Radiotherapy is the standard local treatment for patients with painful bone metastases, but effectiveness has primarily been evaluated in trial populations. The aim of this study was to study pain response to palliative radiotherapy in a prospective cohort of unselected patients with bone metastases.Patients with painful bone metastases referred to the UMC Utrecht for radiotherapy and enrolled in the PRESENT cohort were included in this study. For all patients, pain response to radiotherapy was assessed, and responders were defined as patients with a complete or partial pain response. Patients with stable pain scores, pain increase, or undetermined response were regarded non-responders. Pain scores obtained at baseline and after 2, 4, 6, 8, and 12 weeks following radiotherapy were obtained. Pain response rates of the total treated population, as well as response rates of the assessable patients, were calculated. To measure the percentage of the remaining time spent with pain relief, the net pain relief (NPR) was calculated by dividing the period of pain relief by the period of survival.Of the 432 patients enrolled in this study, 262 patients (61%) experienced a complete or partial response. In the 390 assessable patients, this percentage was 67%. Median time to response was 4 weeks (range 1–15 weeks), and the NPR was 64%.Compared to randomized trial populations, palliative radiotherapy in our unselected patients with bone metastases showed similar pain response rates (61%), with a reasonable duration of this effect. Many patients with cancer develop bone metastases, with pain as a common and severe consequence. Due to improved treatment options for primary tumors and subsequent longer survival, the number of patients with bone metastases is likely to increase. They represent a heterogeneous group with differences in tumor histology, extent of the disease, and expected survival. As the diagnosis of bone metastases often represents incurable disease, the main treatment goal is palliation of symptoms , 2. PallPatients were retrieved from the prospective PRospective Evaluation of interventional StudiEs on boNe meTastases (PRESENT) cohort, which includes all patients with (un)complicated bone metastases referred to the departments of radiation oncology or orthopedic surgery at our center since June 2013 . The PREn = 9), patients not having metastases from solid tumors (n = 18), patients who underwent stereotactic radiotherapy (n = 25), and patients with asymptomatic lesions (n = 27). At our department, patients in good clinical condition with a limited number of bone metastases from favorable tumors are usually treated with long course radiotherapy—with 30 Gy in 10 fractions being the most common long course schedule—but the default radiotherapy schedule is single fraction radiotherapy of 8 Gy.This study was performed after enrollment of the first 500 PRESENT patients. For the present analysis, we excluded patients who did not undergo radiotherapy  to 10 (worst imaginable pain), and the BPI item criteria , completcriteria . SurvivaDescriptive statistics were provided as percentages for proportions, mean and 95% confidence intervals (95% CI), or median and ranges for continuous values. Several proportions of response were calculated: the response rate in the total treated population, the response rate in the population surviving at least 2 weeks after treatment, and the response rate in the assessable population . In addition, two sensitivity analyses were performed: first, a worst-case scenario analysis, assuming all patients without information on pain response to be a non-responder; and a second analysis, in which patients without information on pain response were assumed responders . To explore the influence of the time frame on the pain response rate, pain response was calculated between 4 and 8 weeks following radiotherapy. Pain response rates were assessed for three subgroups: in patients with breast or prostate cancer, in patients with spinal metastases, and in patients in good physical condition. Time to response was measured from date of treatment to date of first response. Survival was measured from date of radiation treatment to date of death or last contact. Response duration was calculated in days in patients who experienced pain relief from the first evaluable date of response to the date of relapse , or in absence of relapse to the date of last assessment or death. Retreatment was considered relapse. To measure the percentage of remaining time spent with pain relief, the net pain relief (NPR) was calculated by dividing the period of pain relief by the period of survival in days and multiplying the result by 100 , 18. RetOf all patients who were invited for the PRESENT study, 87% agreed to participate Fig. . Five huDuring a median follow-up of 3 months, 89 patients (21%) developed new painful lesions outside the initial radiation target volume, which were subsequently irradiated. Median time to irradiation of these new lesions was 17 weeks (range 2–80 weeks). Of these 89 patients, 36 patients (40%) developed new painful lesions within 12 weeks after irradiation of the baseline lesion. Twenty patients (55%) experienced a response before they were treated for a new lesion, 5 patients (14%) did not respond before treatment of the new lesion, and 9 patients (25%) had progressive disease.The 42 patients who did not return the pain questionnaires were different from the rest of the cohort participants; they had more often lung cancer as a primary tumor, were more often treated with single fraction radiation therapy, and their physical condition was worse compared with patients who returned the questionnaires Table . Thirteep = 0.001). Retreatment rate for the entire cohort was 24%, with no significant difference between the patients receiving 8 Gy in a single fraction (26%) and patients receiving long course radiotherapy . Median time to re-irradiation, however, was significantly different between the two groups . The response rate in the population surviving at least 2 weeks after treatment was 63% (95% CI 58–67%). Of all assessable patients, the response rate was 67% (95% CI 62–72%). The two scenario analyses showed different outcomes. In the worst-case scenario analysis, the proportion of response was 61% . In the scenario in which patients with an unknown response were regarded responders, the response rate was 70% (95% CI 66–75%). The period in which pain response rate was recorded was of the influence of the response rate. The response rates between week 4 and week 8 was 51% (95% CI 46–56%) for the total treated population (worst case scenario), and 62% (95% CI 57–67%) for the assessable patients, which is lower than the response rates measured in week 2 to week 12. Median time to response was 4 weeks (range 1–15 weeks). When patients experienced pain relief, the median duration of pain response was 21 weeks (range 0–190 weeks). The NPR in this population was 64% (95% CI 60–66%). The median survival between patients with and patients without a pain response differed significantly .Response rates of 390 patients (90%) were available Table . Responsn = 224) and patients in good physical condition (n = 202) had higher response rates of 70% (95% CI 64%–76%) and 69% (95% CI 63%–76%), respectively  experienced a pain response Table . Patient 95% CI 6%–76%, reIn our prospective PRESENT cohort, pain response rates were 61% in the total treated population and 67% in the assessable patients. Given the median time to response, it is important to inform patients that pain response may still occur after 4 weeks. In line with the literature, pain response for patients with spinal metastases was comparable to pain response in the entire cohort –22, and As long course radiotherapy is, in our department, reserved for patients in a (relatively) good physical condition, it was not surprising that significantly more patients experienced pain relief after long course radiotherapy. Retreatment rates in our cohort were similar between a single dose and long course radiotherapy. This is, however, not in line with randomized trials, as in the Cochrane analyses  retreatmThe pattern of pain response in this unselected cohort of patients with bone metastases is comparable with response rates reported in randomized trials over the past decades. The pooled estimate of the response rates from 29 randomized controlled trials is approximately 60% , 4. Of tThe Dutch Bone Metastases Study is considered a landmark project since it is one of the largest studies assessing the response of patients with painful bone metastases after palliative radiotherapy , 25. In For PRESENT, we systematically approach all patients with bone metastases inviting them to participate. Patients are followed prospectively with extensive measures including patient-reported outcomes and clinical data for a long(er) period of time. Lost-to-follow-up rates are very low in PRESENT (10%) compared to cohorts from other hospitals 19–78%) [8% 7, 2222, 27. RIn 2012, the international consensus guideline was updated to include the NPR in addition to other assessments of pain response. In the PRESENT cohort, the NPR is 64% indicating that responsive patients spent around two third of their remaining life with less pain and without the need for retreatment. Probably, this is an underestimation as there are PRESENT patients who are still alive without reported pain recurrence. It is important to realize that in the last weeks before death, pain intensifies in patients with bone metastases, which has a negative impact on quality of life . AlthougFollow-up in our cohort included data on pain scores and analgesic use, allowing us to report our outcomes according to the international consensus guidelines . Howeverunmasked other lesions appearing more symptomatic. Furthermore, taking analgesic use into account when calculating response is challenging because often other metastatic lesions become (more) symptomatic after the response of the irradiated metastases. In the PRESENT cohort, we enroll all patients with bone metastases, including those patients with multiple painful lesions, possibly lowering the pain response rate. However, the majority of the PRESENT patients (80%) had bone metastases treatable in one target volume. Another limitation might be our time frame of response since we calculated response up to 3 months after radiotherapy. It might be that patients who did not experience pain relief from radiotherapy started with systemic anticancer treatments, such as chemotherapy, hormonal therapy, or even radiopharmaceuticals. It might be that these systemic treatments induced a pain response which was (mistakenly) attributed to radiotherapy and pain response might thus be overestimated. However, as some patients might experience a response even after 12 weeks [We acknowledge that this study has some limitations. As radiotherapy is a local treatment, ideally, the response just to the index lesion is measured. However, it is difficult for patients with multiple lesions to distinguish between painful lesions at relatively small distances and give separate pain scores. As we asked patients to indicate their worst pain score, it might be that radiotherapy was successful for one lesion, but not for another. In fact, treatment to the index lesion might have 12 weeks , we deciIn our cohort, the majority of patients with painful bone metastases treated with palliative radiotherapy experienced pain relief. However, a large proportion of patients did not respond to radiotherapy. New interventions or combination of conventional treatments including radiotherapy, surgery, and systemic treatments for patients with symptomatic bone metastases should aim at improving pain relief. Before implementation in routine clinical care, these interventions are all ideally evaluated in randomized trials. The PRESENT cohort provides an infrastructure aiming at a more efficient evaluation of new (combinations of) treatments. Furthermore, it is important to identify the non-responding patients as they might benefit more from early and proactive palliative care management.


