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Aims: Better documentation of vulvar pain is needed. We examined pain locations marked on general body and genital specific outlines among women with vulvodynia. Methods: 62 women (mean age 32.1 ± 9.5 years) with vulvodynia marked their pain on a digital genital specific outline (22 segments) and 59 of those women also marked their pain on a digital general body outline (48 segments). We used ImageJ software to determine body surface area (BSA) for each outline. Results: On the general body outline, 24/48 segments were marked; 22/22 segments were marked on the genital specific outline. There was a moderate correlation ( r = 0.43; p = 0.001) between the BSA marked on the general body outline and the BSA marked on the genital area outline. Conclusions: Findings support concurrent validity of the BSA as a measure of pain location using either outline.

To gain a deeper understanding of RNs communication related to patient safety.To determine: (1) the associations between the communication of registered nurses (RNs) within their health care teams and the frequency that they reported safety events; (2) the associations between RNs' communication within their health care teams and their perceptions of safety within the hospital unit; and (3) whether RNs' communication had improved from 2016 to 2018.We used the United Kingdom's Safety Culture model as the theoretical framework for this study. Our secondary data analysis from the Agency for Healthcare Research and Quality's Hospital Survey on Patient Safety Culture included 2016 (n = 5298) and 2018 (n = 3476) using multiple regression models to determine associations between responses for Communication Openness and FeedbackCommunication About Error, and outcome responses for Frequency of Events Reported and Overall Perceptions of Safety.Our findings were: 1). In both 2016 and 2018 datasets, Feedback About Error had a greater impact on Reporting Frequency than Open Communication; 2). Feedback About Error had a greater impact on Safety Perceptions than Open Communication; 3). Open Communication and Feedback About Error and their associations with Reporting Frequency and Safety Perceptions showed little change; and, 4). The proportion of variance was low, indicating factors other than Open Communication and Feedback About Error were involved with Reporting Frequency and Safety Perceptions.Pediatric RNs' communication, reporting, and perceptions of patient safety have not improved. (245 words).

Introduction: Acupuncture has demonstrated effectiveness for symptom management among breast cancer survivors. This meta-analysis aims to evaluate the effect of acupuncture on treatment-related symptoms among breast cancer survivors. Methods: The authors searched PubMed, CINAHL, and EMBASE for relevant randomized clinical trials (RCTs) of acupuncture for managing treatment-related symptoms published in English through June 2021. They appraised the quality of each article using the Cochrane Collaboration Risk of Bias Criteria. The primary outcomes were pain, hot flashes, sleep disturbance, fatigue, depression, lymphedema, and neuropathy as individual symptoms. They also evaluated adverse events reported in acupuncture studies. Results: Of 26 selected trials (2055 patients), 20 (1709 patients) were included in the meta-analysis. Acupuncture was more effective than control groups in improving pain intensity [standardized mean difference (SMD) = −0.60, 95% confidence intervals (CI) −1.06 to −0.15], fatigue [SMD = −0.62, 95% CI −1.03 to −0.20], and hot flash severity [SMD = −0.52, 95% CI −0.82 to −0.22]. The subgroup analysis indicated that acupuncture showed trends but not significant effects on all the treatment-related symptoms compared with the sham acupuncture groups. Compared with waitlist control and usual care groups, the acupuncture groups showed significant reductions in pain intensity, fatigue, depression, hot flash severity, and neuropathy. No serious adverse events were reported related to acupuncture intervention. Mild adverse events (i.e., bruising, pain, swelling, skin infection, hematoma, headache, menstrual bleeding) were reported in 11 studies. Conclusion: This systematic review and meta-analysis suggest that acupuncture significantly reduces multiple treatment-related symptoms compared with the usual care or waitlist control group among breast cancer survivors. The safety of acupuncture was inadequately reported in the included studies. Based on the available data, acupuncture seems to be generally a safe treatment with some mild adverse events. These findings provide evidence-based recommendations for incorporating acupuncture into clinical breast cancer symptom management. Due to the high risk of bias and blinding issues in some RCTs, more rigorous trials are needed to confirm the efficacy of acupuncture in reducing multiple treatment-related symptoms among breast cancer survivors.

