Patient-reported outcome measures provide an essential perspective on the quality of health care provided. However, how data are collected, how providers value and make sense of the data, and, ultimately, use the data to create meaningful impact all influence the success of using patient-reported outcomes.The primary objective is to assess post-operative pain experiences by dental procedure type through 21 days post-procedure as reported by patients following dental procedures and assess patients’ satisfaction with pain management following dental surgical procedures. Secondary objectives are to: 1) assess post-operative pain management strategies 1 week following dental surgical procedures, as recommended by practitioners and reported by patients, and 2) evaluate practitioner and patient acceptance of the FollowApp.Care post visit patient monitoring technology (FollowApp.Care). We will evaluate FollowApp.Care usage, perceived usefulness, ease of use, and impact on clinical workload.We describe the protocol for an observational study involving the use of the FollowApp.Care platform, an innovative mobile application that collects dental patients’ assessments of their post-operative symptoms . The study will be conducted in collaboration with the National Dental Practice-based Research Network, a collective Network of dental practices that include private and group practices, public health clinics, community health centers and Federal Qualified Health Centers, academic institutional settings, and special patient populations. We will recruit a minimum of 150 and up to 215 dental providers and up to 3147 patients who will receive push notifications through text messages FollowApp.Care on their mobile phones at designated time intervals following dental procedures. This innovative approach of implementing an existing and tested mobile health system technology into the real-world dental office setting will actively track pain and other complications following dental procedures. Through patients’ use of their mobile phones, we expect to promptly and precisely identify specific pain levels and other issues after surgical dental procedures.The study’s primary outcome will be the patients’ reported pain experiences. Secondary outcomes include pain management strategies and medications implemented by the patient and provider and perceptions of usefulness and ease of use by patients and providers.The online version contains supplementary material available at 10.1186/s12903-022-02573-9. Contributions to the literaturePatient self-report is a critical part of comprehensive pain assessment. By promptly collecting patient health assessments, we will offer practitioners an opportunity to assess the effectiveness of their treatment modalities to understand their patients’ experiences and health outcomes.In this study, dental practitioners can respond in real-time to patient-reported outcomes for post-operative pain management.Evidence suggests that mobile phones are an effective platform for assessing patients’ symptoms and symptom burden. In addition, mobile applications can be effective in collecting and utilizing patient-reported outcomes to tailor care, however, they are rarely used in dentistry.Knowledge of treatment recommendations and/or patient reports will provide useful information in the shaping of dental school curricula.Existing means to address unexpected post-operative discomfort following a dental procedure include preemptively prescribing pain medication that might not be needed or having the patient call/visit the dental clinic before the regularly scheduled follow-up time period. Both approaches do not reflect patient-centered care and carry the risk of under/ overprescribing analgesics - including opioids. As the PEARL network concluded in its 2015 study examining dentists’ post-procedural prescriptions, “dentists tended to expect more pain than patients actually experienced; however, the choice of medication prescribed or recommended did not reflect the dentists’ expectations or the patients’ outcomes .Patient-reported outcomes (PROs) provide an essential perspective on the quality of health care and facilitate clinical decision-making. Electronic and paper-based administration of PROs has proven to be equally effective . Data coCurrent applications of Health Information Technologies (HIT) in dentistry are limited to electronic health records (EHRs) in general , 10, usiWhile research on the effectiveness of text messages and mobile app-related inventions to improve the quality of care is still in its infancy, results from studies using other forms of HIT are promising. For instance, mPOWEr enables patients to provide feedback on the condition of their surgical incision site following discharge from the hospital, while other mobile apps that collect PRO data enable patients to monitor their chronic health conditions, such as diabetes , 26. AddIn our pilot study (AHRQ 1U18HS026135), we successfully explored how an innovative mobile health intervention (FollowApp.Care®) could optimize the quality of acute post-op dental pain management by collecting PRO data from patients after dental procedures. However, it also taught us a number of implementation barriers. Some of these barriers are not new to those collecting PRO data, including difficulties with optimizing workflows and minimizing logistical burdens, further exacerbated by the expanded precautionary settings during COVID; data management in light of staff turnover; and staff training and providers , 31. BarPost-Operative Pain Study) trial , we seek to address the gap in knowledge by implementing an existing mHealth technology (FollowApp.Care) in the dental office setting. Through the FollowApp.Care platform, we will actively track pain and other complications following dental procedures. We expect to identify specific pain experiences associated with surgical dental procedures promptly and precisely. We will also collect information about pain management strategies and medications recommended by the practitioner and utilized by the patient. The results of this study will provide insight into pain and other postoperative complications experienced by patients through approximately 3 weeks following common dental procedures. We will also be able to gauge to what extent practitioners are interested in adopting mHealth technology. We will also learn how patients like to be engaged with text messaging to report post-operative pain and complications.These barriers can substantially hamper the implementation of PROs by the general dentist, to the detriment of advancing patient-centered care in the dental arena. In the POPS  through the UG3/UH3 mechanism. The study was approved by the central IRB (cIRB) of the University of Alabama at Birmingham (UAB), which manages all clinical studies for the Network. All participating entities’ IRB ceded to UAB’s cIRB as required.A populated checklist from the relevant reporting guideline(s) appropriate for this cohort study design is attached.To assess post-operative pain experiences by dental procedure type through 21 days post-procedure as reported by patients following study-eligible dental procedures and assess patients’ satisfaction with pain management following dental surgical procedures.Assess post-operative pain management strategies at 1 week following dental surgical procedures, as recommended by practitioners, and reported by patients.Evaluate practitioner and patient acceptance of FollowApp.Care. We will evaluate FollowApp.Care usage, perceived usefulness, ease of use, and impact on clinical workload.The study includes the following hypotheses:pain management strategy other complicationsThere is a significant difference in pain intensity measured over time and the dental procedure groupings after adjusting for pain management strategies and other complications. More specifically, are their significant variations in pain intensity due to different treatments after adjusting for:pain management strategy other complicationsThere is a significant difference in pain interference measured over time and the dental procedure groupings, after adjusting for pain management strategies and other complications. More specifically, are their significant variations in pain interference due to different treatments after adjusting for:pain management strategy other complications.There is a significant difference in patient satisfaction measured at the end of the 7-day period and dental procedure groupings, after adjusting for pain management strategies and other complications. More specifically, are their significant variations in patient satisfaction due to different treatments after adjusting for:Reported technology acceptance metrics; performance expectancy (PE), effort expectancy (EE), social influence (SI), and behavioral intention (BI) will be consistent with high acceptance of the FollowApp.Care platform.POPS is a longitudinal, prospective cohort study that will be conducted with practitioners and their patients undergoing potentially painful dental procedures. Data about baseline pain intensity and patient demographics will be collected prior to the procedure. The patients will receive push notifications through text messages via the FollowApp.Care platform on their mobile devices which asks them to comprehensively record their pain experience at designated time intervals on days 1, 3, 5, 7, 14, and 21 following their procedure. At the end of the 1st week (day 7), they will be asked to report their satisfaction with their post-operative pain management. On Day 23, after the procedure, they will be requested to complete a questionnaire to measure the platform’s usefulness and ease of use. All participating practitioners will be invited to complete a questionnaire to assess the platform’s perceived usefulness and ease of use. A subgroup of practitioners will also be invited to participate in debriefing/interviews to qualitatively evaluate their experiences with using FollowApp.Care for managing their patients’ post-op pain.The study is being executed in the National Dental PBRN, a collective network of dental practices that includes private and group practices, public health clinics, community health centers and Federal Qualified Health Centers (FQHCs), academic institutional settings, and special patient population . Since iThe study participants include Network dental practitioners who perform endodontic, periodontal, oral surgery, and/or implant dental surgical procedures and their patients. Eligibility criteria for practitioners include: 1) Be a Network practitioner deemed as study ready, 2) Be a dentist who performs at least one of the identified Code on Dental Procedures and Nomenclature (CDT Code)  procedurPain experience refers to both pain intensity and pain interference. Pain intensity is an assessment of how much a patient hurts. The response categories range from “No pain” to “Very severe” on a 10-point Likert scale [Pain interference refers to the extent to which patients have experienced interferences that have prevented them from activities of daily living (ADL), falling asleep, and staying asleep. The response categories range from “Does not interfere” to “Completely interferes” on a 10-point Likert scale. Patient pain management satisfaction refers to the level with which patients are satisfied with the overall pain management following their procedure and shared pain management strategies. The response categories range from “Extremely dissatisfied” to “Extremely satisfied” on a 10-point Likert scale. Additionally, it encompasses whether the patient participated in the decision-making regarding their treatment. The response categories range from “Not at All” to “Very Much So” on a 10-point Likert scale.This study has two primary outcomes, which reflect 1) pain experience and 2) patient pain management satisfaction. rt scale . Pain inAnalgesic medications used by patients that are reported through FollowApp.Care, frequency and dose prescribed captured through the eCRF completed by the practitioners; adherence to pain medications prescribed collected from the patient-reported data through FollowApp.Care, 2) Concordance with pain management strategy as recommended by the practitioner (reported on the eCRF) and reported by the patient. The pain management strategy of each practitioner will be captured on the eCRF, and the mHealth questionnaire will capture the corresponding patient adherence. 