Persistent pain around the greater trochanter is a common complication after total hip arthroplasty. Restoration of biomechanics such as leg length, femoral und acetabular offset is crucial in THA. The purpose of this study was to evaluate postoperative differences of these parameters after THA and to analyze their association to greater trochanteric pain syndrome. Furthermore, we aimed to evaluate the clinical relevance of trochanteric pain syndrome compared to patient reported outcome measures. 3D-CT scans of 90 patients were analyzed after minimalinvasive total hip arthroplasty and leg length, femoral and acetabular offset differences were measured. Clinical evaluation was performed three years after THA regarding the presence of trochanteric pain syndrome and using outcome measures. Furthermore, the patients’ expectation were evaluated. Patients with trochanteric pain syndrome showed a higher absolute discrepancy of combined leg length, femoral and acetabular offset restoration compared to the non-operated contralateral side with 11.8 ± 6.0 mm than patients without symptoms in the trochanteric region with 7.8 ± 5.3 mm (p = 0.01). Patients with an absolute deviation of the combined parameters of more than 5 mm complained more frequently about trochanteric symptoms  than patients with a biomechanical restoration within 5 mm compared to the non-affected contralateral side . Clinical outcome measured three years after THA was significantly lower in patients with trochanteric symptoms than without trochanteric pain (p < 0.03). Similarly, fulfillment of patient expectations as measured by THR-Survey was lower in the patients with trochanteric pain (p < 0.005). An exact combined restoration of leg length, acetabular and femoral offset reduces significantly postoperative trochanteric pain syndrome and improves the clinical outcome of the patients. Persistent pain located around the greater trochanter is a common complication after THA impairing mobility and quality of life. In literature this is described as trochanteric pain syndrome and defined as disabling pain localized over the lateral aspect of the hip3. The prevalence of trochanteric pain syndrome is highly variable in literature. Tan et al. report a prevalence of of over 50% in patients presenting in the spine clinic. Barrett et al. mention a series prevalence of 27.5%. In addition MRI analysis show peritrochanteric lesion in over 30%6. Following total hip arthroplasty (THA) 4–17% of patients report these symptoms according to previous studies11. The reasons of trochanteric pain syndrome as reported in previous studies are manifold and include tendinopathy or microtrauma of the gluteus medius and minimus tendons, often without signs of inflammation13. In literature a female preponderance for Greater trochanteric pain syndrome in patients without THA has been described12.Primary total hip arthroplasty (THA) is one of the most frequently performed orthopaedic operations worldwide, with an increasing number of patients due to an increasing expectation of life14. Another study showed, that a reduced global femoral offset less than 5 mm, leads to an aggravation in the functional outcome, especially of the abductor muscle strength15. This is in accordance with the findings of Spalding et al., who found a reduced motion and strength in the abductor muscle after reduced femoral offset reconstruction in THA16. However, the correct radiographic evaluation of leg length and offset is challenging since plain radiographs harbor the risk of misinterpretation of these parameters due to the variable position of the pelvis in relation to the plane of the film. Especially assessment of femoral offset on plain radiographs seems to be defective and can be underestimated up to 40%17. In contrast three-dimensional computed tomography (3D-CT) enables exact evaluation of leg length and offset with inaccuracies below 1 mm18. To the best of the authors’ knowledge no study has analyzed the association of combined leg length and offset restoration and trochanteric pain syndrome after THA so far.Beside correct component positioning restoration of biomechanics such as leg length, femoral und acetabular offset is crucial in THA. A recent study showed that even leg length and offset differences over 5 mm are associated with altered gait kinematics as measured in gait analysis after THA and thus emphasize the importance of successful biomechanical restorationThe purpose of this study was to evaluate postoperative leg length, femoral and acetabular offset differences after THA using 3D-CT and to analyze their association to greater trochanteric pain syndrome. Furthermore, we aimed to evaluate the clinical relevance of trochanteric pain syndrome compared to patient reported outcome measures (PROMs).19. The primary outcome of this larger study was to assess whether the ROM of the prosthetic joint could be improved by computer-assisted functional optimization of position and containment of the acetabular component. A cohort of 783 patients with hip osteoarthritis was screened. The inclusion criteria of the initial study were: age between 50 and 75 years, an American Society of Anesthesiologists (ASA) score of ≤3, unilateral osteoarthritis of the hip , no prior hip surgery, and no hip dysplasia or trauma. In total, 597 patients did not meet the inclusion criteria. Altogether a consecutive series of 135 patients were enrolled in this single center study.This study is a secondary outcome analysis of a registered, prospective controlled trial The current study is a prospective analysis independent from the primary study. The primary study dealt with ROM improvement by computer-assisted, functional optimization of cup position in primary THA. In the current analysis, we focused on the clinical outcome and source of greater trochanteric pain syndrome after THA in relation to restoration of biomechanics such as leg length and offset. A sovereign power calculation was performed for the study endpoint reduction of postoperative greater trochanteric pain syndrome in relation to accuracy of biomechanical restoration. We assumed a reduction of greater trochanteric pain syndrome about 25% if leg length and offset was successfully restored. Based on these considerations, a total sample size of 84 (63/21) with 3 to 1 distribution achieved a power of 80% using a two-tailed t test on a two-sided 5% significance level .According to the inclusion and exclusion criteria of the main study 135 patients undergoing minimally-invasive THA were included in the study. Postoperative 3D-CTs for leg length and offset measurements were available for 123 study participants. Out of this 123 data sets 15 CT files were not compatible with the software for 3D-CT measurement of leg length, femoral and acetabular offset. Ninety patients of this subgroup were available for clinical follow up of trochanteric pain syndrome and PROMs three years after THA and thus included in the final analysis . This software offers the possibility to assess hips in three dimensions, to exactly determine the axes and to automatically calculate angles and measure distances. First, the pelvis was virtually aligned in order to bring the anterior pelvic plain in congruence with the coronal plain, to have a neutral pelvic tilt and so a constant starting point. In order to exclude any rotational errors both anterior superior iliac spines (ASIS) were orientated to the same height in the coronal, sagittal and axial plane. Acetabular offset was defined as the shortest distance from the center of the femoral head to the bottom of the acetabulum 21 and EuroQol (EQ-5D)22 were obtained. Furthermore, the patients’ expectation were evaluated using the Hospital for Special Surgery Total Hip Replacement Expectations (THR) Survey23. Preoperatively, none of the patients had symptoms of a trochanteric pain syndrome as defined before. The HHS first published in 1969 was established as a new method to evaluate the results after mold arthroplasty15. Since then it has been widely used for assessing outcome after hip surgery24. The HHS covers four dimensions: pain, function, deformity and range of motion. Altogether the HHS consists of 10 items resulting in a maximum score of 100 points. As a clinician based outcome measure it has be obtained by physician or other qualified health care professional. For interpretation score values 100–90 points represent an excellent result, 90–80 points a good result, 80–70 points a fair result and <70 points a poor results, respectively [9]. In contrast to HHS all other outcome measures in this study are patient reported. The HOOS was developed to measure outcome in patients with hip osteoarthritis. All Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)25 questions are included in the HOOS. In addition to WOMAC, HOOS contains subscales for sport and recreation function resulting in a better responsiveness especially in younger patients26. The HOOS consists of 5 subscales: pain, symptoms, activities of daily living, sport and quality of life built by 40 items. For standardized answers five Likert-boxes are available. The best scale is 100 points indicating no problems27. The EQ-5D is a widely used and tested descriptive instrument for evaluating health. It defines health based on five dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 3 response categories ranging from no problems, some problems to extreme problems. The EQ-5D was tested in general population and patient samples for valuing health28.Clinical evaluation was performed three years after THA by an independent observer blinded to the radiographic results, regarding the presence of trochanteric pain syndrome. Trochanteric pain syndrome was defined as tenderness on palpation of the greater trochanter and painful active abduction of the hip. Preoperatively and 3 years after THA, outcome measures such as the Harris Hip Score (HHS)For statistical analysis, continuous data are presented as mean (standard deviation). Group comparisons were performed by Mann-Whitney-U-tests. Absolute and relative frequencies were given for categorical data and compared between groups by chi-square tests. All hypothesis in the study was tested on 5% significance level. Multivariate logistic regression including gender, age, ASA, BMI and Kellgren was performed to search for risk factors associated trochanteric pain syndrome after THA. IBM SPSS Statistics 22  was used for analysis.This investigation was approved by the local Ethics Committee (No.10-121-0263). All procedures were in accordance with the ethical standards of the responsible committee on human experimentation and with the Helsinki Declaration of 1975, as revised in 2000.Informed consent was obtained from all individual participants included in the study.The prevalence of trochanteric pain syndrome in our cohort was 23.3% (21/90).Patients with trochanteric pain syndrome three years after THA showed a higher absolute discrepancy of combined leg length, femoral and acetabular offset restoration compared to the non-operated contralateral side with 11.8 ± 6.0 mm than patients without symptoms in the trochanteric region with 7.8 ± 5.3 mm  whereas other parameters such as gender, age, ASA, BMI and Kellgren score did not correlate with trochanteric symptoms Table .Table 4M30 and has a 5- year post-operative incidence of up to 4.9%, depending on the approach9. Although this complication can successfully treated with corticosteroid injections11, Silva et al. showed no evidence of bursitis or inflammation histologically after THA in patients with greater trochanteric pain syndrome31. Mahmood et al. showed, that a reduced global femoral offset less than 5 mm, leads to an aggravation in the functional outcome, especially of the abductor muscle strength15. This is in accordance with the findings of Spalding et al., who found a reduced motion and strength in the abductor muscle after reduced femoral offset reconstruction in THA16. Following these results, we presumed that a deviation of the three-dimensional hip biomechanics from the native situation might correlate