We observed significant improvements in mental health and productivity across all categories, with productivity and non-work-related functional recovery being greater within the most deprived group. Engagement was high but varied slightly across categories. Together these findings highlight the importance of a patient-centered digital care program as a tool to address health inequities in musculoskeletal pain management. The idea of investigating social deprivation within a digital program provides a foundation for future work in this field to identify areas of improvement.Digital interventions have emerged as a solution for time and geographical barriers, however, their potential to target other social determinants of health is largely unexplored. In this post-hoc analysis, we report the impact of social deprivation on engagement and clinical outcomes after a completely remote multimodal musculoskeletal (MSK) digital care program managed by a culturally-sensitive clinical team. Patients were stratified in five categories according to their social deprivation index, and cross-referenced with their race/ethnicity, rurality and distance to healthcare facilities. From a total of 12,062 patients from all U.S. states, 8569 completed the program. Higher social deprivation was associated with greater baseline disease burden. We observed that all categories reported pain improvements (ranging from −2.0 95%CI −2.1, −1.9 to −2.1 95%CI −2.3, −1.9,  Living location, education, economic stability, and cultural and community context account for nearly 40% of a person’s health status2. These factors can impact on patients’ healthcare timely access, trust (and respective compliance) and affordability. In musculoskeletal (MSK) care, poverty, low education levels, and being people of color have been associated with a higher prevalence of MSK complaints, poorer function, and greater pain severity. Only some of which can be explained by access to healthcare5, highlighting the importance of a holistic patient-centered approach.Healthy People 2030 initiative states that 9. However, poor access to providers, schedule constraints, pressure to work when sick, travel and absenteeism costs and inadequate health literacy, in addition to other SDH, have hindered the access of millions to proper care10. Timely access to care may reduce the need for treatment escalation, minimizing the use of low value care , and preventing opioid use11.MSK pain management guidelines primarily focus on exercise-based interventions14. Telerehabilitation has emerged as an effective solution for MSK pain management15, as it increases access and convenience, fills gaps in provider coverage (particularly in underserved areas), and improves care continuity. However, the impact of telerehabilitation in addressing SDH to promote health equity is an unexplored area.To address geographical and financial barriers, stakeholders must recognize the unique needs of historically marginalized groups. Clinical teams should be culturally diverse, proficient in different languages and have specific training to minimize the potential for discrimination and implicit biasThe present study reports upon a patient-centered digital care program (DCP) combining exercise with education and cognitive behavioral therapy (CBT), which was designed to promote health equity by eliminating geographic and time barriers, while providing a diverse pool of physical therapists in terms of gender, race/ethnicity, cultural background and spoken languages.19, and reported on its effectiveness regardless of race/ethnicity20 and geographical location 21, suggesting its potential in mitigating some health inequities. The present study applies a social deprivation index (SDI) to a broad cohort of patients with chronic MSK pain who underwent this DCP, aiming to assess the impact of socioeconomic context on clinical outcomes and engagement. This post hoc analysis hypothesizes that categories from different socioeconomic contexts would experience similar significant improvements in outcomes.In the past we have validated this DCP for several acute and chronic MSK conditionsp values: 1.23, <0.001 (1st degree); 0.95, 0.298 (2nd degree); 0.95, 0.270 (3rd degree); 1.05, 0.354 (4th degree)).From a total of 16,229 participants screened for eligibility, 12,062 patients (74.3%) started the study as depicted in Fig. p < 0.001), and had a higher body mass index . There were higher proportions of patients of Black  and Hispanic  background, as well as fewer people with higher education  in C5. No changes were observed in employment rates between groups (P = 0.357). Affected anatomical areas were similarly distributed across categories, except for the knee . Back pain was the most prevalent condition in all categories. All categories had patients primarily located in urban areas, with C1 and C5 having the lowest proportion residing in rural areas. Patients in C5 lived closer to healthcare facilities  than those in other categories and had the highest number of available providers within 18 miles of their residence .The cohort distribution across the U.S. Fig.  includedp < 0.001), anxiety , and productivity impairment . Higher social deprivation was associated with worse baseline clinical scores  translating into nonlinear odds ratios between groups , 0.915 (2nd degree), 0.022 (3rd degree), 0.760 (4th degree)).Significant improvements were observed in all clinical outcomes across SDI categories Table . SignifiThe proportion of patients taking pain medication was reduced by program-end in all SDI categories Fig. .Significant and similar improvements in anxiety and depression Table , Fig. 3bProductivity impairment improved significantly in all WPAI domains across SDI categories Table . Improvep values < 0.05, Supplementary Table Patients with higher BMI presented higher baseline pain, depression, overall productivity, and activity impairment regardless of the category (p < 0.001). Engagement with exercise sessions was impacted by gender, BMI, race/ethnicity and rurality. Patients with high BMI , women (C1 and C2) and patients from Asian (C3), Hispanic (C1 and C3) and Black (C1) backgrounds dedicated less time to exercise, whereas those in rural areas (C2 and C3) dedicated more time .Similar satisfaction scores were observed independently of the category: C1 8.9, SD 1.4; C2 8.9, SD 1.5; C3 8.9, SD 1.5; C4 9.0, SD 1.5; C5 9.0, SD 1.4; 22. As previously reported, SDI categories were associated with a growing severity of baseline disease burden, highlighting the existence of particularly vulnerable subpopulations24. These initial scores were not explained by distance to healthcare facilities since patients within the highest deprived category were also the ones geographically closest to the facilities. Independently of SDI, specific demographics were associated with aggravated baseline scores namely women25, overweight people26 and those who identified as Black and Hispanic backgrounds3. Altogether, these factors have motivated new healthcare models to evolve towards a holistic patient-centered care, as the DCP described herein. Low socioeconomic status was reported to be associated with worse treatment outcomes27 in opposition to the results herein observed, which showed a similar recovery path in all clinical outcomes regardless of SDI scores and baseline severity. Particularly for pain, the high and similar improvements and response rates contrast with prior reports, where the most socially deprived individuals attained worse outcomes in pain compared to their counterparts29. The observed improvements were in line with those reported previously after in-person physical therapy for patients with chronic pain31. Pain improvement was accompanied by a reduction in analgesic consumption. Early access to physical therapy has been reported to prevent chronic use of opioids, a potential solution for what has been a national crisis32.The DCP was able to reach a wide range of SDI scores. Most patients fell into categories of low social deprivation, however 10% had high SDI scores, in line with the U.S. Census Bureau report33 exacerbated by SDH24. Significant improvements were observed in mental health outcomes, similarly between SDI categories, further supporting multimodal biopsychosocial approaches34.Mental health is one pivotal factor in MSK pain management considering the frequent comorbidity and feedback loop36. An important success measure for pain interventions comes from the ability of patients to resume their normal lives. MSK pain has been reported as a main driver for loss of productivity37, either through presenteeism or absenteeism. In this study, both metrics improved significantly across categories, within the range of the previously reported for other telerehabilitation interventions38. Within absenteeism, a recovery rate of one day per week (when considering a full-time job) was observed on SDI category 4 which included those who were socially deprived and located in rural areas. The most socially deprived patients outperformed those in other categories in overall productivity recovery as well as in non-work-related activities. Although we cannot disregard the higher impairment levels at baseline and other moderating factors for this observation, or non-specific effects, these results are nevertheless impressive and can be the effect of a patient-centered DCP. These results support telerehabilitation in light of the $264 billion spent in indirect costs associated with MSK pain in the U.S39.Literature evaluating the impact of SDH in the recovery of mental health in patients with MSK conditions is still lacking, with in-person or