For many years, cataracts have been the main cause of vision loss and vision impairments in the world . Currently, the most common surgical method for treating cataracts is phacoemulsification. The aim of this study was to assess the pain perception and acceptance of illness connected with awaiting phacoemulsification cataract surgery under intravenous drip anesthesia, as well as to determine the effect of selected sociodemographic factors on the above. Methods: The study was conducted in a group of patients of the Department of Ophthalmology, University Clinical Hospital in Białystok, Poland suffering from cataracts, who underwent phacoemulsification surgery under intravenous drip anesthesia. The study group consisted of 151 people. The study used an original short questionnaire and three standardized psychometric scales: The acceptance of illness scale (AIS), the Beliefs about Pain Control Questionnaire (BPCQ), and the Coping Strategies Questionnaire (CSQ). Results: The median overall AIS point value was 24 points, which is considered an average score in terms of disease acceptance. Respondents assessed the influence of individual factors on the level of perceived pain and the impact of individual strategies for coping with pain similarly. The level of perceived pain decreased with the patient’s age. People with a higher education level experienced a greater level of pain; however, this relationship was not statistically significant. The place of residence did not affect the level of pain experienced during the procedure. Women had a greater level of acceptance of illness. The respondents’ education level negligibly differentiated the approach to the disease. The place of residence also did not affect the assessment of illness acceptance as measured by the AIS. Whether the surgery pertained to the first or second eye did not significantly affect the approach to the disease. Conclusions: The level of acceptance of illness and pain perception were at a moderate level among the patients. The acceptance of illness was significantly influenced by the age of patients and the waiting period for phacoemulsification, and this level of acceptance decreased significantly with the increasing age of patients. The longer the waiting period for surgery, the lower the acceptance of illness. Sex significantly differentiated the level of pain experienced during the procedure. Education and place of residence did not significantly affect the acceptance of illness and the feeling of pain. For many years, cataracts have been the main cause of vision loss and vision impairments in the world  . The incCurrently, the most common surgical method used to treat cataracts is phacoemulsification. This consists of breaking down the cloudy lenses with the help of ultrasound, and removal of the resulting broken fragments. Phacoemulsification can be used at any stage of cataract development. In place of the removed lenses, a lens is implanted with appropriately selected optical parameters. The advantages of this method include being able to perform the procedure under intravenous drip anesthesia, short duration, and lack of need for hospitalization .Vision disorders are associated with limitations of mobility, everyday activities, and physical acuity . Loss ofIn recent years, there has been rapid development in the research on mutual interactions between pain as a physiological process and its perception by the individual ,9,10. PaAdaptation to and acceptance of illness play an important role in both the control and self-control of diseases. Acceptance of a given disease greatly affects a person’s self-esteem and ability to adapt to existing limitations which, in turn, determine the subjective quality of life . The litThe aim of the conducted study was to assess pain perception and acceptance of illness after phacoemulsification cataract surgery under intravenous drip anesthesia, as well as to determine the effect of selected sociodemographic factors  on the above. An analysis of the literature did not uncover any publications on similar subjects in ophthalmology. It was assumed that the perception of pain after phacoemulsification was at the level of three to five points on the numerical rating scale (NRS). In addition, we surmised that the degree of acceptance of the illness in the group of patients with cataracts would be moderate and comparable to the degree of acceptance of other somatic diseases, such as diabetes, respiratory diseases, and cardiovascular diseases.The study was conducted in a group of patients of the Department of Ophthalmology, University Clinical Hospital in Bialystok, suffering from cataract, who underwent phacoemulsification surgery under intravenous drip anesthesia. The study group consisted of 151 people. Men accounted for almost half of the analyzed population. The largest group of respondents (every third studied person) were patients aged 71–80. Every fifth patient was over 81 years old. Among the respondents, the majority had a vocational education , every sixth respondent completed high school, and 23% had a higher education. In the studied group, the vast majority of people were professionally inactive, 66% were retired, and every fifth person received a pension. More than half of the studied patients were married, and almost every third respondent had lost his/her spouse. The percentage distribution of inhabitants of villages and cities was almost even. The vast majority of the respondents lived with their family (spouse or children). Only 14% of the respondents lived alone, and less than every tenth stayed with a caretaker. The respondents’ detailed sociodemographic data characteristics are shown in Criteria for inclusion in the study included written consent to participate in the study, in addition to having phacoemulsification cataract surgery under drip anesthesia in the course of one-day hospitalization. Each participant could withdraw from the study at any time.Participant selection was intentional. For the study to be representative, the authors aimed to collect at least 150 fully completed questionnaires. More copies of the research tool were distributed (283); however, not all of the questionnaires were returned. A significant percentage of the people included in the study resigned from participating while completing the questionnaire. The response rate was 53.36%, and the attrition rate was 46.64%.The study was conducted from February to June 2019. The respondents received paper questionnaires, which they filled in with the help of an interviewer (a member of the research team) in the hospital up to two hours after the phacoemulsification procedure was completed, after providing detailed instructions for completing the questionnaires. The research conforms with the Good Clinical Practice guidelines, and the procedures followed were in accordance with the Helsinki Declaration of 1975, as revised in 2000 . The study was reviewed and approved by the Bioethics Committee of the Medical University in Białystok (statute no. R-I-002/232/2016).The study used an original short questionnaire and three standardized psychometric scales: The acceptance of illness scale (AIS) by B. J. Felton, T. A. Revenson, and G. A. Hinrichsen, translated into Polish by Z. Juczyński; the Beliefs about Pain Control Questionnaire (BPCQ) by S. Skevington, translated into Polish by Z. Juczyński; and the Coping Strategies Questionnaire (CSQ) by A. K. Rosenstiel and F.J. Keefe, translated into Polish by Z. Juczyński.The original questionnaire consisted of eight closed-ended single-answer and multiple-choice questions. The questions concerned coexisting eye diseases; coexisting systemic diseases; the time of the decision to undergo cataract surgery from the moment of diagnosis, expressed in years; the period of waiting for surgery after enrolling in the queue, expressed in months; information about which eye was operated on and the place where the surgery was performed; and sources of information about the anesthesia used during the cataract surgery.The questionnaire also asked about the severity of pain during the use of drip anesthesia. The numerical rating scale was used for this purpose. The NRS is easy to use and has been shown to have a high sensitivity and reliability compared with other scales employed for pain measurement. It contains 11 degrees of pain intensity, from 0 to 10, where 0 means a complete absence of pain and 10 indicates the worst imaginable pain. This scale is characterized by a significant reproducibility of results and is useful in scientific applications. Due to the fact that it is easy to understand for patients and easy to use, it is currently recommended in clinical practice for both acute and chronic pain .AIS statements express certain difficulties and limitations resulting from health status. The level of acceptance of an illness is shown through a lack of negative reactions and emotions associated with the disease. The AIS can be used to measure the acceptance of any disease. The scale has eight questions describing the negative consequences of poor health pertaining to the limitations imposed by the disease, lack of self-sufficiency, feeling of dependence on others, and reduced self-esteem. In each statement, the respondent determines his/her current state using the five-point Likert scale (from 1 “I definitely agree” to 5 “I strongly disagree”). Definite agreement (one point) expresses bad adaptation to the disease and strong psychological discomfort, while disagreement (five points) indicates acceptance of the disease. The overall score ranges from eight to 40 points. The higher the score, the greater the acceptance of the condition and the less negative emotions associated with the disease. A low score is considered to be less than 20 points, and values above 30 points signify a high level of acceptance of one’s disease, while an average score ranges from 20 to 30 points. Interpretation of the obtained results also depends on the average acceptance rates in different groups of patients. The Cronbach’s alpha for the method is 0.82 ,20.Internal factors;The influence of doctors (the power of others);Random events ,21.The BPCQ refers to scales measuring the localization of control, including health control. It is used to assess the strength of individual beliefs regarding pain control by means of the following:No, I completely disagree;I disagree;I rather disagree;I rather agree;I agree;Yes, I completely agree ,21.The Cronbach’s alpha for the whole scale is 0.75, and for subscales, the influence of doctors is 0.86, the internal localization of pain control is 0.82, and the influence of random events is 0.58. The BPCQ is designed to examine adult patients complaining of pain. It can also be used to measure beliefs about pain control in people who currently do not complain of pain. The questionnaire can be used in the