2.5 at 2 days (24–30) and 28.6 ± 2.1 (25–30) (p = 0.28) at 1 year follow-up.Mean Anxiety and Depression Scale (HADS) scoring was 14.4 ± 5.8 (5–21) preoperatively, 8.5 ± 3.7 (2–14) at 3 months  reached more than a low level of evidence supporting primacy over the others . AccordiThe CLp target, which was selected on the basis of the pathophysiological presence of low threshold calcium spike bursts discharging at 4 Hz, offers advantages over other medial thalamic targets. In contrast to the CM/Pf or to PuM, all targeted in the past , 16, 37,Despite our active proposition to perform a microvascular decompression, two classical TN patients chose MRgFUS CLT and showed high pain relief at follow-up. The MRgFUS CLT represents a chance for patients who have a vascular compression but cannot or do not want to undergo a MVD.The bilateral MRgFUS CLT offers a physiopathologically based approach combining very low morbidity, good efficacy, absence of pain worsening and long term relief from neurogenic pain. Results of this small case series on chronic therapy-resistant trigeminal neuralgia, with a mean follow-up over 4 years, provides support for these characteristics in a given specific neurogenic pain location. Only a larger experience with this approach will demonstrate if it represents a treatment of first choice for patients who are not candidates for MVD.The datasets generated for this study are available on request to the corresponding author.Ethical review and approval was not required for the study on human participants in accordance with the local legislation and institutional requirements. All patients treated with this protocol signed an informed consent form after having been fully informed about the treatment, its results and risks.MG and DJ contributed to the conception, design of the study, acquisition, analysis, interpretation of the data and co-drafted the manuscript. DM co-drafted the manuscript. All authors read and approved the final manuscript.MG, DM, and DJ were employed by SoniModul Ltd., Center of Ultrasound Functional Neurosurgery, Solothurn, Switzerland.


Chronic spinal pain is prevalent, expensive and long-lasting. Several provider-based nonpharmacologic therapies have now been recommended for chronic low-back pain (CLBP) and chronic neck pain (CNP). However, healthcare and coverage policies provide little guidance or evidence regarding the long-term use of this care. To provide one glimpse into the long-term use of nonpharmacologic provider-based care, this study examines the predictors of visit frequency in a large sample of patients with CLBP and CNP using ongoing chiropractic care.Observational data were collected from a large national sample of chiropractic patients in the US with non-specific CLBP and CNP. Visit frequency was defined as average number of chiropractic visits per month over the 3-month study period. Potential baseline predictor variables were entered into two sets of multi-level models according to a defined causal theory—in this case, Anderson’s Behavioral Model of Health Services Use.p = .008) for those with CLBP and some coverage for chiropractic, but coverage had little effect on visits for patients with CNP. Patients with worse function or just starting care also had more visits and those near to ending care had fewer visits. However, visit frequency was also determined by the chiropractor/clinic where treatment was received. Chiropractors who reported seeing more patients per day also had patients with higher visit frequency, and the patients of chiropractors with 20 to 30 years of experience had fewer visits per month. In addition, after controlling for both patient and chiropractor characteristics, the state in which care was received made a difference, likely through state-level policies and regulations.Our sample included 852 patients with CLBP and 705 with CNP. Visit frequency varied significantly by chiropractor/clinic, so our models controlled for this clustering. Patients with either condition used an average of 2.3 visits per month. In the final models visit frequency increased (0.44 visits per month, Chiropractic patients with CLBP and CNP use a range of visit frequencies for their ongoing care. The predictors of these frequencies could be useful for understanding and developing policies for ongoing provider-based care. Chronic low back pain (CLBP) and chronic neck pain (CNP) are the most common types of chronic pain, , 2 and tMany patients with CLBP and/or CNP use medications to manage their pain, including opioids , 20. HowUnfortunately, the ongoing long-term provision of provider-based care for chronic spinal pain, including appropriate visit frequencies, is not well-addressed in health and payer policies –27. To sInformation on how patients with CLBP and CNP utilize ongoing provider-based nonpharmacologic care may be useful to the development of better policies in support of this care. It is estimated that 30% of patients with spinal pain have visited a chiropractor, one type of recommended provider-based nonpharmacologic care . In partThis study took advantage of data gathered from a large national sample of patients with CLBP and CNP who were using chiropractic care . Other aThis study uses observational data collected over 3 months from a national sample of US chiropractors and their patients with CLBP and CNP. These data were gathered between June 2016 and February 2017 as part of a larger project which has been described elsewhere , 49. Dat> 21 years of age; English proficient; no present personal injury/workers compensation litigation; have low back or neck pain) and gave their email address were sent a longer online screening questionnaire to determine their eligibility for the study—i.e., patients with chronic low-back pain and/or chronic neck pain . Eligible patients gave consent, answered several additional questions and then were sent an online baseline survey followed by five shorter biweekly follow-ups to collect data on ongoing care and symptoms, and a longer endline survey at 3 months. At each step, in addition to the survey link respondents were sent up to 3 email reminders and if they missed a survey they were allowed to rejoin the series at any point past baseline. Patients received online gift cards for their response to each questionnaire and those who completed all nine questionnaires received a total of $200. This study used visit data from all surveys. However, all other data came from the