Patients’ self-reported levels of improvement after having attended a chronic pain management program can provide a subjective rating of how successful they perceive they were at accomplishing their goals in the program. Past studies have demonstrated that successful patients differ from less successful ones on several cognitive–behavioral factors such as coping strategies over physical characteristics such as pain intensity.This study explored factors that determine patients’ perceptions of self-improvement after undergoing chronic pain treatment in a pain management program.n = 174) underwent a 4-week, interdisciplinary, multimodal, chronic pain management program at a hospital located in southern Ontario. Questionnaire packages that evaluate pain intensity, pain-related disability, emotional distress , acceptance of pain (activity engagement and pain willingness), readiness to change, and use of adaptive or maladaptive coping strategies were completed by patients at admission and discharge. Participants were grouped into one of three categories depending on their rating of self-improvement on the Self-Evaluation Scale (SES). The groups were compared on the magnitude of change they reported on the variables mentioned above.Participants  were significantly associated with differences in ratings of self-improvement.This study provided insight into what patients value most when rating their self-improvement, which can then be used to facilitate increased patient success and satisfaction with treatment. This approach could then help to improve functioning and adjustment for patients; reduce negatively associated symptoms, beliefs, and behaviors; and help patients to resume their typical daily activities. To help design and facilitate these programs, it is important to gain an understanding of what factors patients find most important to attribute their treatment as a success.Chronic pain is any persistent pain that lasts longer than 3–6 months or longer than the duration of time it would normally take for the body to heal.6Traditionally, chronic pain management programs combine cognitive–behavioral therapy (CBT), which addresses the dysfunctional emotions and maladaptive behaviors associated with chronic pain, with physical therapy, which addresses the physical factors of pain such as restoring mobility, enhancing physical fitness, and remediation of movement. CBT techniques combined with physical therapy tend to show more benefit than physical therapy alone.7 patients who underwent CBT improved more than waitlist controls on factors of pain experience, mood and affective state, use of positive coping strategies, avoidance of negative coping strategies, avoidance of negative pain-related behaviors, and social role functioning. In another meta-analysis of chronic pain management programs conducted by Morley et al.,8 significant reductions were observed in pain interference, pain intensity, pain distress, psychological distress (depression and anxiety), and catastrophizing, whereas higher levels of walking and self-efficacy were observed. Finally, in multiple studies conducted by Hapidou and colleagues,12 patients who attended a 4-week program reported higher levels of acceptance of pain (in terms of both activity engagement and pain willingness), self-management approaches to pain that involve taking action and maintenance of pain management, and adaptive coping strategies such as exercise/stretch, relaxation, pacing, seeking social support, and coping self-statements after treatment. In addition, patients reported lower levels of pain intensity, pain-related disability, emotional distress , health problems, and maladaptive coping strategies such as guarding, resting, and asking for assistance. However, it is important to note that recent reviews of chronic pain management programs involving CBT in the treatment of chronic pain only yielded small to moderate effects sizes (Cohen’s d ranging from 0.2 to 0.5).13 Therefore, there is room to improve such programs in order to increase their positive effects on patient outcomes.Previous literature has evaluated the success of chronic pain management as an effective intervention for improving quality of life and reducing negative pain-related outcomes. In a meta-analysis by Morley et al.,14 A recent shift toward patient-centered treatment has grown in the last decade, which involves more collaboration between health care providers and patients, with providers gaining an understanding of patients’ needs and taking a more individualized approach to help these patients reach their goals. A patient-centered model of treatment has been associated with increases in patient satisfaction with health care, adherence to treatment, and stronger and more sustained patient–provider relationships, in comparison to the traditional medical model of treatment.16 However, more research is needed to understand the factors that patients find important in their journey to improvement, in order to inform patient-centered treatment.In traditional treatment models, the criteria for patient success are determined by health care providers; however, outcomes that may be important to providers may not match the outcomes that patients find important.18 Patients’ ratings of success and improvement have been identified as core outcome domains that should be considered by providers in chronic pain management programming, based on the IMMPACT recommendations.19To help gain an understanding of patients’ needs, it is important to capture what constitutes self-improvement  for patients. For instance, measures that evaluate a patient’s global impression of changes have been found to be useful in identifying the extent to which pain-related variables  needed to be reduced/improved in order to identify a clinically important outcome after chronic pain trials.16 found that for patients to rate their treatment as successful, they required at least 54%–58% reduction in pain intensity, 60%–67% reduction in distress , and 63%–68% reduction in pain interference . Fisher20 found that higher ratings on the Goal Attainment Scale (GAS), a 5-point scale measuring patient-generated perceptions of their goal achievement, were associated with higher levels of improvement in pain intensity, pain-related disability, general health, and exercise. Furthermore, Kerns and Rosenberg21 found that patients’ positive ratings of goal achievement were associated with improvements in readiness to change; in particular, this involved decreases in precontemplation  and increases in action  and maintenance . These studies provide initial insights on factors that may be involved in patients’ perceptions of their success.Within chronic pain management contexts that involve psychosocial therapies, previous literature has explored factors that are valued by patients in their judgments of overall self-improvement. O’Brien et al.22 Additionally, little research has explored the nuance between what makes patients who rate their improvement as successful different from those who rate their improvement as poor. Insight into this issue can help providers understand the unmet needs for patients who differ in their ratings of self-improvement.Though the preceding paragraph outlined initial evidence on what patients value in their chronic pain treatment, given the interdisciplinary and multimodal nature of chronic pain management programs, more research is necessary to examine the association of various additional psychosocial factors on judgments of self-improvements. For instance, little research has explored how improvements in use of approaches such as pain acceptance, adaptive coping strategies, and reduction in maladaptive coping strategies may be associated with patients’ ratings of global self-improvement. This warrants further study because these factors have all been associated with positive functioning in patients.The purpose of this study was to understand the psychosocial factors associated with patients’ perceptions of self-improvement. Improvement in this study was understood as the extent to which a chronic pain management program helped patients accomplish their goals, which included improving fitness, reducing medications, improving general health and nutrition, increase participation in family and social life, and improve functioning at work. The psychosocial factors examined were those recognized from previous literature as important to patients’ ratings of self-improvement as well as those that are yet to be explored. As such, it was predicted that patients who report higher levels of global self-improvement will also report significantly greater improvements on psychosocial factors of pain acceptance , stages of change , and adaptive coping strategies  while reporting significantly greater reductions in pain intensity, emotional distress , health problems, pain-related disability, and maladaptive coping strategies  after treatment, relative to those patients who reported poorer levels of self-improvement.23 Center for Epidemiological Studies–Depressed Mood Scale (CES-D),24 Pain Catastrophizing Scale (PCS),25 Clinical Anxiety Scale (CAS),26 Patient Questionnaire of the Primary Care Evaluation of Mental Disorders (Prime-MD PQ),27 Pain Disability Index (PDI),28 Chronic Pain Acceptance Questionnaire (CPAQ),29 Pain Stages of Change Questionnaire (PSOCQ),30 and Chronic Pain Coping Inventory (CPCI).31 These patients then attended a 4-week, multimodal, interdisciplinary chronic pain management program. At discharge, each patient completed a package that included the same measures mentioned above, along with an additional measure, the Self-Evaluation Scale (SES).9Ethics approval for this study was obtained from an institutional ethics review board. The data analyzed in this study were collected from patients admitted to a southern Ontario hospital between January 2010 and December 2012. Patients had experienced chronic pain following a work-related injury or motor vehicle accident and were referred to the hospital by the Workers Safety and Insurance Board, their insurance company, or their lawyer. After consent was obtained, each patient completed a package of self-report measures consisting of a demographic form as well as 9 initial questionnaires: the Pain Intensity Scale (PIS),Participants consisted of 174 patients who completed the 4-week program and had complete program evaluation data at both admission and discharge. Of this sample, 83 were males and 87 were females (data on sex were not available from two people), between the ages of 25 and 64 years . The majority of the sample were born in Canada (72.4%), were married (53.4%), were unemployed (63.8%), and had sustained injury through a motor vehicle accident (35.1%) or work-related accident (28.7%). On average, participants had been off work for 35.87 months (SD = 47.28), had 13.36 years of education (SD = 3.73), had pain for 54.72 months (SD = 48.85), and had sustained at least two injuries. Participants were taking medications such as opioids, anti-depressants, anti-inflammatory drugs, and sleep medications.Each participant was asked to provide information about his or her age, marital status, education level, employment status, and the number of years he or she had resided in Canada. Each participant also included specific details about the type of injury, including the source, pain duration(s), and number of injuries that he or she had sustained.23 This 11-point scale ranged from 0 (no pain) to 10 (unbearable pain). The PIS has been shown to be a valid measure of pain intensity through its strong association with