with these symptoms after THA.Trochanteric pain syndrome complicates up to 17% of cases after THA9.There are several limitations to our study. First, our results are based on 90 patients with unilateral osteoarthritis of the hip. Therefore, the study is restricted by numbers. However, a power calculation was performed preoperatively according to the posed hypothesis of the study. Second, patients with anatomical disorders such as dysplasia and patients with prior trauma were not included in the study because of the strict inclusion criteria of the main study. Such patients may have a different relation between individual anatomy and greater trochanteric pain syndrome. Third, a minimally-invasive, anterolateral approach to the hip was used in the current study. Previous studies assumed an association between trochanteric pain and the applied surgical approach. Disruption of soft tissue during a lateral approach with resultant abductor tear, tendon defects and tendinitis might be associated with the postoperative prevalence of TPS whereas anterior and posterior approaches might be less prone to TPS. Therefore, the results might be different when using a different surgical approach17.Fourth, there might be different reasons for the development of trochanteric pain syndrome like gait disturbances or lower back problems. We did not analyze these factors particularly, but we have to emphasize that no patient in out cohort had symptoms of a trochanteric pain syndrome before surgery. A strength of our study is its 3D-CT scan dependent measuring protocol of leg length, femoral and acetabular offset, which allowed an exact determination of the anatomy of the hip joint and the used parameters, minimalizing inaccuracy as it occurs on plain radiographs due to projection failures15. Interestingly, our results show that the discrepancy of one single biomechanical parameter such as leg length, femoral or acetabular offset was not different between patients with and without trochanteric symptoms. These results are in accordance with the findings of Abdulkarim et al., who showed no relationship between greater trochanteric pain syndrome and femoral offset or femoral center of rotation29. These results suggest, that the restoration of hip anatomics in THA has to be assessed three-dimensionally17.In answer to the first question of the study, we found patients with Greater trochanteric pain syndrome three years after THA had a higher absolute discrepancy of combined leg length, femoral and acetabular offset restoration compared to the non-operated contralateral side than patients without symptoms in the trochanteric region. Due to the fact, that we used absolute values, both over- as well as underrestoration of leg length and offset compared to the non-operated side are associated to greater trochanteric pain syndrome after THA. Patients with an absolute deviation of combined biomechanical restoration of leg length, femoral and acetabular offset of more than 5 mm complained approximately three times more frequently about trochanteric symptoms, than patients with a biomechanical restoration within 5 mm compared to the non-affected contralateral side. So there seems to be a tolerance interval for the reconstruction of femoral offset, acetabular offset, and leg length within these 5 mm at least. This is in accordance with two previous studies, which showed, that a reduced global femoral offset less than 5 mm, lead to an aggravation in the functional outcome, especially of the abductor muscle strength and that a leg length and offset difference over 5 mm was associated with altered gait kinematics32. This is in accordance with different studies, which analyzed the long-term outcome of patients after primary THA35. The promising results in outcome even apply to patients with severe diseases like haemophilia and rheumathoid arthritis37.Furthermore, this study showed that clinical outcome measured three years after THA such as HHS, HOOS and EQ-5D was significantly lower in patients with trochanteric symptoms than patients without trochanteric pain, as well as fulfillment of patient expectations as measured by THR-Survey was lower in the patient with Greater trochanteric pain syndrome. These results emphasize the clinical relevance of Greater trochanteric pain syndrome on outcome and satisfaction of patients after THA. To classify these results, it is necessary to take a look at the general outcome after THA. A recent study, which analyzed 1234 primary total hip replacements, showed excellent outcome for patients after THA with a positive responder rate of 93% and corresponding PROMs using WOMAC and EQ-5Det al. showed a poor outcome for patients with surgical treatment for greater trochanteric pain syndrome after THA, analyzing patient satisfaction score; 10 cm visual analogue score referring to current level of pain ; Oxford hip score; Likert scale duration of pain relief following the operation; Binary presence of pain when lying on affected side8. This confirms the importance of accurate three-dimensional restoration of the hip joint biomechanics and shows the necessity to prevent this complication already during the initial surgery.In addition, the results of Robertson-Watres In conclusion, combined restoration of leg length, acetabular and femoral offset is crucial in THA. An exact combined restoration of these biomechanical parameters reduces significantly postoperative trochanteric pain syndrome and improves the clinical outcome of the patients. A restoration up to 5 mm seems to be safe for avoiding this complication.


Background: The Revised Short-Form McGill Pain Questionnaire Version-2 (SF-MPQ-2) is a multidimensional outcome measure designed to evaluate neuropathic and nonneuropathic pain. A recent systematic review found insufficient psychometric data with respect to musculoskeletal health conditions.Aims: The aim of this study was to describe the reproducibility (reliability and agreement) and internal consistency of the SF-MPQ-2 for use among patients with musculoskeletal shoulder pain.Methods: Eligible patients with shoulder pain from musculoskeletal (MSK) sources completed the SF-MPQ-2 at baseline (n = 195), and a subset did so again after 3 to 7 days (n = 48) if their response to the global rating of change scale remained unchanged. Cronbach’s alpha (α) and intraclass correlation coefficient  were calculated. Standard error of measurement (SEM), group and individual minimal detectable change (MDC90), and Bland-Altman plots were used to assess agreement.Results: Cronbach’s α ranged from 0.83 to 0.95, suggesting very satisfactory internal consistency across the SF-MPQ-2 domains. Excellent ICC scores were found in support of the total (0.95) and continuous (0.92) subscales; the remaining subscales displayed good ICC scores (0.78–0.88). Bland-Altman analysis revealed no systematic bias between the test and retest scores (mean difference = 0.13 to 0.19). Though the best agreement coefficients were seen on the total scale , they were acceptable for the SF-MPQ-2 subscales .Conclusions: The SF-MPQ-2 provides good to excellent test–retest reliability for multidimensional pain assessment among patients with musculoskeletal shoulder pain conditions.


Fixed orthodontic procedures such as separator placement, archwire placement and activations, application of orthopaedic forces, and debonding of brackets produce pain in patients. This study was conducted to assess pain and oral health-related quality of life among patients undergoing orthodontic treatment.This descriptive cross-sectional study was conducted among 152 orthodontic patients of a teritary care center from January 2019 to October 2019 after receiving ethical approval from the Institutional Review Committee (Ref. no. 2311201813). Convenience sampling method was done to select the participants. Oral health-related quality of life using "Oral Health Impact Profile-14" and pain experienced during the first month of fixed orthodontic treatment were assessed. Data analysis for calculation of frequency and proportion was done in Statistical Package of Social Sciences.Mean pain score of the study participants was 5.05±2.07 and their mean oral health impact was 12.71±7.27. Most of the study participants 86 (56.58%), had experienced moderate pain due to orthodontic treatment. Out of the reported impacts, 134 (88.2%) had painful aching in mouth and 127 (83.6%) had difficulty during eating. Least impact was seen in alteration of taste 35 (23%).The pain intensity experienced by patients was variable. Most participants had moderate pain but few patients perceived no pain at all. The participants had at least one or other oral health impacts due to fixed orthodontic treatment. Orthodontists should counsel the patients regarding possible discomfort so that there is no discontinuation of treatment due to pain. However, some patients experience severe pain that may even impair mastication and tooth brushing.5Perception of pain is subjective showinglarge individual variations.Therefore, this study was conducted to assess pain and oral health-related quality of life among patients undergoing orthodontic treatment in Kathmandu Medical College (KMC), Duwakot, Nepal.A descriptive cross-sectional study was conducted in the Department of Orthodontics and Dentofacial Orthopaedics, KMC, Duwakot from January 2019 to October 2019 after receiving the ethical approval from Kathmandu Medical College and Teaching Hospital Institutional Review Committee (Ref. no. 2311201813). Informed consent was obtained from all the study participants before enrolling them in the study. A total of 152 patients undergoing fixed orthodontic treatment were chosen by convenience sampling method. Sample size was calculated using the formula:2 × (p × q)/e2n = Z2 × (0.9 × 0.1)/(0.05)2    = 1.96    = 138.29n = required sample size5p = prevalence of pain due to orthodontic treatment (90%)q = 1-pe = margin of error, 5%Z = 1.96 at 95% Confidence Intervalwhere,Adding 10% for non-response= 138.29 + 13.82 = 152 approximatelyPatients with ages ranging from 16 years to 30 years undergoing fixed orthodontic treatment with stainless steel brackets were included in the study. Patients who required any intraoral or extraoral appliances , patients with severe Class II or Class III skeletal pattern who needed orthognathic surgery, syndromic patients, individuals with cleft lip or palate, and patients under medication for systemic diseases were excluded.6 Pain levels were rated as 0 = no pain; 1-3= mild pain ; 4-6= moderate pain (interferes significantly with activities of daily living); 7-10= severe pain .Pain during the first month of fixed orthodontic treatment was assessed using a numeric pain rating scale (NPRS). NPRS is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale ranged from 0  to 10 (worst imaginable pain).7 OHIP-14 is a standard pretested questionnaire that has been translated and validated in different languages including the Nepali language. OHIP-14 consists of 14 items and explores seven dimensions of impact: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability and handicap. The responses were coded as ‘very often’ (scoring 4), ‘fairly often’ (3), ‘occasionally’ (2), ‘hardly ever’ (1) or ‘never’ (0). The total score of OHIP-14 ranges from 0 to 56, which is calculated by summing the ordinal values for 14 items. The higher scores indicate increased oral health impact. The total OHIP-14 score and the subscale scores were used to measure the ‘severity’ of adverse impacts produced during the first month of fixed orthodontic treatment. In this study, each item of OHIP-14 scores was further dichotomised as “OHIP= 0 (i.e. no impact) and OHIP > 0 (i.e. impact on daily performance)” for cross-tabulation.A face-to-face interview was done to record the oral health-related quality of life using Nepalese version of Oral Health Impact Profile (OHIP-14).A pre-test was done among 25 patients with fixed orthodontic treatment before data collection for the main study. Inter-rater agreement for OHIP-14 was 0.99 indicating excellent reliability. Data