baseline and screening questionnaires. The chiropractor at each clinic also filled out a questionnaire about their own and their clinic’s characteristics. Because the evidence for nonpharmacologic therapies has focused on non-specific CLBP and CNP, in this study we excluded patients from our sample if they reported that a health practitioner told them that their CLBP and/or CNP was caused by one of a list of medical conditions including cancer, rheumatoid arthritis, spinal stenosis, primary fibromyalgia or fracture.To minimize the burden on clinic operations each clinic front office staff were asked to offer each patient who visited the clinic over the 4-week recruitment period an iPad upon which to fill out a brief prescreening questionnaire. After that point all patient screening, consent and data collection occurred online and did not involve the clinic. Those who filled out the prescreening questionnaire, met those criteria (We specified and estimated 2 sets of multi-level models. The first set examined the predictors of chiropractic visit frequency for those with only CLBP or with both CLBP and CNP but who said that their CLBP was worse (hereafter referred to as those with CLBP). The second set examined the predictors of visit frequency for those with only CNP or with both but said that their CNP was worse (hereafter known as those with CNP).Visit frequency was based on patient self-reported recall of chiropractic use over the past two weeks gathered every two weeks for 3 months. Visit frequency was defined as the average number of chiropractic visits per 30-day month. If patients missed data collection points they were asked for their number of visits since their last data collection and numbers were adjusted accordingly. Patients who dropped out or ended care before the end of the first month were excluded from the analysis. The variables we hypothesized to predict visit frequency were all measured at baseline and are listed below in descending order of their hypothesized importance following Anderson’s Behavioral Model of Health Services Use –56.We measured the enabling factors of patients’ baseline insurance coverage and resulting out-of-pocket costs for chiropractic care in three ways and chose the one that best explained visit frequency. The first is a dichotomous variable for having some coverage or not. The second provides more detail on any limitations  on coverage. And since insurance coverage has a direct effect on the amount the patient pays out-of-pocket per visit, we also considered including these costs instead.Patients’ need factors included the characteristics of their baseline pain and function. We included their pain 0–10 numerical rating scale or NRS,  and the Certain lifestyle or point in care characteristics could also be considered need factors affecting visit frequency. Higher physical demands  have been hypothesized as a justification for ongoing care . Also, bPatients’ goals for their care may reflect perceived need factors and affect visit frequency. These goals were elicited in the baseline survey using an item asking for those with CLBP: Which of the following best describes what you hope to get from your chiropractor regarding your low back pain? The four response options were: Prevent low back pain from coming back or prevent re-injury; Prevent low back pain from getting worse; Ease low back pain or make low back pain go away temporarily; and Make low back pain go away permanently (cure). Those with CNP received a similar item and set of responses but asking about neck pain.Pain beliefs may also be considered perceived need factors and were captured using several measures including patient report of whether they believed their pain was chronic, and what would happen to their pain on a scale of 0–10 if they did not see their chiropractor. This last question was added after pilot studies indicated that this seemed to motivate patients more than their current pain levels, and later analyses confirmed this focus . PatientCertain psychological variables may also be perceived need factors and associated with visit frequency. Patients’ self-efficacy for their pain management was measured at baseline using that 5-item subscale of the Chronic Pain Self-Efficacy Scale  and usedFinally, we included several predisposing factors  to examine their impacts on visit frequency. Several studies have found that those who are older respond less favorably to treatment, , 82, 83 > 50,000 population [Variables for clinic (chiropractor) and region (state and metropolitan area) were used to determine whether visit frequency was clustered by clinic or region. If clustering by clinic was found, we added chiropractor/clinic characteristics to the model to see if they explain how visit frequency varied by clinic, including average number of patients treated per day, percentage of patients seen for preventive/maintenance care, years in practice, clinic location as urban , anWe used hierarchical linear modeling  to aWe first ran unconditional (no predictor variables) HLM models to determine whether visit frequency was clustered by region and/or by chiropractor/clinic. We used the Bayesian Information Criterion (BIC) fit statistic  to choose the best unconditional model in terms of clustering variable . The BICp < .05) for at least one condition. The p-values for each reported coefficient are provided as an indication of the variables providing the most explanatory power in that block.Blocks of explanatory variables were then entered into each model sequentially according to a defined causal theory . The wor2 tests, respectively. All analyses were performed in Stata 16.0. This study was approved by the RAND Human Subjects Protection Committee.Averages and frequencies for the variables considered as potential predictors of patients’ visit frequency were compared between the CLBP and CNP samples using t-tests and χOf the 2024 chiropractic patients with CLBP and CNP who completed the baseline survey,  1708 metp < .001 for both the CLBP and CNP models)—i.e., visit frequency was at least partially explained by the chiropractor seen. Clustering by region was not significant and the lowest BIC was found for an unconditional model that only clustered by clinic .Table Table italics the explanatory power  of each block when it was first entered. As can be seen the blocks of perceived need factors  were not explanatory when added after enabling or need factors for either