Objective We identified challenges and solutions to using electronic health record (EHR) systems for the design and conduct of pragmatic research. Materials and Methods Since 2012, the Health Care Systems Research Collaboratory has served as the resource coordinating center for 21 pragmatic clinical trial demonstration projects. The EHR Core working group invited these demonstration projects to complete a written semistructured survey and used an inductive approach to review responses and identify EHR-related challenges and suggested EHR enhancements. Results We received survey responses from 20 projects and identified 21 challenges that fell into 6 broad themes: (1) inadequate collection of patient-reported outcome data, (2) lack of structured data collection, (3) data standardization, (4) resources to support customization of EHRs, (5) difficulties aggregating data across sites, and (6) accessing EHR data. Discussion Based on these findings, we formulated 6 prerequisites for PCTs that would enable the conduct of pragmatic research: (1) integrate the collection of patient-centered data into EHR systems, (2) facilitate structured research data collection by leveraging standard EHR functions, usable interfaces, and standard workflows, (3) support the creation of high-quality research data by using standards, (4) ensure adequate IT staff to support embedded research, (5) create aggregate, multidata type resources for multisite trials, and (6) create re-usable and automated queries. Conclusion We are hopeful our collection of specific EHR challenges and research needs will drive health system leaders, policymakers, and EHR designers to support these suggestions to improve our national capacity for generating real-world evidence.

Objective Approximately 24–68% of breast cancer survivors report co-occurring psychoneurological symptoms of pain, fatigue, sleep disturbance, depression, and anxiety during and after cancer treatment. This study aimed to assess the feasibility and acceptability of acupuncture for the treatment of multiple psychoneurological symptoms among breast cancer survivors and explore metabolomic changes before and after acupuncture. Methods We conducted a single-arm, prospective pilot study of breast cancer survivors with at least two moderate to severe psychoneurological symptoms (>3 on a 0–10 scale). Acupuncture was administered twice weekly for 5 weeks, for 30 minutes per session. Along with Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaires, a fasting serum comprehensive hydrophilic metabolites panel was analyzed at baseline and after acupuncture. Results Eight participants (mean age 52.5 ± 10.9 years; 62.5% Black) were enrolled. Feasibility was supported, with 67% recruitment, 87.5% retention, and 98% acceptability. Post intervention, PROMIS T-scores were reduced for all psychoneurological symptoms. Significant differences in serum metabolites before and after acupuncture were F-1,6/2,6-DP, glutathione disulfide, phosphorylcholine, 6-methylnicotinamide, glutathione, and putrescine (variable importance of projection values larger than 1.5 and p values Conclusions Acupuncture to reduce multiple psychoneurological symptoms among breast cancer survivors was feasible and acceptable. Study findings also shed light on the metabolic pathways involved in the acupuncture response and will be tested in future studies.

Vulvodynia affects 7% of American women, yet clinicians often lack awareness of its presentation. It is underdiagnosed and often misdiagnosed as vaginitis. The etiology of vulvodynia remains unknown, making it difficult to identify or develop effective treatment methods. The purpose of this article is to (1) review the presentation and evaluation of vulvodynia, (2) review the research on vulvodynia treatments, and (3) aid the clinician in the selection of vulvodynia treatment methods. The level of evidence to support vulvodynia treatment varies from case series to randomized controlled trials (RCTs). Oral desipramine with 5% lidocaine cream, intravaginal diazepam tablets with intravaginal transcutaneous electric nerve stimulation (TENS), botulinum toxin type A 50 units, enoxaparin sodium subcutaneous injections, intravaginal TENS (as a single therapy), multimodal physical therapy, overnight 5% lidocaine ointment, and acupuncture had the highest level of evidence with at least one RCT or comparative effectiveness trial. Pre to posttest reduction in vulvar pain and/or dyspareunia in non-RCT studies included studies of gabapentin cream, amitriptyline cream, amitriptyline with baclofen cream, up to 6 weeks' oral itraconazole therapy, multimodal physical therapy, vaginal dilators, electromyography biofeedback, hypnotherapy, cognitive behavioral therapy, cold knife vestibulectomy, and laser therapy. There is a lack of rigorous RCTs with large sample sizes for the treatment of vulvodynia, rendering it difficult to determine efficacy of most treatment methods. Clinicians will be guided in the selection of best treatments for vulvodynia that have the highest level of evidence and are least invasive.