telerehabilitation interventions reporting highly heterogeneous results in this domain. Nevertheless, the significant changes observed in both mental health outcomes were within the range of the best improvements previously reported in the literature41, and is considered a contributor to worse outcomes27. Moreover, low adherence to physical therapy programs have been associated with poor clinical outcomes42. Although telehealth has been touted as a means to address access and adherence barriers, disparities in the adoption of such alternatives related with SDH have been reported44. Although the COVID-19 pandemic may have impacted the receptivity, compliance and overall perception on the utility of telehealth, especially regarding access to unavailable care options, or by eliminating the need for traveling and in-person contact, opportunities for improvement do remain.Lower accessibility to in-person physical therapy has been observed among people of color, those with lower education levels and socioeconomic status, and living in rural areas45, increased dropout rates were observed across categories, which is also in line with those previously reported46.Despite the overall high completion rate observed in this study, which was within the range of the previously reported for real-world in-person physical therapy47, current guidelines recommend a personalized approach accounting for each patient’s condition trajectory9, which was followed herein. High engagement with the DCP was observed based on the number of interactions with the DPT, educational articles read and performed exercise sessions. The number of sessions varied slightly with social deprivation background, with higher SDI categories performing less sessions, which might be explained by a higher proportion of young and overweight patients, as well as the historical association with marginalized groups48. Nevertheless, similar recoveries in all outcomes were observed across SDI categories, suggesting that engagement level was sufficient to promote clinical improvement even amongst those more socially deprived. These improvements were also accompanied by the high satisfaction with the program reported across all categories. The current study design does not permit conclusions about which specific features of the DCP were responsible for the observed outcomes, with potential drivers being the multimodal approach including exercise with real-time biofeedback, education, and CBT, with tailored treatments reflecting clinical and cultural needs. Research shows that when patients feel a sense of trust with their provider, they’re more willing to get the needed care, more likely to adhere to treatment, have fewer symptoms, get more preventive screenings, and ultimately experience better outcomes49. Cultural competence is critical to promoting a therapeutic alliance and providing compassionate rapport50. One can speculate that the culturally-sensitive clinical team might have contributed to the observed outcomes. Digital interventions supported by optimized communication strategies have been reported to promote similar or even better therapeutic alliance than in-person interventions52. Communication during digital programs  should guarantee not only the practicality of logistics but also ensure respectful and compassionate rapport53. Ultimately, a MSK pain intervention should leverage therapeutic alliance to empower patients with self-management skills to address their pain and improve quality of life54.Considering the lack of consensus in the literature regarding the optimal exercise dosage15, the results herein reported advocate for scalable digital care delivery systems that acknowledge SDH. However, further controlled and large cohort studies are needed to better characterize the effect of health disparities associated with SDI on digital therapy outcomes. Research should focus on understanding which particular features of a DCP are most impactful on access, engagement and outcomes improvement across different socio-economic contexts. Developing studies designed to better understand the impact of having a culturally competent clinical team on rehabilitation’s success is another high priority. One area ripe for investigation includes developing new integrated approaches featuring digital, in-person and hybrid care models, that can optimize healthcare delivery to the general population, including those most vulnerable. Initiatives such as allowing those without internet to access WiFi hotspots and creationing community hubs where patients can easily access the internet more easily could help in the dissemination of telehealth, and therefore should be further explored. Finally, studies with long-term follow-ups and cost-effectiveness analyses are warranted.Thus, in the light of limited resources and growing demand for rehabilitation services55. Importantly, this study demonstrates that a digital care program designed to promote health equity is feasible and similarly accepted by patients from different socio-economical backgrounds. Finally, the idea of investigating social deprivation within a digital program provides a foundation for future work in this field to identify areas of improvement.There are several limitations to this study that warrant discussion. First, this study lacked a control group, which precludes the establishment of causality. Second, the program enrolled beneficiaries of employers’ health benefits; therefore, the current cohort may not be representative of the U.S. general population. Third, this study was partially undertaken in the context of the COVID-19 pandemic, which may have impacted perceptions, receptivity and compliance with digital PT programs. Fourth, despite using a socioeconomic metric encompassing seven domains and accounting for additional confounders, we cannot dismiss the possible effects of other moderating factors. Fifth, the study design does not allow for disentangling the impact of each DCP component on outcomes. Lastly, this study lacked long-term follow-up, which would have enabled to ascertain the benefits of the program at later time points across different SDI. This study also presents important strengths, namely the use of a vast real-world cohort from all U.S. states that included the whole range of SDI, thus enhancing generalizability. A second strength is the DCP itself, which includes features designed to mitigate health equity gaps that standard care has struggled to address. A third advantage is the use of validated metrics for both physical and psychological outcomes, which is in contrast to those reported in other digital interventionsIn conclusion, multimodal, patient-centered digital care may represent a solution for addressing health inequities in MSK pain management. This study covers a wide range of SDI indices across the U.S., reporting similar and significant improvements in pain, analgesic consumption, mental health and productivity despite the greater disease burden observed in the socioeconomically vulnerable. This study showcases the potential of digital care to promote health equity, opening new avenues for future research and development.This is a post hoc analysis of a decentralized, single-arm investigation into clinical and engagement-related outcomes of patients with musculoskeletal (MSK) conditions following a DCP delivered between June 18th 2020 and August 3rd 2022. The trial was prospectively approved (New England IRB number 120190313) and registered on ClinicalTrials.gov (NCT04092946) on September 17th 2019.Adult (≥18 years of age) beneficiaries of employer health plans  from all U.S. states (including Washington D.C.) were recruited through a variety of platforms, including the postal system, e-mail, leaflets and posters. Patients reporting chronic MSK pain  were invited to apply to Sword Health’s  DCP through a dedicated enrollment website. Exclusion criteria included: (1) a health condition  incompatible with at least 20 min of light to moderate exercise; (2) undergoing cancer treatment; and (3) serious neurological signs or symptoms such as neurological weakness, numbness, or bowel or bladder dysfunction. All participants provided electronic informed consent to take part in the study (waiver of documentation of consent approved by New England IRB).The DCP was composed of exercise, education and CBT administered in a 4-, 8-, or 12-week program depending on each patient’s condition. During enrollment, a baseline condition form was filled out and a video call was performed, triggering the condition-specific shipment of a kit  goals with the intervention were met; and (2) significant improvements were achieved.Additionally, patients were provided with condition-specific education content and CBT, through written articles, audio content, and interactive modules. These were developed according to current clinical guidelines and prior research58. The SDI provides a measure of area-level deprivation as a proxy for SDH by converting seven domains  into an index score ranging from 1 to 100. Higher scores equate to increased social deprivation.A Social Deprivation Index (SDI), based on 2019 data, was assigned to each patient based on their ZIP code59 . To assess the impact of availability of healthcare facilities, each patient’s geo-coordinates were cross-referenced with county-level geographic distribution of healthcare resources 60 . The density and proximity of healthcare facilities were calculated considering 6- and 18-miles radii. Additionally, patients’ race and ethnicity were selected choosing from Asian, Black, Hispanic, non-Hispanic white, other and prefer not to specify.Additionally, patients were coded to a specific rural-urban commuting area (RUCA) according to their ZIP codes61;Numerical Pain Rating Scale (NPRS) specific for the symptomatic body region: “Please rate your average pain over the last 7 days” from 0  to 10 (worst pain imaginable)”. A Minimum Clinically Important Difference (MCID) was considered to be 30%Analgesic consumption: “Are you currently taking any pain medication?” (Yes/No);62, and depression was assessed by the 9-item Patient Health Questionnaire (PHQ-9) (range 0-27)63, in which higher scores denote worse symptomatology;Mental health: Anxiety was assessed by the 7-item Generalized Anxiety Disorder (GAD-7) scale (range 0-21)64, with higher scores denoting higher impairment;Work Productivity and Activity Impairment (WPAI) questionnaire collected within employed population to assess overall work impairment , presenteeism (WPAI work), absenteeism (WPAI time) and activities impairment (WPAI activity)Engagement: measured through the following: A) time spent performing exercise sessions; B) completed exercise sessions; C) sessions per week; D) articles read; E) interactions with the DPT ;Satisfaction through the question: “On a scale from 0 to 10, how likely is it that you would recommend this intervention to a friend or neighbor?”