3) Other pain management strategies used by patients , 4) Practitioner acceptance of the platform , 5) Patient perceived usability with the platform (usefulness and ease of use of the platform), and 6) Other complications related to immediate postoperative complications (bleeding and increased swelling).Secondary outcomes include 1) Baseline pain intensity, Patient demographic variables, Type of procedure (CDT), Practitioner demographic variables, Practitioner specialty, Practitioner years in practice , and Practitioner assessment of expected pain intensity.Other covariates are Level 1 Providers - able to see their own patient responses & profilesall patient responses and profiles within their assigned CenterLevel 2 Center Manager - able to see all patient responses and profiles of all CentersLevel 3 Center SuperUser - able to see FollowApp.Care is an existing communications platform that collects patient-generated health data prior to or after a procedure in order to inform treatment care decisions, drive quality, and generate actionable performance reports. This patient-monitoring mobile phone platform has the ability to link with EHR systems without requiring an application program interface (API) and has already been linked to EHRs in the US as well as in Europe and Australia. FollowApp.Care can be deployed through any text message-enabled phone and configured to deliver language translations  and generate aggregate reports at the patient, provider, practice, and organizational levels. FollowApp.Care meets all HIPAA requirements. Data are stored in a self-operated data center and is encrypted in transit and at rest. Different permission levels within the system ensure different levels of accessibility of the data. Using the platform requires few steps Table ; its funmHealth questionnairesSpecific instruments include:Pain Interference questions were taken from the validated Oral Health Impact Profile-14 (OHOP-14) [2.System Usability Scale (SUS) questionnaireThe mHealth Questionnaire #1 includes questions about pre-procedural pain and patient demographics. The mHealth Questionnaire #2 includes questions about pain intensity and pain interference. Pain intensity questions are based on the PROMIS Item Bank v.1.0 – Pain Intensity Scale . On daysOHOP-14)  and the OHOP-14) –43 questFollowApp.Care usability as perceived by patients will be measured by the system usability scale (SUS) [3.Unified Theory of Acceptance and Use of Technology (UTAUT)le (SUS) –46 questPractitioner acceptance with the FollowApp.Care platform will be measured by the Unified Theory of Acceptance and Use of Technology (UTAUT) [4.electronic Case Report Form (eCRF) (UTAUT)  question5.Debriefing/interviewTwo eCRFs record practitioner information (practitioner characteristics) and patient information  at Days 0 & 21 .Telephone debriefing/interviews with purposefully selected practitioners will be conducted to qualitatively evaluate their experiences with using FollowApp.Care for managing their patients’ post-operative pain, including its impact on their clinic workload and workflow patterns, and satisfaction with the effectiveness of pain management.Type of procedure (CDT) will be collected through the eCRF. Practitioner demographic variables, specialty, and years in practice will be collected through the practitioner’s enrollment questionnaire (EQ). This information is already available in the practitioner database, and enrolled practitioners will be asked to update their EQ before the study. Practitioner years in practice will be collected through the practitioner’s enrollment questionnaire (EQ).Participating patients will be encouraged to complete the mHealth Questionnaire #1 prior to the procedure. Baseline pain intensity and patient demographic variables will be collected through the welcome message. expected pain intensity will be collected through the eCRF.Upon completing their procedures, all enrolled patients will receive post-operative instructions and guidance according to the provider’s standard practice. Additionally, all enrolled patients will receive guidance about FollowApp.Care. At the end of each day, the research staff will retrieve the new patient profiles from FollowApp.Care and check the patient contact information for completeness. The patients will receive text/email notifications at pre-determined time intervals  on Days 1,3,5,7,14, and 21 and will be prompted to complete the corresponding mHealth Questionnaire  general information about the study  and (2) specific information . Competency is assessed by the use of the FollowApp.Care platform and entering data in the database using mock participants. See Table A minimum of 150 and up to 215 dental providers will be recruited, and each provider will be expected to enroll an average of 21 patients for a total of 3147. Assuming a 40% missing data rate among enrolled patients throughout the duration of the study, there will be 1888 patients remaining. This includes patient non-response rates as well as item non-response rates for the outcome of interest during the study period. Given a sample of 1888, the GLMM model for repeated measures will be able to detect a 20% reduction in pain intensity between procedure groups over time with 80.0% power. The minimum sample size was derived by the “longpower” sample package in the R statistical computing environment.Standard descriptive statistics will be used to describe both patient and practitioners’ characteristics using 5 data capture methods: 1) the SUS questionnaire, 2) the mHealth Questionnaire distributed on pre-specified days post procedure, 3) the UTAUT questionnaire, 4) the debriefing/interviews, 5) and the practitioner eCRF. Summary statistics such as means, medians, and ranges will be produced for all measured continuous variables. Frequencies and percent contributions will be computed for all categorical and ordinal variables. Graphical methods like X-charts will examine distributions over time and identify potential, influential time points. The balance of baseline characteristics and measures between groups will be compared using appropriate tests, including chi-squared tests, student t-tests, and Wilcoxon rank-sum tests.A challenge for this non-randomized study is confounders – pre-existing variables that affect the outcomes and differ between the treatment groups. In order to reduce bias, potential confounders variables will be adjusted in regression models for the analysis. Once participants discontinue the study, they will not be contacted and will not be replaced as the power calculation has accounted for them. If the discontinuation rate is high, the study team PIs will discuss how to proceed with the Network and NIDCR. We will create a missing category for all missing data and assess the need for any imputation methods.We will estimate the difference in intensity, pain interference, and patient satisfaction dependent on the treatment type. The relative risk (RR) will be the measure of association reported along with 95% confidence intervals. Pain, interference, and satisfaction at the end of the study will be compared among the treatment categories. To model the differential treatment (CDT Grouping) effect on patients’ pain intensity, interference, and satisfaction, on, we will use GLMMs using a Poisson link. Models will include time, treatment type, age, gender, race/ethnicity, medications, and no medication methods as fixed effects. In addition, dentist and Network regions will be included as random effects in the models to account for correlations within clusters.A secondary analysis will be considered for additional evaluation of the FollowApp.Care platform by the practitioners including assessment of usability and evaluation of fidelity. Means and corresponding estimates of precision  and frequency distributions with percentage contributions will be used to report the distribution of each metric. In addition, we will conduct a confirmatory factor analysis (CFA) for multilevel data to test the reliability and construct validity.All statistical analyses will be performed at the standard significance level (α = 0.05) using R and Stata Statistical Software release 15 for StataCorp LP.In our pilot study (AHRQ 1U18HS026135), we successfully explored how an innovative mobile health intervention (FollowApp.Care®) could optimize the quality of acute post-op dental pain management by collecting PRO data from patients after dental procedures. However, it also taught us a number of implementation barriers. Some of these barriers are not new to those collecting PRO data, including difficulties with optimizing workflows and minimizing logistical burdens, further exacerbated by the expanded precautionary settings during COVID; data management in light of staff turnover; and staff training and providers , 31. BarPost-Operative Pain Study) trial , we seek to address the gap in knowledge by implementing an existing mHealth technology (FollowApp.Care) in the dental office setting. Through the FollowApp.Care platform, we will actively track pain and other complications following dental procedures. We expect to identify specific pain experiences associated with surgical dental procedures promptly and precisely. We will also collect information about pain management strategies and medications recommended by the practitioner and utilized by the patient. The results of this study will provide insight into pain and other postoperative complications experienced by patients through approximately 3 weeks following common dental procedures. We will also be able to gauge to what extent practitioners are interested in adopting mHealth technology. We will also learn how patients like to be engaged with text messaging to report post-operative pain and complications.These barriers can substantially hamper the implementation of PROs by the general dentist, to the detriment of advancing patient-centered care in the dental arena. In the POPS (This observational study offers insight into the distribution of patient-reported outcomes, while also capturing information on strategies used by practitioners for pain management. However, a challenge for this non-randomized study is confounders – pre-existing variables that affect the outcomes and differ between the treatment groups. In order to reduce bias, potential confounders variables will be adjusted for in regression models for the analysis. We will create a missing category for all missing data and assess the need for any imputation methods.Additional file 1. Appendix 1.Additional file 2. Appendix 2.Additional file 3. Appendix 3.