diagnosis and treatment of patients with pain, whether treated in the hospital or as outpatients. The questionnaire consists of assessing the content of the given statements on a six-point Likert-type scale:The results cannot be presented as a single indicator. The sum is calculated separately for each dimension of the location of pain control. The range of possible points is from five to 30 for the internal control and from four to 24 for the other two dimensions. A higher score reflects stronger beliefs that the pain can be controlled by the influence of one factor ,21.Active coping ;Diverting attention and taking substitute actions ;Catastrophizing and hoping (catastrophizing and praying/hoping) ,22.The CSQ contains 42 statements describing different ways of coping with pain, as well as two questions about the assessment of one’s own coping skills and pain reduction. The methods of coping with pain reflect six cognitive strategies and one behavioral strategy which, in turn, are part of the three following factors:The evaluation uses a seven-point Likert-type scale. A result ranging from 0 to 36 points is calculated for each strategy. The higher the score, the more important the method for coping with pain. In the case of questions about the degree of mastery and the possibility of reducing pain, the results range from zero to six. The higher the score, the more important are one’s own coping skills and the ability to reduce pain ,22.The questionnaire is used to assess the strategies for coping with experienced pain and their effectiveness in controlling and reducing pain, and is intended for examining adult patients complaining of pain in an outpatient or hospital setting. Previous studies have confirmed that the CSQ is a reliable and accurate measurement tool, and the psychometric characteristics of the Polish version of the questionnaire are satisfactory. The reliability was measured by Cronbach’s alpha as 0.80. A comparison of CSQ results with those of BPCQ has been shown to confirm the theoretical validity ,22.p < 0.05.Data were prepared using Microsoft Excel 2013 and statistical analysis was conducted using STATISTICA 13.3 software. The results are presented in the form of a summary of descriptive statistics in the compared groups . Two groups were compared using Mann-Whitney’s test, and in case of three groups, the Kruskal-Wallis test was used. In addition, the chi-square test of independence was also used. The selection of a nonparametric test resulted from a fairly significant asymmetry in the distribution of pain intensity, as described in detail in the Results section. The results were considered statistically significant at In the discussed group, in addition to the treated cataract, every third person suffered from glaucoma, and a slightly lower percentage (28%) from inflammatory diseases. Additional diseases coexisting with eye diseases most often included diabetes, hypertension, and atherosclerosis. Detailed data are presented in Half of the respondents decided to undergo cataract treatment within one year of diagnosis. The waiting period for surgery was up to half a year for every second patient, up to one year for every fifth person, and over a year also for around every fifth person .Almost two-thirds of the respondents (62.3%) had undergone surgery of the first eye, and the remaining patients (35.7%) had undergone surgery of the second eye. Three people (2.0%) did not answer the question.The vast majority of phacoemulsification procedures  had been performed at the Department of Ophthalmology of the University Clinical Hospital in Białystok. The remaining 7.7% of respondents (n = 19) had undergone treatment at other medical facilities.For the majority of the studied patients, medical personnel in the form of doctors and nurses were the main sources of information about anesthesia .The median overall AIS point value was 24 points, which is considered an average score in terms of disease acceptance . Almost Respondents assessed the influence of individual factors on the level of perceived pain similarly, and the median value of the impact of all three measures on pain control on the BPCQ scale was 40 points . The anaAs with the BPCQ, respondents assessed the impact of individual strategies for coping with pain similarly. The highest median value (17 points) was obtained in the case of praying/hoping, and the lowest was obtained in the case of increased behavioral activity. p = 0.0069). It was significantly higher in the group of women by 1.5 points, on average. The maximum pain level was felt by about every fourth man and almost every other woman.Sex quite clearly differentiated the level of perceived pain during surgery .The level of perceived pain decreased with the patient’s age, which resulted from the analysis of descriptive statistics, mainly the average and median. However, the difference between the groups was not so large that these conclusions could be considered fully reliable .p values, is presented in A detailed summary of the effect of selected sociodemographic characteristics on the occurrence of pain with the use of drip anesthesia, taking into account selected descriptive statistics and p obtained with the Mann–Whitney test was 0.0626) and the adjective classification , was close to statistical significance.Women had a greater level of acceptance of illness. The difference between sex, both in relation to the numerical values .Whether the surgery pertained to the first or second eye did not significantly affect the approach to the disease . Van Damme-Ostapowicz et al.  presenteInterestingly, the mean point value on the AIS among breast cancer patients in studies conducted by Polish authors was significantly higher than in our study ,25. A hiPatients with ulcerative colitis had an even higher mean value of illness acceptance using the AIS . The wasAn assessment of illness acceptance using the AIS, conducted among patients with chronic obstructive pulmonary disease by Uchmanowicz et al. , showed The statistical analysis conducted in our study did not show a correlation between sex and acceptance of illness. The study by Chrobak-Bień et al. also reached the same conclusion . These rThe statistical analysis also included age. Our study indicated a statistically significant negative correlation between age and the level of average values for the AIS. The older the patients, the lower the average level of illness acceptance. Cipora et al.  and Sierp = 0.12). An analysis of the results of the study by Staniszewska et al. [When studying the effect of education level on the acceptance of illness, no statistically significant correlation was found. Chrobak-Bień et al.  showed ta et al.  did not a et al. , who stua et al. , who stua et al.  and Szafa et al. , who exaIn our study, we did not find any statistically significant differences in the level of illness acceptance depending on the place of residence. Cipora et al. noted a similar relationship . HoweverPatients have different strategies for reducing pain. Our study showed that the respondents’ perception of pain was average. Most of the respondents assessed the effect of all three measures on pain control included in the BPCQ similarly. The BPCQ results in the study by Czerw et al.  showed tIn the case of older people, Cybulski et al.  showed tOur research showed that sex statistically significantly differentiated the level of pain experienced during the procedure. It was significantly higher in the group of women. However, there was no significant correlation between the level of pain and the patients’ age. Cybulski et al.  found noOur study showed that people who were better educated perceived pain as more severe; however, there was no statistically significant correlation in this case. Krajewski et al. came to the same conclusions in their study , while CWhen analyzing the place of residence, we found that patients in rural areas had significantly higher pain reduction abilities compared with patients living in urban areas. Krajewski et al. drew similar conclusions . HoweverThe effect of the waiting time for treatment on the subjective feeling of pain was close to the level of statistical significance, whereas the nature of this effect was complex. A higher level of pain was felt by people waiting for surgery for periods that were both relatively short  and relatively long .The conducted study showed that the respondents experienced more pain during the operation of the first eye than the second eye. Gayadine-Harricham et al.  reportedThe study showed that a longer waiting time for surgery enhances the perception of pain, and first-eye surgery is felt to be more painful than second-eye surgery. Therefore, in order to improve the quality of patient care, the waiting time for first-eye surgery should be reduced as much as possible, while the waiting period for second-eye surgery may be a little longer. Clinically, the study showed that the ideal solution would be a controlled administration of anesthetic drugs during phacoemulsification, depending on the patient’s pain. Currently, at the University Clinical Hospital in Białystok, anesthetics are administered only immediately before the procedure, which may affect the level of pain sensation after the surgery.This study had some limitations that need to be considered. They include the cross-sectional nature of the study and the use of only self-report questionnaires. Another limitation of our study was that the group of patients was too small. The sample size, which included data from a clinic located in one hospital, is too small to generalize conclusions that are representative of all patients with cataracts. However, this study could be a starting point for further research on the effect of sociodemographic variables on the acceptance of an illness and the pain perception in patients with cataracts after phacoemulsification. For this purpose, longitudinal studies are justified.The studied group was characterized by an average level of acceptance of the disease and the perception of pain. Patient age and the waiting time for phacoemulsification cataract surgery significantly affected the acceptance of illness. The level of acceptance of illness dropped significantly with the patient’s age, and the longer the waiting period for the procedure, the lower the acceptance of illness. Respondents’ sex and whether the operation pertained to the first or the second eye had a statistically significant effect on the perception of pain. Sex quite clearly differentiated the level of pain experienced during the procedure, and the patients who were operated on for the first time had significantly more pain complaints than patients who had undergone a second surgery. No significant relationships were found between the education level and place of residence and the level of acceptance of illness and perception of pain.