Knee osteoarthritis (OA) is a very common disease in the elderly, and total knee replacement (TKR) surgery is currently considered the most effective treatment. A prospective, observational, repeated measures study was performed to explore the current status and changes in pain and activities of daily living (ADL) in 58 OA elderly patients undergoing unilateral TKR. The Wong–Baker Faces Pain Rating Scale (WBS) for pain and the self-reported Barthel Index for ADL were measured on the day before surgery, 48 hours after surgery, and the day before discharge. Moderate pain was reported before surgery. Pain significantly improved after surgery and before discharge. At all three time points, pain scores were significantly higher in patients who used assistive devices compared to those who did not. Partial independence in ADL was reported before surgery. The ADL scores reported were highest before surgery, and those reported after surgery were lowest. However, ADL scores gradually increased before discharge. ADL scores were higher in the subjects who lived in a detached, single-family homes compared to those who lived in bungalows at all three time points. The results could be used to screen for knee OA elderly patients at high-risk for pain or low ADL and to provide timely intervention strategies as soon as possible. In the elderly, osteoarthritis (OA) is the most common form of arthritis in the knee and is prevalent in East Asia countries. The prevalence of knee OA is higher among women than men and increases with age ,2. The eTotal knee replacement (TKR) surgery is currently considered the most effective treatment for patients with knee OA . In TaiwThe main symptoms of knee OA include experiencing pain particularly when patients moving their knee or at the end of the day, stiffness especially after rest, local hard and soft swelling, and knee joint deformation . ChronicThe relationships between demographic characteristics and pain have been discussed in literature. A previous study of factors related to severity of pain experienced by 1753 knee OA patients over a 6-year period found that risk factors for pain in these patients included obesity, chronic disease, female gender, non-white ethnicity, low education level, and young age . SeveralAlthough some ADL problems are expected shortly after TKR surgery, improvements in ADL are expected over the long term. The Barthel Index (BI) indicates the extent to which the subject can independently perform daily self-care tasks, e.g., eating, dressing, undressing, bathing, brushing hair, etc. ,15. VariThe relationships between demographic characteristics and ADL have also been discussed in literature. One study found that old age, overweight status, and poor ADL before TKR surgery can predict ADL after TKR surgery . HoweverMost recent studies of the effects of pain on ADL after TKR surgery have focused on analysis of long-term follow-up data for pain ,20. EldeA prospective, observational, repeated measures study design was used to investigate changes in pain and ADL during hospitalization after TKR surgery. A sample of consecutive knee OA patients was recruited from the orthopedics ward of a medical center in southern Taiwan. Data were collected with a structured questionnaire. The inclusion criteria were referral for unilateral TKR surgery, age 65 years or older, and ability to communicate in Mandarin or Taiwanese. Patients who met the DSM-IV criteria for mental illness were excluded. Other exclusion criteria were history of stroke, visual impairment, bilateral TKR surgery, cancer, other pain problems, rheumatoid arthritis, or physical disability.The study purpose, process, and measurement procedure were explained to all participants who met the inclusion criteria, and written consent was obtained before data collection. The questionnaires were used to collect demographic data, ADL scale score, and pain scale score. Data collection was performed at three points: before surgery , 48 h after surgery , and before discharge  . The questionnaire required 15–20 min to complete.The study was approved by the Institutional Review Board (KMU-IRB-20120289). Demographic and clinical data, the Barthel Index of Self-Reported ADL, and the Wong–Baker Faces Pain Rating Scale (WBS) were used in this study. In addition, one open question was added and helped to probe for more information regarding patients’ experience with pain or ADL change.The Index of Self-Reported ADL consists of 14 items. Each item is scored from 1 to 7 points, where 7 indicates complete independence (no assistance required) and 1 indicates complete dependence (subject can only perform <25% of the task or is unable to perform the task). Total scores range from 14 to 98 points. Higher scores indicate greater function in ADL: 14 to 20 points indicate complete dependence, 21 to 40 points indicate high dependence, 41 to 60 points indicate moderate dependence, 61 to 80 points indicate moderate independence, 81 to 97 points indicate high independence, and 98 points indicate complete independence. The original ADL scale for assessing functioning after TKR surgery had a Cronbach’s α of 0.86 .The WBS is used to measure pain on a numerical scale . For each number on the scale, the instrument shows a picture of a face to provide a visual depiction of the pain level. The number 0 and a smiling face denote no pain, while the number 10 and a crying face denote the most severe pain. The participants were instructed to indicate the intensity of their pain by circling either the face or the number . The WBSp value <0.05 was considered statistically significant. To show the distribution of data, mean/median and standard deviation were used to represent continuous data. Numbers and percentage were used to describe categorical data. At T1, T2, and T3, repeated measures one-way analysis of variance was used to analyze changes in pain and ADL in the elderly knee OA patients, and repeated measures two-way analysis of variance was used to determine whether pain and ADL were associated with demographic or clinical characteristics. The Scheffe’s least significant difference (LSD) test for consequence comparison was performed for major factors that were statistically significant.The sample size was calculated using G Power statistical software version 3.1 with an effect size of 0.3. For a two-tailed α of 0.05 and a power of 0.8, a sample size of 58 was adequate. Assuming an attrition rate of 10%, a sample size of at least 64 was required. The obtained data were coded and entered into a computer for analysis with SPSS . A n = 46) were female. The mean age of the 58 participants was 74.47 (SD = 4.96) years. The age range was 66 to 83 years (n = 36), and most had an education level below elementary school .A total of 64 eligible knee OA patients were recruited. Of these patients, three refused interviews due to severe postoperative pain, one refused due to postoperative acute renal failure requiring dialysis, and two refused due to fever caused by postoperative urinary tract infection. The resulting valid sample size of 58 represented a completion rate of 90.6%. Most participants . The mean pain score for patients who were illiterate (7.09 ± 1.82) was significantly (p = 0.01) higher than that for patients who had a junior high school education or higher (5.25 ± 2.01). p < 0.001) at T1 (6.36 ± 1.88), at T2 (5.74 ± 1.93), and at T3 (3.28 ± 1.31). An LSD post-hoc analysis showed that the pain score at T3 was significantly lower than that at T1 (p < 0.001) and that at T2 (p < 0.001). p = 0.01). At all three time points, Minnan patients had higher pain scores compared to Mainland Chinese patients. The LSD post-hoc analysis also showed that Minnan patients had significantly higher pain scores compared to Mainland Chinese patients (p = 0.003). Hakka patients also had significantly higher pain scores compared to Mainland Chinese patients (p = 0.04). Additionally, the pain scores at the three time points significantly differed by use of assistive devices (p = 0.04)  . At all p = 0.001). The total mean ADL score in women (92.98 ± 6.58) was significantly (p < 0.001) lower than that in men (96.75 ± 1.86). Additionally, the total mean ADL score in patients who did not use assistive devices was significantly higher than that in patients who used assistive devices (p< 0.001). p < 0.001). In LSD post-hoc analysis, ADL scores at T1 were significantly higher than those at T2 and T3 . The ADL scores at T3 were significantly higher than those at T2 (p < 0.001) (Preoperative ADL significantly differed by gender (< 0.001) .p = 0.02). p = 0.007) and the 75–79 years age group were significantly (p = 0.004) higher than the ADL scores in the 80+ years age group. p = 0.02). Specifically, those who lived in single-family homes had higher ADL scores than those who lived in bungalows (p = 0.04). At T1 and T3, patients who did not use assistive devices had higher ADL scores than those who did use assistive devices. At T3, however, patients who used assistive devices had higher ADL scores than those who did not use assistive devices.ungalows . FinallyThe demographic characteristics of the study were similar to those in previous studies ,23. Chenp < 0.001). In the current study, the pain level measured at the three time points significantly differed by ethnicity (p = 0.01). At all three time points, pain levels were higher in Minnan patients compared to Mainland Chinese patients. The likely reason is that most of the participants in the current study were Minnan. Future research should investigate pain in more ethnic groups. Additionally, the pain levels at the three time points significantly differed between subjects who did and did not use assistive devices. At all three time points, patients who used assistive devices had significantly higher pain levels compared to those who did not use assistive devices. Subjects who use assistive devices tend to have high pain scores because they usually have pain caused by poor joint function.In most of the previous knee OA studies, the duration of follow up was long, and the reported improvement tended to be most obvious at 6 months after surgery . AlthougThe mean total scores for preoperative ADL indicated partial independence in this study. At T1, the ADL items that had the three lowest scores were, in descending order, climbing two to three steps of stairs, walking inside a room, using/getting on and off a toilet, and moving from bed to chair and back. For elderly knee OA patients with knee weakness and pain, the most difficult task was climbing stairs because they could only rely on handrails for added support. At T2 and T3, the ADL items with the three lowest mean scores were—in descending order—climbing stairs, bathing, and moving from bed to chair and back again. Patients who have received TKR surgery have difficulty performing tasks that require stretching in the knee. Climbing stairs was again the most difficult task to perform. Additionally, while undressing and bathing, they may have had difficulty keeping the wound dry and cannot easily bend their knees due to swelling. When moving from bed to chair, they required assistance in moving the affected limb. The use of assistive devices for walking after surgery progressively improved functioning. Kim et al. (2010) tracked 372 Korean women for 12 months after they had received TKR . Of thesIn the current study, the level of ADL at the three time points significantly differed by age. The ADL scores were lowest in patients aged 80 years or older, which is consistent with the literature ,26. The The ADL scores significantly differed by use of assistive