Local pain around the ankle joint is a common symptom in patients with chronic ankle instability (CAI). However, whether the local pain would impose any influence on the balance control performance of CAI patients is still unknown.A total of twenty-six subjects were recruited and divided into the following two groups: pain-free CAI (group A) and pain-present CAI (group B). Subjects in both groups received two independent tests: the star excursion balance test and the single-leg stance test, in order to reflect their balance control ability more accurately.p < 0.05). In the star excursion balance test, group B demonstrated a significantly reduced anterior reach distance than group A (p < 0.05). During the single leg stance test, group B showed a significant increase in the magnitude of electromyographic signals both in peroneus longus and soleus muscles than group A (each p < 0.05). Additionally, group B had a significantly more anterolaterally positioned plantar center of pressure than group A (p < 0.05).Compared with group A, the group B showed significantly more episodes of the history of sprains, decreased ankle maximum plantarflexion angle, and lower Cumberland scores (all CAI patients with local pain around the ankle joint had more episodes of sprains and lower functional scores when compared to those without pain. The balance control performance was also worse in the pain-present CAI patients than those without pain. Lateral ankle sprains are the most common musculoskeletal injuries in both physically active populations and general populations , therebyIt has already been well documented that CAI patients were associated with impaired balance control, due to proprioception and neuromuscular deficits –5. The iPain is reported to occur in 58% of patients with CAI when they participate in different levels of activity . HoweverThis study was designed to investigate the influence of local pain around ankle joint on balance control of the CAI patients through the SEBT and the single-leg stance test. We hypothesized that CAI patients with local pain would have worse balance control performance than pain-free CAI patients and healthy individuals.A total of twenty-six subjects with self-reported CAI were recruited in this study from December 2021 to March 2022. Twelve subjects were assigned to the pain-free CAI group (group A), and fourteen subjects were assigned to the pain-present CAI group (group B). This study was approved by our institutional review board. All subjects provided written informed consent. No conflicts of interest were existing and this was disclosed to all recruited subjects.1-α/2)2(SD)2 /d2 [1-α/2 is standard normal variate, which equals 1.96 at 5% type I error; SD is standard deviation of variable taken from previous study; d is absolute error or precision decided by researchers. SD was 1.7 according to a previous study that recorded Visual Analog Scale of pain of CAI patients [Sample size was calculated by the formula: sample size = (ZSD)2 /d2 . Z1-α/2 patients , and d wThe inclusion and exclusion criteria were designed in accordance with previous literature , 17. ParThe local pain around the ankle joint was assessed by the 11-point Numeric Rating Scale (NRS-11) . The NRSSenior orthopedic surgeons examined the subjects and documented their age, sex, height, weight, and ankle sprain history. The scores of CAIT and the NRS-11 for pain of each subject were also documented. A physical examination of each subject’s ankle was performed to measure the active range of motion (ROM) in a non-weight bearing position.The dynamic balance control was assessed by the SEBT . The subTo assess the static balance control, subjects were instructed to perform a single-leg stance on the force plate for 20 s, using the same tested leg as in SEBT. For each test, the CoP sway parameters and raw electromyographic (EMG) data of the last 10 s were recorded. The single-leg stance was repeated for three times and the average results were calculated for further analysis. The validity and reliability of the force plate  and EMG EMG) values of each channel were calculated by customized programs in MatLab . The RMSEMGrepresents the average level of EMG signals; thus it reflects the activation characteristics of the tasking muscles [The raw EMG data of tibialis anterior (TA), peroneus longus (PL), soleus (SOL), and medial gastrocnemius (MG) were collected by using the OpenSignals surface myoelectric device  at a sampling rate of 1000 Hz. The raw EMG signals were subsequently bandpass filtered (frequency ranging from 10 to 500 Hz) and then passed through the 48–52 Hz notch to reduce power frequency interference . The int muscles .The CoP sway parameters included anteroposterior (AP) amplitude, standard deviation (SD) of AP amplitude, mediolateral (ML) amplitude, SD of ML amplitude, mean velocity of CoP, SD of mean velocity, CoP path and CoP area , 30, 31.p < 0.05.The statistical analysis was performed using IBM SPSS Statistics 24.0. Q-Q map and Kolmogorov–Smirnov tests were used to assess the normality of CoP and EMG data distribution; both CoP and EMG data passed the normality test. Differences in clinical and demographic parameters between group A and B were evaluated by two-tailed independent t-test except sex, which was a categorical variable and was analyzed by Pearson Chi-square test. All biomechanical parameters were continuous variables and were analyzed using two-tailed independent t-test. The level of significance was set a priori at p < 0.05). In terms of ROM of ankle joints, it was found that group B had significantly lower maximum plantarflexion angle than group A (p < 0.05). Moreover, group B had significantly lower CAIT scores than group A (p < 0.05). The occurrence of pain in subjects with CAI was 53.8% (14/26). With respect to the local pain around the ankle joint in group B, the mean NRS-11 score was 4.29. The highest pain percentage was reported when running on uneven surfaces (35.7%). Anterior aspect of the lateral malleolus was the most frequently reported site of pain (35.7%), whereas only 1 individual reported deep pain at the lateral joint area (7.1%) (Table A comparison of the participants’ demographic characteristics between group A (pain-free CAI) and group B (pain-present CAI) is shown in Table 53.8% 14/6. With rp < 0.05). However, no significant differences were found in the SEBT reach distances in posterolateral and posteromedial directions between the two groups.The results of SEBT are presented in Table EMG value of PL was significantly larger in group B (p < 0.05). Further, significant differences were also found in the mean RMSEMG values of SOL between group A and B .The results of CoP parameters of the two groups are summarized in Table In our study, this first finding was that pain-present CAI patients exhibited decreased SEBT anterior reach distance. This may demonstrate the hypothesis that pain-present CAI patients had worse dynamic balance control. The positive association between pain and joint instability has been recognized in other body areas such as shoulder . This waEMG and CoP data were used to quantitively measure the static balance control. Another finding of our study was that pain-present CAI patients had higher levels of muscle activities of PL and SOL during a single-leg stance. It has been found that chronic pain is associated with neural network sensitization that promotes pain and altered nociceptive pathways . FurtherWith respect to CoP, the CoP sway parameters were not significantly different between group A and B (pain-free vs. pain-present CAI), which might indicate that both groups had impaired static balance control at a close level. Furthermore, it was noted that pain-present CAI patients had a more anterolaterally positioned CoP. Pope et al.  and MettThe highlight of our study was that this was the first time that the influence of local pain on the balance performance of ankles with CAI was investigated with biomechanical measures. Pain had been a neglected factor in previous studies related to CAI. Our work demonstrated that the presence of ankle pain in CAI patients resulted in worse balance control. However, we recognized that one limitation of our study was the relatively small sample size. This may affect the generalization of the results. Our work was a preliminary study that investigated the influence of local pain on balance control of CAI patients. Future large-sample studies are required to validate the findings of this study.The SEBT has been described as a reliable measure of dynamic balance control. Decreased reach distances of the SEBT and altered proximal joint neuromuscular control has been observed in individuals with CAI . Most CAStatic balance can be assessed by the single-leg stance test . LiteratPain is one of the major characteristics of chronic musculoskeletal conditions . NeverthPain is reported to occur in 58% of patients with CAI . The etiOur work proved that pain was a significant factor that contributed to the deficits in both static and dynamic balance control of the ankle joint in people with CAI. A reduction in pain may improve the balance control and prevent recurrent sprains in people with CAI. Future studies are needed to investigate the effect of pain reduction therapies on the improvement of CAI.In this study, it was found that pain-present CAI patients had more episodes of sprains and lower functional scores when compared to those without pain. Pain-present CAI patients also had worse dynamic and static balance control than those without pain. In the presence of ankle pain, CAI patients had a more anterolaterally positioned CoP on the plantar surface, and a different activation pattern of lower leg muscles, which might have contributed to worse balance control.


