However, the higher degree of within-group improvements was found for the INYBI + UCMT group. It was concluded that the myofascial release therapy in the suboccipital area is effective in patients with chronic neck pain, either through a manual application or by means of the INYBI tool. Moreover, the addition of craniocervical manipulation achieved the higher within-group improvements, but with no statistical significance.The INYBI is an instrument used to release the suboccipital myofascial area. There is scarce evidence of its efficacy. A randomized controlled, double-blinded, longitudinal and prospective trial was performed. Ninety-six subjects (aged 29.47 ± 5.16 years) (70 women) with chronic neck pain were randomly assigned to the manual suboccipital inhibition technique (MSIT), instrumental suboccipital inhibition (INYBI) or the INYBI plus upper cervical manipulation technique (INYBI + UCMT) groups and received two sessions with a week interval between them. The Neck Disability Index was used before the first intervention and two weeks after the second intervention. Pre- and post-measurements were taken on both intervention days for pressure pain threshold of the upper trapezius and suboccipital muscles, self-perceived pain and cervical range of motion. In spite of a significant general improvement in time that was found for the three groups for all of the outcome measurements ( Cervicalgia is a health and social issue . It limiPatients with chronic neck pain (CNP) exhibit diminished neck range of motion  and hypeThus, in order to manage spinal pain, myofascial release therapy (MRT) and spinal manipulation (SM) are frequently used. Regarding MRT, it implies the application of a low load, long duration force which has classically attempted to achieve its goal by stretching the connective tissues with the aim of improving their properties and restoring their optimal length, and thereby diminishing pain and increasing range of motion ,17. SincOn the other hand, spinal manipulation is also a commonly used intervention for pain disorders. Several mechanisms are thought to be implied in the way that spinal manipulation works, and some of them could be done extensively with MRT . It usesIn general terms, physiotherapy treatments, and especially manual therapy interventions, are not usually composed by the application of isolated techniques, but by a sum of them. Some research has shown that the addition of techniques is more effective than any of them on their own in craniocervical disorders ,15,29. DClinicalTrials.gov; registration number NCT04777890) was performed. The study received the approval by the Research Ethics Committee of the Universidad Rey Juan Carlos  (0312201815318) and was conducted following the ethical guidelines of the Declaration of Helsinki.A randomized, double-blinded, controlled trial (The recruitment took place in a physiotherapy and osteopathy private center in Madrid (Spain). To be included, the patients between 18 and 40 years old had to suffer from mechanical CNP with an evolution of at least 3 months, showing pain increased with maintained postures, with movement and during spinal muscles palpation and that can curse with trapezius pain. Pain should be located between the occipital bone, including the cervicothoracic junction to the fourth dorsal vertebra. Subjects were excluded if they could not read and/or fill in the informed consent; presented psychological pathologies, such as depression or anxiety; had received a manual treatment two months before the beginning of the clinical trial; were in treatment with any type of analgesic, anti-inflammatory or neuromodulator medication or had used it in the previous 72 h; felt fear to vertebral manipulation in the upper cervical area; or presented contraindications to manual therapy, such as: positive Klein Test and other tests of the vertebral artery’s integrity, positive cervical instability test and positive Spurling Test; osteitis; cervical rheumatic diseases; congenital anomalies such as Arnold Chiari or Klippel-Feil; hemorrhages; recent cranial bone fracture at its base; tumors; previous cranial bone or cervical surgery; platybasia; upper cervical osteoarthritis; pathologies that weaken in a significant way the bone system, such as severe osteoporosis, bone metastases; instability signs in the upper cervical region; cervicobrachial neuralgia; diabetes mellitus or any arm/shoulder joint pathologies. A total of 102 participants were randomized because all of them agreed to participate in the study, but one finally decided not to do so and five just completed the first phase and did not receive the second intervention ,31 Figu.The recruiter collected the participants’ informed consent and demographic data , besides relevant clinical information related to the study criteria. A different examiner carried out the pre-intervention assessment. After it, the first intervention was applied by another researcher, and followed by the first post-treatment evaluation, which was undertaken immediately after the intervention (and carried out by the same pre-intervention examiner). One week later, a second session was performed, including the same procedure related to pre- and post-interventions assessment. With respect to the Neck Disability Index (NDI), it was only filled in before the first intervention (in the clinic) and 15 days after the second intervention (the recruiter sent it to the patient via e-mail). The instructions were included in the questionnaire. ® . It is constituted by a floating compass which is attached to the head with Velcro straps. This tool has shown an intratester reliability of 0.87–0.96, and a standard error of measurement of 2.3°–4.1° [The measurement of the cervical ROM was carried out with the goniometer CROM.3°–4.1° . During Neck pain was evaluated with a visual analog scale (VAS). It consists of a horizontal 10 cm line where the participant has to mark the intensity of the pain he/she perceives during the movements of the neck in every plane . A mark 2 contact area, which was applied perpendicularly with an increasing pressure of 1 kg/cm2 per second approximately. With the patient seated upright, each PPT was measured 3 times, taking into account the arithmetic mean of the three of them. All the participants were instructed in the same way to warn when the sensation of pressure became uncomfortable or painful.To assess the sensitization of the suboccipital (SM) and upper trapezius (UT) muscles, their pressure pain thresholds (PPT), which is the minimum amount of pressure needed to evoke discomfort or pain , were meThe NDI is the most used cervical pain disability scale to assess the functional level of the patients . It is mIn order to distribute the sample in three intervention groups , Microsoft Excel  was used as the randomization method. The concealment was guaranteed by the participation of an independent collaborator, who guarded the randomization sequence. To implement random allocation, sequentially numbered opaque sealed envelopes were used. Those researchers involved in recruitment were unaware of the number sequence and the assignment to the intervention groups. As well, the interventions were blinded for the patients, recruiter and examiner, since patients were randomly allocated into the groups, and none of them knew the characteristics of the interventions and which treatment they were going to receive.In the three intervention groups, the participant lied in a decubitus supine position, and all the interventions were carried out by the same therapist. Participants in the control group were treated with the manual SIT (MSIT group) during a 10 min period. This procedure was undertaken according to the literature ,42,43. TIn the INYBI group, the therapist placed the INYBI at the suboccipital area, specifically placing the fingers of the instrument at the posterior arch of the atlas . All patIn the combined (INYBI + UCMT) group, the INYBI was used during a 10 min period, after which the therapist carried out the UCMT. This bilateral manipulation is a high velocity and low amplitude technique performed by cervical rotation around an imaginary vertical axis passing through the odontoid process of the axis. A mild contralateral upper cervical side-bending was added with cephalic traction and no flexion not extension parameters. The manipulative impulse was applied in rotation and attempted to increase the upper cervical joints mobility ,44 Figu.The sample size was determined with the software Granmo online v7.12  for the variable PPT. Taking an alpha risk of 0.05 and a beta risk of 0/2 in a bilateral contrast, 33 subjects were needed in each group in order to notice a minimum difference of 0/35 points between two groups, assuming that there are 3 groups and a standard deviation of 0/4 points. A follow-up loss rate of 15% was estimated.2), and the p value was of <0.05. The statistical analysis was carried out with the software SPSS v22 . The Shapiro Wilk test was made to make sure the sample distributed normally. One-way ANOVA was made to make sure the groups distributed homogeneously when they met normality criteria; if not, the Kruskal Wallis test was carried out. For qualitative variables, the Chi-Square test was used. In order to quantify the difference interval between groups, the least squares estimation was carried out. Moreover, a repeated measured ANOVA with Bonferroni correction was carried out to quantify in the three groups the pre-intervention and immediate post-intervention of the first and second sessions, respectively, as well as a pairwise comparison according to group and time. Global clinical effects for the repeated measure analysis were estimated with the Eta squared value  but for self-perceived pain in flexion, with the worst values found in the INYBI + UCMT group (p = 0.017).The baseline characteristics of the participants in each group are presented in p < 0.001 except for flexion and extension ROM, which was p < 0.05). No between-groups differences were found in any variable but for the VAS during left rotation, with the smaller improvement being obtained for the MSIT group. A large clinical effect (η2 > 0.14) was achieved for NDI, suboccipital algometry and self-perceived pain, while a medium clinical effect (η2 > 0.06) was found for trapezius algometry and ROM in rotation and side bending. A small clinical effect (η2 > 0.01) was obtained for the flexo-extension ROM. In the within-group analysis, even though the only statistically significant difference was found for the self-perceived pain in the left rotation, the combination of INYBI + UCMT obtained the best improvements in most of the variables measured, followed by the INYBI group , PPT  and ROM (left and right rotation), with an increase higher than 5 degrees . To our Thus, our study increases the available information supporting the usefulness of targeting the craniocervical region by means of MRT in subjects suffering CNP. This way, our study highlights that it can also be done with the help of an instrumental tool such as INYBI, with the same success than the manual intervention by a professional therapist. This fact opens the possibility to use the INYBI by the patient himself at home. Further, our study shows that neck manipulation can be added to INYBI to achieve even slightly better results. More investigation is needed to know if these strategies are still effective in the long term.Before concluding, we find it important to talk about how the Coronavirus pandemic influenced the carrying out of the study. We had to carry out some security and hygienic measures, such as giving the patients disinfectant gel for their hands, measuring their body temperature and, in the case of the researchers, wearing bodysuits, surgical gloves, masks and face shields in order to carry out the assessments and interventions. We also had to clean and disinfect every material after use and cite one patient per hour, so that he/she did not meet any other patient. Moreover, most of the losses were due to pandemic conditions, such as fear of getting sick or virus infection. This was not the only limitation of the study; it lacks a long-term measurement of the effects of the interventions, and the therapist carrying out the treatments was not blinded. Nevertheless, one of the strengths of this study is that it is a randomized, double-blinded trial with the collaboration of three trained therapists. MSIT, INYBI and INYBI + UCMT are equally effective in order to improve ROM, PPT, VAS and disability in patients aged between 18 and 40 years old with chronic mechanic cervical pain. The combination of INYBI and UCMT achieves the higher degree of significant improvements, followed by the INYBI group. Further, it seems necessary to investigate more about the possible applications of the INYBI.