obtained were entered in Microsoft Excel Sheet version 2007 and analysed using the Statistical Package for Social Sciences (SPSS version 11.5). The intra-class correlation coefficient (ICC) was used for determining interexaminer reliability in assessing OHIP-14. Descriptive statistics, including the mean and standard deviations, were computed for OHIP-14 and NPRS. Frequency distribution in the level of pain and OHIP-14 among the study population were calculated.Mean pain score of the study participants during the first month of fixed orthodontic treatment was 5.05±2.07 and their mean oral health impact was 12.71±7.27. Mean age of the study participants was 21.48±4.08 years. Among them, 55 (36.18%) were males and 97 (63.82%) were females. Out of 152 study participants, 37 (24.34%) experienced severe pain whereas 4 (2.63%) had no pain at all due to any procedures in fixed orthodontic treatment . However8 Fixed orthodontic treatment provides the force to the tooth that produces prolonged pressure resulting in the acute inflammatory response. This leads to common sequelae of pain and discomfort to the patients.9 Studies have reported different impacts of orthodontic pain on oral health-related quality of life in patients undergoing fixed orthodontic treatment.10 Therefore, this study was conducted to assess pain and oral health-related quality of life among patients undergoing fixed orthodontic treatment in a dental college of Nepal.The experience of pain and discomfort is a common situation during orthodontic treatment.The mean pain score in this study rated by NPRS was 5.05±2.07 indicating moderate pain perceived by the study participants during the first month of their fixed orthodontic treatment. Moderate pain experienced by the participants indicated that it interfered significantly with activities of their daily living.11 In a study from India, 62% of dental practitioners and dental students predicted that the patients during the course of orthodontic treatment anticipate moderate pain and discomfort. However, moderate pain was experienced by 94% of orthodontic patients.12 In the current study, there were 86 (56.6%) participants who experienced moderate pain. Many  perceived severe pain as well, because of which they were unable to perform activities of daily life.Pain due to orthodontic treatment may be more severe than our expectations. Usually, treatment providers underestimate their patients’ pain and may not always know when analgesics are needed.13 In this study, the overall impact of fixed orthodontic treatment during the first month of treatment was 12.71±7.27. The individuals had variable impacts on their oral health-related quality of life due to the commencement of fixed orthodontic treatment. This finding is similar to a study done in Brazil where patients experienced worsened quality of life during orthodontic treatment because of functional limitations and physical pain.14 Not a single participant in the current study was found to be devoid of any impact. This finding was similar to the study done in Switzerland where almost every patient reported some amount of interference in schoolwork or social activities.15Most of the studies done to assess the impact of orthodontic treatment in oral health-related quality of life have reported that patients were considerably compromised in terms of their overall OHRQoL until approximately one month after appliance insertion.10 Likewise, in a study done in Lithuania, patients wearing braces complained of impaired nutrition more than patients wearing removable and functional appliances.18 However, a study done in Michigan showed that only 21.9% of the patients changed their diet due to pain from the braces.11Most of the study participants had painful aching in the mouth  and difficulty in having food . Similar frequency of pain and discomfort due to fixed orthodontic treatment were observed in a study done in India and Pakistan.16 Total of 83 (54.6%) patients in this study reported to have difficulty in doing usual jobs, 57 (37.5%) felt a bit embarrassed and 93 (61.2%) were completely unable to function due to pain and discomfort from fixed orthodontic treatment. This finding is consistent with the study done in China, where physical functioning, body pain and general mental health domains were affected after initial archwire placement indicating patients’ lives being affected by orthodontic treatment.17 These results help orthodontists to inform patients about the likely impact of fixed orthodontic treatment so that the possible pain and discomfort may be accepted by them once they start the treatment.In a study done in Lithuania, it was observed that 26.8% of the patients had discomfort due to impaired speech. However, in this study, more 73 (48%) participants had difficulty in pronouncing words.15 Social discomfort due to fixed orthodontic treatment is more during the initial stages of treatment. Physiological adaptation occurs with time, the speed of which is dependent upon personality characteristics of the patient. The orthodontist should make primary consideration to this matter as an early intervention might help prevent the long-lasting establishment of a stereotype denial of orthodontic appliance.18Pain and its influence on daily life can be the major cause for discontinuation of orthodontic treatment.The study has some limitations. This study is done in a small sample at a single dental hospital which cannot be generalised to all the fixed orthodontic treatments done in Nepal. The study should be conducted in a larger population to elucidate the effect of orthodontic pain on quality of life. The study records pain and quality of life only in the first month of commencement of fixed orthodontic treatment and using only a single wire type. Longitudinal analytical studies assessing pain and quality of life in different orthodontic treatment phases, as well as different wire types, can better evaluate the changes in pain perception and quality of life following orthodontic treatment.The pain intensity experienced by patients in the first month of fixed orthodontic treatment in Kathmandu Medical College, Duwakot, Nepal was variable. More than half of the patients had moderate pain and few patients perceived no pain at all. The study participants had at least one or other oral health impact due to fixed orthodontic treatment. Hence, it is recommended that orthodontists should give more time to communicate and counsel the patients regarding possible discomfort so there are no discontinuations of treatment due to pain.


Cognitive factors impact chronic pain, but the prevalence of fear avoidance (FA) and pain catastrophising (PC) in individuals suffering from chronic neck pain (CNP) has not been investigated in South Africa.To determine the prevalence of FA and PC in patients with CNP at private physiotherapy practices in Johannesburg.α = 0.80) and Pain Catastrophising Scale (α = 0.87) self-report questionnaires were used in a cross-sectional study to determine the prevalence of FA and PC, respectively. Descriptive statistics and correlations using Pearson’s or Spearman’s coefficient were conducted between demographic variables and FA and PC. Non-parametric data were tested using the Wilcoxon rank-sum or Kruskal–Wallis test. Cohen’s d-value or r-value measured strength of associations.The Tampa Scale for Kinesiophobia-11 (TSK-11) (n = 86). Fear avoidance and PC had a prevalence of 25.5% (n = 27) and 15.1% (n = 16), respectively. A positive correlation was found between FA-11-Total and PC-Total  and between FA ) and PC and its subscales . Participants with a secondary education (26.0 ± 3.4) showed a higher FA than those with tertiary education (21.9 ± 1.5). Effect size was moderate (Cohen’s d = 0.60). Pain intensity correlated positively with both FA  and PC .A sample of 106 CNP patients with a mean age of 48.7 years (± 14.8) from 25 randomly selected private practices participated in the study. Of the participants, 81% were women (FA and PC affect a number of patients with CNP. A lower level of education was associated with FA and a higher pain intensity was associated with higher FA and PC.Identifying FA and PC in patients with CNP is important to facilitate holistic management. Chronic neck pain (CNP), with resultant disability, is common in the general population , ethnicity and smoking’  of the South African Society of Physiotherapy, were selected from the OMPTG website after getting permission from the chairman of the organisation. The names of the practices were then randomly selected using the Excel Randomisation Programme. Each practice owner was approached sequentially to identify their willingness to participate in the study. In their turn, the physiotherapists at these clinics identified willing participants based on our inclusion and exclusion criteria and enrolled them sequentially.The estimated size of the sample was based on the proportion of patients with symptoms of FA and/or PC. An estimate of 50% prevalence was used, with 10% precision, a 95% confidence level and an infinite population. Thus, a minimum sample size of 97 patients with CNP was required Daniel .The study was approved by the Human Research Ethics Committee  of the University of the Witwatersrand (Clearance Certificate Number M140434). Informed consent forms were signed by all the participants.A summary of the study procedure is presented in Data were collected over a 16-month period between 2014 and 2015. The study’s inclusion criteria were as follows: participants suffering from neck pain for three or more months; the body areas for symptoms should include pain, muscle tension or stiffness in the neck, shoulder area, upper back area and/or above the costal margin, with or without pain in the arms; participants’ aged 18 years or older; and participants undergoing or had previously received physiotherapy. No participant was excluded based on gender, ethnicity or nationality.The exclusion criteria for the study were as follows: if participants showed signs of neurological impairment from nerve compression (as this might constitute a more acute and specific neck condition), had a progressive neuromuscular condition and unexplained weight loss, received drugs via intravenous means or had undergone any surgical intervention in the previous 3 months.All participants completed a demographic survey and the English versions of two validated self-report questionnaires that screened for FA  and PC . Demographic data included gender, age, marital status, highest level of education and employment status. All the questionnaires were completed by the participants, although they could ask the physiotherapist if they needed clarification.p-values varied between 0.60 and 0.77 in a reliability study and between 0.76 and 0.84 in a validity study  was measured by means of a 10-cm Visual Analogue Scale (VAS) (where 0 represents ‘no pain’ and 10 represents ‘the worst pain imaginable’) to denote the pain experience ‘now’  subscore, an activity avoidance (AA) subscore and a total score. The scale includes 11 items, each with a range from 1 to 4. The TSK-11 total score ranges from 11 to 44, There are no cut-off scores for clinically relevant levels of FA for the TSK-11. The term ‘clinical relevance’ refers to the level where behaviour becomes important in a clinical setting and is frequently used in psychological literature where there is no definite ‘cut-off’ score for a particular behaviour , helplessness (PCS-H) and magnification (PCS-M). A high internal consistency was established: The prevalence of patients with clinically relevant levels of FA and PC was calculated by dichotomising the PCS and TSK-11 scales and subscales, using their cut-off and midpoint scores, respectively. Cronbach’s alpha was determined for the TSK and PCS scales, as well as their subscales. The relationship between PC  and FA  was assessed by the Spearman rank-order correlation coefficient because the PCS data were not normally distributed. The strength of the associations was measured by interpreting the absolute values of the