BackgroundA glenohumeral (GH) joint disease, such as adhesive capsulitis, causes the shoulder capsule's fibrosis and adhesion to restrict mobility. Collagen and growth factors can be produced by platelet-rich plasma (PRP), which promotes stem cells and, as a result, improves the healing process. This study was done to determine the role of PRP injection in the treatment of adhesive capsulitis in terms of improvement in pain.MethodologyThis prospective cohort study was conducted at the Department of Orthopedics, Mayo Hospital, Lahore, Pakistan, from February 2022 to July 2022. A total of 305 patients were enrolled through the outpatient department. Basic demographic and clinical details, including the visual analog scale (VAS) pain score, were noted. First, 20 ml of the patient’s blood was drawn from the superficial saphenous vein by double syringe. After processing, the PRP was collected and injected in the subacromial bursa and intra-articular space adopting the anatomical approach. Then, the process was repeated at weekly intervals for four weeks. In this phase, PRP was injected only in the joint. The pain was assessed before and after six weeks of treatment and improvement in pain as per VAS was noted.ResultsIn a total of 305 cases, the mean age was 60.47±11.55 years. There were 164 (53.8%) male and 141 (46.2%) female cases. The mean pain VAS scores before and after treatment were 6.56±1.79 and 2.42±1.71, respectively, and the mean reduction in pain after treatment was 64.57±19.40%. In 267 (87.5%) cases, an improvement of ≥ 50% was observed while 38 (12.5%) cases had an improvement of <50%.ConclusionThe PRP can be used for the treatment of adhesive capsulitis to reduce pain. This non-operative method of treatment may help reduce the hospital burden of patients suffering from adhesive capsulitis. Adhesive capsulitis is also known as frozen shoulder and is described as a disorder of the glenohumeral joint, which restricts movement due to adhesion and the presence of fibrosis in the shoulder capsule ,2. ManuaThere are different approaches to treating adhesive capsulitis; the primary objective is to provide relief from pain and to make the joint functional whether it is non-operative or an operative intervention . Many caThe rationale of our study was to see the role of PRP in our local population, as data are not available regarding the use of PRP in adhesive capsulitis. PRP is widely used in many orthopedically diseased populations, so this non-operative method of treatment may help reduce the hospital burden and can minimize the risk of limb disability. For the patients, this may contribute to an improvement in their quality of life. This study was done to define the benefits of injectable PRP in order to treat adhesive capsulitis and associated pain.This prospective cohort study was conducted at the Department of Orthopedics, Unit-1, Mayo Hospital, Lahore, Pakistan, from February 2022 to July 2022. The Mayo Hospital, Lahore, is affiliated with King Edward Medical University (KEMU), Lahore. Approval from the institutional review board was acquired (letter number: KEMU/2021/RC/328). Informed and written consent was sought from all study participants. The non-probability consecutive sampling technique was adopted. A sample size of 300 cases was taken considering the improvement in pain as 73.3% (as per the findings of the pilot study) with a 95% confidence level and a 5% margin of error. We enrolled 305 cases for this study adopting the non-probability consecutive sampling technique.Inclusion criteria were patients of either gender aged 40-80 years having a frozen shoulder with a duration of six weeks or more. Exclusion criteria were pregnant or lactating females (as per history). Patients with a history of previous treatment for a frozen shoulder  or systemic inflammation and/or osteoarthritis in other joints  were also excluded. Patients losing follow-ups and not completing the full treatment duration were also excluded.Patients were enrolled from the outpatient department and their basic demographic and clinical details (pain and assessment for frozen shoulder) were noted. Adhesive capsulitis was defined if there was pain > 3 on the visual analog scale (VAS) in the shoulder joint and there was a restricted passive and active range of motion. First, 20 ml of the patient’s blood was drawn from the superficial saphenous vein by double syringe. Next, the blood sample was centrifuged at 5000 rounds per minute (rpm) for five minutes to separate the blood into layers of red blood cells, buffy-coat of leucocytes, and plasma and lastly PRP (leucocyte rich) was collected and injected this product in the subacromial bursa and intra-articular space adopting an anatomical approach. Then, the process was repeated weekly for four weeks. In this phase, PRP was injected only in the GH joint. Shoulder stretching exercise was recommended to the patient after every injection. The pain was assessed before and after six weeks of treatment and improvement was labeled. The outcome was determined in terms of improvement in pain and measured on VAS  and improvement was labeled if there was a ≥ 50% reduction in the pain after treatment at the sixth week. All data were collected on a predesigned proforma.All collected data were entered and analyzed in Statistical Package for Social Sciences (SPSS) version 26.0 . Mean ± standard deviation (SD) was used for quantitative data such as age and pain (before and at the sixth week). Frequency (%) was calculated for qualitative data like gender and improvement in pain (≥ 50%) pain at the sixth week. Data were stratified for age, gender, duration of disease, and baseline pain to address effect modifiers. The chi-square test after stratification was applied to compare the improvement in pain after the treatment, taking p-value ≤0.05 as significant. The paired sample t-test was applied to compare baseline and after-treatment VAS pain scores considering p-value≤0.05 as statistically significant.In a total of 305 cases, the mean age was 60.47±11.55 years (ranging between 40 and 80 years). There were 164 (53.8%) male patients while the male-to-female ratio was calculated to be 1.16:1. Table The mean baseline pain score was 6.56±1.79 (ranging between 4 and 9) while after treatment at six weeks, it was 2.42±1.71 (ranging between 1 and 7), p<0.001. Overall, a reduction of 64.57±19.40% was noted in the VAS pain score before and after the treatment. In 267 (87.5%) cases, the improvement was ≥ 50% while 38 (12.5%) cases had improvement <50%.When cases with a ≥ 50 improvement in pain were compared with those having <50% improvement in pain, no statistically significant differences were found with regards to the distribution of age (p=0.434), gender (p=0.880), duration of disease p=0.092), and baseline pain scores (p=0.279). The details about the comparison of pain improvement with respect to study variables are shown in Table , and basThe conventional approach in the treatment of frozen shoulders is to provide relief from pain and to reinstate the movement of the joint for its proper functioning -10. MultA recent case report reported that after the first injection, the patient reported a 60% improvement in diurnal shoulder pain . As dataIn 2017, a study was conducted involving 54 female patients with frozen shoulders to evaluate the effectiveness of PRP [2, 1 MHz, continuous mode) for the treatment of periarthritis shoulder were randomly divided into study groups [A study by Kothari SY et al., comparing the effectiveness of PRP injection (2 ml single injection), corticosteroids (80 mg methylprednisolone), and ultrasonic therapy (7 sittings in 2 weeks at 1.5 W/cmy groups . Outcomey groups .LimitationsAs this was a single-center study with a relatively small follow-up period, our findings cannot be generalized and studies involving multiple centers and longer duration of follow-ups should be planned to further verify the findings of this study.It is concluded that PRP can be used for the treatment of adhesive capsulitis to reduce pain. The PRP being a nonoperative method of treatment may help reduce the hospital burden of patients suffering from adhesive capsulitis. This can further help improve the quality of life of adhesive capsulitis patients. There is a need for exploring the further pathophysiological impact of PRP treatment in large multicentral cohorts to examine the best approach for the most improved outcomes.


The purpose of this study was to investigate pain and radiological features of different types of first-episode demyelinating optic neuritis (ON).n = 28), myelin oligodendrocyte glycoprotein (MOG) antibody-associated ON  and idiopathic demyelinating optic neuritis  were included in this retrospective case-control study. We assessed optic nerve lesions on magnetic resonance imaging (MRI), acute pain associated with onset of optic neuritis and clinical characteristics of those ON patients with different serum autoantibody status.Eighty-three patients presenting with first-episode aquaporin-4 (AQP4) antibody-associated ON , and enhancement of optic chiasma was most common in AQP4-ON patients . Perineural and orbital enhancement was observed only in patients with MOG-ON (P < 0.001). The length of enhancement was longer in AQP4-ON patients than in MOG-ON and IDON patients.24 AQP4-ON patients (85.75%), 23 MOG-ON patients (88.5%) and 24 IDON patients (82.8%) suffered from ON-associated pain. MOG-ON had mostly retro-orbital pain; AQP4-ON and IDON had mostly neuropathic pain. In addition, pain was more severe in AQP4ON patients than in other ON patients. In MRI, bilateral involvement was more common in AQP4-ON than IDON (26.9 and 3.7%); radiological optic nerve head swelling was more common in MOG-ON than in AQP4-ON and IDON (68.0 vs. 23.1 vs. 25.9%). MRI lesion in peri-optic nerve sheath was more common in AQP4-ON (53.8 vs. 16.0 vs. 3.7%). In 70 patients with ON-associated pain, gadolinium enhancement of orbital optic nerve was most common in MOG-ON patients (82.4 vs. 55.0 vs. 33.3%, Pain is a common symptom in patients with all types of demyelinating ON. AQP4-ON is frequently associated with severe ON-associated pain and longitudinally extensive optic nerve inflammatory lesions. Intra-orbital and peri-optic inflammation were more frequently observed in patients with MOG-ON, which was closely related to optic disc swelling and retro-orbital pain provoked by eye movements. Optic neuritis (ON) is an acute, inflammatory process that causes demyelination of the optic nerve and often leads to varying degrees of permanent visual impairment. ON can be an isolated event or the initial symptom of central nervous system (CNS) autoimmune-mediated demyelinating diseases, such as multiple sclerosis (MS) or neuromyelitis optica (NMO) or myelin oligodendrocyte glycoprotein antibody disease (MOG-AD).Due to the varied pathogenesis, clinical characteristics, therapy and prognosis, NMO-ON, MOG-ON and MS/IDON (idiopathic demyelinating optic neuritis) are increasingly becoming recognized as distinct disease entities. For example, the glial autoantibodies associated demyelinating ON, anti-aquaporin 4 (AQP-4) in NMO and anti-MOG, are associated with unique clinical and radiologic features and varying responses to treatment compared with MS or IDON.Pain in inflammatory and demyelinating CNS diseases can be prevalent and disabling, lead to a lower quality of life, and result in an increased healthcare burden. As in ON patients, pain is a common and disabling symptom and is often refractory to treatment . PatientIn this study, we systematically evaluated acute pain of patients suffering from AQP4-IgG seropositive ON, MOG-IgG seropositive ON, and IDON, with special attention to the comparison of pain syndromes and MRI characteristics in those patients.In this study, we retrospectively assessed 83 patients with unilateral or bilateral acute ON, all of whom