the PDI and other pain measures.34 The PIS has demonstrated high reliability in comparison to visual and verbal measures and high responsiveness to change.36The participant reports his or her “usual” and “least” subjective levels of pain experienced in the past 2 weeks.24 This measure consists of 20 questions on a 4-point scale ranging from 0  to 3 . The CES-D’s criterion validity has been shown, because its scores were positively correlated with other self-report scales that measure symptoms of depression (r = 0.55–0.74) convergent validity; and negatively correlated with scales measuring variables different from depression (r = −0.55) discriminant validity. Evaluated test–retest reliability of the CES-D has found moderate correlations (r = 0.45–0.7) between initial and follow-up scores 3 to 12 months after the initial questionnaire was given.24The CES-D was used to assess symptoms of depressive state experienced by the participant in the past week.25 There are 13 items on a 5-point scale, which ranged from 0  to 4 . The PCS has demonstrated convergent validity, as evidenced by the moderate correlation of total PCS scores with scores on negative affectivity  and self-reported anxiety measures . The PCS has demonstrated acceptable and satisfactory internal consistency for total score (α = 0.97) and its three subscales  (α = 0.87), Magnification (α = 0.60), and Helplessness (α = 0.79), and strong test–retest reliability has been established for 6 weeks (r = 0.75) and 10 weeks (r = 0.70) in a sample population.25The PCS was used to assess the participant’s level of catastrophizing; the participant rates how frequently he or she perceives feelings related to rumination, magnification, and helplessness as a result of his or her pain experience.37 The measure consists of 25 items on a 5-point scale, which range from 1 (rarely or none of the time) to 5 . The CAS has demonstrated good discriminant validity (r = 0.77), effectively distinguishing between low-anxiety and clinical anxiety groups. The CAS has been shown to be a very reliable measure indicated by a high internal consistency (α = 0.94) and low standard error of measurement (4.2).35This CAS was used to assess the participant’s level of state anxiety.27 The scale contains 25 true or false questions, followed by a 5-point rating of the patient’s self-perceived health, as either “excellent,” “very good,” “good,” “fair,” or “poor”. The scale has demonstrated excellent overall accuracy (88%) and good agreement (κ = 0.71). In addition, the PRIME-MD PQ has been shown to be a useful tool in screening mental disorders, demonstrating good to excellent sensitivity across all diagnoses, including mood (69%), anxiety (94%), alcohol (81%), and eating (86%) disorders.27The PRIME-MD PQ was used to assess the participant’s physical and emotional symptoms experienced in the past month.28 The measure consists of seven questions on an 11-point scale, with a range from 0 (no disability) to 10 , to rate the participant's experience in each of the seven categories of life activities: family/home responsibilities, recreation, social activity, occupation, sexual behavior, self-care, and life support activity. The construct validity of the PDI has been established, because patients with higher PDI scores had significantly more pain characteristics, including restriction of activities and psychological distress , than patients with low PDI scores. The PDI has been shown to be a reliable measure, demonstrating high internal consistency (Cronbach’s α = 0.86) and high test–retest reliability (intraclass correlation coefficient = 0.91) in patients who repeated the questionnaire 1 week after its initial completion.38The PDI was used to assess the extent of disability to which the participant attributes his or her chronic pain condition.39 The CPAQ has two subscales: Activity Engagement and Pain Willingness. The participant rates each statement on a 7-point scale, which ranges from 0 (never true) to 6 . The CPAQ has demonstrated adequate predictive validity, because outcomes like depression, pain-related anxiety, and psychosocial disability could be significantly predicted by both Pain Willingness  and Activity Engagement  subscales. The CPAQ has demonstrated good internal consistency for Activity Engagement (α = 0.82) and Pain Willingness (α = 0.78) subscales.39The 20-item CPAQ was used to assess the degree of acceptance that a participant had for his or her chronic pain condition.30 The participant rated how strongly he or she agreed or disagreed with statements using a scale from 1 (strongly disagree) to 5 (strongly agree).30 This questionnaire includes four subscales measuring the four stages of change: Precontemplation, Contemplation, Action, and Maintenance30 The PSOCQ has demonstrated criterion-related validity, because measures of control, accommodation, and active coping were positively related to maintenance  and negatively related to precontemplation .30 Excellent reliability has been established in each subscale  (α = 0.77), Contemplation (α = 0.82), Action (α = 0.86), and Maintenance (α = 0.86), and excellent test–retest reliability has been shown (α = 0.74–0.88 over a 1- to 2-week period).30The PSOCQ was used to assess the participant’s readiness to change and adopt coping strategies taught by the clinicians for his or her condition.31 The measure consists of nine coping strategies presented on nine subscales, six of which were adaptive strategies and were encouraged, whereas the other three were maladaptive and discouraged.31 The adaptive strategies are exercise/stretch, relaxation, task persistence, coping self-statements, pacing, and seeking social support, and the maladaptive strategies are guarding, resting, and asking for assistance.31 The validity of this measure has also been established and can significantly predict pain adjustment .40The CPCI was used to assess the participant’s use of coping strategies, with statements that evaluate how many days in the past week he or she performed certain actions to deal with pain.9 asks, “To what extent do you think you have accomplished your goals in the past 4 weeks?” It was used to determine the patient’s perceived goal accomplishment at the end of the 4-week interdisciplinary chronic pain management program. It was scored using a 5-point scale: 1 (poorly), 2 (fairly), 3 (well), 4 (very well), and 5 (excellent). This was followed by an open-ended section titled “Comments” where the patient could elaborate on his or her perceived goal accomplishment in various areas of functioning. The SES was found to be reliable and valid in assessing goal accomplishment12 in a multidisciplinary chronic pain management program. It has also been previously used in a study on kinesiophobia41 as a reference standard to dichotomize participants into two groups: those who scored 3, 4, or 5 on the SES at discharge were categorized as having an important reduction in their fear of movement/reinjury, and those who scored 1 or 2 were categorized as not having an important reduction in their fear of movement/reinjury.The SES was used to determine the participant’s self-perceived performance in the program. The SESThe quantitative data were analyzed using SPSS . Participants were divided into three groups based on their ratings on the SES. Those who rated themselves 1 or 2 were placed in the “poorly–fairly” group, those who rated themselves 3 were placed in the “well” group, and those who rated themselves 4 or 5 were placed in the “very well–excellent” group. The poorly–fairly group represented perceptions of improvement that were unfavorable in terms of program outcomes, the well group represented perceptions that were moderate, and the very well–excellent group represented those perceptions that were most favorable. To evaluate whether there was an association between psychosocial factors and self-reported improvement between rating groups, a mixed analysis of variance (ANOVA) was conducted using SPSS. This compared the mean scores of multiple dependent variables  with a within-subjects factor (time) and a between-subjects factor (rating groups). A conservative alpha level of 0.002 (0.05/21) was employed to address the use of multiple tests. Post hoc tests with a Bonferroni correction were performed on relationships that demonstrated significant differences.diff = 4.41, P = 0.007).Demographic frequencies and descriptive statistics were gathered for each of the three rating groups and are displayed in Prior to analysis, data on the psychosocial measures were explored to identify whether any missing values existed; it was discovered that 43 participants were missing between 0.6% and 11.6% of data across 10 of the 21 dependent variables. These missing values were filled using a multiple imputation procedure in SPSS to retain the original sample size and to produce valid statistical inferences.P < 0.001); PCS ; CAS , PRIME-MD PQ ; the CPAQ subscale of Activity Engagement ; the PSOCQ subscales of Precontemplation , Contemplation , and Maintenance ; and the CPCI subscales of Task Persistence , Pacing , and Seeking Social Support . Though significance was not reached for the PDI  and the Action subscale of the PSOCQ , both P values were closely approaching significance and thus warrant further exploration.The descriptive statistics for each time point and the results of the mixed ANOVAs are displayed in Analyses of the differences were conducted with post hoc pairwise Bonferroni tests to determine where the difference was on each psychosocial factor. In SPSS, the Bonferroni correction is automatically applied, so results can be interpreted at the 0.05 significance level. The results of these tests, which include the mean differences of each comparison and significance levels, are displayed in For the CES-D, all groups were significantly different from one another; the very well–excellent group improved more than the well group and the poorly–fairly group and the well group improved more than the poorly–fairly group. For the PCS, CAS, PRIME-MD PQ, and the Activity Engagement subscale of the CPAQ, the very well–excellent group improved more than the poorly–fairly group, and the well group also improved more than poorly–fairly group on each of these scales. For the PDI, the very well–excellent group improved more than the poorly–fairly group.For each of the Precontemplation and Maintenance subscales of the PSOCQ, all groups were significantly different from one another; the very well–excellent group improved more than both the well group and the poorly–fairly group and the well group improved more than the poorly–fairly group. On each of the Contemplation and Action subscales, the very well–excellent group improved more than the poorly–fairly group.For the Task Persistence, Pacing, and Seeking Social Support subscales of the CPCI, the very well–excellent group improved more than the poorly–fairly group. In addition, on the Task Persistence subscale, the well group improved more than the poorly–fairly group.This study sought to understand the treatment-related changes in psychosocial factors that correspond to patients’ perceptions of global self-improvement after attending a chronic pain management program. Results from this study showed that participants’ self-reported improvement levels differed significantly on experiences of emotional distress , general health, activity engagement, three of the four stages of readiness to change , and three adaptive coping strategies ; the differences between groups in improvement approached significance on the action stage of readiness to change and on