Chronic pain has become a major health problem across the world, especially in older adults. Unfortunately, the effectiveness of medical interventions is modest. Some have argued that assessment strategies should be improved if the impact of medical interventions is to be improved. Ecological momentary assessment using smartphones is now considered the gold standard in monitoring in health settings, including chronic pain. However, to the best of our knowledge, there is no randomized controlled trial to show that telemonitoring using a smartphone app can indeed improve the effectiveness of medical treatments in adults with chronic pain. The goal of this study will be to explore the effects of using a smartphone app for telemonitoring adults with chronic pain.The study will be a randomized controlled trial with three groups: treatment as usual (TAU), TAU+app, and TAU+app+alarms. All groups will receive the adequate treatment for their pain, which will be prescribed the first day of study according to clinical guidelines. Assessment in the TAU group will be the usual at the Pain Clinic, that is, a paper-and-pencil evaluation at the onset of treatment (beginning of study) and at follow up . The other two groups  will be assessed daily using Pain Monitor, a smartphone app developed by our multidisciplinary team. Telemonitoring will only be made in the TAU+app+alarms group. For this group, physicians at the Pain Clinic may decide to adjust pain treatment in response to alarms. Telemonitoring is not the usual practice at the Pain Clinic and will not occur in the other two groups (TAU and TAU+app), so no changes in treatment are expected in these groups after the first appointment. The total sample size will be 150, with 50 patients in each group. The assessment protocol will be the same in all groups and will include pain intensity and side effects of the medication (primary outcomes), together with several pain-related variables like pain interference, activity level, use of rescue medication, pain catastrophizing, and pain acceptance, among others.We believe that the present trial has important clinical implications. We think that telemonitoring using ecological momentary assessment is crucial to improve current interventions for pain. The armamentarium of available treatments for pain is large, so physicians can turn to different treatments or dosages in the presence of an undesired event. The use of the app for telemonitoring can allow for this rapid detection of unwanted events, thus improving patient safety  and augmenting treatment effectiveness . In a time when smartphones are a mainstream technology, we should take advantage of them in the promotion of health care.NCT03247725. Registered on 25 July 2017.ClinicalTrials.gov, The online version of this article (10.1186/s13063-018-2539-1) contains supplementary material, which is available to authorized users. Pain is “a distressing experience associated with actual or potential tissue damage with sensory, emotional, cognitive and emotional components” . Pain isChronic pain has become a major public health problem due to its high prevalence. This disease is estimated to affect 20–30% of the adult population across the world . ProjectMedical interventions are the first-line interventions recommended in recent guidelines for chronic pain –11. UnfoSome have argued that the limited efficacy of medical treatment for pain might be partly due to deficits in assessment methodology , 17. ForAn example of how assessment can be responsible for deficits in medical treatment for pain is also given in the context of our Pain Clinic at the Vall d’Hebron Hospital, but may be applicable to other pain clinics worldwide. Patients at our Pain Clinic tend to be assessed for pain intensity, side effects of the medication, and other pain-related variables during face-to-face appointments only. When patients have a concern between appointments , it is the patient’s decision to take action. From our past experience, they either go to emergency services, to their general practitioner, they try to contact the Pain Clinic by phone, or they do nothing and wait until the following appointment at the Pain Clinic. This procedure is problematic. First, emergency services and general practitioners are not specialized in pain treatment and have limited treatment knowledge and options when compared to physicians at the Pain Clinic. The phone-call procedure is inefficient, as it is very costly  and does not guarantee that patients’ concerns are clinically relevant nor that all patients with clinically relevant events call the Pain Clinic, which is a threat to patient safety.The use of smartphone applications in health settings has been boosted in recent years, especially as an alternative or adjuvant to on site, face-to-face treatments –27. HoweThis superiority, randomized controlled trial was approved by the Ethical Review Board at the Vall d’Hebron Hospital in Barcelona  and registered in the clinicaltrials.gov registry on July 25, 2017 (NCT03247725). A Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist can be found in Additional file Once eligibility is ensured, patients will be randomly allocated to one of three conditions: 1) treatment as usual (TAU); (2) TAU + daily assessment using the Pain Monitor app; or (3) TAU + daily assessment using the Pain Monitor app with alarms. Assignment will be made by an independent researcher using an online randomization tool. Neither patients nor physicians in charge of treatment will be blind to allocation. The SPIRIT flowchart is shown in Fig.  treatmena.The patient is over 18 years of ageb.The patient does not present with psychological and/or cognitive alterations or problems with language that make their participation difficultc.The patient has the physical ability to use the applicationd.The patient voluntarily wants to participate and signs the informed consent form  age and (b) ability to participate will be introduced to the study. An information sheet will be provided and if the patient agrees to participate in the study, the inclusion criteria (c) and (e) will be explored. Participants meeting all previous inclusion criteria will be asked to sign the informed consent form (criterion d) and will be assigned to a previously randomized study condition.The participants will be 150 patients with chronic pain, attending the pain clinic at the Vall d’Hebron Hospital in Spain. There will be no exclusion criterion in terms of existing treatment for pain at study onset or changes in treatment during the study, so that the sample will be representative of patients treated at the pain clinic. However, this information will be collected in all participants regardless of the assigned condition.Participants in the TAU condition will be identified using a unique alphanumeric code. Their responses will not contain any identifying information. The database provided by the app  will also be completely anonymized, since the system will not store any personal information. The app will only collect the international mobile equipment identity (IMEI), which is a reference unique to each mobile phone. To ensure confidentiality, the storage of participants’ IMEI will be external to the system. The file containing the link between non-identifying codes  and patients’ identifying information  will be stored locally in a separate computer. Data collection and storage will follow Spanish law and data protection rules ”, and “Ley 34/2002, de 11 de julio de Servicios de la Sociedad de la Información y de comercio electrónico”).Content in the app was developed by a multidisciplinary team of psychologists, physicians, and nurses from the Pain Clinic of the Vall d’Hebron Hospital and the Labpsitec group of the Jaume I University via consensus after a set of meetings. Assessed constructs were selected according to existing guidelines on pain measurement , 28–30 aThe primary measures will be pain intensity and side effects of the medication, which are expected to be lower in the app+alarm condition. Secondary measures will include the remaining variables, including pain interference, mood, use of rescue medication, satisfaction with treatment, perceived health status, activity level, fear of pain, pain acceptance, and pain catastrophizing. Again, all of these are hypothesized to show a greater improvement in the app+alarm condition.Two examples of app items are presented in Fig. All participants will receive the usual medical treatment at the pain unit, following existing guidelines for pain management , 45. DurAs shown before, response to undesired clinical events  varies widely across patients and depends on patients’ own judgment. Some patients go to the emergency service or to the general practitioner. Others try to contact physicians at the Pain Clinic by phone, which is not always possible, while a subset of patients just tolerate the symptoms and wait until the next appointment. In all cases, the “alarm” and the response to it is based on the patient’s criterion, which, as shown before, is problematic. In the present study, this procedure will be representative of patients in the TAU and TAU+app conditions. In contrast, in the TAU+app+alarm group, clinically relevant events will be determined by physicians in the app and alarms will be received daily to offer a rapid response .As indicated above, changes in pain medication may not only occur in the alarm group, but also in the other two conditions , so this will be controlled at the end of the study by looking at the hospital database.For all conditions, patients will be asked to respond to the pre-treatment assessment during the beginning of the study appointment, before the treatment plan is proposed. Patients assigned to the app or app+alarm conditions will be asked to download and complete the pre-treatment assessment in the app. The physician will assist in this first app use. In this pre-treatment assessment with the app, patients have to report on demographic and pain information. Then, participants are asked to answer to a morning and an evening assessment daily for 30 consecutive days. Some