were recruited from the Ophthalmology Department of the Beijing Chaoyang Hospital of the Capital Medical University and the Chinese People's Liberation Army General Hospital (PLAGH) from June 2017 and August 2020. ON was the first symptom in all the patients who fulfilled the diagnosis criteria of ON according to the optic neuritis treatment trial (ONTT) , intraocular pressure, pupillary reactions in unilateral or bilateral asymmetric conditions, slit lamp examination, ocular fundus examinations, Humphrey visual field (VF) assessment, and optic nerve function tests. BCVA was tested by using a Snellen chart and was transformed into logarithm of the minimum angel of resolution (logMAR) values by using Petzold et al.  in human NMO/ MOG-transfected HEK293 cells. The samples were scored as positive or negative by at least 2 independent experiments. A dilution of 1:1,000 was employed as the maximum positive value and 1:10 as the cut-off for positive and negative cases.The concerning pain attributable to acute ON was recorded as described by patients according to frequency, intensity, location, characteristics and duration of the pain. The severity of pain from the patients was scored on a scale of 0 (no pain) to 10 (the severest pain subjects can imagine) according to a numerical rating scale (NRS). The patients were instructed not to describe or include any pain syndromes not directly due to onset of ON.After reviewed by a neuro-ophthalmologist and a neurologist, pain symptoms associated with ON were recorded based on categorizations of retro-orbital pain, trigeminal neuralgia, headache, migraine, and mixed pain (having more than two of the four types of pain). The information of each patient's medical visits and prescription medications for pain was also reviewed. We have designated as retro-orbital pain any pain or discomfort localized to the retro-orbital or periorbital regions. Pain is classified as trigeminal neuralgia if sensory signs corresponding to the affected nervous structures are detected on examination. It always demonstrates a paroxysmal nature, often associated with very short-lived, electric-like, severe, stimulus-evoked pain . HeadachMRI scanning was performed on a 3-T MR scanner . All the patients had standardized imaging, including axial T2 weighted and/or fluid attenuated inversion recovery (FLAIR) sequences, coronal T2 or FLAIR sequences of the whole brain, and coronal sequences with or without axial T2 fat suppressed (FS) sequences. T1-weighted axial and coronal sequences were performed following gadolinium administration and used to determine the location of abnormal enhancement. The axial views were used to determine the length of abnormal enhancement. The location and length of abnormal optic nerve enhancement on gadolinium-enhanced and fat-suppressed MRI were documented. Neuroradiology assessment was carried out by a neuroradiologist blinded to the patient's histories and diagnoses. To study the location and extent of lesion involvement, the optic nerves were divided into five subsets: orbital, canalicular, intracranial, chiasmal, and optic tract.This study was approved by the Ethics Committee of the Beijing Chaoyang Hospital and the PLAGH, and was conducted following the Declaration of Helsinki in its currently applicable version. Written informed consents were obtained from all the patients.P-values. The Spearman rank correlation coefficient was employed to statistically analyze the correlations between the pain severity and the number of Gd enhanced segments of lesions in MRI in all the patients with acute pain symptoms and Gd enhancement.Statistical analysis was performed by using SPSS for Windows, Version 24.0. Continuous variables were analyzed using a non-parametric test (Mann-Whitney U test). The Chi-squared test, or Fisher's exact test if applicable, was used to analyze the categorical data. The differences among any three groups were identified by using the ANOVA or Kruskal-Wallis test. In order to reduce Type I errors, Bonferroni correction was applied to the P < 0.001; AQP4-ON&MOG-ON: P > 0.05/3, AQP4-ON&IDON: P < 0.05/3; MOG-ON&IDON: P < 0.05/3). Seven patients  in the AQP4-ON group had a clinical history of myelitis, with myelitis occurring less frequently in the MOG-ON  and IDON  patients (P = 0.002). BCVA at attacks in the acute phase and BCVA recovery were compared. No differences in visual loss during the acute stage were observed between the three groups. At the last follow-up, the AQP4- ON patients were significantly more likely to get poor VA recovery over time than the other patients (P = 0.001).The demographic data and clinical characteristics of the 28 AQP4-ON, 26 MOG-ON and 29 IDON patients were compared . The meaP = 0.003). In the treatment of pain, the use of pain medication was more prevalent in the AQP4-ON patients than in the MOG-ON and IDON patients. However, only 21.4% of the AQP4-ON patients had a pain treatment, whereas the majority of the patients with pain did not have any pain medication.Type, severity, localization and treatment of ON-related pain were compared between different groups of ON . ON-relaP = 0.046). The radiological optic nerve head swelling (P < 0.05/3) and IDON   .P = 0.018, MOG-ON & IDON: P < 0.05/3). In the MOG-ON patients, gadolinium enhancement predominantly involves the anterior segments of the optic nerve, with almost routine inclusion of the orbital segments, while chiasm and optic tract are generally spared. Chiasmal involvement was more common in the AQP4-ON patients than in the MOG-ON and IDON patients. Optic tract involvement was uncommon in all the groups, with AQP4-ON relatively more involved, accounting for 15.0%, but the MOG and IDON groups had no involvement. AQP4-ON tends to involve the posterior segments, including the optic chiasm and optic tract, more frequently. As to IDON, it tends to be more focal and limited in radiological involvement, with the number of affected segments in IDON significantly less than that in the AQP4-ON and MOG-ON patients . Inflammation and enhancement of the peri-optic nerve sheath, partly extending into the surrounding orbital fat, was only seen in MOG-ON patients. This appears crucial, as it was not apparent in either AQP4-ON or IDON patients, which may be one of the useful parameters for distinguishing MOG-ON from AQP4-ON and IDON. Further correlation analyses showed no significant correlation between the pain severity and the number of Gd enhanced segments (P = 0.764).In this study, we also investigated the location and length of abnormal enhancement of the optic nerve in patients with different types of acute ON with pain . In all Pain is one of the most common comorbidities of ON, and it has varied degrees of impact on patient's quality of life . As docuDemyelination lesions of the nervous system can cause eye pain, headache, extremities and trunk pain, and the mechanism underling are different –17: for In AQP4-ON, loss of AQP4, impairment of astrocytes and parallel injury in AQP4-coexpressed molecules , may lead to an excessive accumulation of glutamate in the extracellular space, interrupting the glutamine-glutamate-GABA axis . The balIn MOG-IgG associated diseases, the loss of MOG and the damage of oligodendrocyte are caused by antibody-mediated destruction. This further leads to the accumulation of large amounts of nerve growth factor (NGF) in the CNS, which may lead to aberrant sprouting of unmyelinated nociceptive fibers and cause chronic neuropathic pain . In thisMoreover, in the demyelinating lesions of all types ON patients, microglia plays a significant role in synaptic remodeling, connectivity, and network function changes in neuropathic pain. It also plays active roles in brain regions important for the emotional and memory-related aspects of chronic pain . The actDue to the innervation of sensory nerves around the eye, the pain around the affected eye and accompanying ON is believed to result from irritation of the meninges surrounding the optic nerve , 14. TheIn addition, the location and length characteristics of optic nerve lesion in orbital MRI may be other useful parameters for differentiating different subtypes of ON. MOG-ON was found to have a predominant anterior location, prominent optic nerve swelling, and severe intra-orbital perineural sheath leakage compared with other patients. Additionally, inflammation and enhancement of the perineural and orbital appeared exclusively in the MOG-ON cases, which were present in 38.9% of the MOG-ON patients, as it was not observed in the AQP4-ON or IDON patients. This orbital MRI characteristic can provide invaluable insights into the differential diagnosis of MOG-ON. By contrast, AQP4-ON often involves posterior segments such as the chiasm and optic tract but may also affect the intra-orbital and canalicular optic nerve. More importantly, the AQP4-ON patients tend to have significantly more extensive optic nerve lesions than other patients. Whereas, both the AQP4-ON and MOG-ON patients appear to have a higher incidence of bilateral ON, the IDON patients tends to be unilateral and more limited in radiological involvement.Despite the fact that the types and severity of ON-related pain varied amongst the three groups, we found that the majority of the ON patients with pain are currently not effectively treated, which is consistent with the findings in previous research . Only <2Undeniably, this study also has its limitations. One drawback concerns the retrospective design and unintentional selection bias due to the recruitment of ON patients from referral centers. Another limitation is the lack of more detailed records of the different patterns and prevalence of pain syndromes in the patients with ON and its impact on their daily life. Thirdly, this study did not assess potential comorbidities that may have contributed to pain. In future studies, systematic recording, careful differentiation of different types of pain, and comprehensive evaluation of the efficacy of pain treatment are key points for effective observation and management in patients suffering from ON.In conclusion, pain is a very frequent symptom in ON patients, often with a severe impact on the quality of life of AQP4-ON, MOG-ON and IDON patients. However, medication is currently insufficient in controlling pain, with only a small portion of ON patients receiving pain therapy and none of them being fully pain-free. In addition to relapse prevention, physicians should consider pain treatment as one of the therapeutic objectives in their future treatment of ON. Future prospective studies developing a further understanding in the multiplicity of pain syndromes and its pathophysiological mechanisms of ON-related pain may lead to better management and more rational therapy of pain in patients with ON.The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation.The studies involving human participants were reviewed and approved by the Ethics Committee of the Chinese People's Liberation Army General Hospital and the Beijing Chaoyang Hospital of the Capital Medical University. The patients/participants provided their written informed consent to participate in this study.HK and YT: design and conduct of the study and preparation of the manuscript. HK, XH, and HQ: collection, management, analysis, and interpretation of the data. HK, SW, and YT: design and conduct of the study. Review and final approval of the manuscript by all authors.This work was supported by the National Natural Science Foundation of China (No. 81900849), the Beijing Hospital Authority Youth Programme (No. QMS20200308), and the National Key Research and Development Program (No. 2018YFE0113900).The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The reviewer LJ declared a shared affiliation with the authors HK, HQ, XH, and YT to the handling editor at the time of review.All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.