correlation coefficients Cohen .t-test . Where the data did not meet the assumptions of these tests, a non-parametric alternative, the Wilcoxon rank-sum test  was used. The strength of the associations was measured by means of a Cohen’s d-value for parametric tests and an r-value for non-parametric tests (Cohen www.statsoft.com), was used for data analysis and the 5% significance level was applied.The relationships between the scores for the respective categories of the demographic variables used in the study and each of the PCS and TSK main scales were assessed by means of an unpaired ts Cohen . Dependits Cohen . STATISTOf the 94 practices in our randomised list, 24 participated in the study. Three practices were excluded from the list as they were duplicates.n = 1), declined to participate (n = 8), had no response to telephone call or e-mail (n = 57) and had closed because the owner had emigrated (n = 1). The participating practices were situated within a 30-km radius of central Johannesburg  and the median pain duration was 8 years.The mean scores for the TSK-Total, the TSK-SF (SF) and the TSK-AA (AA), and the median scores for the PCS and its subscales – PCS-R, PCS-H and PCS-M – are provided in The reliability of the TSK-11 and the PCS scales and their subscales, as measured by Cronbach’s alpha, was more than 0.70, exceeding the available values as recorded in the literature   . The corp = 0.013; moderate effect size: Cohen’s d = 0.60), indicating that those with a primary and secondary education were more likely to be fear avoidant than those with a tertiary education. No significant association was found between the highest level of education and PC.The association between demographic variables, pain intensity and the two cognitive factors under investigation, namely FA and PC, was analysed and the following significant results were found. The mean FA (TSK-11) score for those patients with a primary and secondary education (26.0 ± 3.4) was higher than that for those with a tertiary education (21.9 ± 1.5) . Similarly, a significant positive low correlation between PC and pain intensity was found . The effect size was low in both cases. The positive correlation in both cases indicates that as FA and PC increase, so does the pain intensity. However, no significant associations were found between gender, age, employment status, marital status, reduced work load because of pain or pain duration, and the respective TSK and PCS scores.A significant positive correlation, although low, was found between FA and pain intensity , or who believe that their pain cannot be controlled  from pain; feeling empowered by incorporating self-management strategies into practice; and supportive ambience via collaborative relationships with clinicians and support from family and friends.Unhelpful strategies or barriers include ‘difficulty with sustaining motivation for pain self-management; distress experienced from ongoing pain, anxiety and depression; and unsupportive relationships with clinicians, family and friends’  and are utilised by upper- to middle-class populations   Diener . Thus, f) Diener .This study provides valuable information about the prevalence of FA and PC affecting patients with CNP conditions in private physiotherapy settings in Johannesburg, South Africa. Our findings showed that FA and PC are present in a subset of patients undergoing physiotherapy. The level of education and pain intensity impacted these two cognitive factors in our study sample and the findings suggest that clinicians should tailor their treatment according to the presence of these cognitive and psychosocial factors to optimise patient outcomes. Further research is needed to address patients of different geographical areas, socio-economic classes and language groups.


Chronic musculoskeletal pain is one of the main causes of years lived with disability and generates the highest cost of health care among chronic pain conditions. Internet-based treatments have been shown to be an alternative for the treatment of musculoskeletal conditions, in addition to reducing barriers such as travel, high demands on the public health system, lack of time, lack of insurance coverage for private care, and high costs for long-term treatment. The aim of this clinical trial is to develop and test the effectiveness and cost-effectiveness of, an internet-based self-management program based on pain education and exercise for people with chronic musculoskeletal pain.This is a prospectively registered, assessor-blinded, two-arm randomised controlled trial with economic evaluation comparing the Internet-based pain education and exercise intervention with a control group that will receive an online booklet. One hundred and sixty patients will be recruited from Sao Paulo, Brazil. Follow-ups will be conducted in post-treatment, 6 and 12 months after randomisation. The conduct of the study, as well as the evaluations and follow-ups will be carried out entirely remotely, through online platforms and telephone calls. The primary outcome will be pain intensity at post-treatment (8 weeks) measured using the 11-item Pain Numerical Rating Scale. Secondary outcomes will be biopsychosocial factors presents in the chronic musculoskeletal pain condition. Costs due to chronic musculoskeletal pain will be also measured, and cost-effectiveness analysis from a societal perspective will performed.Our hypothesis is that internet-based pain education and exercise will be better than an online booklet in reducing pain and improving biopsychosocial outcomes in patients with chronic musculoskeletal pain. In addition, we believe that there will be good acceptance of patients for the internet-based intervention and that internet-based intervention will be more cost effective than the online booklet.ClinicalTrials.gov .The study was prospectively registered at  Chronic pain is a major burden on the individual and society . It is eThe most common conditions responsible for chronic pain are musculoskeletal disorders of the back, neck and upper limbs; as well as knee and hip osteoarthritis. In the most recent Global Burden of Disease Study, musculoskeletal pain accounted for more than 20% of years lived with disability in the population, and low back pain alone was the leading cause of years lived with disability across the globe . MusculoTreatment for chronic musculoskeletal pain is a challenge for clinicians since it is often accompanied by many factors that are associated with pain, such as disability, emotional distress, work absenteeism, reduced quality of life, and even early mortality –14. TherInternet-based self-management programs have grown with the development of new technologies and have been extensively used for delivering healthcare in many areas –22. InteThe aim of this clinical trial is to develop and test the effectiveness and cost-effectiveness of an internet-based self-management program based on pain education and exercise for people with chronic musculoskeletal pain.This study protocol follows the recommendations of the SPIRIT Statement  for clinThis is a prospectively registered, assessor-blinded, two-arm randomised controlled trial with economic evaluation.Patients will be recruited from the community in Brazil. We will include patients aged between 18 and 60 years, seeking treatment for any chronic musculoskeletal pain condition. Eligibility criteria are: pain of at least 3 points on a 0 to 10 Pain Numerical Rating Scale, able to read and understand Portuguese and with internet access. Chronic pain will be defined as pain lasting more than 12 weeks .Exclusion criteria are: nerve root compromise, serious pathologies , serious cardiovascular and metabolic diseases , recent orthopaedic surgery (over the last 12 months), scheduled to undergo surgery in the next six months, or pregnancy. Patients will also be excluded if there is any contraindication to exercise. We will pre-screen for physical activity participation at baseline using the Physical Activity Readiness Questionnaire (PAR-Q) Portuguese version , 29.The blinded assessor will screen potential participants to determine eligibility. Eligible patients will receive the online consent form and will be informed about the aims of the study. The blinded assessor will then collect the patient’s sociodemographic data, medical history, and the data related to the study outcomes for baseline assessment. The baseline assessment will be performed via videoconference using a personalised link using Whereby platform. All other assessments will be collected by telephone calls, smartphone messages or e-mail  through a questionnaire created on the Typeform platform , 6 and 12 months after randomisation.Eligible participants will be randomly allocated to one of the treatment groups through an electronic platform. After baseline screening, patients will receive a login and password to access the study website. When the patient logs on to the website, he/she will be randomly allocated to one of the two study groups. The assessor who will confirm the eligibility will be unaware about patients’ allocation.The outcome assessor will be blinded to the treatment groups. The assessor will be asked to guess which group the patients were in (intervention or control) at the end of the study to measure assessor blinding. Due to the nature of the interventions, it will be not possible to blind neither the patients nor treatment providers.www.reabilitador.com.br). The content of this intervention will include videos and animations based on pain education, physical activity promotion and general exercises. The pain education component will be based on the E-pain intervention developed by Reis at al [Patients allocated to the intervention group will receive a login and password for individual access to the website designed for the study  by a physiotherapist (5 years of experience) with previous training for the coaching. The aim of the health coaching component is to keep patients motivated to engage with the program. This will include encouragement, motivation, coping, review of the instructions, and if necessary, tailoring of the content of the intervention. For example, if a patient feels any discomfort while doing an exercise, the coach will slightly modify the exercise . Adherence to the program will be recorded in a daily log.The patients allocated to the control group will have access to an online booklet containing general information about self-management of chronic pain, including pain education, advice on healthy lifestyle and sleeping habits and promotion of physical activity. They will also receive one phone call at week 4 and motivational text messages once a week during the study period.The economic evaluation will be conducted from a societal perspective over 12 months . Intervention costs will be determined by the real costs of maintenance and support, monitoring costs, training and project management costs, number and length of telephone calls, and number of text messages sent to participants. Costs associated with preparing the organisation and developing the website and video recordings will be excluded. We will measure costs by the estimate of healthcare utilisation costs (public and private if possible), patients costs, and lost productivity costs (absenteeism) collected using a questionnaire. Costs will be measured based on the participants’ reported use of the resources using a cost diary given to the participants at baseline.The healthcare utilisation costs incurred due to chronic pain  will be valued using the Brazilian standard costs . The patWe will perform cost-effectiveness and cost-utility analyses according to the intention-to-treat principles . DiffereWe determined that a minimum of 160 individuals (80 per group) would be required to provide the trial with 90% power to detect a between-group difference of 1.5 point in a 0 to 10 Pain Numerical Rating Scale, with an estimated standard deviation of 2.75 points and two-sided alpha level of 0.05. The estimated sample size would also allow for loss to follow up rate of up to 15%.The