items are asked twice a day , while others are only asked once, in the morning  or in the evening . At the end of the study (day 30 of app use), information on satisfaction with treatment and pain characteristics  is collected. The app uses a push system to inform patients when to respond. Default hours are set (10 am and 7 pm), but they can be changed with 2-h flexibility.As usual, patients in the TAU condition will be assessed only twice, at the beginning of the study and in the follow-up appointment (end of study). Despite the traditional assessment at the Pain Clinic being limited to assessment of pain characteristics , we will include the whole assessment protocol used in the app to make results comparable. As usual, this assessment will be made in a paper-and-pencil format.d = 0.5). Despite being only speculative, it is also possible that patients allocated to the app without alarm will perform better than those allocated to TAU, if they also perceive that they are being telemonitored even though they are not. However, we expect this effect to be small. Considering 80% power, we will need 50 participants in each group to perform the analyses. Power calculations were made with G*Power [Considering previous studies on the complications of pain treatments , 46, we  G*Power . Data wi G*Power . ChangesTreatment of pain can be complex due to individual differences in response to interventions, the vast repertoire of available treatments, side effects associated with certain interventions, and the challenges of choosing the right dosage for a given patient –44, 49. In the present study protocol, we describe a RCT designed to test the utility of Pain Monitor, an app for daily assessment of adults with chronic pain. The study aims to explore whether the use of the app results in improved pain treatment by adding a telemonitoring tool, that is, alarms in the presence of undesired events like side effects of the medication, lack of response to treatment, or excessive use of rescue medication. To the best of our knowledge this is the first study to evaluate the impact of a smartphone app for telemonitoring in pain settings and should reveal whether daily monitoring indeed improves treatment effectiveness.The present study has some limitations. Blinding participants and healthcare professionals to allocation was not feasible for ethical reasons. Also, the app is still not available for the iOS operating system, so a subset of patients will not be able to participate in the study. We expect this number to be small because, in Spain, 90% of smartphones use the Android operating system . If, indDespite these limitations, if telemonitoring with Pain Monitor leads to the hypothesized results, this will have important clinical implications. Specifically, we expect that daily use of Pain Monitor with alarms will lead to more effective and safer treatments, thanks to the rapid detection of non-response to the intervention prescribed for pain and side effects of the medication. Additionally, the use of Pain Monitor might also be useful to detect changes in other pain-related variables, such as pain interference, activity level, or psychological constructs like pain catastrophizing or pain acceptance, which are key elements in the multidisciplinary treatment of chronic pain . If the The trial is currently recruiting. Recruitment started in September 2017 and will continue until 150 participants have been included.Additional file 1:Standard Protocol Items: Recommendations for Interventional Trials 2013 Checklist: recommended items to address in a clinical trial protocol and related documents. (DOC 119 kb)Additional file 2:Informed consent form. (DOCX 116 kb)Additional file 3:Items in the Pain Monitor app. (DOCX 27 kb)


Information and communications technology (ICT) could support care organisations to cope with the increasing number of patients with diabetes mellitus. We aimed to aid diabetes care providers in allocating patients to the preferred treatment setting , by using the Electronic Medical Record (EMR).A cluster randomised controlled trial. Physicians in primary and secondary care practices of the intervention group received an advisory message in the EMR during diabetes consultations if patients were treated in the ‘incorrect’ setting according to national management guidelines. Primary outcome: the proportion of patients that shifted to the correct treatment setting at one year follow-up.47 (38 primary care and 9 internist) practices and 2778 patients were included. At baseline, 1197 (43.1%) patients were in the correct treatment setting . Advice most often (68.4%) regarded a consultation with the internist. After one year 12.4% of the patients in the intervention and 10.6% in the control group (p = 0.30) had shifted to the correct setting. Main reasons for not following advice were: 1. physician’s preference to consider other treatment options; 2. patients’ preferences.We could not find evidence that using the EMR to send consultation-linked advice to physicians resulted in a shift in patients. Physicians will not follow the advice, at least partly due to patients’ preferences. Patients with diabetes require regular check-ups by physicians and nurses. Diabetes management needs to become as efficient and cost-effective as possible to deal with the increasing number of patients with diabetes. In the Netherlands about 85% of patients with type 2 diabetes mellitus are treated by general practitioners collaborating with practice nurses in a primary care setting  accordinAlmost all general practitioners are organised in care groups that assume financial and clinical accountability and in turn subcontract individual care providers  , 4. For We hypothesise that targeted use of information technology by an alert according to the national management guidelines in the patient’s electronic medical record (EMR) will result in better treatment allocation of patients with diabetes. Therefore, it was aimed to investigate the effectiveness of such messages provided to physicians and to increase our understanding of the reasons of not adhering to advice.‘Diamuraal’, a care group of 66 primary care practices and an outpatient clinic with the practices of 10 internists. It provides diabetes care to over 12.000 patients with type 1 and type 2 diabetes mellitus. All health care providers work with the same EMR, with only one physician (primary care physician or internist) designated as main physician. He or she can use the message function of the EMR to consult another physician who then has temporary access (change of treating physician) to the medical information of a patient. All patients can request a login to a patient web portal that gives them access to their entire personal EMR, including clinical notes, physical examination, laboratory results and secured electronic message with their provider  [This cluster randomised controlled trial was performed between October 2013 and October 2014 in boek.nl) .All physicians were invited to participate in this study. Practices were only included if all physicians consented to participate. Their patients with type 2 diabetes received an information letter about the trial, stating that after informed consent the final decision to follow advice or not should be a shared decision of patient and treating physician.th 2013). Practices were recruited between March 1st and May 30th 2013, patients were included between April 1st and August 1st 2013. Data were collected from the central database at start (October 9th 2013) and end of study (October 9th 2014). At the end of study period patients received a questionnaire, which was sent between October 1st and October 30th 2014. The study was registered at Clinicaltrials.gov . There was a delay in registration due to the maternity leave of the first author and miscommunication with the co-authors. As a result the protocol was registered after start of the patient recruitment. The authors confirm that they are not performing any trial related to this intervention.The study was approved by the Medical Ethics Committee of the University of Utrecht ; 2. Practice type (group or single handed practice) and 3. Practice location . The 10 internists were randomised separately, stratification for number of diabetes patients of whom they are the treating physician (cut-off point of 100 patients). Randomisation was executed at the research centre via a computer generated sequence by an independent researcher.All patients were assessed whether they were treated in the right setting according to the management guidelines for primary and secondary care on treatment setting . For exaIn order to assess the correctness of the treatment setting, we created an algorithm  based onIf a patient in the intervention group was not treated correctly according to the algorithm a message was provided with advice to change setting. The message was sent to the EMR email box of the treating physician and also presented as a pop up in the monitor screen upon opening it, accentuated in yellow. Besides advice to change the treatment setting of the patient, the message gave an explanation on which marker(s) it was based . The heaA general practitioner could receive 3 different types of advice, namely 1. consult the internist using the EMR; 2. refer the patient to the internist; and 3. instruct the patient to use the patient portal for self-monitoring instead of office visits. The internist could only receive one type of advice: referral back to the primary care physician.and an abnormal lipid profile.Advice could be based on one or more markers. Even in case of several markers, only one advice type was sent. For example: we could send the physician a message with advice for consultation with an internist because this patient had blood pressure above target or send a similar message because the patient had a combination of high blood pressure Furthermore, there were patients that had one or more markers leading to advice for consultation and other markers that lead to advice for referral. In these patients both advices were sent simultaneously, for example a high