Substantial quality-of-life (EQ-5D-5L) improvement as assessed at last follow-up was also observed (n = 60). These results suggest that an implanted SCS device capable of combination therapy, while also enabled with patient-specific waveform optimization and stimulation field targeting capabilities, can enable highly effective pain relief and improve quality of life in patients suffering with chronic pain.Given the differing mechanisms thought to underlie therapeutic sub- and supra-perception-based neurostimulative modalities, Spinal Cord Stimulation (SCS) systems designed for combined delivery of these approaches may help improve analgesic outcomes and quality of life, and reduce treatment failures. This multicenter, observational case-series evaluated 188 patients with chronic back and/or leg pain implanted with an SCS device capable of sequential or simultaneous delivery of sub-perception and supra-perception stimulation programming  at 16 in Europe. Following implantation, patients were provided with an array of advanced supra-perception programs , and a custom set of sub-perception programs optimized with specific waveforms and/or field shapes. A mean overall pain score of 7.9 ± 1.7 (Standard Deviation (SD)) was reported pre-trial (Baseline). Overall pain was reduced by 4.4 ± 2.8 points (NRS) at 3-months ( Over the past decade, several new Spinal Cord Stimulation (SCS) approaches have been deployed in the clinical setting, including but not limited to high frequency 1–10 kHz), burst, and high density stimulation in an effort to improve patient outcomes using SCS to treat chronic pain –10 kHz, ,3,4. WhiNumerous basic and clinical studies have now demonstrated that SCS can be therapeutically applied below the threshold of perception , in contrast to conventional methodologies traditionally utilized at or above perception threshold  ,12,13,14To date, only a very limited number of peer-reviewed clinical studies have published outcomes in patients who have been implanted with devices designed to integrate sub- and supra-perception modalities. However, as these types of devices offering this capability become increasingly available to patients, we surmise that it will be important to monitor and track how these systems are used to treat pain as well as associated clinical outcomes ,24,25,26This is a multicenter, observational, retrospective case-series of permanently implanted patients who used an SCS system  to treat chronic pain at 16 centers in Europe . Inclusion criteria required patients to have been previously treated with or eligible to receive a Spectra WaveWriter SCS system (Boston Scientific) and be 18 years of age or older. There were no exclusion criteria , per study protocol.All study data were derived from 188 consecutively enrolled patients from 16 implanting centers in Europe. Ethics Committee approval was obtained from each site, and the study was conducted in accordance with GCP (ISO14155) guidelines and the Declaration of Helsinki.All patients were pre-screened during the Trial Period where, per standard of care, patients attempted to use SCS to determine if they may be good candidates (prior to permanent implant). However, only those patients who received a permanent implant were included for data collection. Stimulation parameters including waveform and electric field shapes were adjusted according to patient preferences per standard-of-care. Due to the retrospective design of this study, data were collected from only those patients who had completed follow-up at the time of the data snapshot. As such, the number of patients assessed fluctuated across time, with a decreased number evaluated at later timepoints because data could not be attained from those who had not yet reached succeeding follow-up visits. To lessen potential partiality, only clinical site staff without sponsor involvement performed data collection from patients directly. Collection of demographic information, pain location, surgical history, and medical history was conducted. Numeric Rating Scale (NRS) scores and Percent Pain Relief (PPR) were collected as part of the chart review. Health-related quality-of-life assessment was conducted using the EuroQol Validity in Assessing the Quality of Life (EQ-5D-5L) standardized measure and was collected at patient follow-up visits . Mean, mt test with two-sided 0.05 significance level was used to calculate whether the mean reduction in baseline pain was greater than 0. A Kolmogorov–Smirnov Test was performed to confirm the normality of the change of NRS score.For demographic data and NRS scores, means and standard deviations were determined. Score distribution was calculated for NRS and Percent Pain Relief. A paired As described in detail in previous work , the SCSn = 188). The mean follow-up (last follow up) duration was found to be 296 ± 207 days (n = 187)  .n = 135), 3.4 ± 2.2 (n = 117), and 3.2 ± 2.3 (n = 90), respectively (p < 0.0001) (n = 96) was noted at 3 months, and this was maintained up to 12 months’ follow-up . In patients assessed at the end of trial and 3 and 12 months following implantation, mean NRS score was reduced to 2.9 ± 2.3 ( 0.0001) A. Some pQuality of life improvement was noted based on EQ-5D-5L assessment. Among those included patients for whom assessment was carried out, a clinically meaningful mean improvement was noted as reflected by a 42-point increase in EQ-5D-5L score B.Thirty-eight percent of patients preferred programs utilizing combination therapy  among the multiple neurostimulative modalities available to patients in this study A. Other n = 53, p < 0.0001) was reported at 3 months that was sustained up to 12 months . At last follow-up (mean duration of 382 days), a 4.3-point improvement was noted . A significant improvement in quality of life was also noted as assessed by EQ-5D-5L .Of the 188 evaluated patients, 69 patients  were implanted with dual 16-contact percutaneous leads with 1 mm edge-to-edge spacing and 67 mm span. Seventy-six percent of leads placed were found to span multiple vertebral levels (electrode tip starting at T8) as shown in The outcomes of this international, real world, observational study demonstrate that patients with chronic pain who used an SCS system capable of combining sub- and supra-perception stimulation modalities as part of an available array of waveform and stimulation field targeting algorithms can achieve successful clinical outcomes that are sustained out to 1-year follow-up. These data are comparable with those reported in previous studies that assessed patients implanted with devices capable of providing options for various neurostimulative programming modalities ,32,33,34Sub- and supra-perception SCS modalities are thought to elicit pain relief through distinct mechanisms, but to date there still remains no concrete understanding of how either of these approaches induces analgesia, although several theories have been proposed ,36,37. HParticular limitations of this study include the retrospective nature of the data collection, thereby restricting this analysis to only the available clinical data contained in medical charts of evaluated patients, as collected per standard of care. As such, functional outcomes such as assessment of disability and opioid drug medication reduction were not able to be obtained. Moreover, this study does not allow for the evaluation of outcomes associated with the specific modes of SCS treatment that patients were able to utilize. Future studies will be required to evaluate whether meaningful associations exist among those who use particular waveforms and when and which clinical correlates, if any, may be associated with specific stimulation programming paradigms. Additionally, whether the utilization of combination therapy, as an available feature on an SCS device that allows for patient-selective waveform programming options and custom targeting of neurostimulation fields, actually can help foster a reduction in the real-world incidence of surgical revision or device explant is also an important question for future clinical investigations to now consider. Further, results obtained in this study also indicate that placements of newly available 16-contact percutaneous leads designed to span multiple vertebral levels, as used by a sub-set included for analysis in this study, are overwhelming performed in a similar manner across patients and are associated with positive clinical outcomes. These preliminary data thus can serve as a basis for future investigation of patients using these newer lead types, when also implanted with SCS devices equipped with enhanced neurostimulative targeting capabilities.This multicenter, international, real-world, observational study demonstrates that a programmable SCS device engineered to integrate different sub- and supra-perception modalities as a combination therapy, while also providing for selectable waveform options and patient-specific stimulation field targeting, can allow for highly effective pain relief and improved quality of life. An implantable device fully equipped with these capabilities may be a valuable tool to personalize SCS therapy and to reduce monotherapeutic treatment failures that provoke surgical revision and/or device explantation. Thus, providing multiple neurostimulative programming options offers substantial autonomy and versatility to patients over the total course of their experience using an SCS-based therapeutic strategy for treatment of chronic pain. Further studies with long-term follow-up are needed to explore the longevity and impact of the use of multiple programs and patient preferences.