normality of the data will be tested by visual inspection of histograms. Baseline characteristics of the participants will be calculated using descriptive statistics. The between-group differences and 95% confidence interval for the post-treatment outcomes at 8 weeks, 6- and 12-months follow-ups will be calculated using Mixed Linear Models using interaction terms of treatment group versus time. An intention-to-treat approach will be used in all statistical analyses.We will use causal mediation analysis to understand the mechanisms by which the internet-based pain education and exercise exerts its effects on the primary outcome, pain intensity at 8 weeks. The proposed intervention aims to reduce kinesiophobia, pain catastrophising, and improve self-efficacy, and pain-related attitudes and beliefs post-treatment. It is hypothesised that short term effects of these putative mediators will cause reduction in pain intensity at 8 weeks. We will estimate indirect effects of the intervention via the putative mediators, and path specific effects (intervention-mediator and mediator-outcome). We will use directed acyclic graphs to identify the minimum sufficient set of confounders that will need to be adjusted. These directed acyclic graphs will be registered before data collection begins. We will use sensitivity analyses to explore how much residual confounding would explain away the indirect effect, if one is detected. We will use the ‘mediation’ R package to conduct these analyses .We hypothesise that the telerehabilitation program will benefit patients with chronic musculoskeletal pain by reducing pain intensity and improving function, and psychological and behavioral outcomes  compared an online minimal intervention approach (booklet). We also hypothesise that the telerehabilitation program will be a cost-effective intervention compared to the control intervention for patients with chronic musculoskeletal pain. As patients usually support the use of telerehabilitation to improve access to care, we expect that the program will be well received by the patients.The program is based on relatively simple interventions , although some support is necessary from the coach. This program was designed to be simple to facilitate its implementation in healthcare settings. The program has the potential to change lives of millions of people with chronic musculoskeletal pain that are everyday waiting for treatment in overpopulated cities in Brazil. If the results of our study prove our hypothesis about the effects of treatment on patients with chronic pain, we can contribute to the discussion of a new perspective of this treatment modality for public and supplementary health. The results of the study may serve as a basis for decision making and possible implementation of this therapeutic modality in the treatment of chronic musculoskeletal pain. The economic evaliation present in the study may provide an observation of an important aspect for the implementation of telerehabilitation in the health system. The possibility of reducing health costs would also make it possible to reallocate investments in healthcare.Additional file 1.


Prostate cancer refers to an epithelial malignant tumor that occurs in the prostate area. In recent years, with the improvement of people's living standards, the incidence of prostate cancer has gradually increased, which has greatly affected people's life and health and quality of life. Acupuncture has its unique advantages in treating cancer pain. We will evaluate the efficacy and safety of acupuncture and moxibustion in the treatment of pain caused by prostate cancer using a clinical randomized parallel control method.This pragmatic randomized controlled trial will recruit 120 patients who are diagnosed with prostate cancer. Simple randomization to conventional drug treatment with a 1:1 allocation ratio will be used. Based on the patient's pain location and the primary lesion, the acupuncture needle insertion position was determined according to the principle of local selection of acupoints. All participants will continue to receive conventional drug treatment.This trial may provide evidence regarding the clinical effectiveness, safety, and cost-effectiveness of acupuncture for pain caused by prostate cancer.ClinicalTrials.gov, ChiCTR2000029801, Registered on 14 February 2020. The incidence of prostate cancer varies significantly worldwide, with the highest incidence being approximately 25 times the lowest incidence. Cancer pain is one of the most important symptoms in patients with advanced cancer. The incidence of this disease is about 70% to 90%, which greatly increases the physical and mental suffering of patients and affects the quality of life.,4 Prostaglandins secreted by patients with prostate cancer will cause bone-absorbent nerve endings around the tumor to be extremely sensitive to the patient's painful stimuli, which can cause pain.Prostate cancer refers to an epithelial malignant tumor that occurs in the prostate area. In recent years, with the improvement of people's living standards, the incidence of prostate cancer has gradually increased, which has greatly affected people's life and health and quality of life.,6 American studies have found that long-term use of anesthetics often promote tumor angiogenesis, accelerate tumor growth, and promote the spread of cancer cells. In addition, clinical treatments have found that the use of this method often results in nausea, vomiting, dizziness, drowsiness, and other adverse reactions.With the continuous progress of modern medicine, we are not only concerned about prolonging the life of cancer patients, we are more concerned about the impact of cancer on their own pain and quality of life. At present, modern medicine mainly uses the “three-step” analgesics recommended by WHO to treat cancer pain. Patients need long-term high-dose anesthetics for analgesia.,9 Therefore, in this study we will evaluate the efficacy and safety of acupuncture and moxibustion in the treatment of pain caused by prostate cancer using a clinical randomized parallel control method. We hope that the results of this study will provide sufficient evidence-based medical evidence for acupuncture treatment of pain caused by prostate cancer, and also provide better treatment methods for clinicians.Acupuncture has its unique advantages in treating cancer pain. It can dredge the meridians, reconcile the blood, and improve the pain caused by Qi stagnation and blood stasis. Recent studies have shown that acupuncture can improve pain and quality of life in patients with prostate cancer.22.1http://www.chictr.org.cn/showproj.aspx?proj=49398 (ChiCTR2000029801). The protocol includes elements recommended in the Standard Protocol Items: Recommendations for Interventional Trials checklist .A brief flowchart of the entire study is shown in Figure 2.2This study will be conducted in China. Patients will be recruited from Urology/Andrology departments of The Second Affiliated Hospital of Shaanxi University of Chinese Medicine. We will enroll participants based on the following inclusion criteria:1.Male patients diagnosed with prostate cancer will be included ;2.The patient's age is 50 years or older;3.Patients all had pain in the lumbosacral region, waist, chest and back, and pubic area to varying degrees; clinical manifestations were single / multiple site involvement.4.Those who have signed informed consent;Participants who meet the following exclusion criteria will not be enrolled:1.Patients with severe organ dysfunction;2.Patients unwilling to cooperate with the study;3.Patients with mental cognitive dysfunction and whose severe mental illness has been detected;4.Patients with a history of critical illness such as cirrhosis;5.Patients with severe anemia;2.3The web-based online randomization system to be used in this trial will be provided by an independent academic data management center at t he Second Affiliated Hospital of Shaanxi University of Chinese Medicine. The attending Physician will identify eligible patients according to the inclusion and exclusion criteria. Informed consent will be taken by the attending physician, and participants will be referred to a research coordinator who will randomly assign them to the intervention or control arm. The randomization list is kept by the biostatistician and research coordinator until the end of the study to ensure allocation concealment; therefore, the data analysts will be kept blinded to the allocation. The participants will be instructed not to disclose the allocation to the attending physician.2.4Intervention group: Apply acupuncture for treatment. The method is as follows: Select a disposable acupuncture needle with a size of 25 mm × 0.25 mm. Based on the patient's pain location and the primary lesion, the acupuncture needle insertion position was determined according to the principle of local selection of acupoints. After local disinfection with 75% alcohol, acupuncture needles are inserted into the subcutaneous tissue. Adjust the number of acupunctures appropriately according to the patient's severity and self-tolerance. Patients with moderate or mild pain should be treated 4 days after stopping the use of analgesics, once a day, with 10 days as a course. After the treatment was completed, the recurrence and duration of pain symptoms were observed. Control group: At the same time as basic treatment, modern chemical analgesic drugs are used in accordance with the guiding principles of cancer three-step pain relief ladder therapy. Commonly used drugs:1.Xilepan , 200 mg orally, once a day;2.tramadol , 10 mg, Orally, once a day;3.Meishi Kangding , 10 mg orally, once a day.2.5The study data collection process is outlined in Table 2.6To assess the pain level of patients with cancerous pain, we will use the Numeric Rating Scale, (NRS) pain standard. Specifically: 0 for painlessness; 1 to 3 for mild pain; 4 to 6 for moderate pain; 7 to 9 for severe pain; and 10 for severe pain. 0 to 10 points represent the patient's pain level. Significant effect: The patient's pain level is reduced by at least two or three levels, or the patient is painless; Effective: The patient's pain level is reduced by one level or the patient presents moderate or mild pain; Ineffective: The patient's pain does not have any relief, even worse trend.2.7As for the secondary outcomes, we will apply the Quality of Life Score scale before and after treatment for patients with advanced prostate cancer. The scale is an assessment scale for the condition and quality of life of advanced, hormone-insensitive prostate cancer created by the University of California, USA. Including nine aspects of physical strength, pain, fatigue, appetite, family/marital relationship, mood, defecation, and general feeling. Each item is calculated with 100 points. The lower the score, the worse the situation. In addition, we will use the international prostate symptom score (IPSS) to evaluate prostate-related symptoms. 0 to 35 points according to the severity of the symptoms. Specific include whether there is endless urination, whether to go to bed at night to urinate, if you feel dysuria, whether you need to urinate within 2 h after urination, whether you can’t wait to urinate, or whether you feel the urine Thinning or whether to interrupt and start multiple times when urinating. 20 to 35 points are defined as severe symptoms; 8–19 points are defined as moderate symptoms; 0 to 7 points are defined as mild symptoms.2.82.8.1Based on the results of our previous study, we will use a 2-sided significance level of 5% and a power of 80%, the required number of patients in each group is 57.Considering dropout cases, we will enroll a total of 120 patients in this study.2.8.2The Full Analysis Set will be used for all primary analysis. Per Protocol Set analysis will be performed for evaluating the sensitivity of results.2.8.3P ≤ .05 indicates that the difference is statistically significant.Data management uses EXCEL software to build a database, double entry, check for outstanding values, and lock. Statistical analysis will be performed using SPSS 25.0 software for statistical analysis. The normality of the measurement data is tested. The data obeying the normal distribution is Student's t test, which is expressed by mean ± standard deviation. The data not obeying the normal distribution is rank sum test. And marginal homogeneity test; count data are expressed by rate and composition ratio, and comparison is performed by chi-square test; repeated measurement data are expressed by mean ± standard deviation, intra-group comparison is performed by analysis of variance of repeated measurement data, and inter-group comparison is by multivariate analysis of variance (MANOVA). 