HbA1c could warrant the advice for consultation with an internist while at the same time this patient could also have a high triglyceride leading to advice for referral. In such a situation both messages were sent to both the provider and the patient.The patients in the control group received care-as-usual, without any messages sent to their diabetes care provider or to the patients themselves whether or not treated in the right setting.The primary outcome was the proportion of patients that changed to the correct treatment setting after one year. Secondary outcomes were the number of different types of advice and the markers they were based on. Furthermore, we measured the reasons for non-adherence to the advice.At baseline and after one year the following measures were collected from the central database of Diamuraal: patient’s age; current treatment setting; type of diabetes ; fasting glucose; HbA1c; systolic blood pressure (SBP); Body Mass Index (BMI); lipids ; kidney function  and the following complications: diabetic ulcer, amputation, retinopathy, myocardial infarction, angina pectoris, heart failure, stroke, transient ischemic attack, peripheral arterial disease. Also the use of oral diabetes medication, insulin (pump), lipid or blood pressure lowering medication, a platelet inhibitor and anticoagulants was assessed.In the intervention group data were collected whether the physician followed advice and, if not, the reasons for not following it (predefined options with more than one possible reason to give and room for free text) .The sample size was calculated on the proportion of patients shifting from an incorrect to a correct setting after one year. We expected that at baseline 25% of patients were at the incorrect setting. After one year this proportion was assumed to be decreased to 12.5% in the intervention group, while in the control group the situation would remain the same. With these assumptions, 2234 patients had to be included to detect a significant difference between groups with 90% power and α of 5%, taking an estimated intra-cluster correlation of 0.075 into account.within groups after one year was analysed with McNemar’s test. The reasons for different advice, physician’s adherence to the advice and the reasons for non-adherence were described with counts and percentages. To determine an intervention effect generalised linear mixed model was used, adjusted for clustering, treatment location (primary or secondary care) at baseline and baseline setting assessment. Analyses were performed using SPSS version 21 .Analyses were according to the intention-to-treat principle, with patients lost-to-follow up analysed as ‘no change in setting’. Baseline differences between groups were analysed with independent samples t-test for continuous variables and Chi-square test for categorical data. The change in setting Of the 66 primary care practices invited, 38 (57.6%) agreed to participate. All 10 internists agreed to participate, but one internist was excluded because he is the main physician of only 17 type 2 diabetes patients. Thus 47 practices were included.From primary care 6755 patients were invited and 2382 (35.3%) returned the consent form . From secondary care 1633 patients were invited, 396 (24.2%) returned the consent form .Participating patients and non-participants did not differ in age (68.5±10.8 years and 68.5±13.2 years (p = 0.95), respectively), but significantly more males participated (57.9% versus 47.8% (p<0.001)).At one year follow-up complete data from 1348 (95.2%) patients in the intervention group and 1297 (95.2%) patients in the control group were available .At baseline 599 (42.3%) patients in the intervention group and 598 (43.9%) patients in the control group were treated in the correct setting . After oNo intervention effect for change in treatment setting after one year was found (adjusted odds ratio 0.99 (95% CI 0.77–1.28)).Advice to change treatment setting was applicable to 817 (57.7%) persons in the intervention group with an incorrect setting at baseline . In 559 Advice for change in treatment setting could be based on one or more markers, for definition of the markers see Advice for consultation of a medical specialist was intentionally followed in only 5.9% of the concerning advices, the advice to refer the patient in only 8.2% and the advice for self-monitoring in 24.4%. In about one in three ((34.5%) cases the internists followed the advice to refer people back to the GP. If GPs did not follow the advice to consult an internist, most frequently they reported not to do so because they wanted to make treatment adjustments themselves. If patients were not referred by the primary care physician, this was hardly (6.7%) the result of a patient’s request. In contrast, internists reported that if they did not refer a patient back, in 40% this was because of patients’ request .This study shows that over 50 percent of patients with type 2 diabetes were not treated in the correct setting according to nationally agreed guidelines. This percentage was twice as high as expected. Sending a computerised prompt to raise physicians’ awareness of the situation, combined with advice for the preferred treatment setting did not result in a shift of the patient flow in the desired direction. Most general practitioners did not adhere to the advice, mostly because they preferred adjustments of the therapy first. Also patient preference was an important reason for non-adherence.diagnostic and therapeutic guidelines on type 2 diabetes in primary care are developed by the Dutch College of General Practitioners, they are highly evidence-based, firmly embedded in primary care and with a high adherence rate. All general practitioners are considered to have experience to follow these guidelines, which provide a stepwise approach for blood glucose lowering therapy. If an adequate diabetes control is not achieved (for whatever reason), the patient should be referred to secondary care [national management guideline on type 2 diabetes, defining the collaboration between internists / endocrinologists and general practitioners had been published less than 2 years prior to this study and is consensus-based [Several reasons are known from literature why physicians do not follow clinical practice guidelines, e.g. because they are not aware of them or do not agree with –10, or rary care . The natus-based . Both tyus-based –14. Maybus-based . We feelfasting glucose level, and this could be a reason for the physician not to follow the advice to consult an internist immediately. Nevertheless, even after having been made aware of the situation, during the follow-up of another whole year, on average 79% of primary care patients (624 out of 788) incorrectly remained treated in solely the primary care setting.Notably, advice for consultation because of high values of HbA1c was based on at least 2 measurements above target and the prerequisite that this situation had existed for over one year. However, it is possible that general practitioners could have adjusted the diabetes treatment resulting in a better Furthermore, attitudes and preferences from both physicians and patients can be a reason for non-adherence –19. A naStrength of the current study is a large population of patients with type 2 diabetes both from primary and secondary care physicians. To the best of our knowledge this is the first study on the effect of advice to health care providers by using the EMR to change treatment setting. However, there are also limitations. Our interpretation of guideline items that were imprecisely formulated, in order to run the algorithm, could have led to more patients in the wrong treatment setting at baseline, although it was done and agreed upon by a team of different diabetes care providers. In daily practice physicians may interpret “persistent high level” loosely and this could lead to clinical inertia. As a result the patient is likely to be worse off. With respect to physician characteristics, although almost 60% of the general practices an almost all internists participated we cannot rule out selection bias. We cannot rule out that physicians who participated are more interested in diabetes than those who did not. Assuming that they are more interested, they might have been more confident in their ability to adjust treatment, without the need for consultation or referral. In this way, selection bias would result in a higher non-adherence to the advice message. Furthermore, literature shows that female physicians prefer to prescribe different types of antihypertensive medication to patients with type 2 diabetes with hypertension compared to male physicians . OverallIn conclusion, we could not find evidence that a consultation-linked electronic advice to physicians that was based upon nationally agreed guidelines to consult an internal medicine specialist or to refer the patient with type 2 diabetes (GP) or to refer patients back  resulted in a shift of patients. Both patient and physician related factors play a role in not following the advice. The content of the guidelines may be discussed.S1 Table(DOC)Click here for additional data file.S2 Table* Predefined reasons at baseline; † Reasons added after evaluating free text; ‡ We checked all these responses: in every case the physician provided this as an answer he was neglecting the specific content of the management guidelines at this point; § i.e. added value of the internist in case of already long term treatment by surgeon (diabetes ulcer), ophthalmologist (diabetes retinopathy) and cardiologist (wrongfully believes that cardiologist takes care of diabetes treatment), or in case of options of discussion new/different medication when there were previous side-effects.(DOC)Click here for additional data file.S1 File(DOC)Click here for additional data file.S2 FileProtocol submitted to Medical Ethics Committee of the University of Utrecht for assessment if participants are subjected to the Medical Research Involving Human Subject Act (WMO). In Dutch.(DOCX)Click here for additional data file.S3 File(DOCX)Click here for additional data file.