The objective of this study is to explore the effect of solution focused approach (SFA) on the complications, pain, sleep, and quality of life in patients with hepatocellular carcinoma undergoing transcatheter arterial chemoembolization (TACE). n = 53) and the observation group (n = 53). The control group implemented routine nursing intervention, and the observation group implemented SFA on the basis of the control group. The clinical data, complications, pain, sleep status, and quality of life scores were compared between the two groups.  Total of 106 patients with hepatocellular carcinoma who underwent TACE in our hospital from July 2019 to June 2020 were selected. According to the admission time, they were divided into the control group (P < 0.05). There was no significant difference in the score of pain perception between the two groups (P > 0.05). The scores of sleep status in the observation group were lower than those in the control group (P < 0.05). The quality of life scores in the observation group was higher than that in the control group (P < 0.05).  The total incidence of complications in the observation group (16.98%) was lower than that in the control group (33.96%) ( SFA can effectively reduce the complications, relieve pain, improve sleep status, and improve the quality of life in patients with hepatocellular carcinoma undergoing TACE. Hepatocellular carcinoma is the cancer that originates from hepatocyte or biliary tract cell. Patients with hepatocellular carcinoma generally have no obvious symptoms in the early stage. With the development of the disease, the symptoms of hepatalgia, hypodynamia, anorexia, and ventosity may appear, which seriously affect the life safety of patients , 2. The At present, people's expectation towards medical service is becoming higher and the nursing working mode is changing. The solution focused approach (SFA) is the intervening model that works through guiding individual to find problems and set goals and then solves the problems focusing on the positive aspects of the individual. It has the characteristics of simple, effective, and affordable and has played a key role in a variety of diseases such as overweight and diabetes , 9. The The SFA plays an important role in clinical treatment at home and abroad. However, research on the application effect of SFA in patients with hepatocellular carcinoma undergoing TACE is relatively rare. Our physicians apply SFA to patients with hepatocellular carcinoma undergoing TACE through the summary of clinical experience and the inquiry of the literature. The paper is aimed to explore the effect of SFA on the complications, pain, sleep, and quality of life of patients with hepatocellular carcinoma undergoing TACE.n = 53) and the observation group  according to the admission time.Total of 106 patients with hepatocellular carcinoma who underwent TACE in our hospital from July 2019 to June 2020 were selected. There were 60 males and 46 females. They were aged from 39∼72 years. The mean age was (49.65 ± 5.13) years. Inclusion criteria are as follows: being diagnosed with hepatocellular carcinoma [The control group was taken care with the usual care such as renal and liver function tests, prevention of infection, and notes instruction. At the same time, intervention such as psychological counseling and scientific knowledge of health teaching was conducted on the control group.st day after operation): feedback was changed with the patient on reaching the goal with giving affirmation and support; patients were encouraged to continue the measures that work well; the methods that cannot work well were corrected; patients were encouraged with words, “With your persistence, many problems have been solved; you are now able to face the effects of the disease positively.” (5) Goal evaluation (7th day after operation): the effectiveness of various aspects of complications, pain perception, sleep status, and quality of life were evaluated to encourage patients to make further efforts and to summarize and analyze the experience.The observation group received SFA on the basis of the control group. The SFA nursing team was composed with the head nurse, nurses who had received SFA professional education. There was one time of intervention practice for each patient, and the intervention time was 30–45 minutes. (1) Problem determination (Day 1 of admission): the basic information of the patients was obtained and it was assessed; nurse-patient communication was enhanced; the real thoughts of the patients were understood; the patient was asked whether he or she is discomfort or not; and the patients are guided to express the physical and psychological conditions, such as follows: “Do you have any problems with TACE? What are your thoughts about physical recovery? What is the quality of your recent sleep? What help would you like to receive?” Based on the results, current problems were determined. (2) Construct goals (Day 3 of admission): the patients were encouraged to construct correct and feasible goals with the medical staff; the patient was instructed on how to cooperate; and the patients were instructed to hypothesize about what benefits and changes in conditions could be achieved after the problem was managed. “What are you going to do to solve the possible complications of the TACE procedure? What methods would you use for pain relief? How do you think what you can do to improve sleep quality? If you can control diet according to doctor's advice, exercise, and improve sleep status with care, you can ease the discomfort of the procedure.” The goals were organized to guide the patients to confront the problem through communication sentences as mentioned above. (3) Explore the exception (3 days before operation): The patients were guided to carry out the plan; the patients were introduced detailed knowledge about hepatocellular carcinoma; the basic principle, treatment process, treatment effect, and precautions of TACE procedure were explained and they were helped to understand the importance of applying TACE procedure; and nurses had introduced patients to the use of analgesics and the use of analgesics at the right time to maximize the effects of pain. After the use of analgesic drugs, the occurrence of analgesic effects and adverse reaction symptoms were recorded in detail, and the patients were continuously assessed for pain. At the same time, nondrug analgesia was administered. Nursing staff guided patients to breathe deeply at a slow pace, talked to patients more, relieved their bad mood, and transferred the attention of patients. Abdominal massage was performed to relax the muscles and reduced abdominal tension to raise the pain threshold and relieved pain; distracted patients' attention through psychological suggestion, language comfort, and other measures to shift patients' attention and help them be active in fighting hepatocellular carcinoma; helped patients recall the occasional improvement; and asked “How did the pain relief happen? How can the exception continue to happen?” Through the practice mentioned above, we assisted patients to develop positive perceptions. (4) Feedback on goals  The Generic Quality of Life Inventory-74 (GQOL-74) [α coefficient of the scale was 0.796.(1) Clinical data such as age, gender, classification of liver function, pathological stage, pathological type, Karnofsky Performance Status (KPS) score, and educational level were recorded for the two groups. (2) Complications such as nausea and vomiting, fever, bleeding, and renal function impairment were recorded in both groups. (3) Visual analogue scale (VAS)  was applGQOL-74)  was applt-test was applied for comparison. The enumeration data were expressed as (%), and the χ2 test was applied for comparison. P < 0.05 means that the difference has statistical significance.SPSS 22.0 software was applied for processing. The measurement data were expressed as mean ± standard deviation (P > 0.05). For details, see There was no statistically significance of difference between the two groups in the terms of age, gender, classification of liver function, pathological stage, KPS score, pathological type, and educational level (P < 0.05). For details, see The complication rate in the observation group (16.98%) was lower than that in the control group (33.96%), and the difference had statistical significance (P > 0.05). For details, see There was no significant difference in the score of pain perception between the two groups (P < 0.05). For details, see All scores of sleep status in the observation group were lower than those in the control group, and the differences had statistical significance (P < 0.05). For details, see The observation group got higher scores of quality of life than the control group. The differences were statistically significant , the total incidence of complications in the observation group (16.98%) was lower. The results showed that SFA can reduce the complications in patients undergoing TACE for hepatocellular carcinoma. We speculate that the reasons are as follows: in clinical practice, traditional nursing is usually carried out for patients undergoing TACE for hepatocellular carcinoma. Although it has a certain role in nursing, it cannot mobilize the self-ability and willingness of the patients. SFA can unearth the positive power and potential of patients undergoing TACE for hepatocellular carcinoma, develop an active way of thinking, mobilize the enthusiasm for treatment, and relieve the psychological crisis. SFA can enable patients to actively participate in their own management, with the characteristics of subjectivity and enthusiasm so as to achieve the goal of positive nursing and improve the ability to prevent complications .We found that there was no significant difference in the score of pain perception between the two groups, but the score of pain perception in the observation group was lower than that in the control group. After summarizing many years of nursing experience, the physician in our department believes that the possible reasons are as follows: patients undergoing TACE for hepatocellular carcinoma often have varying degrees of pain sensation, which is closely related to the type and dosage of chemotherapy drugs, but nursing measures can only relieve the pain sensation to a certain extent. The SFA program focuses on introducing the knowledge of hepatocellular carcinoma in detail to patients undergoing TACE for hepatocellular carcinoma and providing adequate health education and helping them understand the importance of applying TACE surgery. At the same time, SFA can guide patients to be inspired by the excavation of motive power, causing patients to divert their attention to active anti-cancer. In addition, SFA can use a variety of ways to distract patients' attention so that patients can actively seek effective measures to reduce pain sensation and improve pain tolerance, which has a certain improvement effect. Dargan's team research reported that SFA was a method that aims to achieve patient goals by identifying and using the expertise of patients. By implementing SFA for patients with chronic pain for 8 weeks, it could relieve pain and help patients with chronic pain diseases live a good and meaningful life. Our research conclusion is roughly consistent with this conclusion .Because patients undergoing TACE for hepatocellular carcinoma have a sense of uncertainty about the development of the disease, they are prone to a variety of adverse psychological problems, which further lead to sleep disorders such as difficulty in falling asleep, light sleep, and frequent awakening. In addition, painful stimulation may cause dysfunction of the serotonin system and its receptors, leading to rapid eye movement sleep deprivation, thereby reducing the quality of sleep in patients. The results of this study showed that the sleep of patients in the observation group was improved after the application of SFA. SFA can affect the mental health of people, increase individual enthusiasm, establish confidence in overcoming difficulties, and effectively relieve bad emotions. In addition, SFA can reduce the level of pain sensation, thereby reducing the stimulation to the patient and improving the quality of sleep in patients .SFA can guide patients to actively look for problems, formulate scientifically feasible goals, explore practices where exceptions occur, listen to feedback, summarize and evaluate, and divert patients' attention to solutions to problems. The SFA model provides health education to patients according to their existing problems, stimulates their subjective initiative, and encourages patients to discover their own progress. And it can enhance the confidence in fighting the disease so that makes patients realize their self-worth, fully mobilize the enthusiasm for life, and reduce the idea of avoiding and succumbing so as to eliminating difficulties and problems and improve the standard of living. We found that the observation group had a higher quality of life scores, which suggests that SFA can improve the quality of life of patients undergoing TACE for hepatocellular carcinoma .In conclusion, SFA can effectively reduce the complications, relieve pain, improve sleep quality, and improve the quality of life in patients undergoing TACE for hepatocellular carcinoma and is worthy of clinical application. With the transformation of medical mode and the improvement of people's living standards, patients have more demands for comfort during hospitalization. Through the application of SFA, it proves that as long as medical staff have a high sense of responsibility and focus on the patients and do a good job of nursing from the details, they will be able to meet the health needs of patients.However, it should be noted that the number of selected cases in this study is small and only evaluated the patients' nursing efficiency in a short period of time. Therefore, it is still necessary to carry out a large sample and long-term investigation in future studies, which will also become the focus of our team's future research.