pain-related disability. Further comparisons demonstrated that those who rated themselves highly (very well–excellent) in terms of having accomplished their goals also showed greater improvements on the above measures than those who rated their improvement to be poor (poorly–fairly). Taken together, these findings suggest that patients required a large magnitude of improvement in the above stated experiences in order to rate themselves as highly improved overall, as opposed to those who rated their self-improvement as poor or unsuccessful, because they demonstrated much lower magnitudes of improvement in these experiences.20 Furthermore, particularly for experiences of depression, the very well–excellent group demonstrated greater improvements than the well group, and both groups expressed greater improvements than the poorly–fairly group. The cascading effect recognized in ratings of depression across groups suggests that though a certain magnitude of reduction in depressive symptoms may be required for feeling content (well) about one’s improvement, an even greater magnitude of reduction is required for these patients to transition to feeling strongly improved after chronic pain treatment.Reductions in experiences of emotional distress, pain-related disability (approaching significance), and negative health were associated with higher ratings of improvement for participants, and these associations are consistent with previous findings.P value was close enough to warrant further exploration. A reduction in pain-related disability can indicate that the participant has a low perception of pain’s interference with his or her daily activities. Lower pain-related disability could be a result of the development of higher self-efficacy; that is, development of a stronger perception of one’s ability to manage their chronic pain, complete day-to-day tasks, and accomplish their goals.42 This is consistent with previous literature that found that high pain control and high self-efficacy are associated with lower perceived disability and lower levels of pain interference.44 These higher self-efficacy beliefs may have manifested in two ways: through receipt of education regarding management of one’s pain and through performance of tasks throughout the program and witnessing one’s success in them. As suggested by Fox's skill enhancement hypothesis,45 successful performance in tasks helps people reinforce positive perceptions about themselves, and according to the self-enhancement hypothesis, people seek out and engage in tasks in which they can develop positive perceptions about their abilities. As per these hypotheses, participants who engage in tasks successfully will then develop greater confidence in their abilities to perform, despite their pain-related adversity. Thus, they would be more likely to engage in behaviors related to improvement in their situation, which would result in an upward cycle of success and engagement toward the achievement of their goals. Programming that emphasizes the enhancement of one’s perceptions of one’s competencies and abilities can lead to the adoption of positive beliefs and behaviors related to one’s improvement.Though differences between groups on the magnitude of improvement they reported regarding pain-related disability did not reach significance, the 22 The importance of these task-oriented factors hints at the idea that patients value treatment that helps them learn to perform and persist through activities despite pain and that patients may find it important for their overall treatment to help them continue daily functioning. As suggested previously, with a greater repertoire of coping strategies and acceptance of pain (through activity engagement), these approaches may help participants gain higher self-efficacy to perform and persist through tasks and thus reduce perceptions of pain-related disability. This is in line with previous literature that has found acceptance to be complementary to adaptive coping self-management approaches22 and is associated with less pain-related disability. Furthermore, in line with this study’s findings, the literature suggests that activity engagement is powerfully related to depression, anxiety, and pain interference.46It was recognized that participants in this study all required significant improvements in factors of activity engagement, task persistence, and pacing to rate their global self-improvement strongly. These factors are related to one another in that they are approaches to promote engagement in tasks and activities. Activity engagement relates to the extent to which one involves him or herself in a task despite pain; task persistence relates to the extent one continues this involvement; and pacing involves use of strategy that allows engaging in an activity in a gradual manner with intermittent rest or slowdown periods in order to persist in that activity over longer periods of time.47 The resulting improvements may be regarded as positive outcomes of attendance in a group environment; in a study by Subramaniam et al.,48 participants who attended programs in groups displayed better improvement than those who received individual treatment, which was likely due to the collective feedback and mutual support they received from their peers. Support, in the form of feedback, can lead to internalization of positively associated behaviors49; support and feedback received from others may have led to participants’ internalizing and adopting these positive supports as their own values and beliefs and thus report themselves as more improved in comparison to those who do not attain feedback or seek support. By encouraging group interaction and providing mutual support to group members, as well as informing families and friends to do the same, a participant may improve more in the program and rate his or her improvement higher.Seeking social support as a coping strategy has been associated with less pain in chronic pain participants.21 Readiness to change lies on a continuum in which each stage captures a certain set of attitudes and behaviors that become more adaptive as one transitions forward across each stage. The magnitudes of change may be more profound after engaging in treatment, because patients who may previously have been categorized into the precontemplation or contemplation stage have likely transitioned to action and maintenance stages as they adopted a self-management approach. Furthermore, movement through these stages may be catalyzed by the learning, application, and adoption of adaptive coping strategies,50 which patients reported improved use of in this study.Differences were recognized between groups on the magnitude of change they reported on the subscales of the PSOCQ , which measures readiness to change. These findings were in line with previous research that identified improvements in readiness to change related to overall improvement in perceptions.51This study was not without its limitations. A strength of the Self-Evaluation Scale was that it suggests universal criteria for rating one’s improvement , so that participants may be more inclined to rate themselves on these treatment-related goals, rather than on domains of improvement that may not be related to the factors addressed by the chronic pain management program. However, the domains suggested in this scale may not be domains that participants find personally important. To address this issue, a comment section is also included in the scale for the participant to elaborate on and add justification for the rating that he or she provided.52 In addition, some of the measures such as the CES-D and CAS attempted to evaluate global mental states, in which the items in these measures are not pain specific or necessarily pain relevant. If items were more pain specific, their associations with one’s perceptions of improvement may have been more significant in this study if their depressive, anxious, or happy states are influenced by the pain they endure. For example, participants who reported a greater level of global improvement may have reported greater improvements in pain-specific depression than those who reported lower levels of improvement, as opposed to reporting improvements in global experiences of depression. Finally, the measures also varied in the time frames used when asking participants to assess their experiences. For instance, the PRIME-MD PQ asked participants to assess symptoms over a period of 4 weeks, whereas the PIS asked participants to assess severity in the past 2 weeks. This introduces variance in the findings; future studies could address this by ensuring consistency in time frames that are proposed across all measures.All of the questionnaires concerning the psychosocial factors of the program have been tested for reliability, validity, and sensitivity to change. However, possible floor and ceiling effects were not accounted for. For instance, for participants who may have already reported high scores on the measures such as Activity Engagement and have genuinely improved on this factor throughout the period of treatment, a report of a high score at discharge may not reflect the actual magnitude of change they experienced on that factor. This bias would also be present for those who scored low on measures such as the CES-D. This is particularly limiting on questionnaires that involve transition through stages such as the PSOCQ, in which a participant who initially indicated a high score on the Precontemplation subscale and a lower score after treatment would demonstrate a greater magnitude of change than a participant who scored low on the same subscale at both time points. To address these issues, future studies could consider retrospective questionnaires, in which participants rate at the second time point how they felt before treatment to how they feel after treatment. This method has demonstrated greater validity at identifying change than traditional pre–post questionnaires.Future work could look to evaluate the expectations that the participants have of their improvement prior to the program and compare these expectations to their perceptions of self-improvement after treatment. It would be interesting to see whether a patient who projects great improvement and satisfaction in the beginning of the program improves more than those who do not. In addition, providers can utilize the perceived expectations to help create individual goals and realistic expectations that are reachable for the participant; this involvement of the patient in planning his or her treatment based on his or her expectations could help lead to positive perceptions of self-improvement.This study identified some of the psychosocial factors that may be most valued or important to participants in their perceptions of self-improvement. It was discovered that for patients to perceive their improvement as successful as opposed to unsuccessful, they required a greater extent of improvement across multiple domains that relate to improving one’s ability to engage and persist through tasks and reducing experiences of emotional distress and disability. Insights from this study can help inform patient-centered care in addressing the needs of participants as they relate to these valued psychosocial factors by adopting treatment approaches that address the multidimensional nature of the patient’s experience. This understanding can also enhance communication in patient–provider relationships about what criteria can be involved in success for patients to help them create goals, informed choices, and realistic expectations.