.Assessment surveys collected at baseline, 4-, 8-, and 12-weeks were used to analyze the longitudinal mean changes in outcomes between baseline and program-end. The outcomes included:The cohort was categorized into fifths using SDI as the indexing variable. Continuous data was tested for normality by calculating skewness and kurtosis. Comparisons between SDI categories for demographic characteristics, clinical outcomes at baseline, and engagement metrics were performed using 1-way ANOVA or Kruskal-Wallis for quantitative variables, or Chi-square test for categorical variables. Bonferroni post-hoc was used to correct for multiple comparisons.66, estimates overall change based on individual trajectories considering time as a continuous variable. This methodology is estimated as a structural equation model67, with the advantages of providing a measure of fitness and addressing missing data through full information maximum likelihood (FIML)68. FIML outperforms listwise deletion and other imputation models68. mLGCA allows for the creation of separate models in different groups, accounting for unbalanced group size, while simultaneously permitting intergroup comparisons. mLGCA estimates all parameters simultaneously precluding the need for multiple comparison corrections. An additional mLGCA analysis focused on individuals with clinically relevant baseline scores was performed: ≥5 points for GAD-7 and PHQ-963, and >0 for WPAI . The impact of gender, BMI and race/ethnicity was assessed through a conditional model. A robust sandwich estimator was used for standard errors. The impact of the aforementioned covariates plus rurality on training time was assessed by latent basis growth curve analysis.A multiple-group latent growth curve analysis (mLGCA) was used to assess outcome changes across the program  following an intention-to-treat analysis. LGCA, widely used in longitudinal studiesA latent ordinal regression analysis was performed to longitudinally assess the latent distribution of analgesic consumption from baseline to program-end within and between categories.61 was created with patients who achieved a reduction of 30% encoded as 1, while all other patients were encoded as 0. The odds ratio (OR) for being a dropout and for reaching the pain MCID at program-end was calculated using binary logistic regression with SDI group as an ordinal variable , adjusting for the same previously mentioned covariates.A binary variable for reaching the MCID for painP < 0.05 for all tests considering a two-sided hypothesis test.All statistical analyses were conducted using commercially available software  and R , and geocoding using Python . The level of significance was set at Further information on research design is available in the Supplementary InformationReporting Summary


Postoperative dental pain is pervasive and can affect a patient’s quality of life. Adopting a patient-centric approach to pain management involves having contemporaneous information about the patient’s experience of pain and using it to personalize care.In this study, we evaluated the use of a mobile health  platform to collect pain-related patient-reported outcomes over 7 days after the patients underwent pain-inducing dental procedures; we then relayed the information to the dentist and determined its impact on the patient’s pain experience.The study used a cluster-randomized experimental study design with an intervention arm where patients were prompted to complete a series of questions relating to their pain experience after receiving automated text notifications on their smartphone on days 1, 3, 5, and 7, with the resulting information fed back to dentists, and a control arm where patients received usual care. Providers were randomized, and patients subsequently assumed the enrollment status of their providers. Providers or their staff identified eligible patients and invited them to participate in the study. Provider interviews and surveys were conducted to evaluate acceptance of the mHealth platform.A total of 42 providers and 1525 patients participated. For the primary outcome , intervention group patients reported an average pain intensity of 4.8 (SD 2.6), while those in the control group reported an average pain intensity of 4.7 (SD 2.8). These differences were not significant. There were also no significant differences in secondary outcomes, including pain interference with activity or sleep, patient satisfaction with pain management, or opioid prescribing. Patient surveys revealed reluctance to use the app was mostly due to technological challenges, data privacy concerns, and a preference for phone calls over texting. Providers had high satisfaction with the app and suggested integrating additional features, such as an in-system camera for patients to upload pictures and videos of the procedural site, and integration with the electronic health record system.While the mHealth platform did not have a significant impact on acute postoperative pain experience, patients and providers indicated improvement in patient-provider communication, patient-provider relationship, postoperative complication management, and ability to manage pain medication prescribing. Expanded collaboration between mHealth developers and frontline health care providers can facilitate the applicability of these platforms, further help improve its integration with the normal clinic workflow, and assist in moving toward a more patient-centric approach to pain management.https://www.clinicaltrials.gov/study/NCT03881891ClinicalTrials.gov NCT03881891;  The experience of pain is a national and global public health problem with significant physical, cognitive, and emotional costs -3. PostoWhile dentists are prescribing fewer postoperative opioids , currentAdopting a patient-centric approach to pain management involves collecting valuable information about the patient’s experience of pain and related factors, and providing the information back to the dentist to help manage the care . PatientAgainst this backdrop, the use of mobile health  systems for the collection of PROs is on the rise -21. An mTherefore, this study aimed to assess the impact of an mHealth platform on acute dental postoperative pain management in terms of pain experience and patient satisfaction. We also explored the providers’ perspectives on the use of mobile technology in the management of acute postoperative dental pain.A 24-month phase 2 cluster randomized controlled trial was conducted to evaluate the impact of using an mHealth platform on patient postoperative pain experiences, satisfaction with pain management, and dental provider satisfaction with the platform. The multicenter study was conducted at an academic dental institution and a large privately held dental group practice. Data collection spanned February 2020 through January 2022. Consented providers or staff identified eligible patients and invited them to participate in the study.The study was conducted at two dental institutions. One is part of an academic dental site and the other is a large privately held dental group practice of around 50 offices across the Pacific Northwest region of the United States. The academic dental center comprises predoctoral, resident, and faculty clinics. The patient population provides a diverse sample in terms of demographics and socioeconomic status.The provider inclusion criteria were being a general dentist or specialist in oral and maxillofacial surgery endodontics, or periodontics; performing any one or combination of the identified potentially pain-inducing procedures (see list below); practicing for a minimum of two clinic sessions per week (ie‚ one full clinic day); having a minimum of 6 months of practice experience; and having access to and willingness to use a smartphone.The patient inclusion criteria were being 18 years or older and having access to and ability to use a smartphone.The core set of pain-associated dental procedure codes  included were endodontics: D3310, D3320, D3330, D3346, D3347, D3348, D3410, D3421, D3425, D3426, and D3450; periodontal surgery: D4210, D4211, D4212, D4240, D4241, D4249, D4260, D4261, and D4263; oral surgery: D7210, D7220, D7230, D7240, D7241, D7250, D7310, D7311, D7320, and D7321; and implant dentistry: D6010, D6011, D6012, D6013, D6040, D6050, D6100, D6101, D6102, D6103, D6104, and D6081.The mHealth platform deployed in this