Bladder pain syndrome (BPS)/interstitial cystitis (IC) is a debilitating condition characterised by bladder/pelvic pain and pressure as well as persistent or recurrent urinary symptoms in the absence of an identifiable cause. It is hypothesised that in addition to organ specific visceral hypersensitivity, contributions of the hypertonic pelvic floor, peripheral sensitisation, and central sensitisation exacerbate this condition. The aim of this paper is to investigate outcomes of treating underlying neuromuscular dysfunction and neuro‐plastic mechanisms in BPS/IC patients.A retrospective chart review of 84 patients referred to an outpatient pelvic rehabilitation centre with a diagnosis of BPS/IC given to them by a urologist. All 84 patients failed to progress after completing 6 weeks of pelvic floor physical therapy and underwent an institutional review board approved protocol (IRB# 17‐0761) consisting of external ultrasound‐guided trigger point injections to the pelvic floor musculature, peripheral nerve blocks of the pudendal and posterior femoral cutaneous nerves and continued pelvic floor physical therapy once weekly for 6 weeks. Pelvic pain intensity and functionality were measured pretreatment and 3 months posttreatment using Visual Analogue Scale (VAS) and Functional Pelvic Pain Scale (FPPS).Pretreatment, mean VAS was 6.23 ± 2.68 (95% CI 5.65 to 6.80). Posttreatment mean VAS was 3.90 ± 2.63 (95% CI 3.07–4.74). Mean FPPS before treatment was 11.98 ± 6.28 (95% CI 10.63 to 13.32). Posttreatment mean FPPS was 7.68 ± 5.73 (95% CI 6.45–8.90). Analysis of subcategories within FPPS indicated highest statistically significant improvement in the categories of bladder, intercourse and working.Analysis suggests the treatment was effective at ameliorating bladder pain and function including urinary urgency, frequency, and burning in BPS/IC patients. In older studies, prevalence of BPS/IC was comparatively rare (18.1/100 000 women and 10.6/100 000 men), and newer studies demonstrate a greater occurrence (52–197/100 000 women and 40–70/100 000 men) when physicians made the diagnosis. Estimates of patient self‐reports are much higher at 501–865/100 000 patients.Diagnosis is challenging because patients presenting with BPS/IC experience other unrelated disorders such as irritable bowel syndrome, fibromyalgia, chronic fatigue syndrome, and anxiety disorders in addition to their urinary bladder symptoms.This investigation aims to establish the efficiency of an outpatient ultrasound‐guided peripheral nerve block and trigger‐point injection protocol aimed at treating the central neuro‐plastic mechanisms involved in BPS/IC known as (1) peripheral sensitisation and its associated neurogenic inflammation, (2) central sensitisation and (3) pelvic floor hypertonia.22.1Participants were 54 women and 30 men aged between 22 and 86 years diagnosed with BPS/IC by a urologist. The patients' chief complaints included perceived bladder symptoms with associated lower urinary tract symptoms such as bladder pain or pressure, pain or discomfort with bladder filling, urinary frequency, urgency and/or burning for at least 6 months. These patients came to an outpatient pelvic rehabilitation practice between the February 2020 and December 2020. All 84 patients undertook pretreatment evaluations with a detailed medical history and neuromuscular physical examination by one of 11 physiatrists. This examination evaluated the lumbosacral spine, hips and abdomen, as well as an internal evaluation of the pelvic floor, consisting of palpation of the levator ani sling to assess muscle strength and tone as well as palpation over Alcock's Canal and the ischial spines to observe tenderness/tingling known as Tinel's sign. Selected patients demonstrated either a Hypertonic Pelvic Floor with Myofascial trigger points or Allodynia along the pudendal nerve and its branches and along the adjacent posterior femoral cutaneous nerve bilaterally. Patients were excluded if they had an active infection, malignancy, persistent opioid use, incomplete or missing VAS or FPPS questionnaires or could not commit to 6 months of consistent pelvic floor physical therapy.Patient demographics are shown in Table 2.2A retrospective chart review was conducted for 84 patients referred to an outpatient pelvic rehabilitation centre with BPS/IC diagnosed by a urologist using the Pelvic Pain and Urgency/Frequency Symptom (PPUFS) Scale and O'Leary‐Sant Symptom Index. All 84 patients failed to progress after completing 6 weeks of pelvic floor physical therapy and underwent an institutional review board approved protocol (IRB# 17‐0761) consisting of external ultrasound‐guided trigger point injections using 1 cc of Lidocaine 1% to the pelvic floor muscular structure. Once weekly, for 6 weeks throughout the protocol, a global injection was administered into the iliococcygeus, pubococcygeus and puborectalis one side at a time.Simultaneously, while in the prone position, patients underwent ultrasound‐guided, peripheral nerve blocks of the pudendal nerve at Alcock's canal.The protocol was tolerated by all patients as it utilised a 27‐gauge needle with topical anaesthetic spray prior to the treatment. Patients were premedicated with diclofenac 75‐mg P.O. and returned to work the same day after sitting on ice for 10 min.2.3Data of patient's response to treatment were collected at their new patient consult and 3‐month follow‐up, with the 0 to 10 VAS to measure pelvic pain and FPPS to measure functionality. For VAS, patients rated their standard pain intensity across the past 24 h. Pelvic functionality on FPPS encompasses eight categories: bladder, intercourse, sleeping, walking, running, lifting, working and bowel. Patients ranked all categories from 0 to 4, showing regular function and serious debilitation, respectively. Experimenter bias was minimised by keeping follow‐up questions identical for all patients. Patients who had incomplete or missing VAS and/or FPPS questionnaires were excluded from this research study and not included in the analysis.t test  was the average VAS score. After treatment, 3.90 ± 2.63  was the average VAS score. Men saw a higher average decrease in VAS score. Average FPPS score prior to treatment was 11.98 ± 6.28 . Women saw a much higher decrease in FPPS total than men. Results differentiated by sex are summarised in Table P < 0.05, 95% CI = 6.45–8.90). Evaluation of FPPS categories showed that improvement was statistically significant for bladder, intercourse and sleeping. For the bladder category, the average decrease in score after treatment was 0.85  Before treatment, the average was 1.98 ± 1.05 . Posttreatment, the mean was 1.13 ± 0.93 . For the intercourse category, the average score decrease after treatment was 0.73 . Before treatment, the average was 1.94 ± 1.40 . After treatment, the average was 1.21 ± 1.48 . For the sleeping category, the average decrease in score post treatment was 0.54 . Before treatment, the average was 1.12 ± 0.91 . After treatment, the average was 0.91 ± 1.34 .Before treatment, 6.23 ± 2.68  has been studied via randomised trial for its effectiveness in treating symptoms of IC/BPS. However, there is not enough consistent data from these studies to establish a positive effect. Pentosan polysulfate sodium (PPS) is also a well‐documented treatment option and has been shown to successfully treat bladder pain, urinary urgency and frequency of micturition and thus an evident option for the treatment of IC/BPS symptoms. Therapies such as Mindfulness‐based stress reduction (MBSR) and Guided Imagery audio sessions have been studied via randomized trials as well, with MBSR demonstrating no change in VAS scores and Guided Imagery audio resulting in a decrease in VAS scores by 2.57, on average. Dimethyl sulfoxide (DMSO) has been studied via cohort studies and a single randomised trial. Treatment specificities are inconsistent and results from these studies vary greatly.Our investigation found statistically significant improvements in both pain and function for women and men aged 22–86 diagnosed with BPS/IC whose symptoms had not improved after completing 6 weeks of pelvic floor physical therapy. This supports the validity of an outpatient treatment protocol aimed at treating the underlying hypertonic pelvic floor myofascial pain and concomitant peripheral neurogenic inflammation often seen in the major pelvic nerves of BPS/IC patients. The pudendal nerve and the posterior femoral cutaneous nerves were treated as they are the two major sensory nerves that innervate the lower two‐thirds of the pelvis.BPS/IC is thought to have a major component of neurogenic inflammation and pelvic floor hypertonia that through the pelvic cross‐sensitisation process and inter‐neuronal connections, this causes injury/trauma to the bladder and results in symptoms commonly associated with BPS/IC.BPS/IC is traditionally correlated with chronic pelvic pain (CPP) and urinary urgency/frequency suggesting that these diagnoses and symptoms occur concomitantly. The colon and bladder, both involved in collecting, storing and excreting waste, are in immediacy and share mutual innervation from spinal afferent pathways.Decreasing peripheral neurogenic inflammation will ultimately break the spinal path‐way upregulation feedback loop from the PNS to the CNS and help to reverse the central sensitisation process that occurs in BPS/IC.Hypertonic pelvic floor dysfunction has an estimated prevalence of 50–87% in BPS/IC patients.Multiple expert panels such as the American Urological Association,Pain with intercourse and a decreased sexual drive are common distressing characteristics women and men with BPS/IC as proven by the Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) research network which examined the ‘most bothersome pelvic symptom’ in 191 men and 233 women with BPS/IC.4.1A limitation of the study is the retrospective nature that prevents randomised control groups. The efficacy of our protocol in comparison with a placebo will not be possible as it would violate the ethics and trust of our patients who seek relief from their debilitating pain. A future improvement for outcome measures is to include the use of National Institutes of Health Chronic Prostatitis Symptom Index (NIH‐CPSI)The authors declare no conflict of interest.A.S. developed the protocol and conceptualised this study. S.P. wrote the first draft of the manuscript and performed the statistical analysis. All authors were involved in data collection, editing, review and final approval of the manuscript.