devices, and ADL had significant interacting effects with the use of assistive devices. At T1 and T2, ADL scores were lower in patients who had used assistive devices compared to those who had not. Those who had used assistive devices preoperatively due to lack of lower extremity muscle strength or unstable gait were likely to use assistive devices after surgery . At T3, 2 is reportedly associated with low ADL levels after TKR surgery [2) and morbid obesity (40 ≤ BMI < 50 kg/m2) on ADL after TKR surgery. The authors reported that ADL level was significantly lower in those BMI more than 40 kg/m2 [In contrast with previous studies, the ADL scores at the three time points did not significantly differ by gender or by BMI. In previous studies, women have had lower ADL compared to men both before and after surgery, and ADL has shown significant correlations with gender . Compare surgery ,29. Anot40 kg/m2 .A noted limitation of this study was the use of a consecutive sample of patients treated at a single medical center in south Taiwan, which might have contributed to biased the results. In future studies, stratified random sampling is recommended to obtain a sample that represents the overall population. Additionally, the subjects in this study had a high average age. Therefore, some required the assistance of family members to complete the questionnaire. For some participants, the researcher needed to review medical records to obtain correct medical information.This study of knee OA patients undergoing TKR surgery found that those with lower levels of education had a lower pain threshold compared to those with higher levels of education. Therefore, the use of simple language and pictures are suggested to when communicating with TKR surgery patients about pain assessment and pain management . AdditioEven participants who had only received a unilateral TKR had difficulty regaining mobility. To improve these problems, these patients should be advised to use handrails when walking up and down stairs or to avoid using stairs. These patients would also benefit from lower limb muscle training exercises to increase their lower limb muscle strength. After surgery, the patients should wear loose clothing and be careful to keep the wound dry and clean. During bathing, they should use a chair or other device to support their body weight. Long-handled sponges can also make bathing easier. In summary, assistive devices are very useful for patients undergoing rehabilitation. Such devices can accelerate their recovery to normal ADL and can reduce the risk of falls. According to the results of this study, performance of ADL was worst after surgery and improved before hospital discharge. Although not all patients can be expected to achieve the same mobility, knee function, and ADL levels they had before surgery, improvement in ADL is a useful indicator when TKR patients are evaluated for discharge. In future studies, data should be collected at more time points before surgery, including 48 h after TKR surgery, before discharge, and then 1 month, 3 months, 6 months, and 1 year after surgery. The additional data collection would provide a trajectory of data that could be used to evaluate the benefit of TKR surgery and improve recovery. Medical professionals can use the results of this study to screen for high-risk individuals, provide timely intervention strategies, and assist patients in returning to normal ADL as soon as possible.


Eagle’s syndrome is a constellation of signs secondary to an elongated styloid process or due to mineralization of the stylohyoid or stylomandibular ligament or the posterior belly of the digastric muscle. The syndrome includes symptoms ranging from stylalgia  to foreign-body sensation in the throat, cervicofacial pain, otalgia, or even increased salivation or giddiness.We describe a clinical study of 12 patients with Eagle’s syndrome, along with their clinical profile and the treatment offered. Patients were diagnosed based on history and clinical examination, as well as the Xylocaine 2% tonsillar fossa injection test. A visual analog scale (VAS) was used for comparison of pain before and up to 3 months after treatment. Radiology  was used for further exploration. Nine patients underwent tonsillo-styloidectomy surgery and three underwent medical treatment with pregabalin (75 mg/day).The majority of surgically-managed cases (88%) achieved a definitive benefit by tonsillo-styloidectomy surgery, whereas all medically managed cases achieved only short-term pain relief.Besides the common throat diseases, the symptoms associated with Eagle’s syndrome may be similar to those due to cervicofacial neuralgias, dental, or temporo-mandibular joint diseases. Diagnosis is primarily based on symptomatology, physical examination and radiographic investigations, and should not be missed. Treatment by tonsillo-styloidectomy produces satisfactory results in stylalgia. However, the syndrome was named after Watt W. Eagle who described stylalgia in 1937  of the stylohyoid ligament complex. Various sources suggest the possibility that Eagle’s syndrome was identified as early as the 17It seems that diagnosis of the condition is liable to be missed because the number of cases in the population remain underestimated. This is due to the varied and non-specific characteristics of symptoms and the patient’s search for treatment within various specialties such as otolaryngology, neurology, dentistry, and psychiatry. In this study, we intend to describe various clinical and radiological profiles of patients with Eagle’s syndrome and evaluate the results after treatment.This was an institution-based study in which all patients diagnosed with Eagle's syndrome in our hospital during the 3-year duration from January 2013 to December 2015 were included. The follow-up period of these patients was a minimum of 3 months after treatment. The diagnosis of Eagle’s syndrome was made by a history of a chief complaint of intractable throat pain, either dull aching or a pricking sensation in the tonsillar region, which often radiated to the side of the neck, along with a tender feeling on palpation of the prominent styloid process in the tonsillar fossa. Coexistent gastro-laryngopharyngeal reflux (GLPR)/ gastroesophageal reflux disease (GERD) was treated to rule it out as the cause of chronic throat pain.0 (meaning no pain) to 10 (meaning severe intolerable pain); all patients had a VAS score between 7 and 9 at presentation. The lengthened styloid process was confirmed on radiology by a mouth-open Towne’s view X-ray or an orthopantomogram (OPG) , a numerical-pictograph objective tool often employed for the measurement of pain severity. Patients were asked to indicate the severity of the pain felt according to a scale ranging from am (OPG) .Additionally, computed tomography (CT) scans with three-dimensional (3D) recons- truction were performed .A diagnosis of Eagle’s syndrome was further confirmed by the Xylocaine injection test, in which 2 ml of 2% Xylocaine was infiltrated into the tonsillar bed on the affected side with the palpable styloid process in a method similar to the one advocated by Singhania et al. . These patients were managed conservatively with medical treatment  and showed pain relief by more than two-thirds on the VAS scale. At 3 months follow-up, a decrease in pain severity by more than two-thirds of the pre-operative score was considered successful treatment.Out of a total of 12 patients, nine were female and three were male . The mean age of patients was 46 years, with the youngest patient presenting at 28 years and oldest at 80 years of age .The duration of symptoms was less than 1 year in six cases, 1–3 years in four cases, and more than 3 years in two cases. Most (10/12) of the symptomatic cases were unilateral, while two were bilateral. Bilateral radiological elongation was seen in nine cases and unilateral elongation was seen in three out of the 12 cases. Radiologically, the longest styloid measured was 4.6 cm in length, while the shortest was 2.8 cm. Medial angulation in reference to a theoretical vertical midline on OPG or CT scan was observed in seven patients and anterior elongation was observed in three patients . Ten patCoexistent GERD/GLPR was seen in seven patients. During the 3 months of follow-up, four patients had complete pain relief, three by styloidectomy and one patient by pregabalin . Seven patients achieved satisfactory (i.e. more than two-thirds) pain reduction, five patients by styloidectomy and two by medication . One patient treated by styloidectomy had no pain relief and continued with a VAS score of 8. After the end of 3 months follow-up, two out of a total of three patients treated medically had a recurrence of pain symptoms  on discontinuing the treatment. The results were collected, tabulated, and analyzed as shown in .Eagle first defined stylalgia as associated with a lengthened styloid process or due to mineralization of the stylohyoid ligament complex . It was Eagle assessed the incidence of an elongated styloid process in the overall population to be 4%, of whom only 4% were symptomatic . SimilarAlthough styloid process elongation is seen bilaterally in most cases, patients are usually symptomatic unilaterally for stylalgia despite the presence of bilateral elongation ,14. The The syndrome is diagnosed clinically by digital palpation of the tonsillar fossa whereby a sharp pointed hard structure is felt, which on pressing aggravates the pain. Furthermore, stylalgia can be confirmed clinically by the Xylocaine injection test, in which 2% Xylocaine is injected into the tonsillar bed, after which the patient has a significant decrease in pain intensity , althougDepending on the intensity of pain and odynophagia, treatment may vary from a medical to a surgical line of management. For surgical excision, two approaches have been used; the extraoral and the intraoral approach, both of which have various modifications and advantages. The extraoral approach is preferred by some authors mainly because of improved visualization and a lower chance of deep neck space infection. The intraoral approach is usually employed by otolaryngologists who are familiar with the technique of tonsillo-styloidectomy. In our study, all eight surgically treated patients were operated on by the intraoral procedure of tonsillo-styloidectomy. Fortunately, none of the operated cases developed any complications owing to meticulous surgical technique and good post-operative care. In 88% of patients, tonsillo-styloidectomy provided excellent relief at 4 weeks postoperatively. These observations are comparable with other studies. For example, Singh et al. reported a 95% success rate, and 96% success was observed by Yavuz et al. Similarly, Yadav et al.  reportedDifferential diagnoses include various headaches, facial pain and neuralgias, neck pain, ear, nose, and throat diseases, psychosomatic disorders and inflammatory and neoplastic disorders in the head and neck region which need to be ruled out before concluding a diagnosis of Eagle’s syndrome in order to deliver the appropriate treatment ,21.Eagle’s syndrome is an entity in which the symptoms are related to an elongated styloid process. Diagnosis mainly relies on a history and clinical examination, aided by radiology; however, not all elongated styloid processes seen radiologically cause stylalgia. We advocate styloidectomy as an estimable modality of the treatment in stylalgia, but proper selection of patients for surgery is important for proven cases of chronic throat pain due to Eagle’s syndrome so that maximum relief of symptoms is achieved.