study was FollowApp.Care. A detailed description of the platform has been previously published . BrieflyOn completion of any of the eligible procedures, enrolled patients (including intervention and control groups) received postoperative care instructions and guidance according to each institution’s standard practice . The intervention group received additional guidance about FollowApp.Care, including the timing and frequency of text notifications and when to expect a response from providers or office staff, if necessary. Patients in the intervention group received text notifications at predetermined time intervals  on days 1, 3, 5, and 7 prompting them to complete a brief pain assessment survey covering the preceding 24-hour period. Additionally, a comment/chat feature enabled patients to securely communicate more information to their dental care team through FollowApp.Care when needed. The control group received usual care and was advised to contact their providers or dental offices through the usual channels if they experienced any unexpected symptoms or had any complaints or questions. Control participants filled out the PRO pain survey only on day 7. To ensure that FollowApp.Care was implemented as intended, fidelity was also measured.Each of the participating providers was randomized to one study arm , and each patient automatically assumed the randomization status of their provider. As such, each patient was nested within a specific provider . RandomiWe used the mHealth platform (FollowApp.Care) to collect PRO data (pain experience) from patients after dental procedures. Electronic health record (EHR) data for postprocedure prescribing data was extracted using the patient enrollment data. EHR data was then merged with the mHealth survey response data for each patient.The primary PRO of interest was pain intensity—an assessment of the worst severity of pain experienced during the 7 days after an eligible dental procedure—and the data was collected using an item from the validated Patient-Reported Outcomes Measurement Information System (PROMIS) Shortform 3A Version 1 questionnaire . The resPain interference, defined as interference with activity  and interference with affect , was captured using 3 items taken from the validated Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R) form . ResponsSatisfaction with how pain was managed was assessed with the following two statements from the validated APS-POQ-R form, which was measured on a 0 to 10 rating scale :Ability to participate in decisions about pain treatmentSatisfaction with the results of your pain treatmentThe proportion of participating patients who got a postoperative opioid prescription was assessed using data from the patient EHR. Through secondary analysis of the EHR, medication-prescribing patterns were collected by deploying query scripts to identify the patients who received the prescriptions postoperatively, including type, dosage, frequency, and duration.Among the 2 included dental sites, a total of 42 providers were recruited to participate in the study over the 2-year study period. Each provider was expected to reasonably recruit 19 patients per year. The expected number of patients was 1596. Adjusting for a 60% response rate among recruited patients, we calculated a sample of 958. Given a total sample size of 958 patients, a standard significance level of .05 (α=.05), and a within-cluster correlation coefficient of 0.1 (ρ=0.1), we estimated that the power to detect a 2.0-unit effect difference in pain would be 80.7%. The minimum power achieved was derived using R . All statistical analyses were performed at the standard significance level (α=.05) using R.Means and corresponding estimates of precision  and frequency distributions with percentage contributions were used to report the distribution of each variable included in the quantitative analyses. To test whether there was a difference in pain intensity, interference, or satisfaction with pain management between the study groups on day 7, a hierarchical model was performed that adjusted for within-clinic correlations and repeated measures over patient responses. Models included the procedure type, time, age, gender, and race/ethnicity.Fidelity was measured using metrics as outlined in Patient fidelity measuresProvided verbal consent and received the information sheet.FollowApp.Care profile was createdReceived text notifications on day 0Patient response timeNumber of patients who have phone service provided by T-MobileResponse rate day 1Response rate day 3Response rate day 5Response rate day 7Dentist fidelity measuresSigned consent forms before trainingCompleted 1-hr trainingVerified FollowApp.Care profileUnique identifiers providedCompleted Unified Theory of Acceptance and Use of Technology surveyNumber of log-insNumber of successful log-insNumber of unsuccessful log-insNumber of alerts triggeredNumber of alerts resolvedNumber of alerts resolved by chatNumber of alerts resolved by phoneNumber of alerts resolved by acknowledgmentNumber of alerts unresolvedAverage response time to alertsTo assess whether practitioners were unduly burdened by the technology and whether it fit seamlessly into their workflow, the Unified Theory of Acceptance and Use of Technology (UTAUT) questionnaire was administered to those in the intervention group. Four key constructs were measured: performance expectancy, effort expectancy, social influence, and facilitating conditions. A descriptive analysis was performed to describe the constructs of the UTAUT questionnaire.Semistructured virtual interviews were also conducted with dental care providers from both study sites. Nine of these interviews were with dentists alone, and five were group interview sessions with dental care teams that consisted of dentists, dental assistants, dental hygienists, or dental clinic administrative staff. The main aim of these interviews was to evaluate the provider’s experience with using the mHealth platform for managing their patients’ postoperative pain, including its impact on their clinic workload, workflow patterns, and satisfaction with the effectiveness of pain management. Our analysis for this research focused on using this interview data to identify the barriers and facilitators for using an mHealth platform for postoperative acute pain management and communication. One trained interviewer conducted all the interviews. Each interview was audio or video recorded through Zoom video telephonic software (Zoom Video Communications) and then transcribed using Rev speech-to-text transcription services. For the qualitative analysis, a combination of deductive and inductive approaches was used. Independent coding of the transcripts was performed by 2 of the authors, the coding was assessed and discussed for variation and consensus, and codes were identified that fit into the predefined themes of barriers and facilitators for the use of the mHealth platform. The framework method of analysis  was usedThe study protocol was reviewed and approved by the University of Texas Institutional Review Board (IRB# 18-25477) and registered on ClinicalTrials.gov (NCT03881891). Using a standardized template provided by the research team, providers or clinic staff members obtained informed consent from interested patients before their respective surgical procedures.A total of 42 providers , consisting of 24 general dentists, 16 endodontists, and 2 oral surgeons, participated in the trial. The study included 1525 patients  with an average age of 44.5 (SD 14.3) years, of whom 675 (44.3%) were female and 865 (56.7%) were White . The mosResponse rates for the mHealth-administered surveys were 56.9% (484/851) on day 1 and 49.8% (424/851) on day 7 for intervention patients, and 42% (283/674) for control patients. All patients had a FollowApp.Care profile created, and 98.3% (1504/1525) received the day 1 SMS text message notification, with an average response time of about 7 hours. Over the study duration, 349 alerts were generated. Of these, 335 were resolved, 14 were unresolved, and the average response time to patient alerts was 8 hours and 48 minutes.For the primary outcome “How intense was your pain at its worst following your procedure?” (pain intensity), intervention group patients reported an average pain intensity of 4.8 (SD 2.6), while those in the control group reported an average pain intensity of 4.7 (SD 2.8). These differences were not significant. Intervention group patients also responded to the following question: “What is your pain level right now?” The mean pain intensity ranged from 2.9 (SD 2.4) on day 1 to 1.2 (SD 1.8) on day 7 post procedure.In response to the question “Were you allowed to participate in decisions about your pain treatment as much as you wanted to? ,” respondents in the intervention group reported an average of 7.7 (SD 3.5) out of 10 in participation in decision-making, while those in the control group reported an average of 8.3 (SD 3.0). When asked “Select the one number that best shows how satisfied you are with the results of your pain treatment,” respondents in the intervention group reported an average of 8.6 (SD 2.2) out of 10, while those in the control group reported 8.9 (SD 2.0). There was no significant difference between the groups.P=.40) after adjusting for gender, procedure group, and provider.The regression analysis showed that there was no statistically significant difference between the intervention and control arms for all study outcomes, after adjusting for provider, gender, and procedure type.Results from the UTAUT questionnaire indicated that most providers found the platform useful, clear, and understandable; that