model. Estimated coefficients from the final models were reported in Table We first separately added each of the three options for coverage and out-of-pocket costs to the unconditional HLM models clustered by clinic . These rHaving some insurance coverage increases visit frequency by 0.44 visits per month for patients with CLBP but has little to no effect for CNP. Having worse function (higher ODI/NDI scores) and being a newer patient increased visit frequency for both CLBP and CNP. For those with CLBP having some heavy labor at work increased visit frequency and being female decreased visit frequency. On the other hand, those who ended care during the last 2 months of the 3-month study period already had significantly fewer visits before their decision to end.Even after accounting for all available patient characteristics, the characteristics of the treating chiropractors provided significant explanatory power to patients’ visit frequency. Visit frequency was significantly higher for patients of chiropractors who reported treating more patients per day and was significantly lower for patients of chiropractors who have been in practice for 20–30 years. Visit frequency was also significantly higher for patients with CNP when the chiropractor reported a higher proportion of patients being seen for preventive/maintenance care. The block for the chiropractor’s college of graduation did not add significant explanatory power to either model. However, after controlling for all patient and chiropractor characteristics visit frequency was still significantly lower for patients in New York state. After the last block was added to each model, the variance in visit frequency by chiropractor/clinic was no longer significant meaning that the variables added successfully captured the influence of the chiropractor on patient visit frequency.In these samples of patients with CLBP and CNP who were using ongoing chiropractic care, average visit frequency was 2.3 chiropractic visits per month—i.e., just over one visit every two weeks. This visit frequency was found to vary significantly by the characteristics of the patients, the characteristics of the treating chiropractors, and the state in which care was given.Patients with CLBP and some insurance coverage for chiropractic had on average less than one-half visit more per month than those without coverage. However, insurance coverage had little to no effect on visit frequency for patients with CNP. In other analyses about two-thirds of this sample said that having insurance coverage was very or extremely important to their use of chiropractic care . HoweverAs would be expected, patients with either CLBP or CNP and worse function had significantly higher visit frequency. Either going from the mid-point of minimal to the mid-point of moderate disability on the ODI for patients with CLBP (an increase of 30 points ) or goinIncluding all available patient characteristics explained some of the variation of visit frequency seen by chiropractor—i.e., some chiropractors tend to see more of certain types of patients. Nevertheless, including all available patient characteristics did not fully explain the variation in visit frequency seen by treating chiropractor. The characteristics of the chiropractor/clinic also had an influence on visit frequency. Patients of chiropractors who report treating more patients per day, and for CNP who report a higher proportion of patients receiving preventive/maintenance care, have significantly higher visit frequencies, and patients of chiropractors who have been in practice for 20–30 years have significantly lower visit frequencies. The patients of a chiropractor who treated double the average number of patients per day (50 rather than 25) had on average three-quarters to one more visit per month, and patients of chiropractors who have been in practice 20 to 30 years have roughly one less visit per month than those in practice for 5 to 10 years.There has been concern amongst payers and providers that patients’ use of ongoing care was not based on medical necessity or need, but on clinician dependence or coercion, including through lowered patient self-efficacy or heightened patient fear , 95–97. Finally, even after controlling for patient and chiropractor characteristics there seems to be some effect on visit frequency of being treated in New York State. Visit frequencies for patients with CLBP or CNP being treated in New York were more than one visit per month lower than patients being treated in California. This may be because of stricter coverage rules for chiropractic care in New York State.n = 51) and primary medical care (n = 14) clinics [Other studies have reported on visit frequency for chiropractic care. One study compared practice patterns over a year for patients with CLBP in chiropractic ( clinics . They fo clinics . Across This study benefits from extensive data collected from a large sample of patients using chiropractic for chronic non-specific spinal pain and from their chiropractors. Nevertheless, our study has limitations; the main one being that the sample used in this study is not a representative sample of all patients with CLBP and CNP. It is, however, a reasonably representative sample of chiropractic patients with CLBP and CNP  in termsGiven the concern that patients utilize ongoing chiropractic care due to reasons such as clinician dependence or coercion for provider financial gain, another limitation of our study is that it would have been helpful to have a measure of whether patients’ responses were based on what they were told by their chiropractor versus their lived experience. Their having lived with their pain condition for an average of 14 years and the consistency of their responses across the sample  give weiNIH Medline Plus, a publication of the National Institutes of Health, “chronic pain usually cannot be cured, but it can be managed.” [According to anaged.”  Several anaged.” –27 and tanaged.” . This stAdditional file 1: Appendix Table A.1. Results of the unconditional models; Appendix Table A.2. Average visit frequency for each category of each predictor variable in each sample; Appendix Table A.3. Models testing the options for insurance coverage and its effect on out-of-pocket visit costs; Appendix Table A.4. Full results of the final hierarchical linear models predicting chiropractic visit frequency for samples of patients with chronic low back pain and chronic neck pain.