Objective: Chronic pain is a common symptom experienced among patients with sickle cell disease (SCD). Our aims were to assess the feasibility and acceptability of performing acupuncture for the treatment of chronic pain in adults with SCD. Methods: This was a single-arm, prospective pilot study of six adults with SCD. Participants reported ⩾ 3 months of chronic pain and were > 18 years of age. Per protocol, acupuncture was to be administered twice per week for 5 weeks, for 30 min per session. All treatments were performed in the acupuncture treatment laboratory at the University of Illinois Chicago College of Nursing. Pain intensity, pain interference, and other symptoms were measured at baseline and after the intervention. Participants completed a semi-structured interview and a protocol acceptability questionnaire after the acupuncture intervention. Results: Six participants (mean age 52.5 years, six Black) were enrolled. Although the study was suspended due to COVID-19 and not all participants completed the 10-session protocol, completion rates were high with no missed appointments. One participant did not complete the study due to hospitalization unrelated to acupuncture. No adverse events were reported. At completion of the intervention at 4–5 weeks post-baseline, all participants had reduced pain intensity and pain interference. The mean acceptability score on the protocol acceptability questionnaire was 82%. Conclusion: It was feasible and acceptable to implement acupuncture in adults with SCD. This study can be used to guide a larger randomized controlled trial to evaluate the effect of acupuncture on reducing chronic pain in adults with SCD. Trial registration number: NCT04156399 (ClinicalTrials.gov)

Among breast cancer survivors, pain, fatigue, depression, anxiety, and sleep disturbance are common psychoneurological symptoms that cluster together. Inflammation-induced activation of the tryptophan-kynurenine metabolomic pathway may play an important role in these symptoms.This study investigated the relationship between the metabolites involved in the tryptophan-kynurenine pathway and psychoneurological symptoms among breast cancer survivors.Cross-sectional study.Participants were recruited at the oncology clinic at the University of Illinois HospitalHealth Sciences System.79 breast cancer survivors after major cancer treatment.We assessed psychoneurological symptoms with the PROMIS-29 and collected metabolites from fasting blood among breast cancer survivors after major cancer treatment, then analyzed four major metabolites involved in the tryptophankynurenine pathway (tryptophan, kynurenine, kynurenic acid, and quinolinic acid). Latent profile analysis identified subgroups based on the five psychoneurological symptoms. Mann-Whitney U tests and multivariable logistic regression compared targeted metabolites between subgroups.We identified two distinct symptom subgroups (low, 81%; high, 19%). Compared with participants in the low symptom subgroup, patients in the high symptom subgroup had higher BMI (p = .024) and were currently using antidepressants (p = .008). Using multivariable analysis, lower tryptophan levels (p = .019) and higher kynurenine/tryptophan ratio (p = .028) were associated with increased risk of being in the high symptom subgroup after adjusting for BMI and antidepressant status.The tryptophan-kynurenine pathway and impaired tryptophan availability may contribute to the development of psychoneurological symptoms.