Background and Objectives: Currently, one of the most discouraging aspects for many patients undergoing dental procedures is the administration of anaesthesia. Consequently, there is a constant search for new techniques to avoid the invasive and painful nature of the injection. A new motorised syringe system (Dentapen®) has recently been developed, standing out for its convenience and ease of use. Material and Methods: Randomised, controlled, single-blind, and single-centre study including 178 voluntary adult participants aged between 18 and 90 years. Individuals were randomly assigned using a randomised table. Patients were asked to rate the level of pain experienced during the injections, using a 10-point visual analogue scale (VAS). The following data were recorded: pain index, heart rate, blood pressure, and saturation, both before and after anaesthesia. Results: Of the total 178 participants, 87 participants (48.9%) were men and 91 (51.1%) were women. The first variable to be assessed was the pain experienced by patients when anaesthetised with a syringe, obtaining a mean value of 2.63 ± 1.86 on the VAS with the conventional syringe and 1.06 ± 1.28 with the Dentapen® syringe, showing statistically significant differences . When stratifying, based on the procedure that was undertaken, differences were also significant for all treatments  except for endodontics, where differences were likely to be significant . Conclusions: In conclusion, from a clinical standpoint, the Dentapen® syringe is a valid alternative to traditional infiltration syringes, causing minimum pain with the injection. At present, the administration of anaesthesia is one of the most discouraging aspects for most patients undergoing dental procedures, causing many of them ,2,3,4 toGrace et al. stated, in their studies conducted on adolescents and young adults from different countries (Belfast (Northern Ireland), Helsinki (Finland), Jyväskylä (Finland), Dubai (UAE), Dunedin , and Singapore), that dental phobias affected 5–15% of them, and that 11–26% experienced high levels of dental fear and anxiety ,17,18.In a cross-sectional study on 970 children between the ages of 5 and 12 years, Colares et al. found a prevalence of dental fear and anxiety of 14.4% . The greA study on the prevalence of the clinical consequences of untreated tooth decay and its connection with dental fear found that children with fear were 2.05 times more at risk of tooth decay than those with little or no fear .The premise that justifies our study is that the slow injection of anaesthetics at low pressure appears to reduce pain and discomfort during dental anaesthesia. An accurate control of flow and pressure of the injection can therefore mitigate the pain experienced by these patients. Primosch and Brooks revealed that injecting 0.3 mL of local anaesthetic solution at a slow speed with constant flow 161 s/mL) is less painful than with a quicker infiltration (29 s/mL). Other authors stated that, to minimise pain and anxiety, it is important for dentists to start injecting the anaesthetic at a pressure of under 306 mm Hg . Consequ1 s/mL is®) has recently appeared that stands out for its convenience and ease of use, and that currently does not require specific training. It has several injection settings, allowing it to be held like a syringe or pen, and is compatible with all anaesthetic needles and cartridges from all brands.A new, cableless, motorised syringe system . It comprised a single operator and 178 adult volunteers requiring some sort of dental treatment aged between 18 and 90 years, 87 of which (48.9%) were men and 91 (51.1%) of which were women. The study was carried out at the Dental Clinic of the University of Salamanca.® syringe motor was camouflaged with background music, together with the suction system of the dental chair.Treatment for each patient was assigned by a randomization list, automatically generated prior to the start of the study, in which the treatment material was determined. In the case of bilateral treatments, treatment was assigned to one side or the other, according to a supplementary randomization list. The patient randomization was performed in order to avoid sex bias; thus, the final numbers of men and women in each group were not significantly different, to comply with the blind aspect of the study—participants were not informed of the kind of syringe that was to be used. Patients were also asked to don a mask over their eyes, which remained closed throughout the procedure so as not to see the syringe. The sound of the Dentapen® syringe was used in 54.7% of the procedures and a conventional syringe was used in the remaining 45.3%.An average of 1.8 ± 1.9 interventions that required anaesthesia were undertaken on each patient up to a total sample of 287 observations (51% in men and 49% in women). The distribution based on the type of procedure was as follows: 119 extractions, 66 fillings, 55 root canal treatments and root canal retreatments, 27 surgeries where a total of 11 implants were performed, 2 atraumatic and 1 traumatic maxillary sinus lift, 1 lip-repositioning surgery, 2 vestibuloplasties, 3 horizontal bone regenerations, 2 crown enlargements, 2 free gingival grafts, and 20 prepared tooth stumps. A Dentapen®, the green LED speed setting was used, together with the blue ramp-up. For the lower nerve-trunk blocks, however, the Akinosi technique was used, with the purple LED speed setting, together with the blue ramp-up mode. In palatine areas, the purple intra-ligamentary mode was used. Around 4–5 s after the puncture, the needle was further inserted apically, and the activation button was pressed twice to activate the self-suction mode and verify whether blood entered the cartridge or not. Patients were asked to rate the level of pain felt during the injection, using a 10-point visual analogue scale (VAS) that went from: 0–2—no pain, 2–4—moderate pain, 4–6—severe pain, 6–8—extreme pain, and 8–10—unbearable pain. In all cases, patients were placed in a supine position with the head tilted back. Variables, such as blood pressure, measured using a sphygmomanometer , and saturation and heart rate, using a pulse oximeter , were controlled both before and after the anaesthetic injection. The needle used for the infiltrative techniques in the palatine, vestibular, and lingual areas was the Medicaline 30G short 0.3 mm × 25 mm needle, while the Medicaline 27G long 0.4 mm × 38 mm needle was used for the nerve trunks.Each infiltration, irrespective of the type of syringe used, was preceded by the application of a spray containing lidocaine and cetrimonium bromide . After 3 min, the infiltration was carried out, with 1.8 mL of lidocaine 2% and 1: 80,000 . In the vestibular and lingual areas with DentapenHealthy patients, aged between 18 and 90 years, who required any type of dental treatment that entailed the administration of an anaesthetic. All patients agreed to participate and signed the necessary informed consent form.Patients with an ASA III and ASA IV classification, with gumboils, a history of psychiatric illness and/or allergies to lidocaine. Pregnant patients. Patients with drug and alcohol issues, or who had recently suffered a heart attack. Patients with respiratory issues in the last 14 days. Patients with COVID-19 or who were in quarantine.t-test—a statistical deductive tool that evaluates the differences in means between two groups through statistical hypothesis testing. This allowed us to determine, through the data of our sample, if the differences that were found can be generalized to the population, and to verify with a high level of confidence if the Dentapen® syringe induces less pain than the conventional syringe. Similarly, we used an analysis of variance to prove the hypothesis that the means in more than two groups are the same. All analyses and data visualisations were carried out using SPSS 25.0 software  and Microsoft Excel 16.46 .We evaluated the mean reported pain levels measured using the VAS (ranging from 0 (no pain), to 10 (unbearable pain)), based on the type of syringe used, the type of treatment, and the area of injection. We analysed gender-related differences, and whether there were any changes in blood pressure, saturation, or heart rate after anaesthesia with both syringes. To do so, results were expressed as means and standard deviations , followed by the palatine (25.4%), the trigone (20.6%), and the lingual area (3.1%). This information can be found in A Dentapenp-value < 0.01), with lower reported pain when using the Dentapen® syringe, with a mean value of 1.06 ± 1.28 points, compared with the results obtained in procedures where the conventional syringe was used, with 2.63 ± 1.86 mean points. These differences persisted when stratifying by the type of treatment, with highly significant differences , except for in endodontics, where differences were likely to be significant   based on the type of syringe used, showing highly significant differences (.02) see .p-value = 0.000). The lowest pain levels corresponded to the vestibular area (1.21 ± 1.49), which showed statistically significant differences when compared with the remaining areas: 2.49 ± 2.01 in the palatine area , 2.08 ± 1.48 in the trigone area  2.06 in the lingual area . . .p-value = 0.001) and lingual areas . By studying the sample values, we can observe that pain is more stable and notably lower when using the Dentapen® syringe, with highly significant differences in all areas. This information is presented based on the type of syringe used in Furthermore, these differences increased when considering the use of a conventional syringe exclusively. In this case, and in addition to the same overall differences found in our previous analysis, we also identified differences when comparing the trigone area with the palatine (® (red) syringe. Moreover, and in addition to offering higher stability, the differences based on the area of injection were also lower in this group. In contrast, both the pain and the differences by area sharply increased when using the conventional syringe (blue). It is worth mentioning that, with both syringes, patients felt less pain in the vestibular area, with significant differences in relation to the other areas.p-value = 0.518) globally, nor when stratifying by the type of syringe, area of injection, or type of treatment.Thirdly, we studied the differences in the VAS score by gender see . The mea®) and 4 of 4 cartridges . No statistically significant differences were found .Additionally, we compared the need for several cartridges of anaesthesia between the two syringe types. In the entire sample, we had 196 observations of the placement of 1 cartridge, 82 observations of 2 cartridges, 5 of 3 cartridges .Heart rate: We observed a reduction in heart rate with both syringes, with greater variation in patients whose treatment involved the use of a conventional syringe  than with Dentapen® .High blood pressure: In both cases, we observed a small reduction with statistical significance, which was slightly higher with the conventional syringe  than with the conventional syringe .Low blood pressure: In both groups, a small reduction with statistical significance was observed, which was slightly higher with the Dentapen® .Saturation: Saturation increased with both syringes, though this variation was only significant with DentapenWhen evaluating the differences in the variables mentioned above, based on the type of syringe, we found no statistical significance in the “before” and “after” values. We can therefore conclude that the values measured before the procedure do not vary based on the knowledge of the type of syringe that will be used.