Childbirth ranks amongst the most painful experiences a woman has to endure. In developing countries issues related to awareness, acceptability and availability of analgesia exist. This study aims to assess the knowledge, attitude and practices for labor analgesia amongst healthcare workers and patients.We performed a cross-sectional study conducted at Shaikh Saeed Memorial Campus of The Indus Hospital (TIH), Karachi. The study was performed in November 2016. Two surveys were conducted for this study; one for healthcare workers with patient interaction and second on patients attending their first antenatal clinic. The participants were asked to complete a survey following consent.A total of 71 healthcare workers and 1005 patients participated in the study. Among healthcare workers, 43.7% felt that pain relief should be administered, 14.1% believed analgesia had adverse effects on fetus and 11.3% reported increased risk of cesarean section. Results from patients showed 27.9% were aware of labor analgesia and when informed, 85.2% were willing to have labor analgesia. In 14.1% of patients, labor analgesia was unsupported as they stated being a mother meant to endure pain.There is a wide gap between knowledge and practice of labor analgesia. Healthcare workers have a role in educating women, to be advocates for labor analgesia and to educate patients timely for this service. Childbirth is one of the most painful experiences of a woman’s life. A lack of knowledge regarding the birth process and pain during labor and delivery can influence a woman’s attitude towards childbirth. The American Society of Anaesthesiologists, American College of Obstetricians and Gynecologists and National Institute of Clinical Excellence in the United Kingdom recommend provision of education to expectant mothers on the options and availability of effective pain relief for labor.3Labor analgesia in high income countries focuses on methods and complications, while in low and middle income countries (LMICs) awareness and availability of services are of concern5A number of studies have been conducted worldwide, specifically in Africa to determine patient factors.7This study aimed to assess the level of awareness, knowledge and attitude of healthcare staff and patients on their first visit to the antenatal clinic towards labor pain and labor analgesia.We performed a cross-sectional study after obtaining the necessary institutional and ethical approvals (IRD_IRB_2016_10_002). This study was conducted at Shaikh Saeed Memorial Campus of The Indus Hospital (TIH), Karachi during November 2016. TIH is a free-of-cost hospital located in Korangi, serving many low-income communities in Karachi.All staff members with patient contact  and all patients attending the antenatal clinic on their first visit, in November 2016, were invited to participate. Both groups of participants completed the same questionnaire as part of this survey.The questionnaire was adopted from a study performed by Nabukenya et al.On average the translated survey took 10 minutes. Each question examined a single idea (no questions contained “and”) and no questions were phrased in a negative form. Answers were in yes/no/neutral or pain scores on a scale of 0 to 10. The questions were asked via a trained investigator (First Author).Data were entered and analyzed using SPSS version 24.0. Mean ± Standard Deviation (SD) and Median  were computed for all quantitative variables. All the categorical variables were presented as frequencies and percentages. Chi-square test was applied to assess association between various categorical variables. Mann-Whitney U-test was applied to assess difference in quantitative variables between the continuous variables. P-value <0.05 was considered statistically significant.A total of 71 participants were enrolled in the study and their demographics are given in On questioning about methods available for pain relief in labor (multiple answers were acceptable), 74.6% (n=53) reported both regional anesthesia and pain killers, 25.4%(n=18) reported general anesthesia, followed by local anaesthesia 16.9% (n=12) and counseling 21.1% (n=15) only. Moreover, participants reported systemic opioids with adjuvants as the most common means of pain relief during labor (36.6% n=26), followed by systemic opioids only  and regional anesthesia  .On enquiring about their (HCW) perception regarding pain relief in labor, almost half (43.7%) felt that pain relief should be practiced and has no adverse effect. Some believed it prolongs labor (29.6%), others (14.1%) replied that it affects the fetus adversely, and 11.3% reported increased risk of Cesarean section. No significant association of age groups, qualification and designation was found with perception of pain relief in labor .With regards to timing of analgesia counselling, two-thirds of HCWs said that pregnant women should be approached at the antenatal stage, 19.7% at the time of admission and 15.5% at the time of labor. However, none were in favor of not counseling the women for labor analgesia. Moreover, results showed that higher proportion of technicians felt that counseling should be done at the time of admission and of labor as compared to doctors, nurses and mid-wives (p=0.001) .A total of 1005 pregnant women, median age (IQR) of 26 (24-29) years were included in this study. Of these, 135 (13.4%) were illiterate, 213 (21.2%) had primary to secondary education, 651 (64.8%) had higher than secondary school education (6 had missing data regarding education). Almost all the illiterate patients reported that they can neither read nor write.Most women  were multigravida. Of these, the majority  reported that they had labor pain for four to 12 hours in previous deliveries. Some had less than four hours of pain  and others 13 to 18 hours of pain  previously. However, 67 (9.6%) reported labor pain of more than 18 hours in their last delivery. Additionally, when asked about severity, most multigravida women reported severe  or moderate  pain in their last delivery. Only 35 (5.0%) reported no pain.On enquiring about delivery fears, most  reported they were moderately afraid of delivery complications, followed by great fear in 39% (n=392) and only 30 (3.0%) reported no fears at all. More than half of respondents  reported excessive fear to labor pain followed by moderate fear  and no fear to labor pain .There was a significant association of fear of delivery complications and fear of labor pain in the multigravida group (325 (46.6%) and 349 (50%) for moderate and severe pain respectively, p-value 0.037). A very small percentage of primigravida reported no fear of delivery complication or fear of labor pain 2.6%(n = 8) and 3.3% (n = 10) respectively .Out of the total respondents, only 280 (27.9%) were aware of labor analgesia. Amongst them most  reported doctors as source of information, followed by friends  and family . The remaining patients (n=29) did not respond.Respondents were given complete information regarding labor analgesia and asked if they are willing to receive this or not. The majority (85.2%) showed willingness to receive labor analgesia while 14.1% reported non-willingness and 0.7% did not respond. Patients willing to get labor analgesia were older as compared to those unwilling (p<0.0001).Of those who did not show willingness for epidural , 35 (25%) reasoned labor pain a natural process that did not need intervention, 40 (28.6%) believed that motherhood required endurance of these pains, whereas 33 (23.6%) were not confident about the procedure.It was found that women who reported fear of labor pain showed interest in receiving labor analgesia (p<0.0001). Out of these women, most were ready to pay for it (82.5%), whereas, 17.2% refused to pay. In addition, unwilling women were asked if they would consider free-of-cost labor analgesia. Despite this option, 102 (72.5%) of them showed continued reluctance towards receiving the intervention and 36 (25.4%) agreed to it. The remainder  did not respond.Less than half of participant HCWs were of the opinion that labor analgesia should be practiced. Meanwhile, amongst patients, despite most being multigravida, only 27.9% of the total were aware of labor analgesia. Upon learning about labor analgesia, 85.2% were willing to get analgesia for labor pain. This suggests a wide gap in knowledge and perceptions of labor analgesia in both HCWs and patients.10 and a lack of exposure to training and knowledge of labor analgesia was seen.The findings of patient knowledge regarding labor analgesia are consistent with other studies from the subcontinent.To the best of our knowledge, this is the first study where knowledge and attitude of HCWs were surveyed for labor analgesia in Pakistan. The HCWs knowledge regarding labor analgesia and its different modalities is lacking, specifically in nurses and technicians. Yet HCWs coming in direct contact with patients can be a source of valuable information to pregnant women and their relatives regarding labor and labor analgesia. There appears to be lack in training regarding labor analgesia among healthcare workers this finding is similar to other studies.12Less than a third  of patients were their options for pain relief. After getting information, most elderly patients were willing to receive analgesia for duration of labor. These findings are similar to those found in similar studies from other LMICs.It was conducted in consecutive patients coming to the antenatal clinic in one full month and in a single center located in a low-income area. The results may vary if the study was done in a private setting and/or if patients with higher level of education or higher socio-economic status were interviewed. A multi-center study of both patients and healthcare workers will give a much through picture of the knowledge gaps and attitude towards labor analgesia.This study shows a large gap in knowledge of HCWs as well as patients regarding labor analgesia. All HCWs in obstetric units should have appropriate level of knowledge to counsel patients regarding labor and labor analgesia. The majority of patents have insufficient knowledge of it but once informed, are willing to avail the service, irrespective of cost. Hence, information about it should be available to all patients.MA: Patient Data collection and manuscript.SFS: Conception, design of study and editing manuscript, takes the responsibility for integrity of research.AK: Healthcare worker data collection and tables.NG: Statistical analysis of healthcare worker data.