their organization in general thought they should use it; and that they have the necessary resources and knowledge to use the platform. The validated UTAUT questionnaire was administered to 18 intervention providers. The four UTAUT constructs are associated with a behavioral intention to use the new technology (FollowApp.Care app); high scores on each of the constructs are associated with a higher behavioral intention to use the FollowApp.Care platform. The responses to the four items that form the performance expectancy construct showed that most providers found FollowApp.Care useful, enabling them to perform tasks more quickly, increasing productivity, and increasing the chances of a positive performance review. Median scores for each item were ≥4 on a 7-point Likert scale. The responses to the four items that form the effort expectancy construct showed that most providers found that FollowApp.Care is clear and understandable, believing that they can become skillful and that the platform is easy to use and operate. Median scores for each item were ≥5 on a 7-point Likert scale. The responses to the four items that form the social influence construct showed that most providers found that those who influence their behavior, people who are important to them, and their clinical management as well as the organization in general thought that they should use the platform. Median scores for each item were ≥5 on a 7-point Likert scale. The responses to the four items that form the facilitating conditions construct show that most providers found that they have the necessary resources and knowledge to use FollowApp.Care, that it is generally compatible with other systems that they use, and that there is assistance for its operation. Median scores for each item were ≥4 on a 7-point Likert scale (see Three main themes were identified from the perspective of providers regarding the use of the platform for postoperative acute pain management: (1) potential facilitators and barriers to adoption, (2) patient acceptance and hesitancy, and (3) future use of the platform . ProvideIt seemed like we were a lot more accessible. It would lower their anxiety or if they were scared that something was going on, they were able to get answers a lot quicker. I think most of the patients liked it from what I remember hearing.The chat feature was particularly helpful in facilitating direct communication between dentists and patients, resulting in improved patient care and stronger patient-dentist relationships. Dentists found the alert system useful for identifying patients with specific symptoms and reducing unnecessary postoperative appointments. However, they also reported feeling a lack of personal touch through mHealth SMS text messaging. Furthermore, they thought it represented an additional burden on their workload and an invasion of their time due to receiving messages and alerts after work hours.ctually sometimes it (using the platform) was just an additional step, because I had to respond on the app and then call the patient because they still needed to talk to me. I still needed to talk to them. I felt like texting them wasn’t enough. You know? So, yeah, I think in that way it was probably good for data collection and everything, but I think that that created an extra step for us.APatients’ reluctance to use the app was mostly due to technological challenges, data privacy concerns, and a preference for phone calls over texting. Dentists suggested integrating additional features into the app, such as an in-system camera for patients to upload pictures and videos of the procedural site, integration with the EHR system, and including postoperative expectations and instructions in the platform for the patient to access after the procedure.In this prospective, randomized, parallel-arm clinical trial evaluating the impact of an mHealth app on overall dental postoperative acute pain experience, we found no significant differences in pain experience or use of analgesic medication after painful dental procedures between the intervention  and control (standard care) arms. Providers and patients, however, reported that the use of an mHealth platform had significant potential for improving patient-provider communication, patient-provider relationships, postoperative complication management, and the ability to customize pain medication prescribing. Almost all previously completed trials on the use of mobile technology apps for pain management in health care have focused on chronic pain. No trials have been reported in dentistry.Several factors may have influenced the observed lack of difference between the study arms. First, comparisons between intervention and control groups were made on day 7. Previous studies suggest that postoperative dental pain is usually of short duration, reaching its maximum intensity in the early postoperative period (day 1) and petering out before day 7, regardless of the pain control technique . Second,Nevertheless, this study highlights the potential of PROs for providing valuable data for optimizing the delivery of care. Mobile phones have been shown to be an effective platform for assessing various aspects of patient health, including symptoms, symptom burden, health status, health behaviors, and health-related quality of life. In dentistry, mobile apps have been used to encourage evidence-based oral hygiene routines -34, triaOur qualitative analysis revealed that the use of mHealth systems could be clinically useful in ways that have also been reported in other studies. For example, a study conducted in rural Ghana found that providers perceived the use of mHealth technology to be an approach to increasing health care access . SimilarPostoperative pain measurement by recall is difficult to accurately determine. Research on autobiographical memory  indicateThis study was conducted at two sites where standard postoperative care is exemplary, with disciplined adherence to evidence-based guidelines. Future studies should focus on pragmatic trials including sites that are more similar to everyday dental clinics with less stringent protocols, processes, or guidelines in place. EMA approaches should also be incorporated. As the primary outcome was pain intensity, a more predictable pain model, such as one limited to impacted third molar surgeries, might have been, in hindsight, better suited for this study.The study showed that using the mHealth platform did not have a significant impact on acute postoperative pain experience. However, patients and providers indicated increased improvements in patient-provider communication, patient-provider relationship, postoperative complication management, and the ability to manage pain medication prescribing.


In Asia, the proportion of patients with irritable bowel syndrome (IBS) with abdominal discomfort alone is significantly higher than that in western countries. The purposes of this study are to understand the cognition of abdominal pain and abdominal discomfort in Chinese patients with IBS and to compare the clinical characteristics of patients with abdominal pain alone and with abdominal discomfort alone.Patients with IBS with diarrhea (IBS-D) who met the Rome III diagnostic criteria and had episodes of at least one day/week were consecutively enrolled. The cognition of abdominal pain and abdominal discomfort were investigated through face-to-face unstructured interview. Patients were divided into a pain group and a discomfort group according to the cognition interviews, then the characteristics and severity of symptoms , IBS quality of life (IBS-QOL) and psychological state were compared between groups.P = 0.002). There was no significant difference in IBS-SSS, extra-intestinal pain, IBS-QOL, and psychological state between the two groups.A total of 88 patients with IBS-D were enrolled. Most of the patients with self-reported abdominal pain described their pain as spasm/cramping; patients with self-reported abdominal discomfort had as many as 24 different descriptions of discomfort. Most patients having abdominal pain and discomfort could accurately distinguish the two symptoms. The degree of abdominal pain in the pain group was higher than abdominal discomfort in the discomfort group (For Chinese patients with IBS-D, abdominal pain and abdominal discomfort are two different symptoms, but they have similar clinical features.http://www.chictr.org.cn.ChiCTR, ChiCTR1900028082. Registered 11 December 2019 - Retrospectively registered,  Irritable bowel syndrome (IBS) is a common functional bowel disorder, and IBS with diarrhea (IBS-D) is the most common subtype in China, accounting for 74.1% of IBS . HoweverThe cognition of the symptom spectrum of abdominal pain and abdominal discomfort affects the symptom reporting of patients. In the Rome III definition, abdominal discomfort means “an uncomfortable sensation not described as pain” . It is uPatients with IBS-D who met the Rome III criteria and had episodes at least one day per week were consecutively enrolled from the Gastroenterology Clinics of Peking Union Medical College Hospital (PUMCH) from January 2019 to January 2022. Patients with organic gastrointestinal diseases, connective tissue diseases, and metabolic diseases confirmed by laboratory and endoscopy examinations in the last year were excluded. Considering that psychological abnormalities may affect a patients' perception and cognition of symptoms, patients with moderate to severe anxiety/depression assessed by Hamilton Anxiety Scale (HAMA) and Hamilton Depression Scale (HAMD) were also excluded. This study was approved by the Ethics Committee of PUMCH (JS-1753). All