® system for local anaesthesia. Secondarily, we considered the variations in parameters such as heart rate, blood pressure, and saturation, before and after the injection.We evaluated patient-reported pain levels experienced during the administration of anaesthetics for dental procedures, comparing the results of using conventional syringes and the DentapenThe design chosen for this work was that of a randomised clinical trial with two groups. Although similar studies opted for a split-mouth approach, with the advantage that individuals can act as their own control, we decided against it due to the difficulty of recruiting patients with a need for similar dental interventions in both sides of the arch. Furthermore, the classification of the pain level of the second anaesthetic injection can be less reliable with these designs, given the influence of the first .® syringe was used, which, in addition, offered greater stability. Regarding the use of conventional syringes, we observed a sharp increase in patient-reported pain, with differences based on the area of injection. Patients felt less pain in the vestibular area with both syringes, with significant differences compared with the other localisations. This concurs with the findings of Campanella et al. [In this study, pain perceived by patients was notably lower in all the areas where the Dentapena et al. , Garret-a et al. , Grace ea et al. , and Moha et al. , who repCCLAD systems can reduce injection flow to a specific, fixed pressure, regardless of the variation in tissue resistance . This efOverall, we found no significant differences in terms of patient-reported pain by gender. Our results when taking into account the type of syringe, the area of injection, and the type of treatment concurred with previous findings, such as in the studies by Gibson et al. and Allen et al. . SimilarA variable of potential interest that could not be included in our analysis was the anxiety experienced by patients. Notwithstanding, not all previous studies on the matter had analysed it, presumably as a result of several authors, such as Tahmassebi et al.  and Camp® syringe is a valid alternative to conventional infiltration syringes, causing minimum pain with the injection. Regarding clinical discomfort, the use of the Dentapen® syringe provides a deep anaesthetic effect, which we achieved in the different dental procedures undertaken for this study, thereby increasing patient satisfaction.In conclusion, from a clinical perspective, the Dentapen


Oral mucositis related pain during CTRT in head and neck cancers is a common problem. Unfortunately, in spite of it being common, there is limited evidence for selection of systemic analgesic in this situation. Hence, this study was designed to compare the analgesic effect of a non-steroidal anti-inflammatory drug (diclofenac) versus a weak opioid (tramadol).This was an open-label, parallel design, superiority randomised controlled study. In this study, head and neck cancer patients undergoing radical or adjuvant chemoradiation, who had grade 1 or above mucositis (in accordance with Common Terminology Criteria for Adverse Events version 4.03) and had pain related to it were randomly assigned to either diclofenac or tramadol for mucositis related pain control. The primary endpoint was analgesia after the first dose. The secondary endpoints were the rate of change in analgesic within 1 week, adverse events and quality of life.p = 0.05619). Five patients (8.1%) in the tramadol arm and 11 patients (16.7%) in the diclofenac arm required a change in analgesic within 1 week of starting the analgesic (p = 0.184). There was no statistically significant difference in any adverse events between the two arms. However, the rate of any grade of renal dysfunction was numerically higher in the diclofenac arm .One hundred and twenty-eight patients were randomised, 66 in diclofenac and 62 in tramadol arm. The median area under the curve for graph of pain across time after first dose of pain medication for the diclofenac arm and the tramadol arm was 348.936 units  and 420.87 , respectively, (In this phase 3 study, evaluating diclofenac and tramadol for chemoradiation induced mucositis pain, there was no statistical difference in analgesic activity of these two drugs. Mucositis is common in head and neck cancer patients undergoing concurrent chemoradiation . The oveManagement of mucositis related pain is an important component of the treatment of mucositis –8. Both The World Health Organization (WHO) pain ladder is commonly used to guide the selection of systemic analgesics –20. Non-This was an open-label, parallel-arm, superiority, pragmatic, phase 3, randomised study conducted at Tata Memorial Centre, Mumbai, India. The study protocol was approved by the Institutional Ethics Committee. The trial was registered prospectively with the Clinical Trial Registry of India (CTRI/2016/09/007302 (Registered on 23/09/2016)). It was conducted in accordance with the guidelines for Good Clinical Practice – International Conference on Harmonisation E6(R2), Declaration of Helsinki and Indian Council of Medical Research guidelines. All patients provided written informed consent prior to participation. The study was funded by an intramural grant from the Tata Memorial Center Research Administration Council (TRAC). The funding agency had no role in design and conduct of the study, collection, management, analysis and interpretation of the data, preparation, review or approval of the manuscript, and decision to submit the manuscript for publication. The study protocol  had no amendments post its initial approval and the investigators adhered to the approved study protocol.Adult (age ≥ 18–70 years) head and neck cancer patients who were undergoing concurrent chemoradiation were invited to participate in the study subject to fulfilment of below-mentioned eligibility criteria. The planned dose of radiation had to be 60 Gy or above and administered in a conventional fashion, 1.8–2 Gy per fraction with radiation delivery 5 days a week. Patients with Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0–2, with adequate haematological and liver functions, with mucositis related pain of 1 or more on the visual analogue scale (VAS) were invited for the study. Patients who were already on analgesic or had deranged serum creatinine  or had an allergy to study medications were excluded.Patients were randomised in a 1:1 fashion between the two arms. The random allocation sequence was generated by an independent statistician. The allocation was performed by block stratified randomisation. The factors considered for stratification were the site of the tumour , T grouping , N grouping  and pain score on VAS (below 5 versus 5 or above). Sixteen strata were generated with each having a block size of 4. The study investigators or coordinators did not have access to the randomisation sheets and it was performed by an independent person.The study had two interventional arms, arm A and arm B. Patients in arm A received tablet diclofenac for pain relief. Diclofenac was administered in a dose of 50 mg per os (PO) thrice daily (TID). Patients in arm B received tablet tramadol for pain relief. Tramadol was administered in a dose of 50 mg PO TID. All patients in both arms received a local rinse with local anaesthetic (benzocaine 20% w/w) and antacid  in addition to the systemic analgesic. The first dose was administered under the supervision of the trial staff. Pain scores at baseline (on VAS) and at 5, 15, 30, 60, 120, 240, 300 and 360 minutes after the first dose of analgesic were noted. The VSA had a minimum score of 0 and a maximum score of 10 represented in a horizontal line with 10 cm separation between 0 and 10. The patients were instructed by the trial staff to plot their scores in accordance with the pain felt where 0 – represented no pain, while 10 – represented maximum bearable pain. The score at each time point was measured using a ruler (line gauge).Subsequent follow-up were conducted weekly till completion of chemoradiation (CTRT). At each week, blood investigations inclusive of complete blood count, serum creatinine, serum electrolytes , serum glutamic-oxaloacetic transaminase (SGOT), serum glutamate-pyruvate transaminase (SGPT) and total bilirubin were performed. In addition, pain control, compliance with pain medications and adverse events (in accordance with Common Terminology Criteria for Adverse Events version 4.03) were assessed. Pain and analgesic effect were assessed at each visit as per the VAS. If inadequate pain control was noted, then the patient’s analgesic was changed. The definition of inadequate pain control was the presence of pain of 1 or more on VAS. This