Pain drawings (PDs) are an important tool to evaluate, communicate, and objectify pain. In the past few years, there has been a shift toward tablet-based acquisition of PDs, and several studies have been conducted to test the usefulness, reliability, and repeatability of electronic PDs. However, to our knowledge, no study has investigated the potential role of electronic PDs in the clinical assessment and treatment of inpatients in acute pain situations.The aim of this study was to evaluate whether knowledge of the patients’ electronic PD has the potential to improve the doctors’ understanding of their patients and to influence their clinical decision making. Furthermore, we sought to identify differences between electronic PDs of patients and their treating pain specialists in an acute pain situation and to find those specific characteristics derived from the PDs that had the largest impact on doctors’ understanding.We obtained electronic PDs from 47 inpatients in acute pain situations before their consultation with a pain specialist on a tablet personal computer with a stylus. Before looking at their patients’ drawings, these specialists drew their own conception of the patients’ pain after anamnesis and physical examination. Patients’ drawings were then revealed to the doctors, and they were asked to evaluate how much the additional information improved their understanding of the case and how much it influenced their clinical decision on an 11-point Likert scale . Similarities and differences of patients’ and doctors’ PDs were assessed by visual inspection and by calculating Jaccard index and intraclass correlation coefficient (ICC) of the pain area and the number of pain clusters. Exploratory analyses were conducted by means of correlation tables to identify specific factors that influenced doctors’ understanding.P<.001) and to a lesser extent their clinical decision . Electronic PDs of patients and doctors showed fair to good similarity for pain extent  and widespreadness  were important factors helping doctors to understand their patients.Patients’ PDs significantly improved the doctors’ understanding (mean score 4.81, SD 2.60, In a clinical setting, electronic PDs can improve doctors’ understanding of patients in acute pain situations. The ability of electronic PDs to visualize differences between doctors’ and patients’ conception of pain has the potential to improve doctor-patient communication. Pain is a very complex and subjective phenomenon. It is regarded as a symptom of an underlying condition or as a condition of its own. For adequate medical treatment, however, it is compulsory to classify the reported pain. Hints to the correct pain diagnosis are given by a pain assessment looking at the intensity of the pain, its distribution and duration, as well as the quality of the pain. Despite many new technological advances, however, objectification of pain is still an unsolved problem . Asking In this study, we examined the potential role of electronic PDs collected on a tablet PC in the clinical assessment and treatment of inpatients in acute pain situations. Therefore, we evaluated if knowing the patients’ PDs improved the pain specialists’ understanding of their patients and influenced their clinical decision making. Furthermore, we sought to identify differences between PDs of patients and doctors and to find those specific characteristics of the drawings that had the largest impact on doctors’ understanding.To this end, we collected electronic PDs from a sample of inpatients that received a consultation by a pain specialist from acute pain service (APS) because of severe pain . We then asked the pain specialists to draw their own impression of the patients’ pain after anamnesis and physical examination but without having seen the patients’ drawings. PDs of the patients were then revealed to the doctors, and they were asked to evaluate how much the additional information improved their understanding of the case and how much it influenced their clinical decision. Similarities and differences of patients’ and doctors’ PDs were assessed by statistical image analysis and visual inspection. Finally, exploratory analyses were conducted to identify specific factors that had the greatest impact on doctors’ understanding of the patients.Our study population were inpatients from different departments of Hannover Medical School. All patients were in acute pain situations that required a consultation by a pain specialist, which is provided by members of the APS. APS members visit the patients and adjust their pain management individually according to the requirements of each patient’s situation. Eligible patients were adult (age ≥18 years in Germany) inpatients of Hannover Medical School with acute pain and the ability to give written informed consent. Furthermore, they had to be physically able to complete an electronic PD on a tablet PC. We recruited 69 patients  for participation in our study, and all of them prepared a PD. Due to a technical failure of the tablet PC, 1 drawing was lost. The treating pain specialist prepared a PD for 61 of the remaining patients, all of which were included in the analysis. Of these 61 patients with complete data, however, only 47  were discussed and rated because of the absence of some of the treating pain specialists during the meeting of the APS in the afternoon (see below). Characteristics of the final study population can be found in The study was approved by the Ethics Committee of Hannover Medical School (#2987-2015) and was conducted in accordance with the Declaration of Helsinki. All patients gave written informed consent after information of the purpose of the study.Data collection was divided into 3 steps: (1) the patient draws a PD shortly before the consultation, (2) the pain specialist draws a PD of the same patient directly after the consultation based on anamnesis and bodily examination results, and (3) the pain specialist rates the patient’s PD’s influence on his or her understanding of the patient as well as on clinical decision making.Two of the authors (NS and AA) screened all patients on schedule for consultation by the APS. All eligible patients were informed about the study purpose and asked for participation after checking inclusion criteria. Written informed consent was obtained, and patients were asked to rate their pain intensity on an 11-point NRS ranging from 0 for “no symptom” to 10 for “maximum imaginable intensity.” Next, the use of the tablet PC and the SymptomMapper app  was explConsultation by the APS consisted of anamnesis and clinical examination by a member of the service. All members participating in the study were anesthesiologists with at least 5 years of clinical experience and either pain specialists or in training for pain specialization. On the basis of the anamnesis and findings of the physical examination, doctors drew their patients’ pain and related sensations during or immediately after the consultation but before seeing the patients’ drawing. They used the same kind of tablet PC and app like the patients. However, in addition to pain and related sensations, they were also free to draw pain-related symptoms such as allodynia, hyperalgesia, erythema, swelling, hyperhidrosis, and muscular defense. After doctors had finished their PD, they continued with their usual clinical procedures, such as starting the pain treatment or modification of an ongoing treatment.Patients’ PDs were shown to the doctors during the meeting of the APS in the afternoon, where each new patient is reviewed and treatment options are discussed. When discussing a study participant, we revealed his or her PD to all doctors, and they were free to discuss it. After the meeting, the doctors were asked for their anonymous rating of the following 2 questions: (1) “How much did the electronic PD improve your understanding of the patient?” and (2) “How much did the electronic PD influence your clinical decision?” Both questions were followed by an 11-point Likert scale from 0 for “not at all” to 10 for “very much.” Doctors were only allowed to rate PDs from patients that they themselves were treating.All electronic PDs were acquired on tablet PCs type Samsung Galaxy Note 2014 edition 10.1 (SM-P600) running Android 5.1.1 with an electronic pen (stylus) based on inductive digitizing technology. The tablet had a 10.1-inch touch screen with a resolution of 800×1280 pixels, and its stylus was used for all data entry. In contrast to entering data by finger on the capacitive touchscreen, the tablet records stylus interactions with a separate inductive digitizer, which allows for a higher resolution while eliminating unwanted activation of the screen, for example, by the palm.We used SymptomMapper , a softwIn the symptom specification module, users were asked to specify any pain-related symptom in an iterative process. They first chose the type of sensation from the following list of descriptors (in German): burning, cold, cramping, dull, electric, heavy, hot, numb, pressing, pricking, shooting, stabbing, tender, throbbing, tingling, and tugging. Next, they rated the intensity of the sensation on a visual analog scale, ranging from “no symptom” to “strongest imaginable intensity.” Finally, they entered the perceived depth of the sensations by choosing among different depth descriptors.In the drawing instructions module, the user was asked to color every point of the body outline where the specified pain sensation or related symptom was present and to use all available body views. Other ways to mark a body region, such as hatching, ticking, or marking by arrows or other symbols, were