Chronic discogenic low back pain (CDP) is frequently diagnosed in patients referred to specialized pain clinics for their back pain. The aim of this study is to assess the impact of CDP both on the individual patient and on society.  Using the baseline records of 80 patients in a randomized trial assessing the effectiveness of a new intervention for CDP, healthcare and societal costs related to back pain are calculated. Furthermore, the impact of the condition on perceived pain, disability, health-related quality of life, Quality of life Adjusted Life Years (QALY), and QALY loss is assessed.  Using the friction costs approach, we found that the annual costs for society are €7,911.95 per CDP patient, 51% healthcare and 49% societal costs. When using the human capital approach, total costs were €18,940.58, 22% healthcare and 78% societal costs. Healthcare costs were mainly related to pain treatment. Mean pain severity was 6.5 (0–10), and 46% suffered from severe pain (≥7/10). Mean physical limitations rate was 43.7; 13.5% of the patients were very limited to disabled. QALY loss compared to a healthy population was 64%.  This study shows that in patients with CDP referred to a pain clinic, costs for society are high and the most used healthcare resources are pain therapies. Patients suffer severe pain, are physically limited, and experience a serious loss in quality of life. Low back pain is one of the most common disabling conditions worldwide . ApproxiCLBP may emerge from several different etiologies but about 40 to 50% of CLBP, treated in specialized pain or orthopedic clinics, is alleged to be of discogenic origin –14. DiskLittle is known about the specific impact of CDP on patients and its burden for society. About the impact of CLBP in general, there is more information , 13, 20 Therefore, the first aim of this study is to provide healthcare and societal cost information about CDP patients who have been referred to pain specialized care. The second aim is to assess the impact of CDP on patients' pain, disability, health-related quality of life, and QALY loss.This study is a CDP evaluation with both a cost of illness analysis and assessment of outcome .There are two methods available to estimate costs of disease. Top-down healthcare cost data can be obtained from central data collecting sources like medical insurance agencies , 23. TheEighty consecutive patients with CDP, as diagnosed by clinical history, physical examination, magnetic resonance imaging, and provocation discography, were eligible for the IMBI study and were included in this evaluation. Inclusion and exclusion criteria were described in detail in the study protocol of the RCT . PatientThe baseline data used for this study included sociodemographic characteristics, pain severity and pain medication use, disability, and health-related quality of life . FurtherPatients rated their low back pain in a pain diary, 3 times a day during 4 days, using 11 box (0–10) numeric rating scales (PNRS); zero represents no pain and 10 excruciating pain .0–20% minimally limited: patient can get along with most daily activities. There is normally no treatment indicated except advice about sitting, lifting, and exercises.21–40% moderately limited: patient experiences pain when lifting, sitting, and standing. Travel and social life is sometimes difficult, and absenteeism can occur. Normally, there are no limitations in daily activities, sexual activity, or sleeping.41–60% clearly limited: pain is problem in activities. Treatment is indicated.61–80% very limited to disabled: back pain affects all aspects of life of the patient. Treatment is very desirable.81–100% disabled. These patients are often bedridden.Physical functioning was measured with the Oswestry Disability Index (ODI) . The valHealth-related quality of life was assessed with the Rand-36 and the EuroQol (EQ-5D-3L) –30. The The QALY is a composite measure which multiplies life years with the quality of these life years. One QALY represents one life year in perfect health. QALYs lived in one year were calculated based on the EQ-5D-3L at baseline, using the UK algorithm . It was Health care and societal costs were measured with cost questionnaires with a recall period of 3 months, which were filled out by patients online .The patients were asked to record the resource use specifically related to their treatment of back pain, such as visits to primary care, medical specialists, physical therapists, and complementary and alternative medicine. Furthermore, the questionnaire queried specifically about back pain-related medication costs, extra requirements such as adaptations to home or equipment for their mobility, and professional caregiving costs. Moreover, patients were asked to report societal costs that included lost productivity and informal caregiving costs. Work absenteeism was measured with the productivity and disease questionnaire (PRODISQ) .ClassApps.com) and MACRO  [With the exception of the pain diary and the EQ-5D-3L, which were presented to the patient in a booklet, all data were collected by web-based questionnaires software, SelectSurvey  . Before don, UK) . If a gudon, UK) . Informadon, UK) .All costs-related information from the baseline questionnaires in which patients were asked about information covering a period of 3 months before entering the study were multiplied by 4 to calculate annual costs per patient. Study-related costs, like costs made for informed consent consults, were not included in the cost analysis. The cost of work absence (productivity losses) was calculated using the friction cost method, which assumes that each worker is replaceable within 85 workdays or 12 weeks , 35, 36.In this study, we estimated the costs of absenteeism due to CDP for each patient by multiplying the total number of sick days by the mean number of daily working hours and the costs per hour . Using tResults are presented as means, range, and standard deviation. Costs results are presented as bootstrapped means and 95% confidence intervals of means (CI). Statistical analyses were performed using SPSS version 24 .Eighty patients included in the IMBI study  were assThe mean physical limitations rate was 43.7 (SD: 14.9) as measured by the ODI . All patHealth-related quality of life as measured with the Rand-36 and EQ-5D-3L is shown in Sixty-seven patients (84%) regularly used analgesics for their low back pain: 33% of patients regularly used paracetamol, 31% used nonsteroidal anti-inflammatory drugs, 14% used weak opioids analgesics, and 11% of patients used strong opioids. The mean yearly cost for medication was calculated at €144.56 (CI: 89–200). Approximately 80% of healthcare cost are targeted at pain therapies and related therapies like physical therapy (12%), psychosocial therapy (6%), and 4% for complementary and alternative medicine (CAM). Daycare clinic and pain clinic both made up for 53.5% of the healthcare costs.The total mean societal costs were composed out of informal caregiving and costs related to work absence see . Thirty-Using the friction cost approach, the mean annual total costs per patient with CDP were €7,911.95: €4,015.38 (51%) healthcare cost and €3,896.57 (49%) societal costs.When the human capital cost approach is used, the total mean annual cost per CDP patient was calculated to be €18,940.58: €4,015.38 (22%) healthcare cost and €14,925.20 (78%) societal costs.The main objective of this study was to assess the costs of CDP for patients and society. Furthermore, we assessed the impact of CDP on patients' pain, disability, health-related quality of life, QALYs, and QALY loss.Almost half (46%) of CDP patients reported severe pain (>7 of PNRS 0 to 10), 54% suffered moderate pain. A European prevalence study in chronic pain suffering patients showed that 34% had severe pain and 66% had moderate pain . In agreIn this study, we found that the annual cost per patient for the society is €7,911.95: €4,015.38 (51%) healthcare cost and €3,896.57 (49%) societal costs, using the friction costs approach. Using the human capital approach, the mean cost is €18,940.58: €4,015.38 (22%) for the healthcare cost and €14,925.20 (78%) societal costs per patient.Costs are on average 56% lower in studies using the friction cost approach than in studies using the human capital approach, because it takes into account that employees can be replaced after a certain time period, i.e., for this study, 85 workdays or 12 weeks , 36. In The cost for disability wages  was only considered in the human capital approach . IncludiThe inclusion and exclusion criteria for the RCT, from which this study retrieved information, could have an effect on the outcome considering that the patients with more than 35 BMI, or degeneration of multiple discs (>2) were excluded. Furthermore, patients with very severe disc degeneration  were excluded in the RCT, and this study used data from , 25. It In comparison, a study in rheumatoid arthritis  patientsThe HRQoL was not only low in the scores for physical functioning but also general health and bodily pain scores were low. The mean utility value  based on the EQ-5D was extremely low (0.36) in the CDP patients. General population score of people in Europe around 45 years of age is approximately 0.85; for instance, a chronic low back pain population in Finland scored mean 0.74 . SimilarThe lowest scores of the Rand-36 were shown on the item “role limitations due to physical functioning” mean 15.3 (SD: 26.3) and bodily pain 32.9 (SD: 17.2). In comparison, the Dutch general population scored, respectively, 79.5 (SD: 35.4) and 80.5 (SD: 24.4) . OverallOur study showed that the patients with CDP in our study suffered moderate to severe pain for on average 10 years , are phyThis study was performed in 4 pain centres across the Netherlands: 3 general hospitals and 1 university pain clinic. Only patients with a confirmed diagnosis of chronic discogenic low back pain were included in this study. Our study comprised 57/80 (71%) female patients. Although this seems a disproportional amount of the female gender, research shows that a larger part of the female CLBP suffering population has back pain with impairment: 70% in women versus 57% in men . Our stuThe prevalence of CLBP is estimated to be 9%  in the gAs far as we know, this is the first study that shows the economic burden for society and the impact of CDP on patients. A comparable study with bottom-up information conducted with patients from a pain clinic showed that the total costs of chronic pain suffering patients was US$24,043 using the human capital cost approach . In thisOn average, CDP patients are in the middle of their productive life at the age of 40, have growing up children, have to pay off mortgage and plan ahead for the studies of their children. Patients suffering low back pain tend to return to work within 6 weeks to 3 months after the acute phase of the condition . HoweverAlthough many healthcare resources are used (and much money is spent each year), the patients included in this trial at baseline still suffer pain and experience loss in quality of life. Innovations and further development of effective treatments are essential to better manage CDP and diminish associated patient burden and societal costs in the future.Society spends €7,911.95 (friction costs approach) or €18,940.58  each year per CDP patient. Societal costs are for a large part caused by work absence. In patients with CDP, healthcare resources are mostly used for pain therapies. Despite these efforts, baseline patients for this study suffer severe pain, are physically limited, and experience serious loss of quality of life.