Background and Objectives: The aim of the present study was to evaluate the efficacy of a multimodal pain therapy (MPM) regarding the objective parameter muscle strength of segment-dependent lower limb muscle groups before and after such a treatment. Materials and Methods: 52 patients with a history of low back pain and/or leg pain received standardized multimodal pain management. Strength of segment indicating lower limb muscles were assessed for each patient before and after ten days of treatment by handheld dynamometry. Results: Overall strength increased significantly from 23.6 kg ± 6.6 prior to treatment to 25.4 ± 7.3 after treatment, p ≤ 0.001. All muscle groups significantly increased in strength with exception of great toe extensors. Conclusions: Despite lower basic strength values at the beginning of treatment, all investigated muscle groups, except for the great toe extensors, showed a significant increase of overall strength after completion of the multimodal pain management concept. Increased overall strength could help with avoiding further need of medical care by supporting patients’ autonomy in daily life activities, as well as maintaining working abilities. Thus, our study is the first to show a significant positive influence on lower limb strength in patients with low back pain after a conservative MPM program. Chronic low back pain (LBP) is of increasing socio-economic importance ,2. In 20Chronic low back pain is often described in the literature as mixed pain. This means that most patients have both neuropathic and nociceptive pain components .Unless there is an absolute surgical indication such as cauda equina syndrome (CES), conservative therapy should then be carried out first. Since, as mentioned before, chronic low back pain is normally a mixed pain, it should be addressed in a multidisciplinary approach. Different treatment options are described in the literature for the non-surgical treatment ,10. In tIn combination with accompanying treatments such as physical therapy and psychological counselling as a multimodal analgesia management, injection therapy can be used to control chronic pain symptoms and avoid surgery with accompanying treatments such as physical therapy and psychological counselling ,14.Up to now, the visual analogue scale (VAS) or the numeric rating scale (NRS) have mostly been used in the literature as indicators for successful therapy . HoweverThe aim of the present study was to evaluate the efficacy of a multimodal pain therapy regarding the objective parameter muscle strength of segment-dependent lower limb muscle groups before and after such a treatment.This prospective study was approved by the local ethics committee on 21 March 2018 (Nr. 18-931-101). Written informed consent was given by all patients participating in this study. Patients were included in the study if they were indicated for inpatient, multimodal pain management in a single center  from June 2018 to April 2019 and met the following inclusion criteria: age between 18 and 80 years, radicular pain originating from a specific nerve root or clearly attributable muscle strength impairment of the lower limb without surgical indication, and a pain level of at least 5 on the numeric rating scale.Exclusion criteria were tumors with spinal implication, congenital spinal malformations, former spinal surgery, and rheumatic or inflammatory spinal diseases. Demographic data are shown in Inpatient care was provided for each patient for a total of 10 days. The concept consisted mainly of lumbar spinal nerve root analgesia (LSPA) in the affected region, using a freehand technique, which has already been described elsewhere . The injA hand-held dynamometer  was used to measure strength. All values were documented in kilogram. The measurements were performed on two different days. The first measurement took place on the day of admission to determine the basic strength values, and the second on the day of discharge. Each measurement was performed independently by two examiners for each assessment. Both examiners received instruction and training in the use of the measurement device prior to the study.The contact surfaces were marked with a skin-friendly pencil to ensure equal measurement points. The marked areas were repainted by the patient himself, if necessary, . The contact surfaces were chosen in a manner that allowed for comfortable measurement with the highest achievable leverage. The best testing position for each muscle group was described by Mentiplay  While inTo record the patients’ pain, a numerical rating scale (NRS) from 0 to 10 was used. The patients were interviewed before each measurement regarding the pain level. The strength values were documented immediately in standardized, electronic form. In addition, the descriptive data of every individual was collected .t-tests for dependent variables. Absolute and relative frequencies were given for categorical data. Inter-observer agreement was assessed using the intraclass correlation coefficient (ICC). The following values were determined according to Koo et al. [p < 0.05 were considered statistically significant. IBM SPSS Statistics 25  was used for analysis.For statistical analysis, continuous data are presented as mean values and standard deviation. Group comparisons were performed by two-sided o et al. : less thIn total, 52 Patients were included analyzed with a mean age of 63.2 years (±12.1), 25 male and 27 female. Patients were treated in-hospital for 9.19 days (±0.56) on average. The painful side was right in 12 patients, left in 15 patients, and both in 25 patients.Overall Interrater Reliability was excellent with ICC = 0.94 for measurements at the day of admission and excellent with ICC = 0.96 for the second measurements at discharge.p < 0.001.NRS decreased significantly for both back and leg pain from 5.9 (±2.2) to 3.3 (±2.2) and 4.5 (±2.8) to 2.5 (±2.0), respectively, Infiltration of the facet joints were administered 45 times (86.5%), epidural injections 47 times (90.4%), and nerve root blocks 19 times (36.5%).p = 0.013) by 7.2% from the first day to discharge.Hip flexors strength increased significantly (p < 0.001). For the knee extensors, the power of the muscle group increased significantly by 12.6% (p < 0.001). Ankle extensor strength increased by 4.75% (p = 0.041). Ankle flexor strength increased by 9.5% (p < 0.001). For great toe extensors, a reduction of strength was noted by −4.0%, which was statistically not significant, p = 0.103. Mean values for strength development are shown in Knee flexors showed an increased rate of 7.4%,  with a similar testing setup ,31.In 2000, Stoll et al., published higher maximal isometric muscle strength in hip flexion values of 25.1 kp (1 kp = 9.81 N) to 38.0 kp in healthy adults . The incFor ankle dorsal extension and plantar flexion, a significant increase was also found, showing a considerably higher base value for the plantar flexors of about 14% in comparison to the dorsal extensor, which increased even after treatment to about a 21% difference. Mentiplay et al., could show higher levels of baseline values, ranging from about 21 kg and 31 kg for dorsal extensors and about 48 kg and 51 kg for plantar flexors . This inThe results for great toe extensors in this study slightly decreased over the treatment period. However, clinical testing of the extension force of the big toe is difficult due to the small contact surface on the one hand and the rather low extension force of the big toe compared to the force of the examiner’s hands on the other. Interestingly, the extension force of the big toe has rarely been studied in literature, despite the fact that the extensor hallucis longus is the segment-dependent muscle of the L5 nerve root. In 1995, Jönsson et al., reported an improvement in the function of the extensor hallucis longus after surgical treatment of disc herniation and affection of the L5 nerve root, but the classification of the force ratios was only categorical and not absolute . FurtherAfter treatment, the patients showed a significant side-to-side-difference, which was not the case prior to the multimodal pain management. According to Lanshammer et al., normally existing side-to-side differences reoccur, which emphasizes the positive effect of the multimodal pain therapy . HoweverDespite lower basic strength values at the beginning of treatment, all investigated muscle groups, with the exception of the great toe extensors, showed a significant increase of overall strength after completion of the multimodal pain management concept. Increased overall strength could help with avoiding further need of medical care by supporting patients’ autonomy in daily life activities, as well as maintaining working abilities. Thus, to our best knowledge, the present study is the first to show a significant positive influence on lower limb strength in patients with low back pain after a conservative MPM program. Altough, our findings are of limited value (low level of evidence), and it is unknown whether these effects are sustained in the long term.