explicitly prohibited.In the final module, users were shown a body outline of matched sex to draw the location of the symptom or finding specified in the previous module. Drawings could only be made using the tablet’s stylus, and drawing was restricted by the app to within the borders of the body outline. Adherence to the other drawing instructions was checked by the author supervising the drawing process (NS or AA). After finishing the drawing, users could either choose to end data entry or to add another symptom, which would bring them back to symptom specification.The doctors’ version of the app differed only slightly from the patients’, in that its symptom specification module provided the user with a list of common pain-related diagnostic findings in addition to the list of pain descriptors.All statistical calculations were done in R version 3.4.3   and Micrt test. Here and in all further statistical tests, a P value of .05 or less was considered significant.The average of doctors’ ratings of improvement in understanding and influence on clinical decision were individually tested for their difference from zero using a 1-sided 1-sample We extracted the following data from each PD for statistical analysis: (1) number of drawn pixels (pain extent), (2) number of clusters, (3) number of body views used in PD, (4) number of symptom descriptors, (5) average intensity per symptom, and (6) widespread pain index . The firt tests for all quantities mentioned above. Furthermore, we assessed the similarity of doctors’ and patients’ PDs by means of the Jaccard index and by calculating intraclass correlation coefficients ; Shrout and Fleiss classification) for the pain area and the number of symptom clusters. Both indices were calculated separately for each body view and averaged over all body views excluding those that were empty in both the doctors’ and the patients’ PD. When the drawing contained multiple pain symptoms, they were merged, and the maximum intensity was used for each pixel.To identify potential systematic differences between doctors’ and patients’ PDs, we calculated 2-sided paired We further calculated the average pain distribution of all patients for visual comparison by pixel-wise averaging of all these individual drawings using FSL Maths. Doctors’ and patients’ PDs were analyzed independently. Due to the large diversity of pain states and syndromes encountered in our study sample, we did not attempt a direct statistical comparison of the data. The final images were thresholded to show only those body regions where at least 10% (5/47) of all users had drawn a symptom. This was an arbitrary threshold used to reduce the impact of single drawings with very large pain areas. As doctors’ and patients’ drawings were thresholded the same way, it does not obscure any differences between the 2 but allows the reader to focus on relevant areas.To identify factors of relevance that improved doctors’ understanding of their patients’ pain, we calculated cross- correlation coefficients for the ratings of improvement in understanding and the quantities derived from the patients’ PDs (see above).P<.001) and to a lesser extent their clinical decision . Results are shown in Knowing patients’ PDs significantly improved the doctors’ understanding of their patients  than the doctors, who used 2.43 (SD 1.30) descriptors. The average pain distribution drawn by patients and doctors and the frequencies of pain descriptors are shown in P<.001) and thresholded clusters (P=.01). Pain extent, average pain intensity, and the number of nonempty body views on the other hand showed no significant differences between patients and doctors.Patients drew on average 1.25 (SD 0.53) pain symptoms, a number closely matched by the doctors’ who drew 1.34 (SD 0.64) symptoms. With 3.34 (SD 2.82) different pain descriptors, patients described their pain more detailed  and the WPI  as calculated from the PD , whereas WPI showed a tendency .Exploratory cross-correlation analysis revealed that the understanding of pain was influenced most strongly by 2 factors: the area of the pain as drawn by the patient . There are 2 possible explanations for the fact that a relatively large improvement in understanding resulted in rather modest changes in clinical decision. First, in the majority of cases, additional pain clusters drawn by the patients do not lead the physicians to new diagnoses that would require additional medical investigation or intervention. Instead, most of these clusters reveal previously diagnosed chronic pain sources that are unrelated to the acute problem. To take one of our examples (patient number 2 from The similarity of PDs from patients and their treating doctors observed in our study was considerably lower compared with studies looking at test-retest reliability of PDs in chronic pain patients. We found only fair reproducibility for pain extent (ICC: 0.57) and poor reproducibility for the number of pain clusters ICC: 0.37). In contrast, Barbero et al and Neubert et al, using PDs from different chronic pain populations, found ICCs from 0.92 to 0.97 for pain extent 7. In con. ResultsThe above-mentioned issue raises the rather philosophical question, which of the drawings contains the correct information. On the one hand, only the patient is able to perceive the symptoms that are expressed in the PD. As several studies have shown, generating a PD is a highly reproducible and reliable process ,16. ThusIn our opinion, both patients’ and doctors’ PDs are valid drawings in their own right. When analyzing their contents, however, it must be acknowledged that they do not represent the same thing and that there may be systematic differences that will influence the results of the analysis. These differences will be discussed in the next section.In our study, we did not find significant differences between patients’ and doctors’ PDs regarding pain extent, average pain intensity, and the number of body views used in for the PD. Together with our findings regarding the low similarity of doctors’ and patients’ drawings, this means that both groups drew about the same number of pixels with the same intensity but in different places on the body. We further found that doctors used significantly fewer pain clusters and symptom descriptors than patients when drawing their pain symptoms. There are several possible explanations for this. On the one hand, it is likely that doctors’ drawings exhibit less specificity of pain location than the patients’, simply because some level of information loss is to be expected for verbal communication of bodily symptoms. This can be seen in Our innovative methodology of electronic PD analysis allowed us to extract a variety of information from the acquired PDs. This included characteristics such as the area of pain, average intensity, and WPI  as well When looking at differences between patients’ and doctors’ PDs, however, only the absolute differences in pain area improved the doctors’ understanding. Thus, an over- or underestimation of pain area by the doctor made seeing the patient’s PD valuable for the doctor. Among other things, this finding indicates that doctors do consider information from the patients’ PD as being “correct.”Although our study was not aimed at comparing electronic PDs with their pen-on-paper counterparts, we would nevertheless like to emphasize the advantages of using the electronic version. In the last 10 years, several research groups have developed PD apps to be used on tablet computers -7,28. A Although our study has reached the planned aims, there were some limitations that we could not avoid. First, our sample consisted of inpatients in acute and often severe pain. Thus, the accuracy of completing PDs may have been lower compared with, for example, chronic pain patients that have had some time to adapt to their pain. Of course, such lower accuracy will also influence all further analyses, for example, regarding similarity of patients’ and doctors’ PDs. Second, our procedure of rating the improvement in understanding and influence on clinical decision was suboptimal as only the treating doctor was allowed to give a rating and this rating was anonymous. This made it impossible to assess potential bias, for example, by certain doctors, giving only good or bad ratings. Furthermore, we did not ask for the explicit reasons why a PD was considered helpful or why its knowledge did or did not influence clinical decision. Third, our sample size of 47 patients was rather small and may have led to false-negative results in all analyses directly comparing patients with doctors. Finally, the fact that all doctors that rated the impact of the patients’ drawings on their understanding and clinical decision also prepared drawings themselves may be seen as a confound. Although we believe that the instructions for rating were unmistakably aimed at the impact of seeing the patients’ drawing , we cannot rule out the possibility that the act of drawing may have confounded the rating in some individuals.Future studies should assess the importance of patients’ PDs independently from that of PDs made by the doctors, that is, compare doctors using the app with those not using it. Furthermore, it would be desirable to assess improved understanding of the patient by more objective means than self-report.We have shown that in a clinical setting, electronic PD can improve doctors’ understanding of patients in acute pain situations based on their own judgment. The ability of electronic PDs to visualize differences between doctors’ and patients’ conception of pain has the potential to improve doctor-patient communication.