2.9The management structure will comprise the principal investigator (PI), a trial management group, and a data monitoring committee. The trial management group will be responsible for conducting the trial and will meet monthly to discuss the trial progress. The PI will visit each collaborative hospital for face-to-face meetings and to share information to promote patient recruitment. The data monitoring committee will review safety and efficacy data. All data will be monitored every month through a central monitoring method. Additional monitoring may be performed at the discretion of the monitoring manager. The data monitoring committee have met once prior to the start of patient recruitment. At least twice per year, participating investigators, research assistants, and research nurses will be required to attend a training workshop on clinical research to ensure strict adherence to the study protocol and familiarity with the trial administration process. The data collected in this trial will comprise information recorded in case report forms and questionnaires. Data quality will be checked regularly by research assistants and overseen by monitors; all modifications will be marked on case report forms and data managers will recheck the data before they are officially logged. The database will be locked after all data have been cleaned. If participants withdraw from the trial during the study period, the reasons will be documented and the dropout rate will be statistically analyzed.3,11 According to statistics from the World Health Organization, there are about 10 million new cancer patients every year in the world, and 300 million to 1 billion cancer patients fail to receive timely and effective treatment. The trial results of many second-line hormones and chemotherapy methods are unsatisfactory and costly. In distant metastasis of prostate cancer, bone is the most common target organ, and bone metastasis occurs in 80% of prostate cancer patients. The lower lumbar spine is the most common site of bone metastases. Clinical manifestations often include chills, fatigue, bone pain, spinal nerve compression symptoms, osteoporosis, pathological fractures, and so on. Seriously reduced the quality of life of patients. At this time, the disease is in its advanced stage, and the research on palliative treatment is particularly important because of the lack of curative methods. The ultimate goal is to extend patient survival and improve quality of life.Cancer pain is one of the most important symptoms in patients with advanced cancer. The incidence is about 70% to 90%, which greatly increases the physical and mental suffering of patients and affects the quality of life. Traditional acupuncture has analgesic effects by regulating neurotransmitter release, changes in hormone levels in the body, and reducing local edema between tissues. From the perspective of traditional Chinese medicine theory, acupuncture can dredge the meridians, reconcile the blood, and improve the pain caused by Qi stagnation and blood stasis. From the perspective of modern hospital research, the principle of acupuncture selection during acupuncture analgesia refers to the meridian theory. Through the body surface acupoints, it acts on internal organs and regulates the patient's neuroendocrine function, activating the body's pain modulation system to achieve analgesic effects. Recent studies have also shown that acupoint stimulation can release various mediators and opioid peptides. Together these endogenous substances form the body's “anti-pain system” and produce acupuncture analgesic effects. Therefore, in this study, we will evaluate the efficacy and safety of acupuncture in the treatment of pain caused by prostate cancer using a clinical randomized parallel control method. We hope that the results of this study will provide sufficient evidence-based medical evidence for acupuncture treatment of prostate cancer pain, and also provide better treatment methods for clinicians.Acupuncture analgesia has been widely used in tumor bone metastasis treatment and daily care because of its simple operation and no toxic and side effects such as oral drugs.The authors would like to thank all the trial participants. The authors are grateful for the support for this study: trial coordinating team, surgical staff, nurses, and research departments.YL, YYD, JSW, XDY, and RJL designed the study protocol and drafted the manuscript.HMS reviewed the study protocol and drafted the manuscript. JML is responsible for the statistical design and analysis as trial statistician. All authors carefully read and approved the final version of the manuscript.


The ACCURATE study demonstrated non-inferiority and superiority of dorsal root ganglion stimulation (DRGS) over traditional spinal cord stimulation (t-SCS) in patients with complex regional pain syndrome (CRPS). Yet, its efficacy in patients who had previously failed SCS therapy is unknown. A mid-60-year-old-male patient with right foot CRPS previously implanted with SCS system experienced relapse in pain. The patient was offered DRGS at right L5/S1 with 90% pain reduction. The patient subsequently proceeded to implant with continued pain relief. This case report demonstrates the effectiveness of DRGS in a patient who previously failed SCS. DRGS can be a viable salvage treatment option in the face of tolerance or loss of efficacy with SCS. Complex regional pain syndrome (CRPS) was previously called reflex sympathetic dystrophy (RSD), “causalgia,” or reflex neurovascular dystrophy (RND) . The BudThe consensus definition of CRPS describes an array of painful conditions that are characterized by regional pain that is disproportionate in time or degree to the usual course of any known trauma or lesion and shows variable progression over time . There aSpinal cord stimulation (SCS), a procedure in which electrodes are placed into the dorsal epidural space, is an available treatment option for neuropathic pain conditions such as failed back surgery syndrome and CRPS. In a randomized study involving 24 patients with CRPS, SCS plus physical therapy (PT) reduced pain and improved health-related quality of life more than PT alone for up to two years. Yet, no difference in pain was perceived during three to five years following implantation [Advances in neuromodulation technology have led to the development and implementation of dorsal root ganglia stimulation (DRGS). An increasing number of pain centers are using DRGS as either first-line neuromodulation or in cases where SCS has failed. The ACCURATE study was a prospective, randomized, multi-center, controlled clinical trial that demonstrated non-inferiority and superiority of DRGS over traditional SCS (t-SCS) at three months, with results sustained at 12 months. Data from the study suggests that DRGS could be used in patients suffering from chronic intractable pain conditions that are refractory to t-SCS .Yang and Hunter reported a case series of two CRPS patients who failed t-SCS and were offered DRGS as salvage therapy . The firAlthough recent data support DRGS over t-SCS in patients with CRPS, there is little research on effective treatment options in patients who have failed t-SCS. In this case report, we present a patient with CRPS refractory to t-SCS who was successfully treated with DRGS.We present the case of a mid-60-year-old male who suffered a tear of the right posterior tibial tendon due to a motor vehicle accident years ago. After fixation and immobilization, the foot remained painful and swollen, while the healing of the fracture was considered to be favorable. After six months, CRPS was suspected and the patient referred to a pain medicine specialist. CRPS diagnosis was confirmed according to the following criteria: continued pain disproportionate  to the inciting event, foot hyperesthesia, skin color (redness), stiffness, and weakness of the foot and ankle (positive Budapest criteria). The patient was offered a DRGS trial at right L5 and S1 with 90% pain reduction; however, his commercial insurance plan failed to cover the DRGS implantation, deeming it experimental. He then underwent a Boston Scientific SCS trial with >50% relief and was implanted with an Boston Scientific  SCS system (16-contact lead placed at the top of T8) in 2019. After a successful trial, the patient reported 80% pain relief with the SCS system. Unfortunately, the patient reported worsening of pain symptoms after four months. Imaging was obtained to rule out lead migration. The system was reprogrammed several times without success for pain relief, with multiple wave forms being trialed. Unfortunately, none could recreate his pain relief and functional improvement from the prior DRGS trial.The patient presented to our clinic with right foot pain that he reported as eight out of ten on the numeric rating scale (NRS). He complained that he is easily fatigued with walking. Physical examination of the right foot was notable for allodynia and nail discoloration.With a change in his insurance plan, he subsequently proceeded with a DRGS implantation that was approached in the same manner as described by Liem et al. . The AbbDRG leads were placed at the right L5/S1 and S1 neural foramen. Adequate paresthesia mapping was achieved intraoperatively over his painful right lower extremity. Three days after the implantation, the patient reported greater than 90% improvement in CRPS pain. Furthermore, the patient was ambulating with one out of ten on the NRS.On his six month follow-up appointment, the patient mentioned rare pain flare ups of eight to nine out of ten on the NRS and had weaned himself off opioid medication (oxycodone/acetaminophen tablets). He occasionally felt “flutter” of his posterior distal leg muscles. These issues were remedied when the DRG system was reprogrammed. His pain score has remained one out of ten most times. The device has been used 24 hours a day. The patient’s SCS system was explanted after achieving superior relief with his Abbott DRG neurostimulation system. Verbal informed consent was obtained from the patient for anonymized patient information to be published in this article.Tolerance to neurostimulation is one of the greatest challenges to long-term efficacy in neuromodulation for chronic pain . There iThe patient presented in this case reported a decline in the ability of the SCS device in relieving pain. Hardware-associated failure of SCS  was ruled out by troubleshooting and reprogramming attempts by the manufacturer. X-ray ruled out obvious lead fracture or migration. The exact etiology of failure of SCS device in this patient is still unknown. In our patient, DRGS therapy resulted in a clinically significant result. The pain level went from an initial NRS score of eight to one to two and he regained increased ambulatory ability. Our results with DRGS therapy are promising and in line with another published case report .This case report demonstrates the effectiveness of DRGS in a patient who previously failed SCS. DRGS can be a viable salvage treatment option in the face of tolerance or loss of efficacy with SCS. Although a case report is related to the care of an individual patient, it can be a source of new ideas in medicine, providing treatment guidance for clinical practice and generate hypotheses. To date, our patient remains satisfied with DRGS and has not experienced any complications related to the neurostimulation device.