Purpose: Stable angina is ischemic chest pain on exertion or with emotional stress. Despite guideline-directed therapy, up to 30% of patients have suboptimal pain relief. The aims of this study were to: (1) determine the feasibility and acceptability of a randomized controlled trial (RCT) of acupuncture; and (2) evaluate preliminary efficacy of acupuncture with respect to reduction of pain and increased functional status and health-related quality of life (HRQoL). Methods: Participants with stable angina for ⩾1 month received either a standardized acupuncture protocol, twice per week for 5 weeks, or an attention control protocol. Measures included the McGill Pain Questionnaire (average pain intensity (API), pain now) and the Seattle Angina Questionnaire–7 (functional status, symptoms, and HRQoL). Feasibility was defined as ⩾80% recruitment, ⩾75% retention following enrollment, and ⩾80% completion. Descriptive statistics and mixed-effects linear regression were used for analysis. Results: The sample (n = 24) had a mean age of 59 ± 12 years, was predominantly female (63%), and represented minority groups (8% White, 52% Black, 33% Hispanic, and 8% Other). Feasibility was supported by 79% retention and 89% completion rates. The recruitment rate (68%) was slightly lower than expected. Acceptability scores were 87.9% for the acupuncture group and 51.7% for the control group. Outcomes were significantly better for the acupuncture versus control groups (API, b = −2.1 (1.1), p = 0.047; functional status, b = 27.6 (7.2), p Conclusions and implications: Acupuncture was feasible and acceptable in our diverse sample. We were slightly under the recruitment target of 80%, but participants who started the study had a high likelihood of completing it. Acupuncture shows promise for stable angina, but its effectiveness needs to be confirmed by a larger, adequately powered RCT. Trial registration number: NCT02914834 (ClinicalTrials.gov).

BackgroundClinical trial articles often lack detailed descriptions of the methods used to randomize participants, conceal allocation, and blind subjects and investigators to group assignment. We describe our systematic approach to implement and measure blinding success in a double-blind phase 2 randomized controlled trial testing the efficacy of acupuncture for the treatment of vulvodynia.MethodsRandomization stratified by vulvodynia subtype is managed by Research Electronic Data Capture software’s randomization module adapted to achieve complete masking of group allocation. Subject and acupuncturist blinding assessments are conducted multiple times to identify possible correlates of unblinding.ResultsAt present, 48 subjects have been randomized and completed the protocol resulting in 87 subject and 206 acupuncturist blinding assessments.DiscussionOur approach to blinding and blinding assessment has the potential to improve our understanding of unblinding over time in the presence of possible clinical improvement.

Supplemental Digital Content is Available in the Text., Objectives: To evaluate self-reported sensory pain scores of women with generalized vulvodynia (GV) and provoked vestibulodynia (PVD), characterize pain phenotypes, and assess feasibility of using the Internet for recruitment and data collection among women with vulvodynia. Methods: Descriptive online survey. Data collected using an online survey accessed via a link on the National Vulvodynia Association web site. Convenience sample, 60 women aged 18 to 45 years (mean = 32.7 ± 5.5); 50 white, 2 black/African American, 4 Hispanic/Latino, and 4 Native American/Alaskan Native, diagnosed with vulvodynia, not in menopause. Pain assessment and medication modules from PAINReportlt. Results: Women with GV (n = 35) compared to PVD (n = 25). Estimated mean pain sites (2.5 ± 1.4 vs 2.2 ± 1.0, P = 0.31), mean current pain (8.7 ± 1.4 vs 5.5 ± 4.0, P = 0.0008), worst pain (8.1 ± 1.8 vs 6.1 ± 3.6, P = 0.02), and least pain in the past 24 hours (4.4 ± 1.8 vs 2.0 ± 2.0, P < 0.0001). Average pain intensity (7.1 ± 1.2 vs 4.6 ± 2.9, P = 0.0003) on a scale of 0 to 10, mean number of neuropathic words (8.3 ± 3.6 vs 7.7 ± 5.0), and mean number of nociceptive words (6.9 ± 4 vs 7.5 ± 4.4). Nineteen (54%) women with GV compared to 9 (38%) with PVD were not satisfied with pain levels. Conclusion: Women with GV reported severe pain, whereas those with PVD reported moderate to severe pain. Pain quality descriptors may aid a clinician's decisions about whether to prescribe adjuvant drugs vs opioids to women with vulvodynia.