This study aims to compare the effectiveness of the two modes of 940 nm diode lasers on gingival depigmentation.  Twenty patients  participated in this study; they were free of any systemic or local condition and randomly assembled into two groups: continuous wave (CW) and pulsed groups, in contact modes. The diode laser was of 940 nm wavelength and 1-2 W irradiation power for the two modes in all cases. A single session of irradiation was applied to the facial gingivae of the upper and lower anterior segments. Photographs were taken preoperatively and postoperatively for all patients, and a questionnaire and follow-up were carried out for the next four weeks and after three years. p ≤ 0.05) was noticed during the first week of follow-up within each group. Nonetheless, the two groups showed a close pattern of decline with no statistically significant differences between them. It was also clear that pain and discomfort were strongly correlated with each other within each group, and the correlation was statistically significant. On the other hand, carbonization was minimal in a few cases treated with CW mode but still not statistically significant. Finally, although the gingival pigmentation index (GPI) differences were not statistically significant between the two groups, they were significant within each group.  The intraoperative duration of both modes was considerably short, with a short chair time subsequently. A statistically significant decrease in the intensity of pain, discomfort, and bleeding ( The diode laser (940 nm) offered an effective and safe modality, providing an optimal aesthetic result that can meet patient satisfaction with minimal pain, bleeding, discomfort, intraoperative time, and the possibility of recurrence in the treatment of gingival hyperpigmentation. Melanin is a brown pigment that appears as a result of melanin granules produced by melanocytes of the basal and suprabasal layers of the gingival epithelium , 2. It iThe management of gingival depigmentation involves different therapeutic approaches, among which the conventional scalpel technique, free gingival autograft or cellular dermal matrix allograft to conceal pigmented gingival, abrasion with a large round diamond bur, and lasers .Nowadays, the laser has been distinguished as the most effective, reliable, and comfortable technique for the ablation of cells that contain and produce melanin pigment. It is less invasive with minimum postoperative bleeding and pain when compared to the most commonly used conventional scalpel technique, in which several drawbacks were documented, such as healing by secondary intention, experiencing pain, discomfort, and unpleasant bleeding both intraoperatively and postoperatively, and a subsequent extended chair time added to the necessity of the periodontal pack protection and the delicate scar left at the surgical sites –7.Reduced mechanical trauma, postoperative pain, swelling, and scarring;Surgical site sterilization via bactericidal effects;Ability to coagulate, vaporize, and cut tissues;Dry surgical field as a result of homeostasis following diode laser irradiation that seals off the adjacent blood vessels in the surrounding tissue up to a diameter of 0.5 mm; andDecreased intraoperative time, all of which are helpful, particularly during the current circumstances of the COVID-19 pandemic. Whereas the most commonly encountered disadvantage of lasers is their relatively high cost , 8, 9.On the other hand, the laser technique has many advantages, among which are the following:2 lasers [The latest literature has documented evidence of successful depigmentation using diode lasers, and considered it as the best laser for soft tissue treatment due to the smaller size of the unit and lower cost if compared to other types of lasers, added to shallow tissue penetration that prevents deleterious effects to the teeth roots , 10–12. 2 lasers .This study compared the effectiveness of two different modes of 940 nm diode laser on gingival depigmentation since earlier studies have only compared different types and/or wavelengths of the same laser mode.The Human “Research Ethical Committee” at the College of Dentistry/University of Mustansiriyah/Baghdad, Iraq, approved the ethical standards in this study, in compliance with the Declaration of Helsinki, 1975. With a reference number (REC109).The study was conducted on 20 eligible patients who attended the College of the Dentistry/University of Mustansiriyah seeking aesthetic management of hyper-pigmented gingiva anteriorly and were willing to participate in the study.Participants were free from any systemic or local condition that might affect the healing process, such as autoimmune diseases, uncontrolled diabetes, smoking, pregnancy, or periodontal diseases. The consort flow chart of eligibility, allocation, and analysis is presented in Appendix .Written informed consent was obtained from all patients after explaining the procedure`s details and the study's purpose.The patient sample size was determined in accordance with previous studies , 16 and Operating staff and patients wore protective eyeglasses, particularly designed for diode lasers at 940 nm , to fulfill the FDA laser safety rules. Reflective instruments were not used during the surgical procedure to avoid laser beam reflection, and the area surrounding the surgical site was protected with sterile gauze. Treatment was achieved in a single session and was painless, as stated by the participants, with no need for any type of local anesthetic [The 940 nm wavelength diode laser was emitted in continuous mode for the CW group and in pulsed mode for the pulsed group by a 400 nm diameter flexible fiber optic hand-piece tip that is initiated with a special block, and the aiming beam was 625 nm. The power setting was gradually increased in both groups, from 1– 2 W, according to the operator's experience and manufacturer instructions.Laser ablation was achieved in a brushing or painting-like technique beginning from the mucogingival junction toward the free gingival margin, from the second premolar to the contralateral tooth of the jaw; whenever the interdental papilla was hyperpigmented it was also included in the ablation process.During the procedure, the epithelial remnants after laser ablation were removed with sterile gauze soaked in normal saline to enhance visualization and cool the tissue until the gingival surface appeared free of pigmentation. Thus, enough care was taken to lessen the laser's thermal side effects on the surgical site in order to avoid unnecessary tissue necrosis after laser application.The laser ablated the gingiva and gradually removed the pigment without any bleeding, though some bleeding may be noticed during the ablation. Consequently, no periodontal pack was needed.Some deep black or brown spots that do not disappear during the procedure were left to avoid overheating or bone exposure. At the end of the appointment, each patient was given a personal evaluation questionnaire to be answered for clinical analysis. Clinical photographs were taken during the preoperative, immediate postoperative, succeeding four weeks, and after 3 years of the surgery, as displayed in , a 10 cm horizontal, continuous interval scale with its left endpoint marked as “no pain” and its right endpoint marked as “severe pain.” The patients checked a mark to evaluate their postsurgical pain level on each day of the first week by answering a questionnaire specially designed for this research .  0 = No pain;  0.1–3.0 cm = Slight pain;  3.1–6.0 cm = Moderate pain;  6.1–10.0 cm = Severe pain.Scores of pain were measured as follows:A similar scale was used to evaluate the degree of patients' discomfort.Bleeding was assessed immediately after surgery and for the next two weeks. Bleeding scores were measured as follows: .A = None; B = Slight; C = Moderate; D = Severe.  0 = absence of pigmentation.  1 = spots of brown to black color or pigments.  2 = brown to black patches but not diffused pigmentation.  3 = diffused brown to black pigmentation, marginal, and attached.Melanin pigmentation in the oral cavity is classified differently according to its color degree, gingival position, and gingival color alteration . In thisThen, the GPI scores of the two groups were evaluated within the first month and after 3 years of the treatment to assess its effectiveness and adequacy to fulfill patients` satisfaction.U test was used to identify the statistical differences in GPI, operative duration, post-operative pain, discomfort, and bleeding between the two groups, whereas the Friedman test was used to explore the statistical differences of the same variables within each group, with a level of p ≤ 0.05 considered to be statistically significant. The Spearman correlation coefficient was applied to check the correlations of parameters to each other.Data analysis was performed using statistical software . Since it is nonparametric ordinal data, nonparametric tests were applied. Mann—Whitney In this study, twenty patients were evaluated, with their mean age ranges ± SD being 21 ± 4.7 years in the CW group versus 23 ± 3.9 years in the pulsed group. The demographic data are detailed in , with nop ≤ 0.79).A very slight difference was noticed between the two groups regarding mean operative duration ± SD. Results were 3.5 ± 1.6 minutes and 3.7 ± 1.7 minutes for CW and pulsed groups successively, which were not statistically significant as well .One patient in the CW group stated severe pain on the first day postoperatively, whereas five patients out of 10 (50%) complained of slight pain on the 1st and 2nd days, and by the 5th day, 100% of the CW group participants recorded no pain. However, in the pulsed group, 40% of patients (4 out of 10) had severe pain on the 1st day, and 70% of them had slight pain on the 2nd day, after which the percentage of patients feeling pain gradually decreased till it reached 10% at the end of the first week. Mann—Whitney layed in . This deIn the CW group, nearly half of the patients (40%) recorded mild discomfort on the first 3 days postoperatively, and all of them revealed no discomfort by the 7th day. Likewise, in the pulsed group, 40% of patients had mild discomfort on the 1st day, which increased to 60% on the next two days and then decreased to 20% by the end of the first week. Again, the differences between the two groups were statistically not significant. As shown in p ≤ 0.05).Yet, the decrease in discomfort sensation was statistically significant within each group throughout the first week (P ≤ 0.067), as shown in  successively. Where pain on the second day correlated strongly with that on the first day , this correlation was also true for discomfort on each pair of succeeding days, i.e., the 1st with the 2nd, the 3rd with the 4th, etc.An approximately similar statistically significant pattern of pain-discomfort correlations was observed in both CW and pulsed groups, for the first group; pain and discomfort of the first 2 days exhibited very strong positive correlation values  and a strong positive correlation for the 2nd with the 3rd, the 5th with the 6th, and the latter with the 7th days.Yet, for the pulsed group, pain on the 1st day was strongly related to discomfort on the first 3 days, and pain on days 2–4 was strongly and directly proportionate as well, whereas discomfort followed the same pattern as the CW group, with a very strong positive correlation at the 4th with 5th days . An exactly similar result was documented by Singh et al. in their 18-month of comparative observational period after depigmentation with diode laser and cryosurgery . It is aratively .2 laser gingival depigmentation [On the other hand, Nakamura et al. documented repigmentation in four out seven cases within two years of follow-up after COentation , whereasentation .To conclude, despite the limitations of this study, CW and pulsed modes of the 940 nm diode laser were observed to be equally effective and safe to enhance optimal aesthetic results and to reduce pain, discomfort, and bleeding, as well as the intraoperative duration of gingival depigmentation, with a lower possibility of recurrence over 3 years of follow-up, when compared to other types of lasers.