subjects gave their written, informed consent before inclusion. The study was registered at China Clinical Trials Registration Center (ChiCTR1900028082).A questionnaire was developed with reference to the survey of abdominal pain and abdominal discomfort and the cognitive interview of IBS patients in the United States , 13, comThe cognitive interview process is as follows. First, inform the purpose of the interview, then ask patients to describe in detail the symptoms of abdominal pain/abdominal discomfort they experienced. Next ask if abdominal pain/abdominal discomfort is associated with defecation. After that, explain to the patient in detail the definitions of “abdominal pain”, “abdominal discomfort” and “associated with defecation”. Abdominal pain means an unpleasant feeling and emotional experience caused by actual or potential tissue injury in the abdomen: it can also occur with other symptoms. Abdominal discomfort means a subjective and unpleasant feeling not described as pain or bloating, distension, flatulence, urgency, difficulty in defecation, incomplete emptying, or anorectal pain, but it can also occur at the same time with the above symptoms . AssociaAfter explanation, patients are asked to confirm whether they have definite abdominal pain/abdominal discomfort associated with defecation; and patients with both abdominal pain and abdominal discomfort confirm whether abdominal pain and abdominal discomfort are the same symptoms. Then they are asked whether abdominal pain and abdominal discomfort occur at the same time, what is the difference, and whether they can accurately distinguish between the two symptoms. The location, degree, frequency, duration, and effect on IBS quality of life (IBS-QOL) of abdominal pain/discomfort reported by the patients were recorded. The degree of abdominal pain/discomfort associated with defecation was evaluated by visual analogue scale (VAS) based on the recorded symptoms over the most recent three months.Patients were divided into two groups according to the confirmed symptoms of defecation-associated abdominal pain/discomfort after the cognitive interviews. Pain group: patients have defecation-associated abdominal pain only, without abdominal discomfort. Discomfort group: patients have defecation-associated abdominal discomfort only, without abdominal pain. The main study purpose of this section is to compare abdominal pain and abdominal discomfort, we did not further evaluate and compare the clinical data of patients with both abdominal pain and abdominal discomfort.After the cognitive interviews, gastrointestinal (GI) symptoms were assessed using the IBS symptom questionnaire, including demographic information, main bowel symptoms, and extra-intestinal pain. The frequency of symptom episodes was recorded as four grades: 1 day/week, 2–3 days/week, 4–6 days/week, and daily. The duration of symptom episodes was recorded as five grades: < 10 min/day, 10-30 min/day, 30-60 min/day, > 60 min/day, and persistently. The stool form was scored by the Bristol Stool Form Scale. The severity of IBS symptoms was evaluated by the IBS symptom severity scale (IBS-SSS) .. according to Patrick was used to evaluate the quality of life of patients ) and ratio, respectively. Continuous normal distribution variables were analyzed by independent two-sample In total, 88 patients with IBS-D were enrolled . Their mean age was 39.6 ± 10.45 years. The mean disease course of IBS-D was 6.5  years.Before the interviewer explained the definitions of abdominal pain and abdominal discomfort, a total of 67 patients reported abdominal pain, of whom 44 (65.7%) described it as colic, spasm/cramping, twisting, or throbbing. Of 15 patients who described abdominal pain as dull pain, 4 reported it as swelling pain, 2 as bearing-down pain, 2 as ache, 4 as burning pain, and 1 as stuffy pain. Among them, 5 had multiple descriptions of abdominal pain.A total of 50 patients reported abdominal discomfort before the explanation, of whom 23 (46%) described abdominal discomfort as indescribable, unspeakable uncomfort of the abdomen. Six patients (12%) described abdominal discomfort as pain or mild pain, and these patients also reported abdominal pain at the same time. Five patients (10%) described abdominal discomfort as bloating, flatulence, or sensation of defecation. A few patients described abdominal discomfort as sore, sour, cool, needling, abdominal hardening, burning, carsickness, emptiness, tightness, unrelaxing, numbness, or presence of abdomen.After the interviewer explained the definitions of abdominal pain, abdominal discomfort, and associated with defecation, 67 patients with self-reported abdominal pain confirmed that they actually had abdominal pain, and it was clear that abdominal pain was associated with defecation. Of the 50 cases of self-reported abdominal discomfort, 36 (72%) confirmed that they actually had defecation-associated abdominal discomfort.A total of 15 patients reported both defecation-associated abdominal pain and abdominal discomfort. After the explanation of the definitions, 14 patients (93.3%) believed that abdominal pain and abdominal discomfort were different types of symptoms and they could distinguish two symptoms, and 12 patients thought that abdominal pain and abdominal discomfort would cause different functional damage. The majority (13/15) believed that abdominal pain had a greater impact on life.n = 52, 27 male, 25 female) and a Discomfort Group  according to abdominal pain/discomfort associated with defecation confirmed after cognitive interviews. There were no significant differences in age, body mass index (BMI), labor type, education level, and economic status between groups. The percentage of male patients in the discomfort group was significantly higher than that in the pain group  . Abdominal discomfort was located in the upper abdomen in 9.5% of patients, and 9.5% were “unclear” about the location of symptoms in the discomfort group      . There was no significant difference in the proportion of retrosternal pain, epigastric pain, headache, other pain , dyspareunia, or dysmenorrhea in female patients between the two groups  and 76.2% (16/21), respectively    . There was no significant difference in the frequency of abdominal pain/discomfort, number of bowel movements or stool form during symptom onset, extra-intestinal pain, depression or anxiety state, or quality of life between the two groups [Chinese IBS patients can accurately experience and report abdominal pain. In our study, 65.7% of the patients described abdominal pain as spasm/cramping, and other descriptions were associated with pain, which is similar to American patients , indicatAccording to reports, 13.9% ~ 29% of IBS patients have both abdominal pain and abdominal discomfort , 13. In Abdominal pain in patients with IBS is associated with visceral hypersensitivity caused by a variety of mechanisms, including diet, low-grade intestinal inflammation, changes in intestinal microbiota and psychological abnormality . Spasm/cIBS-D is the main subtype in China, other subtypes were not included in this study. Cases with both abdominal pain and abdominal discomfort were relatively few. There was only one interviewer in this study. She received professional psychological training for the cognitive interview to maintain as much objectivity and consistency as possible, It is unclear if this possibly biased the results. Considering the possible effects of depression and anxiety on symptom experience and report, patients with obvious psychological abnormalities were excluded, and the results could not reflect the condition of these patients.Abdominal pain and abdominal discomfort are two different symptoms for Chinese IBS-D patients, but they have similar clinical characteristics. Abdominal discomfort is one of the main symptoms of Asian IBS patients, which has a significant impact on disease severity and quality of life. Further comparative study of the pathophysiological mechanisms of abdominal pain and abdominal discomfort will be helpful to formulate diagnostic criteria and treatment strategies for IBS in Asian populations.


Haemorrhoids can be either external or internal, with the latter graded on a scale of grade I–IV2. A number of non-operative and operative strategies have been implemented to treat symptomatic haemorrhoids, but, for larger grade III–IV haemorrhoids, a surgical haemorrhoidectomy remains the gold standard2–4. However, haemorrhoidectomy is also associated with adverse effects, with postoperative pain being the most common2–4.Haemorrhoids are a common condition worldwide and are thought to be a result of prolapsed anal cushions that have undergone pathological changes4–6, but other causes may include local nerve-end damage, creation of an anal fissure, or suture placement below the dentate line6–8. Numerous modalities of pain management have been suggested, with multiple studies looking at the use of topical pain relief. The studies have shown promising, albeit mixed, results, examining the use of topical interventions like lignocaine, nitroglycerin, metronidazole, and diltiazem9–13.Post-haemorrhoidectomy pain is thought to be related to spasm of the internal anal sphincter14. One such CCB, diltiazem, has shown success in multiple RCTs in significantly reducing post-haemorrhoidectomy pain and likely reducing overall opioid use amongst patients9–13. Another CCB, nifedipine, has been less documented in the literature with respect to its topical use in relieving post-haemorrhoidectomy pain. One RCT was able to show a significant reduction in pain relief post-haemorrhoidectomy when topical nifedipine was