Several methods have been proposed to reduce pain during injection. The main aim to this study was to compare the pain perception in patients receiving palatal injections of local anesthesia using two different computer-controlled local anesthetic delivery systems (C-CLAD) – Dentapen® and The STA Wand®). A randomized, split-mouth and simple blind clinical trial was carried out at the Dental Hospital of the University of Barcelona (Spain) involving a sample of 20 healthy volunteers. Each participant received two palatal injections in the same session (0.3 ml of 3% mepivacaine without vasoconstrictor), using The STA Wand® on one side and the Dentapen® on the contralateral side. The order of the devices and the side of the injections were randomly selected. Pain perception was recorded after each injection using a 10-cm numeric rating scale (NRS). A descriptive and bivariate analysis of the data was performed.p>0.05). The STA Wand® and Dentapen® groups yielded a mean pain score of 2.40 cm (standard deviation (SD) = 1.47, range 0-6) and 2.35 cm , respectively. Most participants referred mild pain (80%), and none experienced severe pain. There were no adverse events. Pain perception was similar with both devices ( In the majority of cases (80%), both C-CLAD devices allow the administration of local anesthetics in the palatal area with mild pain. Both The STA Wand® and Dentapen® are equally effective in reducing pain perception levels for palatal injections. Key words:Computer-controlled local anesthetic delivery, dental anesthesia; palatal anesthesia, The STA Wand, Dentapen. Since most dental treatments might cause pain, local anesthesia is an essential tool to reduce or eliminate pain perception in the dental office. However, patients often express more fear of the injection of local anesthetics than of the dental treatment itself ,2.According to the American Dental Association, dental fear is the most common reason for not visiting the dentist, especially in children and teenagers, as it is associated with pain, discomfort and anxiety ,3. In adLocal anesthesia can cause pain for various reasons, including soft tissue damage during penetration of the needle, pressure on injecting the anesthetic solution and its temperature and low pH . SeveralAlthough traditional syringes are still the most commonly used method to administer local anesthetics ,9, sinceA single-blind, split-mouth, randomized clinical trial involving 20 dental students was performed. The study was conducted at the Dental Hospital of the University of Barcelona (Spain) between April and May 2019 after obtaining approval from the local Institutional Review Board . The study was designed complying with the CONSORT recommendations for clinical trials, and followed the Declaration of Helsinki guidelines. Before enrollment, all subjects were explained the objectives, implications and possible complications of the study and agreed to participate by signing an informed consent.et al. , and the clinical trial of Romero-Galvez et al.  was takeHealthy subjects over 18 years of age (American Society of Anesthesiology (ASA) score I and II) were included. The exclusion criteria were pregnancy, allergy or intolerance to mepivacaine or amide-type anesthetics, patients under treatment with analgesics or drugs that might affect pain perception, and any alteration at the injection site .We used 3% mepivacaine without vasoconstrictor  and short needles 30G 0.3 × 25 mm  in all cases. Local anesthesia was administered by a single researcher (A.R.R.) with The STA Wand®  and Dentapen®  devices. The order of the devices (The STA Wand® or Dentapen®) and the injection side were randomized based on the website http:/www.randomization.com. The decision of enrolling patients in the trial was made before randomization .Before the injection, the patients were notified about the duration of the study and were asked to complete the modified dental anxiety scale (MDAS). The MDAS score ranges from 5 to 25, and patients scoring over 19 are considered to be highly anxious. The participants then received two injections, one with each device (The STA Wand® or Dentapen®), in a symmetrical location of the palate. To make sure that the participants were blinded, a black mask was placed over their eyes, and protective hearing devices were employed during the procedure, since the injection systems produced different acoustic signals.All patients were placed in a similar position (supine position with the head tilted backwards), and topical anesthesia was not employed. Injections were performed in the palatal area between the first molar and second premolar, approximately 3 mm below the papilla Fig. . The neeBoth devices allow control of the flow rate and pressure of the anesthetic solution during injection. The STA Wand® was set with the ControlFlo speed and the Dentapen® system was used with the slow speed setting (90 seconds / ml). The programs of both devices have a comparable speed.Immediately after each injection, the patients were asked to rate pain intensity on a horizontal 10-cm numeric rating scale (NRS) ranging from 0 (“painless”) to 10 (“worst imaginable pain”). Numeric rating scale values ranging from 0 to 3.9 were considered to be comfortable; 4 to 7 cm were considered indicative of moderate pain; and values > 7 cm were classified as severe pain.7 The pain score was regarded as the primary outcome variable.The data were processed using the SPSS version 25 statistical package . Descriptive  and ranges) and bivariate analyses were performed. After checking that the scale variables had a normal distribution (Kolmogorov-Smirnov test), paired Student t-tests were employed to compare the groups.p = 0.902). Fifty percent of the participants referred more pain with The Wand® and 45% with Dentapen®, while 5% experienced the same pain with both devices . The mean pain intensity score was of 2.40 cm  for The STA Wand® and 2.35 cm  for Dentapen® , Fig. 2. devices . None ofThe mean MDAS questionnaire score was 7.5 (SD = 1.43), and 20% and 80% of the participants were classified as moderately and mildly anxious, respectively .No adverse events were recorded in any of the groups.The results of the present study show that both C-CLAD injection systems (The STA Wand® and Dentapen®) seem to yield similar outcomes in terms of pain perception during palatal injections.C-CLAD systems are able to reduce the injection flow at a fixed pressure, regardless of variations in tissue resistance . This efSince both systems performed similarly in the present trial, selection of the most suitable device should be made according to the personal preferences of the clinician.It is interesting to discuss the main differences and limitations of the two tested systems.The STA Wand® consists of three elements: a disposable handpiece, a computer control unit, and a foot pedal Fig. . It is kOn the other hand, Dentapen® is a wireless device in which the control panel is located in the same main unit Fig. . This alet al. , computer delivery controlled-flow injection systems allow the administration of local anesthetics in the palatal area with only mild pain. Both systems (The STA Wand® and Dentapen®) seem to be equally effective in reducing pain perception when palatal injections are needed.