Having a history of a previous spontaneous preterm birth (sPTB) is the strongest risk factor for recurrent sPTB. It is unknown if there are differences in postpartum cervical remodeling between women who have delivered spontaneous preterm (sPT) and full-term. No studies have evaluated the role of postpartum remodeling between the two groups. Quantitative ultrasound (QUS) is a noninvasive ultrasound technology used to quantify tissue microstructure and function. QUS biomarkers were used to evaluate postpartum cervical microstructure in women who delivered sPT and full-term. Data were collected from 54 women:14 who delivered sPT and 40 who delivered full-term. Transvaginal QUS scans were performed at 6 weeks (±2 weeks) after delivery. Attenuation coefficient (AC), backscatter coefficient (BSC), and shear wave speed (SWS) QUS biomarkers were collected. BSC was significantly higher at six weeks postpartum in women who delivered sPT versus full-term (p = 0.01), while the AC approached statistical significance (p = 0.09). QUS biomarker BSC was able to identify cervical microstructure differences at six weeks postpartum between women who delivered sPT and full-term. QUS technology may improve our understanding of postpartum cervical remodeling and has the potential to noninvasively direct precision-health approaches for recurrent sPTB. [Work supported by NIH 5F31NR019716.]

Vulvodynia is debilitating vulvar pain accompanied by dyspareunia (pain with sexual intercourse). Ehlers-Danlos syndromes (EDS) and hypermobility spectrum disorders (HSD) may represent a predisposing factor for vulvodynia given a high rate of dyspareunia in these conditions. We conducted an online survey of women with EDS or HSD to assess rates of dyspareunia and estimate rates of vulvodynia, report rates of comorbid conditions common to EDS or HSD and vulvodynia, and examine rates of conditions contributing to dyspareunia in women with EDS or HSD. Women with EDS or HSD (N = 1,146) recruited via social media were 38.2 ± 11.5 years old, primarily White (94.4%), and resided in the United States (78.5%). 63.7% of participants reported dyspareunia and 50% screened positive for vulvodynia. The rate of comorbid conditions common to EDS or HSD and vulvodynia were: irritable bowel syndrome, 6.5%; fibromyalgia, 40.0%; temporomandibular joint dysfunction, 56.4%; migraine, 6.7%; interstitial cystitis, 1.7%; and mast cell activation syndrome, 10.2%. Participants reporting dyspareunia also reported ovarian cysts, fibroids, or abdominal or pelvic scars, 47.5%; endometriosis, 26.5%; and genital lacerations, 19.3%. Women with EDS or HSD may have a higher rate of vulvodynia (50.0%) than women in the U.S. population at large (8%) and should be assessed for dyspareunia and vulvodynia.

Patients often tell others about their pain using their own verbal descriptors of pain intensity, but the meaning of this pain language is not universally evident, which could contribute to misinterpretation about pain severity. The study purpose was to discover the intensity values of verbal pain intensity descriptors. The 248 randomly selected inpatients used a visual analogue scale to assign a value to each of 26 pain intensity descriptors. Each participant completed 36 randomly ordered visual analogue scales, 10 of which were replications. Except for descriptors with medians close to 0 or 100 mm, there was large, across-person variability for the descriptors. For example, medians ± SD for some exemplar descriptors were no pain 0.7 ± 2.4; mild 16.2 ± 12.2; discomforting 31.3 ± 22.2; distressing 55.3 ± 24; horrible 87.8 ± 13.6; and excruciating 94.6 ± 9.3. Test-retest reliability indicated small within-person variability on scores assigned to each descriptor. Thirteen descriptors showed some statistically significant but rather small effects of presentation order. Findings contribute estimates for the magnitude of pain represented by each of the 26 descriptors. Clinicians, text data miners, and researchers should consider these values as they interpret the meaning of the descriptors that they hear in daily practice or research settings or that they find in electronic health records, email messages, or social media posts. Despite the wide variability in the magnitude of each descriptor, findings provide insights about the intensity of pain when individuals use verbal pain intensity descriptors in conversations, social media, or clinical encounters.