combined with lignocaine versus a control group of lignocaine alone4. Additionally, multiple studies examining chronic anal fissures suggest that nifedipine appears to have more effective healing rates than diltiazem16. Thus, given the lack of literature on the use of topical nifedipine in post-haemorrhoidectomy patients, and its reported success in healing anal fissures, the planned study seeks to establish if nifedipine alone, like diltiazem, versus a topical placebo, can reduce postoperative pain, as well as limit opioid use.Calcium channel blockers (CCBs), available in topical preparations, are thought to decrease internal sphincter spasm due to blockage of myocytes and subsequent relaxation of smooth musclesversus those receiving the placebo ointment.The primary study hypothesis is that topical nifedipine (0.5 per cent) ointment, compared with topical placebo alone, leads to a significant reduction in pain experienced by patients post-haemorrhoidectomy. The secondary study hypothesis is that topical nifedipine ointment leads to less use of rescue oral opioid analgesia by patients, post-haemorrhoidectomy, who are on a standardized postoperative analgesia regimen, with no significant differences in adverse effects between those receiving the topical nifedipine ointment intervention versus a topical placebo ointment alone in reducing post-haemorrhoidectomy pain. Secondary outcomes will include rescue oral opioid analgesia use and adverse effects . The trial began in July 2023 and aims to finish recruitment by July 2024.A single-centre, randomized, prospective, double-blind placebo trial will be conducted comparing the efficacy of topical nifedipine ointment Patients over the age of 18 years who are scheduled to undergo three-column haemorrhoidectomy, using a closed technique, will be considered for inclusion and will be recruited by surgeons during either their initial consultation for haemorrhoidectomy surgery or on the day of planned surgery. Exclusion criteria will be patients who: are younger than 18 years; are pregnant or breastfeeding; have concurrent non-haemorrhoidal anorectal disease; have a known allergy to nifedipine; have co-morbidities or take medications that are a contraindication to nifedipine use; have impaired renal function where parecoxib is contraindicated; have a chronic pain condition requiring ongoing regular analgesia; cannot provide informed consent; and cannot have a general anaesthetic.Supplementary material.For each included patient, demographics and clinical data will be recorded as reported in the After written informed consent, patients will be randomized to either the intervention group  or the control group (placebo ointment) by computer randomization. This will be achieved through the use of a random sequence generated by the study statistician using a package created using MS Excel 2013 software. The patients will be allocated using a randomized block procedure, with a block size of two. Surgeons will be blinded to this allocation.All patients will receive a general anaesthetic along with intravenous paracetamol (1 g), alfentanil (1 mg), oxycodone (0.05–0.1 mg/kg), and parecoxib (40 mg). After surgery patients will receive recovery analgesia consisting of intravenous oxycodone (2 mg), as required, with a maximum of 10 mg available. Also, local anaesthetic consisting of 20 ml bupivacaine (0.5 per cent) with adrenaline (1 : 200 000) will be used for local wound infiltration.Upon discharge, patients will be provided with a prescription for regular oral paracetamol (1 g four times per day) and celecoxib (100 mg twice per day) for 5 days (to start 18 h post-parecoxib). They will also receive rescue oxycodone , with 20 tablets (100 mg), in total, available.Patients will receive a supply of anorectal ointment that is de-identified and randomized, that is either the intervention nifedipine ointment or the placebo ointment, thus blinding the patients appropriately. The intervention ointment will consist of a jar containing 30 g of nifedipine (0.5 per cent) in pluronic lecithin organogel (PLO), a common compounding medium for topical medications, with the control group receiving a placebo of PLO only. All patients will be instructed to apply a pea-sized amount of their ointment, using a glove, 1–1.5 cm into the anus circumferentially, as well as to the external anus. This will be done twice a day for 4 weeks.As stated, the primary outcome measured will be post-haemorrhoidectomy pain experienced by subjects. This will be measured using a 10-point standardized and validated visual analogue scale (‘VAS’). Scores will range from 0  to 10 (worst pain imaginable). Pain scores will be recorded at the following time points: before surgery (baseline); at recovery; at 4 h (discharge); daily (week 1); and at 2, 3, and 4 weeks.Supplementary material).Secondary outcomes measured will include rescue analgesic use and adverse effects , based on α = 0.05 and power = 0.9, based on the primary outcome (pain). Estimating an attrition rate of 20–25 per cent, a sample size of 60 (30 per group) was chosen. The sample size was calculated utilizing STATA 17  considering a two-tailed test.The statistical plan and intention-to-treat analyses are detailed in the An ethics application has been submitted to the local Cabrini Monash University Human Research Ethics Committee. The trial is registered in the Australia New Zealand Clinical Trials Registry (ANZCTR 12623000514606p). Recruitment started in July 2023 and is expected to finish in July 2024.Post-haemorrhoidectomy pain has a pathophysiology that is proposed to be similar to non-healing chronic anal fissures. Given the success of topical nifedipine in healing anal fissures, the authors present a protocol for a single-centre, double-blind, placebo RCT assessing the use of topical nifedipine in haemorrhoidectomy patients, with post-operative pain as the primary outcome.The literature supports the use of topical CCB diltiazem to relieve post-haemorrhoidectomy pain; however, to the authors’ knowledge, the planned study will be the first to examine the use of nifedipine alone in this cohort. Additionally, the authors aim to better establish guidelines on the administration, dosing, and length of time for topical nifedipine use in this cohort. Furthermore, the planned study will investigate if there is a difference in the use of rescue oral opioid analgesia and any reported adverse effects between the groups.zrad095_Supplementary_DataClick here for additional data file.


BackgroundUltrasound-guided (USG) suprainguinal fascia iliaca (SIFI) block is being used widely for post-operative analgesia in patients undergoing hip and femur surgeries. However, the optimal volume of local anesthetic required for SIFI block is not well defined. Thus, we compared different volumes of 0.2% ropivacaine in SIFI for post-operative pain relief in lower limb surgeries.Material and methodsA total of 90 patients undergoing hip and femur surgeries were randomly allocated into three groups: A, B, and C, who received USG SIFI block with 20 mL, 30 mL, and 40 mL of 0.2% ropivacaine, respectively. Intravenous tramadol was used as rescue analgesia when the numeric rating scale (NRS) score exceeded 3. Time to first request of rescue analgesic was the primary outcome. NRS scores in the first 24 hours post-operatively, total amount of tramadol consumption in 24 hours, and patient satisfaction with pain management were secondary outcomes.ResultsThe time to first request to rescue analgesic was significantly longer in group B and group C as compared to group A. NRS scores were significantly reduced in group B and group C than group A in the 24-hour post-operative period. Median 24-hour tramadol consumption was significantly less in group C as compared to group A and group B. Patient satisfaction with pain management was better with group B and group C as compared to group A.ConclusionIn comparison to 20 mL of 0.2% ropivacaine, 30 mL and 40 mL of 0.2% ropivacaine in SIFI compartment block are more efficacious in reducing post-operative pain after hip and lower limb surgeries. Surgery for femur and hip fractures is known to be associated with moderate-to-severe post-operative pain for the first 24-48 hours, which may adversely affect early mobilization and physiotherapy, eventually affecting rehabilitation of the patient. This pain is primarily due to extensive bony and soft tissue damage and instrumentation. Adequate pain control is an important part of post-operative care for enhanced recovery after surgery as severe pain may lead to an increased stress response and unanticipated hemodynamic changes, which can then trigger major cardiovascular and cerebrovascular complications such as cerebral hemorrhage and myocardial infarction. Thus, early and aggressive application of safe and effective analgesic modalities is essential to improve the outcomes in these patients, especially for older adults with multiple underlying diseases ,2.Previous studies have shown that nerve blocks effectually reduce the pain from femur fractures and provide rapid-onset local analgesia, which is more effective than conventional analgesia . PeripheRecently, ultrasound-guided suprainguinal approach has been proposed as a novel method for performing FICB. As opposed to the classical approach, the suprainguinal approach directs the puncture needle cephalad, allowing for easier spread and improved analgesic effects from only a small amount of medication ,12. HoweTrial design and registrationThis is a double-blind, randomized, prospective interventional study that was registered at the Clinical Trials Registry - India (CTRI) (vide reference