N = 570). Following a telephone consultation and based on preestablished admission guidelines, a decision was made at baseline (T0) to either admit the patient for treatment or perform remote management by providing advice and/or drug prescription. Patients were then followed up systematically at 1 wk and 1 mo. Management failure was defined as the need for emergency admission for patients managed remotely since T0 and for new emergency admission for those admitted at T0. The global follow-up rate of patients with a complete data set was 91.4% (N = 521). Of included patients, 49.3% could be managed without admission for emergency reasons for 1 mo. The proportion of successful management was 71.8% and 90.2% at 1 mo for remote and on-site management, respectively. To conclude, the proposed triage-based emergency management strategy with systematic follow-up was a good compromise between limiting patient admission and ensuring effective symptom relief and pain control. The strategy can be useful in situations where regulation of the emergency patient flow is required.Due to the global coronavirus disease 2019 pandemic, the high risk of cross-contamination and the overload of hospital facilities have resulted in a real urgency for restricting dental emergency patient flow. In this context, the objectives of the current work were to 1) measure the ability of a triage-based management strategy to limit patient admission and 2) evaluate the success rate of both on-site and remote emergency management regarding symptom relief and pain control over a 1-mo period. We included all patients contacting the dental medicine department for an emergency consultation during the lockdown, between April 1 and April 30, 2020 ( In response to the initial outbreak of the coronavirus disease 2019 (COVID-19) pandemic, lockdowns and calls for community discipline were enforced worldwide to prevent the spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus responsible for the disease. All nonessential activities were suspended at the time, both in daily life and in the medical field. With the exception of COVID-19 treatments, medical activities were restricted to emergencies. The determination of an emergency situation was subject to interpretation and without formal guidelines or explicit criteria to support decision making. In this context, reconsideration of dental emergencies was required to ensure continuity of care while addressing the high risk of spreading COVID-19 .It was essential to maintain a dental emergency activity, first to ensure appropriate treatment but also to inform and advise our patients. Dental infection is notably a common and potentially severe condition, arising mostly from dental caries . The sevConsequently, the objectives of the present work were to 1) measure the ability of a triage-based management strategy to limit patient admission over a 1-mo period and 2) evaluate the success rate of both on-site and remote emergency management over a 1-mo period.n = 44) belonging to pediatric, prosthetic, and conservative dentistry and endodontics were involved in emergency management over the lockdown period. There was a daily assignment of 7 practitioners, all sharing treatment, telephone triage duties , and follow-up calls 7 d a week from 09:00 to 20:00.This cohort study conformed to STROBE guidelines and included all patients contacting the dental medicine department of the Cliniques universitaires St Luc  for an emergency consultation between April 1 and April 30, 2020 (inclusive). The COVID-19 data related to this period and location are presented in the Appendix. For all patients, a triage strategy was applied via telephone by the practitioners to determine if the patient required admission based on the admission guidelines . A decisThe admission guidelines were established during the first 2 wk of the Belgian lockdown , based on best-practice recommendations  and valiOur admission guidelines were not binding but indicative, leaving a certain freedom of interpretation to practitioners. The guideline document  was avaiFollowing the treatment decision at T0, a follow-up telephone call was conducted systematically at 1 wk (1W) and 1 mo (1M) . The patOf the 570 patients included at T0, we excluded those showing inappropriate behavior at T0 , those who did not attend despite an admission decision at T0, and those with lack of follow-up at 1W or 1M.Systematic forms were used to collect the data during each phone call.Patient administrative data, symptoms, pain intensity on a 0 to 10 numerical rating scale, medication use, telediagnosis, nonpharmacologic and pharmacologic advice if provided, and the seniority of the dentist in charge of teleconsultation were collected at T0. For admitted patients, the clinical diagnosis and type of treatment provided were also recorded. Pain scale assessment was not collected for children aged <12 y.At 1W, the follow-up teleconsultation aimed to evaluate the efficacy of the treatment prescribed at baseline (T0) . Data collection included the evolution of symptoms compared with the baseline, pain intensity, nonpharmacologic and pharmacologic advice (if provided), or whether the patient had contacted or visited another dentist.At 1M, the follow-up teleconsultation aimed to evaluate the stability of the results achieved at 1W with the addition of COVID-19 status. The latter consisted of 3 categories: no suspicion or diagnosis, suspicion , or confirmed . If an additional advice or treatment was provided at, or between, 1W and 1M, the reasons were also recorded, that is, whether it was due to the resumption of activity of the general dental practitioner  or an emergency visit due to escalating symptoms.The various types of emergency diagnoses were grouped by category for descriptive statistics and statistical analysis  (Appendix).The medications were grouped by 2 categories: 1) antibiotics  and 2) analgesics (ATC codes N02A and N02B) and nonsteroidal anti-inflammatory drugs (NSAIDs) (ATC codes M01A) (separate and combined use).Three categories of dentist seniority were chosen according to the number of years postgraduation .Within the remote management group (patients not admitted at T0), management success was defined as nonemergency admission at any time (≤1M). Within the on-site management group (patients admitted at T0), management success was defined as no further emergency admission (≤1M). An admission to a different treatment facility for emergency reasons was considered in the same way as one in our institution .The first main outcome was the ability to limit patient admission, quantified as the proportion of the included patients who could be successfully managed remotely without the need for emergency admission  over the follow-up period of 1 mo.The second main outcome was the success rate within each group (on-site and remote) over the follow-up period of 1 mo.Secondary outcomes were also considered. First, the evolution of symptomatology and pain intensity (from T0 to 1W and from 1W to 1M) was evaluated in both groups for successful cases that did not require any additional treatment or advice at any time. Second, the risk of COVID-19 infection within the month following emergency dental treatment was evaluated for patients and practitioners involved in the study.P value <0.05 was considered statistically significant. A more detailed description of statistical analysis can be found in the Appendix.Continuous variables were compared between groups using a Kruskal-Wallis test and categorical variables using Pearson χ² or Fisher-Freeman-Halton test. The Wilcoxon signed-rank test was used to compare pain score evolution. Factors associated with admission at T0 and management failure were assessed using a binary logistic regression. A n = 16), the management failures of both groups were grouped together for this analysis.Remote management was decided for approximately two-thirds of the included patients, and the remaining one-third was admitted at T0 . ApproxiP < 0.05) (P < 0.05) in the multivariate regression were not included in N = 64, data not shown).A binary logistic regression was conducted to identify the factors associated with patient admission decision at T0. Admission of patients aged ≥12 y was significantly associated with age, pain score, diagnosis, dentist seniority, and analgesics and NSAID use ( < 0.05) . The varThe proportion of successful management was 71.8% and 90.2% for remote and on-site groups, respectively.The factors associated with admission (management failure) within the remote management group in binary logistic regression are presented in n = 0/20). For patients aged ≥12 y, none of the variables were significantly associated with failure in the multivariate model (P > 0.05) . The large majority of management failures in both groups occurred ≤1W (68.8% for on-site and 74.2% for remote management)  .N = 187 for remote management and N = 127 for on-site management) and pain score (N = 154 for remote management and N = 108 for on-site management). The evolution of symptomatology for the majority of those cases was favorable at 1W and 1M  without any significant differences between groups  were qualified as suspected cases over the patient inclusion period or within the month thereafter.The first major finding was the relative success of our triage-based management strategy, which allowed a high reduction in patient flow since approximately half (49.3%) could be managed remotely without the need for emergency admission within the first month following initial contact. The COVID-19 situation has created unique circumstances in which a dental emergency management strategy involving triage and prospective follow-up was both possible and necessary. Unlike the context of military scenarios or dentistry in remote locations, access to dental care in the current pandemic was possible but restricted as recommended in many countries. Here, the stability of patient symptoms and pain score observed (for 1M) following the emergency management has enabled safe and effective reduction of the demand within emergency clinics.The second major finding was the high proportion of successful management for both remote (71.8%) and on-site (90.2%) strategies. The high success rate of on-site emergency management could be expected since it was performed in accordance with best-practice recommendations. On the contrary, the relatively high success rate of the new approach of remote management, associated with favorable evolution of symptomatology and pain score, was very encouraging. The stability of patient relief between 1W and 1M, despite the high initial level of pain, illustrates the lasting effect of the treatments provided. This was the case with both on-site and remote strategies, which underlines that most dental emergencies involve the management of acute phases (<1W) by means of advice and/or drug prescription or local treatment. The data also show that definitive treatments (if indicated) can be safely postponed for at least 1 mo.The results of the multivariate analysis suggest that the success of remote management could be further improved by slightly revising admission guidelines regarding patients using NSAIDs and those with pulp pathologies, given the higher management failure risk in these patients. The admission decision in patients ≥12 y (constituting most of the sample) was mostly motivated by pain score, diagnosis, analgesics and NSAID use, patient age, and dentist seniority. The first 3 variables confirm a good adherence of the practitioners to the suggested and nonbinding guidelines, whereby admissions increased with intense pain, combined use of analgesics and NSAIDs, trauma, and periapical pathologies. The need for minor adjustments in admission decision making may simply rely on the experience level of each practitioner in the group, since more senior personnel tended to admit more and were associated with a lower proportion of management failure among the nonadmitted patients. Therefore, experience proved useful for interpretation of the guidelines. It may have been expected that the protective effect of patient age regarding admission and the higher risk of severe COVID-19 forms among older patients  would han = 521) and the high global follow-up rate (91.4%). Another important aspect was that such a prospective evaluation at similar timepoints of remote and on-site emergency management strategies has, to our knowledge, never been reported before. Nevertheless, there were perhaps limited reasons for conducting such a study prior to the onset of the current global pandemic. This investigation has provided a new perspective on dental emergency management linked to the degree of emergency rather than the severity of the pathology. Contrary to the latter, the former is compatible with telediagnosis, which is mostly based on patient history, with limited or no clinical or imaging elements available.An apparent strength of this work was the large sample size (The number of practitioners involved and the nonbinding characteristics of the guidelines enabled the applicability of the study in a large clinical facility. No calibration was performed regarding admission decision making due to the urgency of the situation and to allow a more clinically representative situation where dentists with different levels of experience maintained a certain freedom of interpretation. This degree of freedom was also consistent with the Comparison of the data presented in this study with other previous research is impossible due to the novelty of the disease and the absence of similar works. Unlike the current study, the recommendations for dental emergency management available to date have not included any clinical data regarding patient outcomes . FurtherSince the infectious COVID-19 status of patients was not tested at T0, it is not possible to formally conclude the safety of the present strategy with regards to the risk of cross-contamination. However, there is a likelihood that a proportion of treated patients was positive and asymptomatic . In thisThe proposed triage-based emergency management strategy investigated here has provided an effective compromise between limiting patient admission and ensuring their pain control and symptom relief. The information and advice provided remotely need to be combined with a systematic follow-up, which proved significantly beneficial not only for verification of the treatment efficacy but also to reassure the patient. The strategy responded to several points made by a recent J. Beauquis, J.G. Leprince, contributed to conception, design, data acquisition, analysis, and interpretation, drafted and critically revised the manuscript; A.E. Petit, contributed to design, data analysis, and interpretation, critically revised the manuscript; V. Michaux, V. Sagué, contributed to data acquisition and interpretation, drafted the manuscript; S. Henrard, contributed to data analysis and interpretation, drafted and critically revised the manuscript. All authors gave final approval and agree to be accountable for all aspects of the work.Click here for additional data file.Supplemental material, sj-pdf-1-jdr-10.1177_0022034521990314 for Dental Emergencies Management in COVID-19 Pandemic Peak: A Cohort Study by J. Beauquis, A.E. Petit, V. Michaux, V. Sagué, S. Henrard and J.G. Leprince in Journal of Dental Research