Low back pain is one of the most common health problems and a main cause of disability, which imposes a great burden on patients. Mobile health  affects many aspects of people’s lives, and it has progressed rapidly, showing promise as an effective intervention for patients with low back pain. However, the efficacy of mHealth interventions for patients with low back pain remains unclear; thus, further exploration is necessary.The purpose of this study was to evaluate the efficacy of mHealth interventions in patients with low back pain compared to usual care.This was a systematic review and meta-analysis of randomized controlled trials designed according to the PRISMA  statement standard. We searched for studies published in English before October 2020 in the PubMed, EMBASE, Web of Science, and Cochrane Library databases. Two researchers independently scanned the literature, extracted data, and assessed the methodological quality of the included studies. Bias risks were assessed using the Cochrane Collaboration tool. We used RevMan 5.4 software to perform the meta-analysis.P<.001), and larger efficacy in reducing disability, as measured by the Rolland-Morris Disability Questionnaire . Subgroup analyses showed that compared with usual care, mHealth using telephone calls significantly reduced pain intensity  and disability score . However, without the use of telephone calls, mHealth had no obvious advantage over usual care in improving pain intensity  and the disability score . The group that received a more sensitive feedback intervention showed a significantly reduced disability score .A total of 9 studies with 792 participants met the inclusion criteria. The simultaneous use of mHealth and usual care showed a better reduction in pain intensity than usual care alone, as measured by the numeric rating scale (mean difference [MD] –0.85, 95% CI –1.29 to –0.40; The use of simultaneous mHealth and usual care interventions has better efficacy than usual care alone in reducing pain intensity and disability in patients with low back pain. Moreover, the results of subgroup analysis revealed that mHealth using telephone calls might play a positive role in improving pain intensity and disability in patients with low back pain. Low back pain is one of the most common health problems worldwide, and is a main cause of disability according to the latest Global Burden of Disease Study . In 2015The term mobile health  refers to the use of mobile devices such as mobile phones, patient monitoring equipment, and other wireless devices to provide medical support and health management , which mAt present, few meta-analyses have been performed on the efficacy of mHealth for patients with low back pain, and therefore the ability to provide more effective or accurate clinical advice is limited. In light of the various advantages of mHealth that are different from usual care and the current global status of low back pain, we performed a meta-analysis to clarify the efficacy of mHealth for patients with low back pain.Data were retrieved from the PubMed, Embase, Web of Science, and Cochrane Library databases. We searched for studies in English published until October 2020. The key search strings consisted of two concepts: mHealth and low back pain . The refSearch 1: /expSearch 2: : title/abstract/keywordsSearch 3: Search 1 OR Search 2Search 4: “low back pain”/exp OR “backache”/expSearch 5: : title/abstract/keywordsSearch 6: Search 4 OR Search 5Search 7: Search 3 AND Search 6The following inclusion criteria were used: (1) the study design was a randomized controlled trial (RCT); (2) mHealth  and usual care  were used simultaneously in the experimental group, and usual care or usual care and placebo were used in the control group; (3) participants were confirmed to have low back pain; and (4) the outcomes were measured using the numeric rating scale (NRS) and/or Roland-Morris Disability Questionnaire (RMDQ), with data expressed as mean (SD). Two researchers selected the studies independently in accordance with the above criteria.Studies were excluded from the meta-analysis if: (1) not all of the participants were diagnosed with low back pain; (2) the study population included pregnant women or patients recovering after spinal surgery; or (3) email had been used as an intervention for office workers in the workplace. The latter criterion was based on previous studies -20 indicThe required data were extracted independently by two researchers and crosschecked to avoid potential data extraction errors. Disagreements during the extraction process were resolved by seeking the opinion of a third researcher. The extracted information included the first author’s name, year of publication, sample size, age, sex ratio, and participants’ scores on the NRS and RMDQ. The final postintervention data with the longest follow-up time was used in our analysis if the study ie, -23) repo repo23])Z‐statistics, and statistical significance was considered at P<.05. The χ2 test was used to examine the heterogeneity of the results: if P≥.10 and I2≤50%, a fixed-effects model was used for the meta-analysis; otherwise, a random-effects model was used.We assigned participants who used telephone calls, internet/email, mobile phones, or other mHealth methods and usual care at the same time to the mHealth experimental group, and those who used usual care alone to the control group. RevMan 5.4 software was used for the meta-analysis, with the mean difference (MD), SD, and 95% CI as the statistics of interest. The overall pooled effect estimate was assessed using Given reports of positive effects of telephone calls on patients’ self-management and compliance , we defiThe risk of bias was assessed using the Cochrane Collaboration Tool for Assessing Risk of Bias in Randomised Trials . We evalA total of 17,670 studies were identified during the initial examination. After all studies were screened and filtered using the inclusion and exclusion criteria, 9 studies were included in the final meta-analysis. These studies comprised 792 participants, 407 of whom were allocated to the mHealth group and 385 were allocated to the usual care group, as shown in the flowchart in Features of the included studies and outcome data are summarized in The Cochrane Collaboration Risk of Bias Tool was used to assess the risk of bias of the 9 included studies. Seven studies used computer-generated random numbers ,22,26-30The overall risk of bias was relatively low, but performance bias was relatively high, as 3 of the studies used a single-blinded method ,28,31 F. However2=9%; P<.001)  .2 =31%; P<.001)  .2=48.5%, P=.16). Compared with usual care, mHealth using telephone calls significantly reduced pain intensity in 3 studies ; however, without the use of telephone calls, mHealth had no obvious advantage over usual care   .2=69.3%, P=.04). Compared with the group that received usual care, the experimental mHealth group that involved telephone calls showed a significantly reduced disability score in 4 studies . The group that received a more sensitive feedback intervention showed a significantly reduced disability score in 1 study , and the group that did not receive an intervention with telephone calls showed no significant difference in their RMDQ scores from the two other groups in 3 studies   .A sensitivity analysis was performed using one-by-one elimination of studies that reported the outcomes of the NRS and the RMDQ. No significant change was found in the outcomes, indicating that the results were stable. According to the Cochrane Group, a funnel plot to detect publication bias is not recommended when fewer than 9 studies are included in a meta-analysis . Hence, 2=9%, P<.001) and disability . The subgroup analysis of the scores on the NRS and RMDQ showed that the use of telephone calls or more sensitive feedback devices for the intervention might be superior to other types of mHealth interventions or usual care in terms of improving pain intensity and disability. This conclusion is consistent with a study by Niznik et al [This meta-analysis of 9 studies with 792 patients revealed a significant positive effect of the simultaneous interventions of mHealth and usual care compared with usual care only on patients with low back pain. The mHealth intervention performed significantly better than usual care on measures of pain intensity  are observed at the group level for pain intensity when compared to the control group, which do not meet the minimal clinically important difference criterion of –1.77 . HoweverThe objective of this study was to examine the influence of mHealth interventions on the pain intensity and disability of patients with low back pain. Our investigation highlights differences between the intervention of usual care alone and the simultaneous use of usual care and mHealth. Compared with using usual care alone, the intervention of telephone calls had a significant beneficial effect on patients’ disability. These findings are expected to provide guidance for clinical decisions and contribute to this field.Our study has several limitations. First, this meta-analysis may be biased if the literature search failed to identify all trials reporting on differences between mHealth and usual care or if the selection criteria for including trials were applied in a subjective manner. To reduce these risks, we performed thorough searches across multiple literature databases and clinical trial databases, and used explicit criteria for study selection and data extraction and analysis. Second, mHealth may have specific effects that vary by the type of low back pain. That is, to better evaluate the efficacy, and save human resources and time costs, passive sensing in mHealth may be more suitable for chronic low back pain, whereas active sensing may be more suitable for acute low back pain, which can be administered multiple times a day to capture short-term variations in responses . HoweverThe results of this meta-analysis suggest that the simultaneous interventions of mHealth and usual care, compared with usual care alone, are significantly better for reducing pain intensity and disability in patients with low back pain. The use of telephone calls or more sensitive feedback interventions may further increase the positive effects of these simultaneous interventions on the disability of patients with low back pain. The wider use of mHealth may contribute significantly to the population of patients with low back pain. Therefore, the simultaneous interventions of mHealth and usual care may be a promising method worth considering.