Multimodal analgesia may include pharmacological components such as regional anesthesia, opioid and nonopioid systemic analgesics, nonsteroidal anti-inflammatories, and a variety of adjuvant agents. Multimodal analgesia has been reported for a variety of surgical procedures but not yet for lower limb amputation in vasculopathic patients. Perioperative pain management in these patients presents a particular challenge considering the multiple sources and pathways for acute and chronic pain that are involved, such as chronic ischemic limb pain, postoperative residual limb pain, coexisting musculoskeletal pain, phantom limb sensations, and chronic phantom limb pain. These pain mechanisms are explored and a proposed protocol for multimodal analgesia is outlined taking into account the common patient comorbidities found in this patient population. Multimodal analgesia, a concept first articulated by Kehlet and Dahl , is now Patients will benefit from multimodal combinations that hold favourable profiles when considering the specific requirements of both their particular surgical procedure and their medical comorbidities , 3, 8. LMultimodal analgesia has not been described in this patient population as it has been for other surgical procedures , 8. ThisLower limb amputations are commonly performed as a consequence of long-term damage from peripheral vascular disease and diabetes mellitus. The complexity and challenge in managing pain in patients undergoing LLA begins with our limited understanding of the exact pathophysiology and mechanisms underlying the preamputation and postamputation phenomena. These patients may experience several different types of pain  following LLA . In factThe majority of patients who require LLA typically have lengthy histories of ischemic limb pain and have been established on analgesic regimes that may include high doses of opioid . TherefoAlthough common, phantom limb pain (PLP), a neuropathic pain, is difficult to prevent and treat since the exact underlying mechanism for the development of this phenomenon remains unknown . While nAssociated musculoskeletal pains such as back, hip, and knee pain have been identified as issues in the majority of LLA patients postoperatively . Such coLower limb amputations are commonly performed on individuals who are predominantly elderly and have significant comorbidities. In the vasculopathic patient, significant coronary atherosclerosis is common. In fact, LLA may be associated with a 30-day mortality as high as 17% . Prior tAn assortment of pharmacological agents has been proposed for use in LLA, which may be utilized in a multimodal analgesia regime . It is iWith respect to multimodal analgesia, perhaps the most profound opioid-sparing effect may be seen with the use of regional anesthesia. Immediately following amputation, there is a continuous barrage of painful sensory input that results in inflammatory changes both peripherally and centrally. Regional anesthesia interferes with the transmission of painful stimuli along the pain pathway to the cerebral cortex .Over the years, a variety of regional anesthesia techniques have been described in the treatment of LLA. Initial reports suggested promise with the use of epidural analgesia preoperatively to prevent or reduce PLP for amputation patients . HoweverIn contrast, a recent study did show that optimized epidural or systemic analgesia initiated 48 hours preoperatively was indeed effective in reducing PLP at 6 months . In factAnticoagulation issues, however, are common in the perioperative period for the vascular amputation patient which may preclude the use of central neuraxial regional anesthesia techniques. The perineural analgesia technique obviates such concerns, while providing benefits of an extended regional blockade of painful somatic stimuli postoperatively. Unlike continuous epidural or spinal anesthesia, continuous perineural analgesia is simple to administer, circumvents risks and costs, and avoids the complications of hemodynamic alterations in this highly susceptible patient population , 44, 45.Fisher and Meller introduced the use of an intraincisional nerve block catheter, positioned at the distal end of the sciatic or posterior tibial nerve, which is inserted by the surgeon at the time of lower limb amputation . PatientThis surgically placed sciatic CPNB catheter infusing local anesthetic has been shown to reduce opioid requirements and provide improved pain relief immediately and in the early postoperative phase following LLA , 28, 47 Opioids are not added into CPNB infusions but are ordered concurrently, either orally or parentally, with other nonopioid analgesics to manage patients' pain following LLA. Complications related to this technique are rare. Patients in Fisher and Mellor's study did not complain of PLP for approximately one year following amputation . UnfortuThe optimal duration for CPNB infusions is unknown, but an average duration of treatment of 4 to 5.5 days following LLA has been described , 47, 48.Opioids remain the mainstay for treatment of acute pain following any surgery. Choice of opioid and dosing should be individualized and determined by the patient's preoperative opioid requirements, age, liver, and renal function. Long-term use is not recommended as patients may develop tolerance, chemical dependence, and the potential for opioid-induced hyperalgesia . In factIn contrast, there is some evidence that opioids may interrupt central cortical reorganization where PLP is thought to originate . MorphinNonopioid and nonsteroidal anti-inflammatory drugs (NSAIDs) are appropriate for alleviating postsurgical inflammatory pain but not for the prevention of neuropathic PLP. Acetaminophen is an effective analgesic for mild to moderate pain, results in few side effects, and has a relatively safe profile. It is recommended that acetaminophen be administered only to a maximum 4000 mg daily (for only 3–5 days duration), less for debilitated patients and used cautiously for individuals with liver impairment .It may be reasonable to add a low-dose NSAID in the short term or for treating breakthrough pain, as long as renal function is adequate and there are no contraindications. However, routine or long-term use of NSAIDs is not recommended because of the increased risk for gastrointestinal and renal toxicity in this patient population .A variety of drugs that have shown promise in the treatment of neuropathic pain have also been investigated in the treatment of acute and chronic pain after LLA. These include gabapentinoids, NMDA receptor antagonists, antidepressants, lidocaine, calcitonin, clonidine, and Botulinum neurotoxin. Unfortunately, some of these agents have not been tested in controlled studies . SeveralIf an adjuvant was utilized preoperatively, it should be resumed in the postoperative multimodal analgesia regimen. If postoperative pain control becomes an issue, the gradual initiation of an adjuvant may be trialled . The oveGabapentin has opioid-sparing effects that may be beneficial in limiting the development of opioid tolerance, if opioids are also being prescribed. However, its efficacy in treatment of PLP is inconclusive, with dose-limiting side effects of somnolence, dizziness, headache, and nausea , 20–22. The NMDA receptor antagonists ketamine and dextromethorphan have provided some benefit in reducing PLP in the short term , 20–22. With regard to antidepressants, amitryptyline was determined to have inconsistent benefits in the treatment of PLP , and 22.Only variable results were observed in the treatment of PLP with calcitonin , and 21.A “best practice” multimodal protocol for managing pain following LLA was created for vascular patients at our acute care hospital . This prThis protocol was developed to promote a consistent way to relieve pain in the preoperative and early postoperative phases for amputation patients, minimize opioid use and its side effects, facilitate recovery, enable earlier physiotherapy, and enhance functional outcomes. In fact, a recent large study with the use of such stump catheters has indeed confirmed its benefits and safety . Of partPerioperative pain management of patients undergoing LLA is indeed complex and challenging. The mechanisms of pathophysiology that underlie the postamputation phenomena of pain remain incompletely understood. Despite these issues, it is hoped that implementation of a strategy utilizing a multimodal analgesia protocol will address and enable pain control management at these multiple complex levels and pathways. Pain following LLA may interfere with an individual's functioning, psychological well-being, and may even result in the development of chronic pain. Thus, it is important for all health care practitioners caring for patients undergoing LLA to be aware of the various analgesic options and interventions available in order to implement an aggressive pain management plan that best promotes recovery and rehabilitation. The multimodal analgesic protocol proposed here represents a compilation of commonly used agents that have been shown to be effective for LLA. Further inquiry is required to develop insight into additional approaches  that may


Groin pain is a frequent complaint in surgical practice with an inguinal hernia being at the top of the differential diagnosis. The majority of inguinal hernias can be diagnosed clinically. However, patients with groin pain without signs of an inguinal hernia on anamnesis or physical examination provide a diagnostic challenge. If ultrasonography shows a hernia that could not be detected clinically, this entity is called a clinically occult hernia. It is debatable if this radiological hernia is the cause of complaints in all patients with inguinal pain.The objective of this study is to assess whether watchful waiting is non-inferior to endoscopic totally extraperitoneal (TEP) inguinal repair in patients with a clinically occult inguinal hernia.The EFFECT study is a multicenter non-blinded randomized controlled non-inferiority trial. Adult patients with unilateral groin pain and a clinically occult inguinal hernia are eligible to participate in this study. A total of 160 participants will be included and randomized to TEP inguinal hernia repair or a watchful waiting approach. The primary outcome of this study is pain reduction 3 months after treatment, measured by the Numeric Rating Scale (NRS). Secondary outcomes are quality of life, cost-effectiveness, patient satisfaction and crossover rate. Eight surgical centers will take part in the study. Participants will be followed-up for 1 year.This is the first large randomized controlled trial comparing treatments for patients with groin pain and a clinically occult inguinal hernia. To date, there are no interventional studies on the effect of surgery or a watchful waiting approach in terms of pain or quality of life in this subset of patients. A trial comparing the outcomes of the two approaches in patients with a clinically occult inguinal hernia is urgently needed to provide data facilitating the choice between the two treatment options. If watchful waiting is not inferior to surgical repair, costs of surgical repair may be saved.NTR6835) registered on November 13, 2017.The study protocol (NL61730.100.17) is approved by the Medical Ethics Committee (MEC-U) of the Diakonessenhuis, Utrecht, The Netherlands. The study was registered at the Netherlands Trial Registry (The online version of this article (10.1186/s13063-018-2711-7) contains supplementary material, which is available to authorized users. Groin pain is a frequent complaint in surgical practice that encompasses a large number of possible etiologies. A well-known cause of groin pain is an inguinal hernia. Elective inguinal hernia correction is the most commonly performed operation worldwide with an estimated 30.000 procedures in the Netherlands annually .In the majority of cases, an inguinal hernia can be diagnosed clinically. A classical hernia presents as a reducible groin swelling with a positive cough impulse , with or without the presence of discomfort. However, patients with groin pain without signs of an inguinal hernia on anamnesis or physical examination provide a diagnostic