Objectives: Sickle cell disease (SCD) is a serious illness with disabling acute and chronic pain that needs better therapies, but insufficient patient participation in research is a major impediment to advancing SCD pain management. The purpose of this article is to discuss the challenges of conducting an SCD study and approaches to successfully overcoming those challenges. Design: In a repeated-measures, longitudinal study designed to characterize SCD pain phenotypes, we recruited 311 adults of African ancestry. Adults with SCD completed 4 study visits 6 months apart, and age- and gender-matched healthy controls completed 1 visit. Results: We recruited and completed measures on 186 patients with SCD and 125 healthy controls. We retained 151 patients with SCD with data at 4 time points over 18 months and 125 healthy controls (1 time point) but encountered many challenges in recruitment and study visit completion. Enrollment delays often arose from patients’ difficulty in taking time from their complicated lives and frequent pain episodes. Once scheduled, participants with SCD cancelled 49% of visits often because of pain; controls canceled 30% of their scheduled visits. To facilitate recruitment and retention, we implemented a number of strategies that were invaluable in our success. Conclusion: Patients’ struggles with illness, chronic pain, and their life situations resulted in many challenges to recruitment and completion of study visits. Important to overcoming challenges was gaining the trust of patients with SCD and a participant-centered approach. Early identification of potential problems allowed strategies to be instituted proactively, leading to success.

Purpose Only a few studies have reported quantitative sensory testing (QST) reference values for healthy African Americans, and those studies are limited in sample size and age of participants. The study purpose was to characterize QST values in healthy, pain-free African American adults and older adults whose prior pain experiences and psychological status were also measured. We examined the QST values for differences by sex, age, and body test site. Patients and methods A cross-sectional sample of 124 pain-free African American adults (age 18-69 years, 49% female) completed demographic and self-reported pain, fatigue and psychosocial measures. QST was performed to obtain thermal and mechanical responses and associated pain intensity levels. Results We found thermal detection values at the anterior forearm were (29.2 °C±1.6) for cool detection (CD) and (34.5 °C±1.2) for warm detection (WD). At that site the sample had cold pain threshold (CPTh) (26.3 °C±5.0), heat pain threshold (HPTh) (37.8 °C±3.6), and mechanical pain thresholds (MPTH) (16.7±22.2 grams of force, gF). There was a significant between sex difference for WD, with women being more sensitive (q=0.027). Lower body sites were less sensitive than upper body sites across all thermal modalities (q

Background Chronic pain in adults with sickle cell disease (SCD) may be the result of altered processing in the central nervous system, as indicated by quantitative sensory testing (QST). Sensory pain quality descriptors on the McGill Pain Questionnaire (MPQ) are indicators of typical or altered pain mechanisms but have not been validated with QST-derived classifications. Objectives The specific aim of this study was to identify the sensory pain quality descriptors that are associated with the QST-derived normal or sensitized classifications. We expected to find that sets of sensory pain quality descriptors would discriminate the classifications. Methods A cross-sectional quantitative study of existing data from 186 adults of African ancestry with SCD. Variables included MPQ descriptors, patient demographic data, and QST-derived classifications. Results The participants were classified as central sensitization (n = 33), mixed sensitization (n = 23), and normal sensation. Sensory pain quality descriptors that differed statistically between mixed sensitization and central sensation compared to normal sensitization included cold (p = .01) and spreading (p = .01). Aching (p = .01) and throbbing (p = .01) differed statistically between central sensitization compared with mixed sensitization and normal sensation. Beating (p = .01) differed statistically between mixed sensitization compared with central sensitization and normal sensation. No set of sensory pain quality descriptors differed statistically between QST classifications. Discussion Our study is the first to examine the association between MPQ sensory pain quality descriptors and QST-derived classifications in adults with SCD. Our findings provide the basis for the development of a MPQ subscale with potential as a mechanism-based screening tool for neuropathic pain.