number CTRI/2021/09/036144) and approved by the Institutional Ethics Committee.ParticipantsA total of 90 patients, aged >18 years, of American Society of Anesthesiologists (ASA) grades I, II, and III, undergoing above knee lower limb surgeries under subarachnoid block were recruited for the study. The above knee lower limb surgeries included hip hemiarthroplasty and proximal femur fixations. The procedure was conducted in accordance with the Helsinki Declaration 2013. Exclusion criteria were patient refusal, contraindications to the suprainguinal FICB , chronic opioid abuse, and neuropathies.Randomization and blindingPatients were divided into three study groups  by computer-generated randomization codes contained in sealed, sequentially numbered envelopes. The patients as well as the observer involved in the study were kept unaware of the group allocation. The allocation envelope was opened by an anesthesiologist who was administering the block to the patient. A blinded observer assessed pre- and post-operative pain scores. These codes were decoded at the end of the study period. Patients in groups A, B, and C received 20 mL, 30 mL, and 40 mL of 0.2% ropivacaine, respectively, in suprainguinal fascia iliaca (SIFI). A written informed consent was obtained from each patient.ProcedureOn the operating table, patients were positioned in the supine position and ASA monitoring was instituted in the form of 5-lead electrocardiography, non-invasive blood pressure, temperature, and pulse oximetry. Baseline pain score at rest using the numeric rating scale (NRS) was recorded prior to the administration of block. NRS score was determined by asking the patient to rate the pain from 0 to 10, with 0 being the least pain and 10 being the maximum pain. With the patient in the supine position, the anterior superior iliac spine (ASIS) was palpated. An anesthesiologist stood on the side of block, and a linear high-frequency probe  was placed in the inguinal crease to identify the femoral artery in the short axis. From the femoral artery, the transducer was translated laterally to identify the sartorius muscle. The sartorius was traced cephalad to its insertion on ASIS. Using this technique, the hypoechoic shadow of the ASIS was easily identiﬁable just cephalad to the insertion of the sartorius. Medial to the shadow of the ASIS lied the iliacus muscle. With the ASIS and iliacus identiﬁed, the medial end of the transducer was rotated to point at the umbilicus, which was the ﬁnal transducer position. With the transducer in the ﬁnal position, sonographic anatomy was identiﬁed, from superﬁcial to deep, consisting of subcutaneous fat, the internal oblique muscle, the transverse abdominus muscle, the fascia iliaca overlying the iliacus muscle, and the iliacus muscle itself. A 21-gauge, 100-cm stimuplex ultra 360  needle was introduced 1 cm cephalad to the inguinal ligament. Using an in-plane approach, the needle tip was positioned beneath the fascia iliaca, and hydrodissection was used to separate the fascia iliaca from the iliacus muscle. The needle was then further advanced in this space in a cranial and slightly dorsal direction. An injection was considered successful if spread of the local anesthetic is observed cranial to the point where the iliacus muscle passes under the abdominal muscles. If adequate spread was not observed, the needle was repositioned. A proper injection was ensured by the separation of fascia iliaca by the local anesthetic in the mediolateral direction. A successful block was defined as a visible deposition of ropivacaine in the fascia iliaca plane as viewed on ultrasound. After 15 minutes of block or when the NRS score was <4, the patient was administered a subarachnoid block in the sitting position with 2.5 mL of 0.5% bupivacaine heavy and 25 mcg of fentanyl via a 26G Quincke needle. Post-operatively, injection paracetamol 1 g intravenously (IV) was given six hourly to all patients. Injection tramadol 50 mg IV was used as a rescue analgesic whenever the NRS score was ≥4, with a maximum of 150 mg within 24 hours; in case the NRS score was still >4, then another rescue analgesic, injection fentanyl 1 mcg/kg IV, was administered as a slow bolus. NRS for pain was recorded post-operatively, immediately on shifting to the post-anesthesia care unit, and then every hour for the first 4 hours and then two hourly for the next 8 hours and then four hourly till 24 hours post-operatively. Post-operative observations were recorded by another anesthesiologist.OutcomesPrimary outcome was the time to first requirement of rescue analgesic, which was defined as the time when the NRS scale score was ≥4 for the first time post-surgery, with time 0 being the time of initiation of block. NRS pain scores, total requirement of rescue analgesics (tramadol and fentanyl) in the first 24 hours after surgery, and patient satisfaction with the pain management were recorded as secondary outcomes. Patient satisfaction score was measured by asking the patient to rate their satisfaction on a 5-point Likert scale  at 24 hours after surgery.Statistical analysisData were defined in terms of range: mean ± standard deviation (±SD), median, frequencies (number of cases), and relative frequencies (percentages) as appropriate. Quantitative variables  between the study groups were compared using Student’s t-test and Mann-Whitney’s U test for independent samples for parametric and non-parametric data, respectively. For comparing categorical data , chi-square (χ2) test was used, and Fischer’s exact test was used when the expected frequency would be less than 5. A probability value  of less than 0.05 was considered statistically significant. All statistical calculations were conducted using Statistical Package for the Social Science (SPSS) Version 21 .Sample size estimationThe sample size was estimated from the results previous studies ,15,16 usA total of 90 patients were enrolled in the study, and all of them completed the study Figure . They weAll three groups were statistically comparable with respect to the demographic data Table .Figure Time to first rescue analgesic or the mean duration of analgesia was 577.83 + 138.95 minutes in group A, 728.26 + 313.96 minutes in group B, and 937.35 + 31.33 minutes in group C. The difference was statistically significant among all three groups (p=0.023)  scores at 6 and 12 hours after procedure with 30 mL of 0.2% ropivacaine in SIFI block in comparison to infrainguinal FICB in 50 patients undergoing hip surgeries  to deterThe total requirement of opioid analgesics (tramadol) in the first 24 hours after surgery was significantly lower in group C as compared to group B and group A in our study. Desmet et al. hypothesized that a higher dose of ropivacaine (0.5%) is essential for successful analgesia in suprainguinal FICB . They usQuality of block assessed by patient satisfaction score at the end of 24 hours was also observed to be significantly better with group B and group C as compared to group A in our study. We found no literature on patient satisfaction among different volumes of SIFI block.These findings imply superior analgesic efficacy of 30 mL and 40 mL over 20 mL of 0.2% ropivacaine in suprainguinal FICB. A preliminary cadaveric study conducted by Vermeylen observed the spread of different volumes in a single-injection suprainguinal FICB in cadavers via computed tomography (CT) scan as well as dissection by a blinded anatomist . They obA double-blind comparative study was conducted by Helayel et al. to calculate the effective volume of 0.5% ropivacaine and 0.5% bupivacaine in 50% (EV50%), 95% (EV95), and 99% (EV99) of the cases to achieve FICB . The volThe patients in our study did not exhibit respiratory depression, pruritus, nausea, and vomiting, probably due to the opioid-sparing effects of the suprainguinal FICB. In our study, we gave single-shot FICB over continuous FICB as it is simpler and easy to administer with comparable opioid-sparing effect. Continuous FICB requires insertion of perineural catheters, which are expensive and require maintenance.There were a few limitations in our study. Firstly, all patients received spinal anesthesia, which could be a confounding factor resulting in a variable effect on post-operative analgesic requirement. For this purpose, patients enrolled in this study were of similar demographic characteristics, and a standard dose of 12.5 mg of bupivacaine with 25 micrograms of fentanyl was used. Secondly, block was given after spinal anesthesia; thus, the analgesic efficacy of block could not be assessed. But despite this limitation, one major advantage our study design offered was that the blocks were administered using ultrasound guidance, resulting in better success rates in terms of analgesic efficacy. Thirdly, the post-operative pain was assessed at rest only; dynamic pain was not assessed. Also, we used the Likert scale for assessment of patient satisfaction score. However, it is multifactorial and thus a poor assessment tool, which is another limitation of the study.Ninety patients undergoing hip hemiarthroplasties and proximal femur fixation under spinal anesthesia were enrolled in our study. They all received successful SIFI block for post-operative pain. From the results of our study, we conclude that 30 mL and 40 mL of 0.2% ropivacaine in suprainguinal FICB are equally efficacious in significantly reducing pain in the post-operative period after hip and lower limb surgeries in terms of NRS scores, time to first rescue analgesic, and patient satisfaction scores. Also, these volumes were significantly more effective for providing post-operative analgesia as compared to 20 mL.