change was done with the discussion and concurrence of two clinicians. The pattern of change of analgesic was predefined. In case of inadequate pain control in the diclofenac arm, a weak opioid was added. While in case of inadequate pain control in the tramadol arm, an NSAID was added. In case of subsequent inadequate pain control in any arm after the first change, a strong opioid was considered. Quality of life questionnaire -c30 and QLQ-HN-35) was administered to patients at baseline, at each subsequent visit till end of treatment.t-test with an equal-variance assumption.Assuming a 5% significance level, with 80% power to detect a clinically meaningful effect size of 0.5 of a standard deviation between the two arms, we required 128 patients (64 patients for each arm) based on the two-sample The primary endpoint of the study was analgesia for 6 hours post first dose of studied analgesic.X-axis and pain scores on the Y-axis. On the X-axis, the time points 0, 5, 15, 30, 60, 120, 240, 300 and 360 minutes were represented by values 1, 2, 3, 4, 5, 6, 7, 8 and 9 to avoid overweighting the later time points. The values of Y-axis were plotted with the baseline score being considered as 100% and the rest of the scores were adjusted accordingly. The secondary outcomes were to compare the proportion of patients requiring a change in analgesic within 1 week of the start of studied analgesic, adverse events, weight loss and quality of life at the end of treatment.For quantification of the analgesic effect, an area under the curve (AUC) was plotted with time being represented on the p-value of 0.05 or below was considered as statistically significant while an effect size of 0.5 or above was considered as clinically significant. Post hoc sensitivity analysis was performed using two methods. First was comparing AUC between the two arms using the Wilcoxon rank-sum test. However, the missing data was tackled using the listwise deletion method . The second was comparing the pain scores at different time points between the two arms using Linear Mixed Effect Model. The comparison of change of analgesic within 1 week, adverse events and weight loss was performed using Fisher’s test. The quality of life analysis was performed as per the European Organization for Research and Treatment of Cancer (EORTC) guidelines. The linear mixed effect was performed as an extension of the linear model to compare quality of life domains between the two treatment arms. The data were censored for analysis on 9 July 2019.Statistical Package for the Social Sciences version 20 and RStudio version were used for analysis. Intention to treat analysis was performed. Descriptive statistics were performed. Ordinal and nominal variables were expressed in terms of percentages with 95% confidence interval (CI) while continuous variables were expressed in terms of the median with range. Missing data were imputed using the multivariate imputation by chained equations. The AUC for analgesia was calculated using the trapezoidal rule. The AUC was compared between the two arms using the Wilcoxon rank-sum test. The effect size index was calculated for the difference in the AUC between the two arms and interpreted as per Cohen. A The study recruited 128 patients between 26 April 2017 and 20 May 2019, with 66 patients in diclofenac and 62 patients in tramadol arm. p = 0.06) with the complete dataset method using Wilcoxon rank-sum test. The calculated Cohen effect size for this difference was 0.125, suggesting it was not clinically significant (p = 0.11) with the listwise deletion method using Wilcoxon rank-sum test. The sensitivity analysis performed using a linear mixed effect model also confirmed the same findings (p = 0.46) and complete dataset methods (p = 0.58) and the results were in line with the primary analysis.Pain scores in 8 6.25%) patients were missing at time points at 5, 15, 30, 120, 240 and 300 minutes. While for 9 (7%) patients, the data of pain scores at 60 and 360 minutes were missing. The pain score at different time points overall and between the two arms is shown in nificant  and 2. T5% patienfindings . A post p = 0.18) (p = 0.15). The adjusted odds ratio was 2.329 (95% CI: 0.69–7.855) in favour of tramadol arm (p = 0.173) (Five patients (8.1%) in the tramadol arm and 11 patients (16.7%) in the diclofenac arm required a change in analgesic within 1 week of starting the analgesic ( = 0.18) . The cau= 0.173) .p = 0.37). The cause of change in analgesic in all patients except one was inadequate pain relief. One patient in the diclofenac arm had a rise in serum creatinine and hence the analgesic was changed. The unadjusted odds ratio for change in analgesic was 1.425 , while the adjusted odds ratio was 1.612  (p = 0.038). Data are shown in Twenty-nine patients (43.9%) in the diclofenac arm and 22 patients (35.5%) in the tramadol arm had a change in studied analgesic till the end of chemoradiation (= 0.222) . The onlp = 0.18). Tramadol and morphine were required in the diclofenac arm in 23 (34.8%) and 8 (12.1%) patients, respectively. While diclofenac and morphine were required in 16 patients (25.8%) and 7 patients (11.3%), respectively, in the tramadol arm.The median duration of analgesic in the study was 28.5 days (range: 7–63). The median time to change to analgesic was 28 days (95% CI: 18.248–37.752) for diclofenac versus 54 days (95% CI: 30.617–77.383) for tramadol (p = 1). The incidence of nasogastric tube insertion was 54.5% (36) and 56.5% (35) in diclofenac and tramadol arm, respectively, (p = 0.86). The adverse events in both arms are shown in p = 0.33).The compliance in diclofenac and tramadol arm was observed in 55 (83.3%) and 52 (83.9%), respectively, (n = 61), while in the tramadol arm 55 patients  received a cumulative dose of cisplatin ≥ 200 mg/m2 (p = 0.06).The details of radiation dose planned, technique, chemotherapy planned are shown in The quality of life at baseline and at each visit was similar between both arms. The results of quality of life analysis using linear mixed effect models are shown in This study evaluated the role of systemic analgesia in mucositis pain. In the current study, there was a decrease in pain scores after administration of the first dose of systemic analgesic ; howeverThe selection of any drug, as the drug of choice, rests on adverse event profile if efficacy is similar. The adverse events were similar between both arms and were largely dictated by the adverse events related to cancer-directed therapy. However, there was a numerical difference in the rate of renal dysfunction between the two arms, with the incidence being twice in diclofenac arm than tramadol arm. The rate of renal dysfunction in the current study is overall lower than that reported in western literature and is primarily because of predominant use of weekly cisplatin , 29. ConThe focus of research on analgesic treatment of mucositis pain is largely restricted to local analgesics , 11, 14.2 or more was lower in the diclofenac arm. The probable reason for this is due to renal dysfunction caused by diclofenac. A cumulative dose of cisplatin of 200 mg/m2 or more is an important factor influencing efficacy outcomes in head and neck cancer [Mucositis pain is associated with weight loss, delays and noncompliance with anticancer treatment , 34. In k cancer .The current study has its strengths and limitations. The strengths of this study are that it is a unique study evaluating the role of commonly prescribed systemic analgesics, provides data regarding compliance, longitudinal change of analgesic and quality of life, which is sparse in literature. The limitations are that the study was a single centre, open label study and there was no placebo arm in this study. Since there was no placebo arm, the impact of diclofenac and tramadol over placebo could not be studied. However, this aspect was considered at the time of conceptualisation of the study and it was considered unethical to deny patients of an analgesic. The study was conducted in a single centre. However, it led to a uniform treatment decision across both arms. The study was an open label study and hence both patients and physicians were aware about the study arm. However, the study methodology required patients to mark the pain on VAS and a change in analgesic was not permitted unless the prespecified VAS score criteria in the protocol were met, thus decreasing the probability of physician bias.In this phase 3 study, evaluating diclofenac and tramadol for mucositis pain, analgesic efficacy of both analgesics was found to be similar but diclofenac was associated with a numerically statistically non-significant higher rate of renal dysfunction.CTRT, Chemoradiation; NSAIDs, Non-steroidal anti-inflammatory drugs; AUC, Area under the curve; CTRI, Clinical Trial Registry of India; WHO, World Health Organization; TRAC, Tata Memorial Center Research Administration Council; ECOG PS, Eastern Cooperative Oncology Group Performance Status; VAS, Visual Analogue Scale; EORTC QLQ, European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire; 3DCRT, Three-dimensional conformal radiation therapy.The authors declare the following financial interests/personal relationships which may be considered as potential competing interests:Dr. Noronha reports grants from Dr. Reddy’s Laboratories Inc., grants from Amgen, grants from Sanofi Aventis, outside the submitted work.Dr. Prabhash reports grants from Biocon Ltd, grants from Dr. Reddy’s Laboratories Inc., grants from Fresenius Kabi India Pvt Ltd, grants from Alkem Laboratories, grants from Natco Pharma Ltd, grants from BDR Pharmaceuticals Intl Pvt Ltd, grants from Roche Holding AG, outside the submitted work.None of the other authors have anything to declare that may be considered as potential competing interests.Clinical Trials Registry-India (CTRI): CTRI/2016/09/007302 (Registered on 23/09/2016) Trial Registered Prospectively.This work is supported by TRAC (Grant Number - not applicable). The funding agency had no role in design and conduct of the study, collection, management, analysis, and interpretation of the data, preparation, review or approval of the manuscript, and decision to submit the manuscript for publication.