BackgroundPostoperative pain associated with total knee arthroplasties (TKAs) is routinely managed with ultrasound-guided adductor canal blocks (ACBs). Computer-assisted instrument guidance (CAIG) systems can supplement the existing ultrasound machinery and block needles. CAIG systems allow the operator to navigate the needle in real time while displaying a projected trajectory of its path onto the ultrasound monitor. This study explored how ACBs performed with CAIG compare with conventional ultrasound-only ACBs in terms of block efficiency, success, and potential tissue damage for patients undergoing TKA.MethodologyA total of 26 patients undergoing TKA under spinal anesthesia with an ACB were randomized to ACB utilizing conventional real-time ultrasound or to ACB utilizing real-time ultrasound supplemented with CAIG. The primary outcome measure was time to block completion. The secondary outcome measures included number of needle insertions, postoperative pain scores until postoperative day three, postoperative muscle weakness, opioid requirements on postoperative day zero, length of stay, and patient satisfaction with pain management.ResultsThe time required to complete the block as well as the number of needle insertion attempts were similar between the CAIG and conventional ACB groups. Postoperative outcomes such as pain scores up to postoperative day three, postoperative muscle weakness, opioid requirements on postoperative day zero, length of stay, and patient satisfaction with perioperative pain management were comparable between the CAIG and conventional ACB groups.ConclusionsCAIG does not reduce ACB performance times or patient outcomes when performed by experienced anesthesiologists. In 2017, approximately 700,000 total knee arthroplasties (TKAs) were performed in the United States, and this number is predicted to increase to 3.5 million annually by the year 2030 . AdditioComputer-assisted instrument guidance (CAIG) has been demonstrated to facilitate faster breast biopsy , and hasThe Clear Guide ONE  is a CAIG system that allows the operator to view the needle in three dimensions outside of the patient’s skin without having any part of the device come in contact with the patient’s body. This system uses proprietary algorithms to display a projected path and trajectory of the needle onto the ultrasound monitor . ExistinWe studied the use of CAIG in the context of ACBs for TKA. Our primary hypothesis was that the addition of CAIG would reduce the overall time to complete ACB versus performing the ACB with conventional ultrasound-only technique. Secondary hypotheses included that decreased needle repositions and decreased needle punctures would lead to less tissue damage in CAIG ACBs compared to those without CAIG, as evidenced by lower postoperative pain scores, lower opioid requirements, and greater patient satisfaction.Participantsclinicaltrials.gov (NCT02614222).We conducted a pilot randomized clinical trial to compare block performance times and postoperative pain with ACB using CAIG versus ACB performed without CAIG. This study was conducted at Cooper University Hospital in Camden, New Jersey between October 2015 and May 2016. Inclusion criteria included: 18 years of age or older, undergoing TKA under spinal anesthesia with a planned ACB for postoperative pain management, and ability to provide informed consent. Potential subjects were screened for enrollment through the institution’s operating room schedule and were informed of the possibility to participate by telephone one to three days prior to surgery. All subjects provided written informed consent after all study procedures were described in detail by an investigator. The Cooper University Hospital Institutional Review Board approved this study (IRB nr.: 15-095), and this study was registered on Randomization and blinding proceduresUsing a computer-generated random list, patients were assigned to either the control group, which received the ACB without CAIG, or the investigational group, which received ACB with the supplemental CAIG system. Patients receiving the ACB and research staff who obtained postoperative information from patients were blinded to the assigned study arm, while clinicians performing the block could not be blinded.Clear Guide ONEThe Clear Guide ONE is a United States Food & Drug Administration-approved  system fAdductor canal blockThe ACB was performed around the mid-thigh level after ultrasound identification of the femoral artery in the adductor canal. A 20-gauge, 100-mm echogenic needle  was inserted in-plane in a lateral-to-medial orientation and advanced toward the femoral artery. Once the needle tip was visualized into the adductor canal and after careful aspiration, 1-2 mL of 0.25% bupivacaine was injected to confirm the proper injection site. When injection of local anesthetic did not appear to result in its correct spread circumferentially around the target nerve, additional needle repositions and reinjections were used until local anesthetic spread was optimized. After confirmation of correct positioning, the remaining volume of 0.25% bupivacaine was injected .Three attending regional anesthesiologists performed all the adductor canal regional blocks in this study. Each anesthesiologist had a minimum of seven years post-residency experience and had performed more than 100 ACBs annually.Anesthesia and postoperative careAll patients received spinal anesthesia using 2 mL of 0.75% bupivacaine with dextrose. Rescue opioid medication was administered when patients reported pain greater than 4 on a 0-10 numerical visual analog scale (VAS).OutcomesThe primary outcome of this study was the time to ACB completion which was defined as the time from first ultrasound probe application on the operative limb to successful injection of all local anesthetics into the adductor canal, which was visually confirmed on ultrasound. Secondary outcomes included the number of needle insertions, opioid requirement on postoperative day zero, numerical VAS pain scores up to postoperative day three, a 0-10 patient satisfaction score with perioperative pain management, length of stay, and potential side effects of ACB, including but not limited to muscle weakness.Data and statistical analysisTotal opioid medications administered throughout the hospitalization were converted to oral morphine equivalents using an opioid analgesic equivalent calculator  based onA total of 26 patients were enrolled, randomized, and completed the study. The study flowchart  is presePatient characteristics are displayed in Table Primary outcomeTime to block completion was not statistically different between the CAIG  and conventional ACB  groups  Figure .The number of needle insertion attempts was similar between the groups Table .Secondary outcomesPain scores up to three days after surgery were not statistically different between the study arms (Block Type P = 0.83, Block Type × Time P = 0.39; Figure Principal findingsThis pilot study explored the effect of using Clear Guide ONE, a CAIG system, on block performance and postoperative pain management in patients receiving ACBs. We predicted that compared to blocks performed without Clear Guide ONE those performed with CAIG would provide a 20% improvement in block efficiency and reduce postoperative pain scores, opioid consumption, and enhance patient satisfaction. We found that block performance characteristics were similar between the CAIG and conventional groups. Secondary outcomes of postoperative pain scores, opioid consumption, and patient satisfaction were similar between groups as well.Previous studies on computer-assisted instrument guidanceWilson et al.  studied Hauglum et al.  reportedPractical implications and future directionsThe findings of the present pilot study do not support the use of CAIG for increasing the efficiency of ACB performance. Although the duration of block performance was similar between the CAIG and conventional ACB groups, it was striking that the conventional group had achieved block performance in a median time of 120 seconds. Moreover, all blocks were achieved in one attempt. These characteristics suggest that CAIG is of limited value in the context of improving performance when an ACB is performed by an experienced regional anesthesiologist in the clinical setting. It is possible that CAIG may have further value in more challenging blocks, or in blocks where needle and target visualization are problematic. Additionally, it is possible that this technology has added value in the context of learning regional anesthesia procedures in either the clinical or stimulated environment. Further studies involving the use of CAIG for training and education purposes in the realm of peripheral nerve blocks might provide additional information on the value of this technology in enhancing performance skills of newer regional anesthesia practitioners, potentially favorably influencing block efficacy and patient outcomes.LimitationsThis pilot study was limited in size and thus underpowered to detect small differences between the CAIG and conventional groups.CAIG does not reduce ACB performance times or patient outcomes when ACBs are performed by experienced anesthesiologists. Further studies involving the use of CAIG for training and education purposes in the realm of peripheral nerve blocks might provide additional information on the value of this technology in enhancing performance skills of more novice regional anesthesiologists.