Pain is frequent in Parkinson's disease (PD) and Parkinson-plus syndrome. This study aimed to assess the prevalence, characteristics, therapy , and associated symptoms of pain in Parkinson's disease and multiple system atrophy (MSA) patients.  Seventy-one PD patients, sixty-five MSA patients, and forty age-matched healthy controls were enrolled and evaluated by using the German pain questionnaire and visual analogue scale (VAS). In addition, the influence of pain in PD patients on anxiety, depression, and the quality of life was assessed with the Hospital Anxiety and Depression Scale (HADS) and Parkinson's Disease Questionnaire (PDQ-39). P < 0.01, P < 0.01). PD patients had a higher presence of pain than MSA patients (P=0.007). No difference in VAS scores was observed between the PD and MSA patients (P=0.148). A total of 21 PD patients (42.85%) with pain and 13 MSA patients (43.33%) with pain received treatment. A total of 13 PD patients with pain and 6 MSA patients with pain had an improved pain intensity after using dopaminergic medication. The differences in the disease duration, Hoehn and Yahr stages, and scores on the Unified Parkinson's Disease Rating Scale motor score, HAD-D, HAD-A, and PDQ-39 were significant between the PD patients with and without pain.  Compared to that of the healthy controls, the PD and MSA patients had a significantly higher presence of pain ( PD and MSA patients are prone to pain with insufficient treatment. Pain interventions should be provided as soon as possible to improve the patient's life. Parkinson's disease (PD) is a common neurodegenerative disorder with a prevalence of approximately 1.7% in the population over 65 years of age in China. Pain is an important and common nonmotor symptom in PD, which has been frequently studied . StudiesA previous study showed that both PD and MSA patients were more likely to complain about pain than other Parkinson-plus disease patients. However, the differences in clinical characteristics and treatment of pain between PD and MSA patients have not been studied.Quantitative measurement of pain is difficult because pain is a subjective symptom. In addition, the disparity of pain questionnaires contributes to the differences in the prevalence rate of pain in PD patients. Survey-based prevalence studies of PD have used short and simple questionnaires, such as the Brief Pain Inventory . TherefoTherefore, this study aimed to assess the prevalence, basic characteristics, and therapy  of pain in PD and MSA patients with the DSF and visual analogue scale (VAS). We also aimed to study the influence of pain on anxiety, depression, and quality of life with the Hospital Anxiety and Depression Scale (HADS) and Parkinson's Disease Questionnaire (PDQ-39) in PD patients with pain.A total of 71 PD patients, 65 MSA patients, and 40 age-matched healthy controls (HC) were enrolled from the Anhui Provincial Hospital between January 2016 and September 2018. The PD diagnosis was based on the United Kingdom Brain Bank criteria [The pain intensity was evaluated using the VAS. The VAS is designed to present to the respondents a rating scale with minimum constraints. Respondents mark the location on the 10-centimetre line corresponding to the amount of pain they have experienced.The DSF is designed based on the principle of “Medical-Psychology-Society.” Compared with other more popular pain questionnaires, the DSF can be used to record the pain history more entirely and in a more orderly manner . In thisBasic clinical characteristics were recorded, including age, gender, and disease duration. For the PD patients, disease severity was assessed according to Hoehn and Yahr (H&Y), and the motor disability and motor type were assessed using the Unified Parkinson's Disease Rating Scale motor score (UPDRS-III). We used the HADS to record depression and anxiety and the PDQ-39 to assess the quality of life in the PD patients. We divided the MSA patients into MSA-P and MSA-C groups.t-test, and categorical data were compared using the chi-square test.For descriptive analysis, quantitative parameters were expressed as mean ± standard deviation and qualitative parameters as frequency and percentage. Means were compared using t-test.At first, pain presence and gender among the groups of PD patients, MSA patients, and healthy controls were analyzed using the chi-square test. Age and disease duration among the three groups were assessed by the independent-samples t-test. Gender differences between the two groups were compared by the chi-square test. We divided PD patients with pain into three types: tremor-dominant group, akinetic-rigid group, and equivalent group and divided MSA patients with pain into two types (MSA-P and MSA-C). The differences of pain presence of PD types and MSA types were analyzed with the chi-square test, respectively. And we analyzed the pain localization proportions and treatment in PD and MSA patients with pain by the means of bar chart.Secondly, clinical and demographic characteristics between PD and MSA patients with pain were further compared. The statistical differences of VAS scores, age, and disease duration between the two groups were estimated using the independent-samples t-test.At last, according to accompanied with or without pain, we divided PD patients into two groups and compared clinical and demographic characteristics. Age, disease duration, HY stage, the UPDRS-III, and scores of HAD-D, HAD-A, and PDQ-39 between the PD patients with and without pain were compared using independent-samples P value < 0.05 was considered significant.SPSS version 22.0 was used to analyze the data. A two-tailed P < 0.01, P < 0.01). And PD patients had a higher presence of pain than MSA patients (P=0.007). According to clinical features, we divided 49 PD patients with pain into three types  and 30 MSA patients with pain into two types (21 MSA-P and 9 MSA-C). No difference was observed in the presence of pain among the PD types. And no difference was observed in the presence of pain between the MSA-P and MSA-C groups . The demographic data and pain presence of the PD patients, MSA patients, and HC are presented in P=0.148). Compared to that of the MSA patients with pain, the PD patients with pain had longer disease durations (P=0.008). The means of VAS scores of PD and MSA patients with pain were 5.08 ± 1.98 and 4.47 ± 1.60, respectively. There was no difference of VAS scores between the two groups (The most common pain location in the PD patients was back pain (38.8%), followed by neck or shoulder, multiple sites, legs, and arms pain. The top two most common pain locations in the MSA patients were back pain (36.7%) and neck or shoulder pain (23.3%). P=0.018). And there were differences of HY stages and UPDRS-III scores between the two types . In addition, differences of scores on the HAD-A, HAD-D, and PDQ-39 were significantly different between the PD patients with and without pain   .Our study found that pain was prevalent in PD and MSA patients. However, only approximately half of the PD or MSA patients with pain received treatment, suggesting that the current treatment of pain associated with Parkinson's syndrome was not valued and that no effective and specific treatment was available. PD patients with pain are more likely to be anxious and depressed and have a reduced quality of life than PD patients without pain.We found that 69.1% of the PD patients suffered from pain. At present, the pathological mechanism of pain is still unclear. The basal ganglia integrate incoming nociceptive information and contribute to coordinated motor responses in pain avoidance and nocifensive behaviors. Nigral and extranigral pathology involving the cortical areas, brainstem nuclei, and spinal cord may contribute to abnormal central nociceptive processing in PD patients with or without pain . A meta-We found that 30 MSA patients (46.15%) suffered from pain. There was a trend towards a higher prevalence in MSA-P compared to MSA-C patients although the difference was not significant, which might be due to the small sample size. Few studies have investigated the pain mechanism in MSA patients. Several brain regions are neurodegenerative in MSA, such as the thalamus and the locus coeruleus, resulting in striatal neurodegeneration and changes in dopaminergic system function. Thus, pain in MSA results from striatal neurodegeneration. MSA patients presented alteration of pain perception with both lower subjective and objective pain thresholds than those of healthy controls . In addiP=0.007). The result was inconsistent to that of a recent study with 65 PD patients and 21 MSA patients [β-CIT SPECT images, with greater atrophy of the middle cerebellar peduncle, the cerebellum or the pons (including the locus coeruleus), and hypometabolism in the brainstem [In our study, there was difference in the pain presence between the PD and MSA patients with pain. PD patients had a higher presence of pain than MSA patients  with pain and 13 MSA patients (43.33%) with pain received treatment. A total of 13 PD patients with pain were diagnosed with PD relevant pain, whereas the others improved their pain using massage or pain killers. The low rate of clinical treatment for pain may be related to the lack of effective treatment for pain. For PD patients with pain, there are two pain treatment methods (drug and nondrug treatment). For pharmacological therapy, pain can be significantly alleviated or abolished by adjustment of dopaminergic medication . In our For MSA patients, few studies have found useful treatment. In our study, we found that 6 MSA patients with pain improved their pain intensity through the use of dopaminergic medication, including levodopa and pramipexole. Therefore, although dopaminergic medication is not useful for motor symptoms, it can be experimentally used for the treatment of pain for MSA patients with pain. Four MSA patients with pain in our study improved their pain intensity with regular rehabilitation exercise, which showed that regular exercise might be another pain treatment method.In this study, the predominant sites of pain in the PD and MSA patients were the back and the neck and shoulder, which were considered to be skeletal muscle pain by Ford . SkeletaPain is a nonmotor symptom that is somewhat neglected. In this study, we found that anxiety and depression were more likely to occur when PD patients suffered from pain and that the quality of life declined. Therefore, formulating an effective treatment for pain in PD and MSA can largely improve a patient's emotional state and quality of life.Although the DSF scale is not a widely accepted questionnaire for PD patients with pain globally, our study selected the DSF scale as a tool to evaluate features of pain. The DSF is an effective and reliable tool that records the multidimensional experiences of patients with pain. The pain of more than 85% of patients can be fully assessed using this questionnaire. A high degree of agreement was found between clinical and psychosocial diagnoses of pain and the patients' pain data collected by the DSF. Therefore, doctors can adjust the treatment of pain according to the patient's pain clinical characteristics, basic psychological state, and influence on social work collected by the DSF [This study has some limitations. First, this study is a cross-sectional observational and retrospective study. Second, the selected population and the number of patients have limitations. In addition, the pain score of the study was evaluated using questionnaires, which can easily be affected by subjective factors. Our follow-up plan is to select quantitatively detectable pain thresholds and obtain more objective results.This study found that PD and MSA patients often experienced pain. However, treatment of pain associated with Parkinson's syndrome has not been taken seriously. Clinicians should treat pain as seriously as the motor symptoms of Parkinson's syndrome and take corresponding measures for the treatment of pain to improve the patients' quality of life.