Background: Chronic postsurgical pain is a highly prevalent public health problem associated with substantial emotional, social, and economic costs.Aims: (1) To review the major risk factors for chronic postsurgical pain (CPSP); (2) to describe the implementation of the Transitional Pain Service (TPS) at the Toronto General Hospital, a multiprofessional, multimodal preventive approach to CPSP involving intensive, perioperative psychological, physical, and pharmacological management aimed at preventing and treating the factors that increase the risk of CPSP and related disability; and (3) to present recent empirical evidence for the efficacy of the TPS.Methods: The Toronto General Hospital TPS was specifically developed to target patients at high risk of developing CPSP. The major known risk factors for CPSP are perioperative pain, opioid use, and negative affect, including depression, anxiety, pain catastrophizing, and posttraumatic stress disorder–like symptoms. At-risk patients are identified early and provided comprehensive care by a multidisciplinary team consisting of pain physicians, advanced practice nurses, psychologists, and physical therapists.Results: Preliminary results from two nonrandomized, clinical practice–based trials indicate that TPS treatment is associated with improvements in pain, pain interference, pain catastrophizing, symptoms of anxiety and depression, and opioid use. Almost half of opioid-naïve patients and one in four opioid-experienced patients were opioid free by the 6-month point.Conclusions: These promising results suggest that the TPS benefits patients at risk of CPSP. A multicenter randomized controlled trial of the TPS in several Ontario hospitals is currently underway. Health-related quality of life of Ontarians with chronic pain is lower than that reported by people with most other chronic diseases, including heart disease, diabetes, and chronic obstructive pulmonary disease.2 The annual incremental medical cost to manage chronic pain in Ontario is estimated at $1742 per person in 2014 Canadian dollars,3 which translates to a ~$10 billion burden annually to the Canadian health care system, not including direct out-of-pocket costs incurred by the person with pain or indirect costs such as lost income. Chronic postsurgical pain (CPSP) is a significant driver of this cost4 given the high rates of CPSP. The magnitude of the problem is evident when one jointly considers that 312 million major surgeries are performed annually worldwide5 and the one-year incidence of moderate-to-severe CPSP is ~12% and ~22% for adults6 and children,7 respectively. It is not surprising, then, that more than 20% of adults8 and 17% of children9 attending specialized chronic pain centers have been referred for CPSP. Innovative research designs12 and novel solutions14 are needed to halt—and potentially reverse—the transition of acute pain to chronic pain, improve quality of life, and reduce personal/system costs related to unnecessary hospitalizations, medications, disability, and unemployment.Chronic pain is the silent epidemic of our times.The aims of the present article to are (1) review the major known risk factors for CPSP; (2) describe the implementation of the Transitional Pain Service (TPS) at the Toronto General Hospital, a multiprofessional, multimodal preventive approach to CPSP involving intensive, perioperative psychological, physical, and pharmacological management aimed at preventing and treating the factors that increase the risk of CPSP and related disability; and (3) present recent empirical evidence for the efficacy of the TPS.16 The pain (1) developed after a surgical procedure, (2) is at least 2 months in duration, (3) interferes significantly with health-related quality of life, (4) is a continuation of acute postsurgical pain or develops after an asymptomatic period, (5) is localized to the surgical field and/or projected to territory or dermatome innervated by a nerve in the surgical field and (6) is not caused by other factors .Substantial variability exists among surgical procedures, including the anatomic structures and physiologic processes affected as well as the time required to heal and recover. Nevertheless, the following 6-point definition appears to capture the most important aspects of CPSP.26 although the question of causality remains unanswered.29 There are many risk factors for CPSP. The following are those most consistently reported in the literature. Type of surgery has long been recognized as a major risk factor for CPSP, with surgeries that involve deliberate or inadvertent damage to nerves showing the highest prevalence,19 though not all CPSP is neuropathic.30Considerable progress has been made in identifying risk and protective factors for CPSP,31 The data clearly show that the presence32 and intensity of preoperative chronic pain,35 the intensity of acute postoperative pain,36 the time spent in severe pain after surgery,6 pain intensity in the weeks after surgery,38 and pain in other body parts39 reliably predict CPSP across a range of surgical procedures. Higher consumption of postoperative analgesics, typically a proxy for intense postoperative pain, is associated with more intense CPSP.41 Negative cognitive–affective states including perioperative depression,43 anxiety,44 pain catastrophizing,44 and posttraumatic stress symptoms45 also predict the development of CPSP. Finally, preoperative opioid use, with a prevalence of ~25%,46 is a risk factor for CPSP,47 in part due to opioid-induced hyperalgesia.49The most robust risk factor for CPSP is pain itself.52 Inadequately controlled acute pain and excessive opioid use delay recovery and hospital discharge after many surgeries.56 Notably, many of the above risk factors for CPSP are also associated with persistent opioid use after surgery, including mood disorders,57 anxiety,57 pain catastrophizing,58 preoperative neuropathic and nonneuropathic pain,57 and greater pain intensity on the day of surgery.58Negative affect and pain catastrophizing are also risk factors for intense, acute postoperative pain and excessive opioid use.61 The following sections describe the Toronto General Hospital TPS and preliminary clinical outcomes.Management of these known risks before and after surgery is hypothesized not only to reduce pain, suffering, and opioid misuse but also to benefit the health care system by facilitating earlier discharge and reducing costs.61 was established in 2014 to address the problem of CPSP with a seamless approach to perioperative pain and opioid use using multidisciplinary, integrated care. Patients are assessed and managed as early as the preoperative visit, treatment is extended into the in-hospital setting after surgery, and it is maintained for up to 6 months across the post–hospital discharge period once patients have returned home. The primary aim of the TPS is to offer timely and effective treatment to patients at high risk of developing chronic postsurgical pain and persistent opioid use after undergoing a variety of surgical procedures, including those for cancer , cardiac disease , and organ transplants . The three major goals of the TPS are to (1) provide comprehensive pre- and postoperative pain management for patients who are at high risk of developing chronic postsurgical pain and pain disability, (2) manage opioid medication while in hospital and after discharge, and (3) improve coping and functioning in the immediate and long term to provide as high a quality of life as possible. At present, clinical services at the TPS include multimodal medication optimization by anesthesiologists, postsurgical physical therapy and acupuncture, and a pain psychology intervention consisting of pain education, mindfulness training, brief hypnosis, and a form of cognitive–behavioral treatment called acceptance and commitment therapy (ACT). The service also includes an administrative assistant and a patient care coordinator. In 2016, the TPS began a partnership with ManagingLife, whose mobile platform and app, Manage My Pain, allows TPS patients to quickly and easily track their pain on a daily basis using an Apple iPhone, Android smartphone, or a responsively designed web app through their mobile or desktop browser.62The Toronto General Hospital TPSThe TPS provides proactive, timely support in a multidisciplinary setting to inpatients and outpatients with complex postsurgical pain for up to 6 months after surgery. Patients are screened for physical and mental health problems and flagged for known risk factors  if they 29 The main goal of the TPS ACT intervention is to teach patients a mindful approach to their postsurgical pain that allows them to live a fuller life.63 The ACT intervention teaches them how to stop the negative cycle of intense postoperative pain, emotional distress, behavioral avoidance, and escalating opioid use that inhibits functioning and degrades quality of life. Patients learn to expand their capacity to experience pain—including the negative thoughts and feelings that inevitably arise when pain is present. Pain sensations—as well as the patients’ reactions to them—are observed neutrally and nonreactively, while focusing on enhancing motivation and commitment to engage in personally meaningful, achievable, goal-oriented activities. They are taught to do so without engaging in problematic avoidance behaviors that typically make the pain worse and limit functioning. Ultimately, patients become more psychologically flexible; they learn to adapt their behavior in a way that enables them to live a rich and meaningful life while open to their internal psychological and emotional experiences, including pain.There is growing understanding of the important role that psychological interventions can play in reducing pain perception, negative affect, and avoidance behaviors after surgery.In addition to our psychology team, the nursing, physiotherapy/acupuncture specialists, and recently our yoga specialist are all integral to the TPS. The Acute Pain Service nurse practitioners are the backbone of the TPS. They identify patients immediately after surgery who are not recovering as they should and then refer to our inpatient coordinator, who then arranges an in-hospital visit and the scheduling of the outpatient clinic visit. The outpatient clinic has also recently expanded to include a pain and opioid misuse (addiction) specialist nurse practitioner who has been a critical addition to the team and a significant resource to the hospital. The nurse practitioner’s role is to manage complex pain patients with opioid and other use disorders within the institution (expanding beyond perioperative care). Our acupuncturist manages patients who are amenable to treatment in the