To our knowledge, there have been no published clinical trials to assess the synergistic effects of applying pulsed radiofrequency (PRF) stimulation of the suprascapular nerve (SSN) plus physical therapy on pain and function in patients with adhesive capsulitis. Therefore, we will conduct this present randomized, double-blind study to evaluate the synergistic effects of applying PRF stimulation of the SSN plus physical therapy on pain and function in patients with adhesive capsulitis.The study protocol is a randomized, controlled, double-blind design. Recruitment will be started in March 2021 and completed in October 2022. The treating surgeon will assess 90 patients for eligibility. The study protocol was approved through Institutional Review Board in the People's Hospital of Beilun district of Ningbo. Each patient will be randomized into 3 treatment groups, receiving PRF stimulation of the SSN or physical therapy or both of them. After baseline examination, all patients will be given a full explanation of the treatment protocol and will be required to sign a written informed consent for study participation and for publication of the results. All the data collectors, surgeons, statistical analysts, as well as result assessors are not aware of grouping assignment. The outcomes include Constant score, visual analog scale score, range of motion, and strength.This protocol will provide a reliable theoretical basis for the following research.It is assumed that there will be a remarkable difference in postoperative outcomes between the intervention and control groups.10.17605/OSF.IO/PZ9ES. Common nonoperative regimens for adhesive capsulitis include supervised neglect with analgesia, supervised physical therapy, an intra-articular corticosteroid injection, a suprascapular nerve (SSN) block, manual brisement, and saline dilatation. No therapeutic intervention is currently universally accepted as most effective for restoring range of motion and decreasing pain in patients with this disease.,4Adhesive capsulitis, or “frozen shoulder,” is a painful condition commonly encountered in outpatient orthopedic clinics. It has a prevalence of 2% to 5% among outpatients but of about 20% to 30% in patients with diabetes mellitus. PRF is designed to create bursts of heat through the delivery of an electrical field. The short bursts allow for the alleviation of pain in neural tissue, while allowing the tissue to maintain a temperature below 42°C, preventing the nerve damage associated with conventional radiofrequency. Many studies have confirmed the effectiveness of PRF for multiple pain conditions. Recent studies have successfully applied ultrasound-guided PRF stimulation to the medial nerve , interscalene brachial plexus (neoplastic plexopathic pain), intercostal nerve, trigeminal nerve , and sciatic nerve (chronic knee pain).–10 The ultrasound-guided technique offers improved quality of regional nerve blocks and limits neural trauma. Moreover, ultrasound is radiation-free, more affordable, and more expedient than the computerized tomography and fluoroscopy that are conventionally performed for PRF guidance.Recent research reported that pulsed radiofrequency (PRF) lesioning of the SSN was effective in treating chronic shoulder pain, including adhesive capsulitis, and it facilitated functional recovery without risking paralysis of the supra- or infraspinatus muscles.,12Physical therapy agents including superficial and deep heat with analgesic currents are commonly used to decrease pain and spasm owing to adhesive capsulitis. Rehabilitation methods, including stretching, range of motion, strengthening exercises, and mobilization maneuvers are used to improve joint mobility and restore function. However, these interventions are usually painful and prevent the individual from fully participating in the rehabilitation program. Therefore, PRF lesioning of the SSN may be preferred for adhesive capsulitis before applying physical therapy.To our knowledge, there have been no published clinical trial to assess the synergistic effects of applying PRF stimulation of the SSN plus physical therapy on pain and function in patients with adhesive capsulitis. Therefore, we will conduct this present randomized, double-blind study to evaluate the synergistic effects of applying PRF stimulation of the SSN plus physical therapy on pain and function in patients with adhesive capsulitis. It is assumed that there will be a remarkable difference in postoperative outcomes between the intervention and control groups.22.1The study protocol is a randomized, controlled, double-blind design. The study protocol was approved through Institutional Review Board in the People's Hospital of Beilun district of Ningbo (HN20201208) and was registered in the OSF Registries (with number: 10.17605/OSF.IO/PZ9ES).2.2The study included patients with idiopathic adhesive capsulitis of the shoulder between the ages of 18 and 80 years who had primary adhesive capsulitis of the shoulder. Our diagnosis of adhesive capsulitis of the shoulder was based on a consensus definition, characterized by functional restriction of both active and passive shoulder motion for which radiographs of the glenohumeral joint are essentially unremarkable. All patients underwent a thorough history, physical examination, and radiographic imaging studies, including standard plain radiographs and ultrasound imaging scan by the treating orthopedic surgeon with 10-year of shoulder US experience.The exclusion criteria for the study were patients with diagnosed rotator cuff tear, calcific tendinitis, or impingement syndrome by ultrasound imaging, patients with symptomatic cervical radiculopathy, patients with previous fracture or surgery around shoulder, acute or chronic infection around shoulder, a pregnancy, patients with a recent history of injection around the shoulder (within 6 weeks), and other secondary conditions possibly related to shoulder dysfunction (rheumatologic disease or hemiplegia).2.3www.randomizer.org). Sequentially numbered opaque sealed envelopes containing treatment allocations will be prepared and opened in sequence by an independent research assistant who is not involved in treatment. All the data collectors, surgeons, statistical analysts, as well as result assessors are not aware of grouping assignment  is used for the whole procedure. The suprascapular notch is identified under C-arm fluoroscopy at an angle slightly oblique to the treated side and angled cephalo-caudal. After sterile preparation and administration of local anesthesia, a 22-gauge 10 mm active tip RF needle 10 cm in length is inserted and advanced toward the suprascapular notch. Proper localization of nerve is achieved by sensory and motor stimulation. Sensory stimulation is performed  and the patient reports paresthesia in the shoulder joint. Upon motor stimulation , muscle contractions in the suprascapular and infrascapular muscles are observed. Two PRF cycles of 180 s are performed after localization. The RF current is delivered at a width of 20 ms and at 45 V. The tip temperature works at 38°C initially, and then the temperature increases slowly to 42°C within 30 s. The patients are observed for 30 min after the PRF lesioning procedure. If no significant complications  are observed, the patient will be discharged.2.5Initially, hot pack application and transcutaneous electronic nerve stimulation are performed for groups. Then, for 12 weeks, stretching exercises, mobilization, and therapeutic exercises  are performed under the guidance of a therapist who is blinded to patient allocation.2.6All patients will be assessed for pain and functional status before and immediately after the treatment by a researcher blinded to the patient groups. The range of shoulder mobility and functional status will be assessed using the Constant Shoulder Scale, which was developed to evaluate functional recovery of the shoulder. The total Constant score ranges from 0 to 100 points, with higher scores indicative of better function. The score is divided into four sections: pain (15 points), activities of daily living 20 points), range of motion (40 points), and strength (25 points). Pain is scored using a visual analog scale. The activities of daily living score are divided into 4 subscales of sleep, work, recreational activities, and ability to position the hand in space. Range of motion is assessed in 4 active positions, with 10 points for each. Flexion and abduction are assessed by a goniometer, whereas functional internal and external rotation is assessed by the position of the hand. Strength is tested by a calibrated spring dynamometer, at 90° abduction of the shoulder with the forearm pronated and scored as the maximum of 3 repetitions (Tables 0 points,2.7P < .05. A power analysis is conducted to estimate the requisite sample size. From preliminary research in our hospital, a clinically significant difference reduction in the pain score was defined as 3 cm; a standard deviation of 3.49, probability of a Type I error of 0.05, and power of 0.8 resulted in an estimated sample size of 25. Consequently, a total of 90 subjects will be recruited.All analyses will be performed using SPSS for Windows, version 16, and GraphPad InStat. Analysis of variance is used for comparing mean values of patient's age, weight, height, and body mass index. For nonparametric measures such as pain score and functional scores, differences between baseline and posttreatment scores for each group are computed by the Wilcoxon signed ranks test. The difference between each treatment group is performed by the Kruskal--Wallis test. The level of statistical significance is set as 3In the early stages of adhesive capsulitis, the aim of management is to alleviate pain so that rehabilitation can be used to restore normal shoulder range of motion and activity. Previous studies indicated that some patients could not finish rehabilitation because of the presence of intractable pain, leading to subsequent studies for investigating the effect of pain relief before rehabilitation. One of the most frequently used methods is intraarticular injection with a steroid. However, one review concluded that an intraarticular steroid injection before rehabilitation provided only a short-term benefit. Our study is the first to investigate the effect of PRF lesioning of the SSN plus physical therapy. The rapid onset of pain relief after PRF lesioning of the SSN apparently makes it easier for patients to tolerate rehabilitation therapy. However, more research is needed before we can recommend widespread adoption of this method as a treatment for adhesive capsulitis.To our knowledge, there have been no published clinical trial to assess the synergistic effects of applying PRF stimulation of the SSN plus physical therapy on pain and function in patients with adhesive capsulitis. Therefore, we will conduct this present randomized, double-blind study to evaluate the synergistic effects of applying PRF stimulation of the SSN plus physical therapy on pain and function in patients with adhesive capsulitis. It is assumed that there will be a remarkable difference in postoperative outcomes between the intervention and control groups.Weifeng Liao and Xinning He conceived, designed, and planed the study. Weifeng Liao and Xinning He are recruiting the study participants and performing the interventions. Zhiyong Du supervised the study. Zhiyong Du will interpret and analyze the data. Weifeng Liao drafted the manuscript. Yi Long critically revised the manuscript for important intellectual content. All authors have full access to the manuscript and take responsibility for the study design. All authors have approved the manuscript and agree with submission.Conceptualization: Xinning He.Data curation: Weifeng Liao.Formal analysis: Weifeng Liao, Xinning He.Funding acquisition: Yi Long.Investigation: Weifeng Liao, Xinning He, Zhiyong Du.Methodology: Weifeng Liao, Zhiyong Du.Project administration: Zhiyong Du, Yi Long.Resources: Yi Long.Software: Xinning He.Supervision: Yi Long.Validation: Xinning He.Writing – original draft: Weifeng Liao.Writing – review & editing: Zhiyong Du, Yi Long.