The fear-avoidance model is a theoretical paradigm for explaining acute and chronic pain. In this model, pain catastrophizing plays an important role. On the other hand, self-efficacy influences whether patients view their pain optimistically, ultimately preventing the conversion of pain into intractable pain. The aim of the present study was to evaluate the factors that influence self-efficacy in patients with chronic pain.n = 74; group H: PSEQ greater than 35 points, n = 73). The factors that influenced self-efficacy in these patients were analyzed using univariate and multiple linear regression analyses.Study participants included 147 outpatients  with intractable chronic pain who visited our hospital between September 2014 and July 2015. Their mean age was 71.0 (range 32–92) years. Pain sites were as follows: low back, 97 patients; knee, 71 patients; shoulder, 34 patients; and hip, 15 patients. All patients were assessed using the following measures: Numeric Rating Scale (NRS), Pain Catastrophizing Scale (PCS), Hospital Anxiety and Depression Scale (HADS), Pain Disability Assessment Scale (PDAS), and Pain Self-Efficacy Questionnaire (PSEQ). All participants were further divided into two groups based on median PSEQ scores (group L: PSEQ of 35 points or less, Significant differences were observed in gender; pain duration; and NRS, PDAS, HADS, and PCS scores between group L and group H. Multiple linear regression analysis revealed that self-efficacy was correlated with PDAS score, HADS depression score, and pain duration.Patients with longer pain duration indicated greater self-efficacy and patients with higher pain disability and depression exhibited lower self-efficacy. It is widely known that chronic pain results in substantial medical expenses and economic loss due to prolonged temporary employment leaves –4. The rSelf-efficacy is defined as confidence that a patient can successfully execute a course of action to produce a desired outcome . Given tThe present retrospective study was performed at the author’s institution. Ethical approval was obtained from the hospital board of ethics. Participants included 147 outpatients  with intractable chronic pain who visited our pain liaison outpatient clinic between September 2014 and July 2015. Inclusion required pain persisting longer than 3 months without relief after conservative treatment . The exclusion criteria included ongoing litigation, dementia, delirium, or other conditions that made completing questionnaires difficult.The Numeric Rating Scale (NRS) for pain is a reliable, valid, and widely used tool for the self-evaluation of chronic pain intensity . NRS scoThe Pain Self-Efficacy Questionnaire (PSEQ) score was used to assess participant self-efficacy Table . This isThe Pain Catastrophizing Scale (PCS), which is used to measure pain catastrophizing, is a 13-item questionnaire composed of items assessing rumination, magnification, and helplessness . RuminatThe Hospital Anxiety and Depression Scale (HADS) was used to assess anxiety and depression , 21. TheThe Pain Disability Assessment Scale (PDAS) was used to assess the degree to which intractable chronic pain interfered with various activities of daily living during the previous week . The PDAU tests and subjected to univariate analyses. Then, factors that influenced the PSEQ score in all patients as well as female patients were identified using multivariate linear regression analyses. Potential predictive variables were included in the multivariate model when p < 0.05 was obtained via univariate analyses. A multiple regression model and 95% confidence intervals were used to identify the factors that significantly influenced PSEQ scores. Statistical analyses were conducted using SPSS version 23.0  for Windows .All patients were divided into two groups based on a median PSEQ score of 35 points. Patients with PSEQ scores of 35 points or lesser were included in the low PSEQ group (group L), and patients with scores greater than 35 points were included in the high PSEQ group (group H). Patients’ background and measured factors were compared between the two groups using chi-square and Mann-Whitney n = 97), knee (n = 71), shoulder (n = 34), and hip (n = 15). Patients with two or more pain sites were also included. The mean participant age was 71.0 years (range 32–92 years), with a mean duration from pain onset to study enrollment of 58.0 months (range 3–624 months). Table In the present study, 147 patients with intractable chronic pain who visited our pain liaison outpatient clinic and completed all questionnaires were included. Pain sites included the low back . Significant differences were found between the two groups in gender, pain duration, NRS, PCS, HADS anxiety, HADS depression, and PDAS .All patients were divided into two groups in accordance with the median PSEQ scores of 35 points. Group L (< 35 points) included 74 patients, and group H (≥ 35 points) included 73 patients. Chi-square test for binary variables and Mann-Whitney y) were positively correlated with pain duration (x1) and negatively correlated with HADS depression (x2) and PDAS (x3) scores for all patients  and other variables. The explanatory variables included gender; pain duration; and NRS, PCS, HADS anxiety, HADS depression, and PDAS scores. We found that PSEQ scores (ts Table . These rn = 112). The explanatory variables included age; pain duration; and NRS, PCS, HADS anxiety, HADS depression, and PDAS scores. We found that PSEQ scores (y) were positively correlated with age (x4) and negatively correlated with HADS depression (x5) and PDAS (x6) scores in female patients. These results yielded the following prediction formula: y = 32.98 + 0.22x4 − 1.29x5 − 0.32x6  and other variables in female patients  is a mode of psychotherapy to treat depression, and multidisciplinary CBT-based treatments have also been introduced in psychosocial fields and chronic pain –28. CBT While it offers some significant benefits to the field, the present study also has some limitations, which warrant discussion. First, patient outcomes were evaluated only at a single time point, including patients in various phases of therapy. There may be an influence of treatment phase on the reported outcomes. Second, given that patients who experienced prolonged pain were usually treated previously at another hospital, pain duration, which predicted self-efficacy here, was inferred. Assessing the exact therapy period and the context of treatment was challenging and thus served as a further, related limitation of the present study. Third, patients who experienced pain for less than 3 months were not included in the present study and were thus not assessed for self-efficacy or pain improvements. We predict that patients with high self-efficacy who experienced a short duration of pain may have experienced more immediate improvements in their pain with any treatment and thus have finished their treatment. Excluding these patients and their clinical courses is a further limitation of the present study. Further prospective study would be needed to prove the relationship between self-efficacy and pain duration.This present study demonstrated that higher self-efficacy was correlated with lower pain disability and depression. Further, multidisciplinary therapy, for example, including physical therapy to improve activities of daily living and cognitive behavioral psychological therapy to relieve depression, may improve self-efficacy and thus, result in improved outcomes in patients with intractable chronic pain.