outpatient setting and we are planning to evaluate its effectiveness in the immediate postoperative time period. Finally, we have a certified hatha yoga instructor who has developed a postoperative yoga pathway that we are currently evaluating for efficacy.62We encountered several barriers to implementation of the TPS. Some have been overcome but we continue to grapple with others. First, institutional acceptance of the program took time, and acceptance by our surgical colleagues regarding the added value of this novel care pathway was initially lukewarm. Today, the referrals overwhelm the team and currently a major limitation is the inability to keep up with the increased capacity demands within the institution. Discharging patients after they have stabilized has also proven to be a challenge. This is partly due the patients’ positive connection to the interdisciplinary team and their reluctance to move back to a single-provider model of care. The lack of primary care providers for some patients has also proven to be a factor limiting our ability to discharge TPS patients within the 3- to 6-month postoperative time frame. The added burden of the opioid crisis has also delayed our ability to discharge stable TPS patients who were unable to wean off their opioid medications because many primary care providers simply refuse to inherit opioid prescriptions not initiated by them or refuse outright to prescribe opioids at all. We also encountered initial challenges integrating the Manage My Pain (MMP) app into the daily clinical service of the TPS. One of the biggest hurdles in the implementation of the MMP platform at Toronto General Hospital was safe stewardship of patient health information. Issues involved data security, sharing patient data with the care team, authenticating the clinical user, and access to patient data after TPS treatment has ended. These concerns regarding the safeguarding of patients’ electronic private health information have been resolved to satisfaction of the TPS, MMP, and patients.65 and a detailed case report63 showing promising psychosocial outcomes and opioid weaning rates. The two clinical practice–based studies are reviewed in detail below. A multicenter randomized controlled trial of the TPS in several Ontario hospitals is currently underway, funded by the Ontario Ministry of Health and Long-Term Care.At present, the best evidence we have for the efficacy of the TPS comes from two clinical practice–based cohort studies64In the first study, patients receiving TPS psychological services (ACT group) were compared to those not receiving psychological services (no ACT group) on measures of pain, pain interference, key psychological constructs, and opioid use for the duration of TPS treatment.66 pain catastrophizing,67 symptoms of anxiety and depression,68 and opioid use were compared between the two groups and across time, beginning with the first TPS visit and ending with the last. Patients referred to the ACT group were significantly more likely to report a mental health condition preoperatively, had significantly higher opioid use at the first postsurgical visit, and, at both time points, reported significantly higher sensitivity to pain traumatization and anxiety scores than the no ACT group. These pretreatment differences are not surprising given that patients who are referred to TPS psychology services typically are the most distressed and are having the most difficulty coping. On the other hand, likely because of these differences, the ACT group was involved with the TPS for a significantly greater number of weeks and had significantly more medical visits to the TPS than the no ACT group.A total of 382 TPS patients participated in the study. Ninety-one received ACT and 252 did not (no ACT). Pain intensity, pain interference, sensitivity to pain traumatization,By the last TPS visit, both groups showed significant reductions in pain intensity, pain interference, pain catastrophizing, anxiety, and opioid use. Compared to the no ACT group, the ACT group showed greater reductions in opioid use and pain interference. Moreover, only the ACT group showed a significant reduction in depressed mood by the last TPS visit. These results indicate that patients who are referred for psychology services upon admission to the TPS are a higher-risk group of patients. Nevertheless, learning the ACT approach to behavioral pain management enabled them to wean off opioid medications to a greater extent than the lower-risk, no ACT group while at the same time reporting greater improvements in mood and less pain interference. However, differences in treatment duration between the ACT and no ACT groups raise the question as to whether the no ACT group would have achieved additional reductions in opioid weaning, pain interference, and depressive symptomology given an equivalent follow-up time. With these caveats in mind, these results provide preliminary support for the ACT-based intervention in targeting and successfully managing TPS patients at risk of CPSP and persistent opioid use.65 compared opioid consumption and opioid weaning rates an average of 6 months after surgery between TPS patients who were opioid naïve or opioid experienced presurgically. Opioid consumption in daily morphine milligram equivalents (MME/day) was examined on admission to the TPS, at hospital discharge after surgery, and on the day of their last TPS visit an average of 6 months after surgery.The second clinical practice–based studyn = 137) were taking a mean of 78.8 ± 100.2 MME/day prior to surgery. The daily dose almost doubled to 140.5 ± 124.0 MME/day by the time they were discharged from hospital after surgery. At the last TPS visit ~6 months after surgery they were taking 78.3 ± 113.9 MME/day (44.3% decrease), which was essentially the same dose they had been taking prior to surgery (Opioid-experienced patients ( surgery . In termn = 110), were taking a mean of 106.7 ± 80.6 MME/day at the time of hospital discharge after surgery, which was reduced to 37.3 ± 61.1 MME/day at the final TPS visit (65% decrease) ~6 months after surgery. In terms of weaning rates, by 6 months after surgery, 51 (46%) had been successfully weaned from opioids, 39 (35%) had reduced opioid use by >50% of their hospital discharge dose, 11 (10%) had reduced opioid use by <50%, and 9 (8%) had increased their opioid use from hospital discharge.In contrast, opioid-naïve patients, who nonetheless were identified as high risk for postsurgical pain  show treatment successes and the two upper quadrants (red shading) show failures. The lower left quadrants show patients who were below the recommended 90 MME/day at both time points split into those who were totally weaned by 6 months, those who were below 90 MME/day at discharge and even lower at 6 months, and those whose 6-month dose, though lower than 90 MME/day, was higher than their hospital discharge dose. The lower right quadrant shows patients who were above 90 MME/day at hospital discharge and who were totally weaned by 6 months or had managed to reduce their opioid dose to the recommended dosage or lower. As noted above, these patients represent treatment successes. In contrast, the upper left quadrant shows patients whose discharge dose was 90 MME/day or less but were taking more 6 months later. The upper right quadrant shows patients who were above the 90 MME/day limit on both occasions split into those whose dose was above or below the hospital discharge dose. r = 0.46) is lower than that in r = 0.59), providing evidence for the efficacy of TPS treatment, which likely was responsible for reducing the magnitude of the relationship  between hospital discharge and end of TPS treatment opioid use.Importantly, Brief Pain Inventory (BPI) pain intensity and interference scores at the last TPS visit were significantly lower than their respective post–hospital discharge scores (pre-TPS treatment) in both opioid-naïve and opioid-experienced groups, with the former group reporting larger improvements in pain interference than the latter group . These r65As noted above, 19% percent of opioid-experienced patients increased opioid use from hospital discharge to the 6-month time point. This subgroup is clearly of interest because these patients comprise our treatment failures, having faced the greatest challenge weaning from opioids. When compared with opioid-experienced patients who successfully reduced opioid consumption, this subgroup was more likely to be male, an organ transplant patient, and to have been diagnosed with a mental health disorder. For the entire sample of opioid-experienced patients, the predictors of opioid dose reduction from hospital discharge to the last TPS visit included lower pain catastrophizing scores, lower prevalence of neuropathic pain, and a negative history of recreational drug use. In contrast, the only predictor of dose reduction for opioid-naïve patients was the daily morphine milligram equivalent at hospital discharge.71 Fifty-four percent and 32% were discharged from hospital on “weak” and “strong” opioids, respectively. At the end of the outpatient program 3 months later, 20% and 6% of patients were taking weak and strong opioids, respectively. Information on preoperative opioid use and daily morphine milligram equivalent doses before and after surgery were not reported, making it difficult to compare these findings with the TPS results presented above.To our knowledge, this is the first study to report detailed data on opioid weaning rates and opioid doses in patients receiving comprehensive, targeted care for postsurgical pain and opioid use in the months after surgery. A multidisciplinary Acute Pain Service outpatient clinic similar to the TPS reported on a sample of 200 patients after surgery.To date, the major known risk factors for CPSP are perioperative pain, opioid use, and negative affect, including depression, anxiety, pain catastrophizing, and posttraumatic stress disorder–like symptoms. The Toronto General Hospital TPS was specially developed to target patients at high risk of developing CPSP based on the above risk factors. Patients are identified early and provided comprehensive care by a multidisciplinary team consisting of pain physicians, advanced practice nurses, psychologists, and physical therapists. Preliminary results from two nonrandomized controlled trials indicate that the TPS effectively reduces pain intensity, pain-related interference, pain catastrophizing, symptoms of anxiety and depression, and opioid use. Almost half of opioid-naïve patients and one in four opioid-experienced patients were opioid free by the 6-month point. A multicenter randomized controlled trial of the TPS in several Ontario hospitals is currently ongoing.