Cervical radiculopathy caused by disc herniation is a frequent public health issue with economical and socio-professional impacts. The objective of the present study is to evaluate the patient-reported outcomes and satisfaction from cervical epidural steroid injection during a 2-year follow-up.  Results based on patients’ reports from a previously performed intervention of cervical epidural steroid injection on patients with cervical radiculopathy due to cervical disc herniation are prospectively collected. Outcome measures are Neck Disability Index (NDI), numerical rating scale (NRS) for pain assessment, and 5-scale patient satisfaction questionnaire (PSQ) plus opioid medication for pain relief, additional injections, and progression to surgery.  Of total 37 cases, 34 were available for follow-up after 2-year postoperatively. The mean preoperative NDI was 21.17 and improved to 17.38, and the mean NRS was 7.7 and improved to 5.00; both were statistically significant. Mean patient satisfaction after 2 years was 3.17 out of 5. 11 cases needed additional injections, and 4 of patients proceeded to surgery.  We showed that transforaminal cervical epidural steroid injection for cervical radiculopathy is an effective non-surgical treatment option, providing significant pain relief and functional improvement during 2-years follow-up along with higher-than-average patient satisfaction in most of our patients. Cervical radiculopathy caused by disc herniation is a frequent public health issue with economic and socio-professional impacts. A combination of multiple pathological processes including disc degeneration, disc material herniation along with the formation of osteophytes may cause neck pain and radiculopathy by mechanical compression or irritation of the nerve root in the foraminal canal and the vertebral artery passing through the intervertebral and transverse foramina , 2. CompThe present prospective study was designed and conducted in an interventional pain management referral center , during 2018 to evaluate results based on patients’ reports from a previously performed intervention of cervical epidural steroid injection on patients with cervical radiculopathy due to cervical disc herniation. The study protocol was approved by the local ethics committee of the university (ID: IRSBMURETCH1397833), and the study was performed in accordance with the ethical standards of the 1964 Declaration of Helsinki. The study population was all patients who had undergone cervical epidural steroid injection in our medical institution during 2016.Inclusion criteria were age>18 years, history of neck pain and radiculopathy for more than six months due to cervical intervertebral disc herniation which was confirmed by diagnostic medical imaging, and no response to conservative treatments such as physical therapy, reduction in activities and anti-inflammatory medications in last six months. Exclusion criteria were the history of previous spinal surgery, cervical myelopathy, cervical ossification of the posterior longitudinal ligament, kyphotic deformity or diminished vertebral canal diameter, history of psychological illness, alcohol or drug abuse and inability to communicate in the Persian language. Sampling was done using census method, and all the participants of the previous study who met the criteria were included in the present study. Baseline and demographic characteristics for participants were recorded in each patient’s profile, and each participant was called by an independent researcher. If any patient was unavailable after three calls in different times of a day and different days of a week, the patient was excluded from the study. During the phone call interview, Study aim and objective were described to each patient and participants were instructed to respond to the questions or rate each scale independently. Outcome measures were classified as pain intensity and neck disability index, assessed at baseline and 24 months following the treatment. Patients’ satisfaction from the intervention and current opioid intake were also evaluated. Additional cervical spine injection and progression to surgery during the past two years were secondary outcome measures.The pain intensity was evaluated based on the verbal numerical rating scale (NRS). NRS is one of the most commonly used self-report scales for measuring pain, likely due to its ease of use  and because its 0 to 10 metric is preferred by health care professionals. Patients typically were asked, “How strong is your pain during the past 14 days, where 0 is no pain, and 10 is the strongest or worst pain you can imagine?”. The validity and reliability of this scale have been previously established [Functional ability was evaluated based on the Neck Disability Index (NDI). The NDI is a 10-item self-administered disease-specific questionnaire evaluating the effect of neck pain on a patient’s daily life and the corresponding disability. The questionnaire ranges from 0 to 50; the higher the score, the greater the disability. The validity and reliability of this scale have been previously established .Patient satisfaction was registered at 2-year follow-up and categorized as excellent to poor based on patients’ satisfaction questionnaire (PSQ) among five choices . The validity and reliability of this scale have been previously established . PatientData were analyzed using SPSS . Continuous variables are presented as mean ± SD and median (range) according to the normal or not-normal distribution of data. Ordinal data are presented as count (%). Paired t-tests were used to compare the variables at baseline and 2-year follow-up between patients. P-value<0.05 was considered to be statistically significant.During the past recruitment period, a total of 37 subjects with cervical radiculopathy had undergone cervical epidural steroid injection in our tertiary medical center. After two years of follow-up post-procedure, 34 (91.8%) of the 37 subjects were available. Baseline and demographic characteristics of the participants were analyzed. Mean age of participants was 52.32 years, ranged between 28-75 years. Twelve subjects were male (32.4 %), and 20 cases (54.1%) reporting no comorbidity. Of 17 cases who had reported comorbidity, 2 cases were known cases of hypertension (HTN), 4 were known cases of diabetes mellitus (DM), 2 were known case of ischemic heart disease (IHD) and 5 cases were previously diagnosed with hypothyroidism; while 1 patient reported was diagnosed with DM and HTN, 1 reported was diagnosed with IHD and HTN, 1 reported was diagnosed with IHD and DM, and 1 patient was diagnosed with DM, HTN, and IHD at the same time. C5-6, C6-7 was the most common level of herniation. Baseline data are demonstrated in et al. found favorable results in 2 weeks and moderate results in 8 weeks in patients with axial pain due to cervical disc herniation [et al. aimed at showing the positive short-term effects of an inpatient multimodal pain management concept with the focus on cervical translaminar epidural steroid injection for patients with cervical radiculopathy. Fifty-four patients who had undergone inpatient multimodal pain management for ten days were evaluated before and after 10-days treatment. Neck pain was reduced by 57.4% and arm pain by 62.5%. 2 days after the epidural steroid injection, the pain was reduced by 40.1% in the neck and by 43.4% in the arms. Authors concluded that this modality seems to be an effective short-term approach to treating cervical radiculopathy [et al. evaluated 68 consecutive subjects suffering from cervical radiculopathy. Subjects received a fluoroscopically guided transforaminal cervical epidural steroid injection. Sixty-two percent of the cases had relief with transforaminal cervical epidural steroid injection. At the mean follow-up of 39 months (range 4–112), 76% had complete relief of arm pain, and 24% had a mean pain score of 2. Prior to treatment, 75% had a weakness. At follow-up 73% no longer experienced weakness. Eighty-four percent did not feel their symptoms interfered with their capacity to work [et al. on 128 patients, the patient satisfaction at 12 months after the procedure was reported excellent in 57 patients (44.5%), good in 65 patients (50.8%), and poor in one patient (0.8%) [et al., pain medication was significantly reduced after single-shot epidural steroid injection for radicular pain [et al. regarding the conservative management of patients with cervical radiculopathy after epidural steroid injection showed a good or excellent response to cervical epidural steroid injection [et al., outcomes of transforaminal epidural steroid injection were measured. The investigators reported pain reduction, and elimination in analgesic use in 60% of patients at 12–45 months’ follow-up [et al., researchers show that opioid use did not decrease in the six months after epidural steroid injections [In our study, the patient-reported outcomes after 2-year follow-up showed statistically significant improvement in NRS and NDI postoperatively with an average patient satisfaction rating PSQ: 3.17/5). Cervical epidural steroid injection has demonstrated clinical success with high patient satisfaction in earlier studies , 17-20 b/5. Cervirniation . In a rarniation . Anotherulopathy . In a pr to work . In the  to work . In term range 4–2, 76% hat (0.8%) , 30, howlar pain . Initialnjection -34. In aollow-up . To evalollow-up . Anotherollow-up . Howeverjections . In our We demonstrate that cervical epidural steroid injection for cervical radiculopathy is an effective non-surgical treatment option, providing significant pain relief and functional improvement during 2-years follow-up along with higher-than-average patient satisfaction in most of our patients, to the extent that nearly 1/3 of patients needed additional injections and only 1/10 of the patients finally proceeded to surgery.We would like to thank Miss. Atefe Alaee for performing a comprehensive language edition that greatly improved the present manuscript.No commercial party having a direct financial interest in the results of the research supporting this article has or will confer a benefit on the authors or on any organization with which the authors are associated.