challenge.For patients with groin pain in whom no swelling can be identified, current guidelines advise ultrasonography of the groin, followed by MRI if ultrasonography is inconclusive , 3. WhenHowever, it is debatable if in all cases a symptomatic inguinal hernia truly exists or whether the hernia on additional imaging is an incidental finding with an alternative cause for the pain complaints. The radiologic finding might even be false-positive in some cases. Considering this, it is likely that not in all patients with a clinically occult hernia a surgical procedure is justified, and it is possible that (chronic) pain complaints persist or increase after surgery. This consideration is important for adequate patient information and avoidance of unnecessary surgical interventions.The incidence of groin pain in combination with a clinically occult inguinal hernia is not well described in literature. A prospectively registered database kept in the Hernia Clinic of the Diakonessenhuis  shows inguinal pain without symptoms of an inguinal hernia on physical examination or anamnesis but presence of an inguinal hernia on ultrasonography in 9.5% of patients.Up till now, there are no studies performed specifically focusing on the course of pain and quality of life after correction of a  occult inguinal hernia or a watchful waiting approach. A trial comparing the outcomes of the two approaches in patients with a clinically occult inguinal hernia is urgently needed.The objective of this study is to assess if watchful waiting is non-inferior to endoscopic totally extraperitoneal (TEP) inguinal repair in patients with a clinically occult inguinal hernia.The EFFECT trial is designed as a non-blinded, randomized controlled non-inferiority trial comparing surgical treatment by TEP repair to watchful waiting in patients with a clinically occult inguinal hernia. This study is conducted in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice guidelines. The independent ethics committee of the Diakonessenhuis Utrecht (MEC-U) has approved this study protocol (protocol number NL61730.100.17). Eight Dutch centers participate in this study: Diakonessenhuis Utrecht/Zeist, Meander Medical Center Amersfoort, Onze Lieve Vrouwe Gasthuis (OLVG) Amsterdam, Maasstad Hospital Rotterdam, Maxima Medical Center (MMC) Veldhoven, Elkerliek Hospital Helmond, Rode Kruis Hospital (RKZ) Beverwijk and Treant Care Group Hoogeveen.Patient recruitment started on December 29, 2017. Written informed consent will be obtained from all participants by the study coordinator. Inclusion will take up to a maximum of 2.5 years and participants will be followed up for 1 year in total. The total duration of the study will be 3.5 years. All study participants will be asked to fill out written questionnaires at different time points  and will be scheduled for physical examination by experienced hernia surgeons at two additional time points at the surgical outpatient clinic for the purpose of this study Participants can withdraw from the study at any time, for any reason.Randomization, collection and storage of study data will take place through a uniform electronic case report form (eCRF).A SPIRIT figure and checklist for this study protocol are provided in Fig. .Adult patients with groin pain and a clinically occult inguinal hernia are eligible to participate in this studyAll patients presenting to the outpatient clinics of participating centers are physically examined by experienced hernia surgeons and screened for trial eligibility Fig. . PatientAge ≥ 18 yearsUnilateral groin painNo features of an inguinal hernia on anamnesis No features of an inguinal hernia on physical examination Radiological diagnosis of an inguinal hernia on ultrasonographyEach subject must meet the following inclusion criteria:Previous inguinal hernia on the symptomatic sidePrevious surgery in inguinal region of the symptomatic sideBody mass index (BMI) ≥ 40American Society of Anesthesiologists (ASA) classification > IIIFactors that complicate follow-up by means of questionnaires Unwillingness to undergo surgeryA potential subject who meets any of the following criteria will be excluded from participation:After informed consent is obtained, the study coordinator will directly randomize patients to either TEP repair or a watchful waiting approach by means of an online random treatment generator, stratified by center.The surgeon, patient and coordinating researcher are not blinded for the allocated treatment.At baseline, all participants are asked to fill out electronic questionnaires. Also, all participants will undergo X-ray and magnetic resonance imaging (MRI) of the pelvis, to be able to assess baseline comparability of the groups in a later stage. The surgeon will be blinded to the outcomes of these investigations and they do not influence treatment. Only in rare severe cases (e.g. a tumor or fracture) radiologists are instructed to contact the treating physician.Patients will be randomized to TEP inguinal hernia repair or a watchful waiting approach.The patients randomized to an operative treatment will undergo endoscopic totally extraperitoneal (TEP) inguinal hernia repair. This procedure will be standardized according to current guidelines in all participating centers , 3.A preperitoneal synthetic mesh will be placed in a standardized manner. Perioperative findings  hernia classification, presence of a lipoma) and perioperative complications are recorded in the operation chart , 3.After induction of general anaesthesia, a sub-umbilical incision is made. The anterior rectus sheath is divided transversely to expose the rectus muscle, which is retracted laterally. A 10 mm trocart is inserted into the preperitoneal space after which the preperitoneal space is created digitally  and insufflated. A 5 mm trocart is placed at midline between umbilicus and symphysis, after which the pubic bone and cavum Retzii are dissected. Below the level of the epigastric vessels lateral dissection takes place, and a second 5 mm trocart is placed laterally. . A possible lateral hernia sac is dissected with identification of the vas deferens and vessels. A possible medial of femoral hernia is reduced. The peritoneum is dissected cranially. Possible lipomas are identified and reduced or resected. A synthetic mesh is introduced and positioned against the anterior abdominal wall, covering the internal ring, the femoral canal and the medial space. Next, under endoscopic sight the preperitoneal space is desufflated, and all trocarts are removed. The rectus sheath is closed with vicryl, the dermis is closed with monocryl.Patients are discharged at the day of surgery, unless complications prohibit early discharge.Participants are advised to avoid strenuous physical activity during the first postoperative week.A selected number of trained surgeons will perform TEP hernia repair. Hereby, we maintain quality of the operations and minimize differences in success rates. Surgeons in the participating centers have completed their learning curve and are sufficiently experienced  in TEP inguinal hernia repair.Patients in the watchful waiting study arm will be treated with rest, pain killers and optional physical- and/or physiotherapy. It is expected that the patients in this group will present with a variety of complaints and will not experience the same (intensity of) complaints, therefore we cannot standardize the treatment in this study arm. Intensity and frequency of this treatment will depend on the amount of complaints the individual patient is experiencing and is expected to differ between patients. The decision to offer physical- and/or physiotherapy will be in the hands of the treating physician, who will decide if he or she suspects the kind of complaints where physical- and/or physiotherapy will be of help.The primary outcome will be pain reduction after 3 months, measured at rest and during physical activity. The first pain score is obtained at baseline. The first three questions of the validated EuraHS Quality of Life (EuraHS-QoL) reflect intensity of pain on an 11-point numeric rating scale (NRS) (0–10 where 0 reflects “no pain” and 10 reflects “the worst possible pain”) . PatientSecondary outcomes include quality of life, cost-effectiveness, patient satisfaction and crossover rate. Quality of life will be assessed by the validated EuraHS-QoL and Euro Quality of Life-5D-5 L (EQ5D-5 L) questionnaires at baseline, and 1.5, 3, 6 and 12 months postoperatively [Cost-effectiveness will be based on all resources used within and outside the hospital and productivity loss for both groups of patients. The acquired data will consist of all health care professional visits, hospitalizations, imaging, biochemical investigations and surgery. Health care use will be monitored through the medical consumption questionnaire (MCQ), a generic instrument for measuring health care use and calculating medical costs, at 1.5,3, 6 and 12 months after treatment . We aim Patient satisfaction will be measured at 3 and 12 months after treatment. The measuring instrument for the outcome parameter patient satisfaction is a self-designed 11-point scale ranging from 0 (“no satisfaction”) to 10 .The crossover rate will reflect the percentage of patients initially assigned to the watchful waiting group that crosses over to surgical treatment.Other study parameters include baseline characteristics , perioperative outcomes  and postoperative complications. Also, the percentage of clinically occult hernias in the watchful waiting group that develop into clinically overt inguinal hernias will be assessed.The sample size determination is based on the assumption that a watchful waiting approach is non-inferior to a TEP inguinal hernia correction; from this assumption there is no expected difference between the difference scores of both groups. No consensus exists concerning a minimal clinically relevant difference on the NRS, though previously published literature describes a difference of one point . We usedThe primary outcome measure is the difference in pain intensity  3 months following treatment compared to baseline. Difference scores of the NRS (posttest minus pretest) will be used in both treatment groups. The NRS score will be used as a continuous variable. For comparison of difference scores an ANCOVA will be used, in which the estimated difference in pain scores will be corrected for the pain intensity at baseline.Continuous secondary outcomes 3 months following treatment will be analyzed similarly to the primary outcome, with an ANCOVA on the difference scores correcting for baseline scores. Outcome measures at 1.5,3,6 and 12 months following treatment will be analyzed using linear mixed-effects models to adjust for repeated measurements within individuals. Contrasts will be used to investigate differences between the study arms at the post-treatment time points.The primary analysis of outcome parameters is an intention-to-treat analysis. Primary and secondary outcomes 3 months after treatment will also be evaluated only for the patients who remained in the arm to which they were randomized .Data will be analyzed by means of IBM SPSS Statistics version 23 or higher .This is the first randomized controlled trial comparing surgery to a watchful waiting approach in the specific subset of patients with a clinically occult inguinal hernia.The current guidelines provide no clear advice on the treatment of the particular subset of patients that has a clinically occult inguinal hernia , 3. To dA trial comparing the outcomes of the two approaches in patients with a clinically occult inguinal hernia is urgently needed to provide data facilitating the choice between the two treatment options. With this trial, we aim to determine which treatment strategy is the most (cost-)effective for this particular subset of patients. If watchful waiting is non-inferior to surgical repair, costs of surgical repair and complications may be saved.The study was opened to recruitment in December 2017. Recruitment is ongoing. The duration of the study period will be 3.5 years.Additional file 1:SPIRIT checklist for recommended items to address in a clinical trial protocol and related documents. (PDF 104 kb)