Diabetic neuropathy is one of the most common causes of neuropathic pain. LANSS, sLANSS, DN4 and painDETECT are scales which are commonly used worldwide. There are not many studies comparing these screening tools in specific neuropathic pain subgroups.The aim of this study is to compare the utilities of LANSS, sLANSS, DN4 and PainDETECT for the diagnosis of diabetic neuropathic pain.One hundred-one individuals without diabetic neuropathic pain were included in control group, 102 patients with diabetic neuropathic pain to DNP group. LANSS, sLANSS, DN4 and painDETECT scores of the groups were compared.The difference between the groups was significant for all questionnaires and for all questions/titles they included. DN4 had the highest sensitivity and painDETECT had the highest specificity.All questionnaires seemed to be useful for detecting diabetic neuropathic pain. DN4 had a high specificity and sensitivity. PainDETECT, also had a high sensitivity and specificity when cut off value was accepted more than 12. Neuropathic pain could be seen in up to 7–8% of the population  and one Many screening tools were developed for the diagnosis of neuropathic pain but none of them have 100% diagnostic accuracy, so currently the gold standard for the diagnosis of neuropathic pain is still accepted to be the clinicians’ opinion .Each screening tool has its own advantages and disadvantages. To use each scale is not possible in clinical practice or when grouping patients for clinical researches. The Leeds Assessment of Neuropathic Symptoms and Signs (LANSS), self Leeds Assessment of Neuropathic Symptoms and Signs (sLANSS), Douleur Neuropathique 4 (DN4) and painDETECT questionnaires are some of these scales which are commonly used worldwide and which have Turkish validation and reliability studies.LANSS was developed in 2001 by Bennett  and TurkBouhassira developed DN4 in 2006, which had 10 items questioned under 4 titles including examination of allodynia and hyperalgesia . TurkishIn 2006 Freynhagen developed painDETECT scale  which inThe sensitivity and spesificity of these screening tools were reported to be 85% and 80% for LANSS, 74%—76% for sLANSS, 83%-90% for DN4 and 80%-85% for painDETECT in their original versions .These screening tools were developed by studies using large study groups of neuropathic pain including many subgroups. There are not many studies designed for the utility of each screening tool in a specific neuropathic pain subgroup or comparing these screening tools in specific neuropathic pain subgroups. DN4 has a validation study for diabetic neuropathic pain but was not compared with other scales in that study .The aim of this study is to compare the utilities of LANSS, sLANSS, DN4 and painDETECT for the diagnosis of diabetic neuropathic pain which is a common cause of neuropathic pain in clinical practice.The study was approved by the Clinical Research Ethics Committee of Pamukkale University . Informed consent was required from all participants included to the study.102 patients who had submitted to outpatient clinic for neuropathic pain and were diagnosed as diabetic neuropathic pain by two different clinicians were included to the diabetic neuropathic pain (DNP) group. 101 patients who had submitted to Physical Rehabilitation outpatient clinic and whose pain was defined as non neuropathic pain by two clinicians were included to the control group.All individuals were between 18–75 years old. The patients who were taking medicine that should be used for the treatment of neuropathic pain were excluded.LANSS, sLANSS, DN4 and painDETECT questionnaires which had Turkish validity and reliability studies were applied to all individuals. Both groups scores were compared in order to demonstrate the utilities of these scales in the diagnosis and differential diagnosis of diabetic neuropathic pain. All 4 questionnaires were done by patients and clinician together, in same day and at one session. Physicians have done the questionnaires randomly.The cut off values were accepted as the ones suggested in their original studies. For LANSS and sLANSS the scores ≥ 12 and for DN4 scores ≥ 4 were accepted as positive for the diagnosis of neuropathic pain. For painDETECT; scores ≤ 12 as negative, scores between 13 to 18 as unclear, and scores ≥ 19 as positive for the diagnosis of neuropathic pain.P value above 0.05 was considered statistically significant.Statistical Package for Social Science ) was used for data analysis. Continuous variables were denoted as mean ± standard deviation and categorical variables as numbers and percentages. Sensitivity, Specificity, Positive Predicted Value, Negative Predicted Value and ROC curves were used to examine method performances. p > 0.05).Two hundred-three patients were included in the study. There were 102 patients, including 48 males and 53 females in the control group, and 44 males and 58 females in the diabetic neuropathic pain (DNP) group. There were not significant differences between the groups’ mean age and gender ratios (p = 0.00). Considering the cutoff values referred in its original version; scores between 0–12 were defined as negative, 13–18 were defined as unclear, and scores above 18 as positive for neuropathic pain. All 101 patients in the control group had scores smaller than 13(negative). Of the 102 patients in DNP group; 3 patients had negative, 47 patients had unclear and 52 patients had positive scores . As referred in their original versions for LANSS and sLANSS, scores lower than 12 were defined as negative and upper than 12 as positive for neuropathic pain. Ninety eight of 101 patients in the control group had negative and 3 had positive scores. Nineteen patients in DNP group had negative and 83 had positive values . Ninety seven of 101 patients in the control group had negative and 4 had positive scores. Twenty one patients in DNP group had negative and 81 had positive values . As referred in its original version scores lower than 4 were defined negative and 4 or more as positive. All patients in the control group and only 1 in DNP group had negative values .Every question of these 4 screening tools were compared one by one between all individuals of the groups. The difference was significant between groups for every question .r value between 0.3–0.7). This correlation was more significant between LANSS and sLANSS  analysis. ROC Curves were made for each questionnaires Figs. , 3 and 4The cut-off values were defined by Youden analysis. As a result of the ROC analysis, Area Under the Curve (AUC), sensitivity and specificity values were interpreted for the diagnostic performance of the scales. With optimal cut-off points obtained from Youden Index; sensitivity, specificity, positive and negative predictive values were determined and performance results were examined. The optimal cut-off value for painDETECT was12.5 points with 97% sensitivity and 100% specificity. It was 9.5 points with 93% sensitivity and 94% specificity for LANSS and 7.5 points with 98% sensitivity, 88% specificity for sLANSS. For DN4 scale detected optimal cut-off value was 3.5 points with 99% sensitivity and 97% specificity. According to these cut-off values the diagnostic power of the questionnaires were evaluated as PD = DN4 > sLANSS > LANSS  and Neuropathic Pain Questionnaire (NPQ) for detecting neuropathic pain reported that DN4 and NPQ should be the most useful ones for clinical purpose; but also mentioned, that they may not get ahead of clinicians’ opinion .Another study comparing DN4, painDETECT, NPQ and LANSS in chronic pain suggested that DN4 might be the more sensitive and LANSS might be the less .A comparison of DN4, painDETECT, NPQ and LANSS in spinal cord injury reported a diagnostic accuracy of 88% for DN4, 78% for PainDETECT, 65% for NPQ and 55% for LANSS .A study for validation of DN4 in painful diabetic neuropathy reported that the sensitivity was 80% and the specificity was 92% for the cutoff value 4 .Another study designed to evaluate the validity and reliability of LANSS in Libya, included diabetic patients to the study and demonstrated that it was useful .A study comparing LANSS and DN4 in diabetic neuropathic pain in China reported that the sensitivity was 82.7% for DN4 and 58% for LANSS. The specificity was 97% for both .In this study we aimed to compare the utilities of 4 screening tools; LANSS, sLANSS, DN4 and painDETECT for detecting diabetic neuropathic pain, which to our knowledge was not present in the literature. We thought it would give additional information about their usage in clinical practice.Our results suggested that DN4 had high specificity and sensitivity for screening diabetic neuropathic pain which supported the data reported in previous studies , 19.Similar to previous studies, our data also suggested that LANSS and sLANSS should also be used for screening diabetic neuropathic pain but seems to have a lower sensitivity and specificity , 17, 19.Among these screening tools, there seems to be various results for painDETECT in the literature which might be caused by the different cutoff values this scale includes. In our study if the cutoff value was accepted as 19 points, the sensitivity decreased. If the cutoff value was accepted as 13 the sensitivity was high as DN4 (97%). The specificity was 100% for each cutoff values. The observation that there were no patients with more than 12 points in the control group suggested that cutoff value of 13 should be useful when using painDETECT for screening diabetic neuropathic pain. Additional clinician observation should be needed for the individuals who had 13 to 18 points.Another fact about these screening tools for detecting neuropathic pain is that DN4 and LANSS include physical examination while painDETECT and sLANSS do not.In the light of foregoing, we would like to state once again that the gold standard of the diagnosis diabetic neuropathic pain is the clinician's opinion. However, DN4 seems to be one step ahead of the other scales evaluated in this study in terms of not requiring two separate cut-off values and being easy and practical to use in daily clinical routine. The percentages calculated in our study should not be considered as alternative values for the ones demonstrated in large population studies designed to detect neuropathic pain. Also to talk about their specificities and sensitivities in subgroups like diabetic neuropathic pain, there should be more studies including larger patient populations.All screening tools seemed to be useful for detecting diabetic neuropathic pain and correlated each other. DN4 and painDETECT  seemed to have higher sensitivity and specificity.