Background Women with vulvodynia, a chronic pain condition, experience vulvar pain and dyspareunia. Few studies examine the range and combination of treatment strategies that women are actually using to reduce vulvodynia. Aim To describe pain experiences and pain relief strategies of women with vulvodynia. Methods Convenience sample, 60 women with vulvodynia (median age 32.5 [interquartile range {IQR} 8.5] years; 50 white, 10 racial/ethnic minorities) completed PAINReportIt and reported use of drugs and alcohol and responded to open-ended questions. Univariate descriptive statistics and bivariate inferential tests were used to describe average pain intensity scores, alcohol use, smoking, number of pain relief strategies, and their associations. Women’s open-ended responses about their pain experiences and drug and non-drug pain relief strategies (NDPRS) were analyzed for patterns. Outcomes Our mixed methods analysis connected data from pain measures, prescribed treatments and self-reported behaviors with women’s free responses. This enabled nuanced insights into women’s vulvodynia pain experiences. Results Women’s descriptions of their pain and suffering aligned with their reported severe pain and attempts to control their pain, with a median pain intensity of 6.7 (IQR 2.0) despite use of adjuvant drugs (median 2.0 [IQR 2.0]), and opioids (median 1.0 [IQR 2.0]). 36 women (60%) used alcohol to lessen their pain. 26 women (43%) listed combining analgesics and alcohol to relieve their pain. 30 women (50%) smoked cigarettes. 54 women (90%) used ≥1 NDPRS. The mean number of NDPRS used was 2.1 ± 1.3 (range 0–6). The 5 most common NDPRS from women’s comments were herbal medicine (40%), acupuncture (27%), massage (22%), hypnosis (15%), and mental healthcare (13%). Clinical Implications Severe pain in women with vulvodynia may be a clinical indicator of those at higher risk of combining prescription pain medications with alcohol, which are all central nervous system depressants and may potentiate overdose. Strengths and Limitations This pilot study demonstrated that the mixed methods approach to help understand the complexity of vulvodynia was feasible. We identified data showing a reliance on a high-risk mix of prescriptions and alcohol to reduce vulvodynia pain and a high prevalence of cigarette smoking. However, as a pilot study, these results are considered preliminary; the sample may not be representative. Perhaps only women at the extreme end of the pain continuum participated, or women took the survey twice because identifiers were not collected. Conclusion Despite attempts to reduce pain using multiple therapies, including alcohol, women’s vulvodynia pain is severe and not controlled.

CONTEXT: It’s difficult to conduct experiments using a double-blind design in controlled clinical trials of acupuncture. To resolve this problem with blinding, we designed double-blind needles (DBNs) with stuffing to mimic the resistance felt during insertion of a regular acupuncture needle. Results of the past studies using 0.16-mm-diameter DBNs found that the resistance felt by the acupuncturists during insertion successfully blinded them. OBJECTIVE: The study intended to compare the effects on an acupuncturist’s blinding when the practitioner used penetrating DBNs with 0.14, 0.16, 0.18, and 0.20 mm diameters. DESIGN: We conducted a double-blind randomized trial. SETTING: The study took place at the Japan School of Acupuncture, Moxibustion. and Physiotherapy in Tokyo, Japan. PARTICIPANTS: The participant was one licensed acupuncturist who performed 320 needle insertions during acupuncture for 20 healthy students, who were familiar with acupuncture and who attended the Japan School of Acupuncture, Moxibustion, and Physiotherapy. METHODS: The acupuncturist was informed she would administer a penetrating or non-penetrating needle; however, only penetrating needles were used. She inserted the four sizes of needles in both of each student’s dorsal forearms using an alternating twirling technique. This procedure was repeated once more on another day, with at least one day between sessions. PRIMARY OUTCOME MEASURES: After the acupuncturist removed each needle, we asked her to guess: (1) the type of needle inserted, (2) her level of confidence in the guess, and (3) the clues that contributed to her guess. A chi-squared test was used to determine whether the ratio of correctly or incorrectly identified needles met an expected probability of 0.5 for each needle diameter. RESULTS: Of the 320 needle insertions, the acupuncturist correctly identified 54% of 0.14 mm, 45% of 0.16 mm, 46% of 0.18 mm, and 50% of 0.20 mm needle insertions. The correct and incorrect ratios of identified needles were fitted with a probability of 0.5, with no significant differences in the acupuncturist’s confidence (p=0.16). In 99% of the tests, the cue that contributed to the acupuncturist’s guess was the feeling of the needle insertion. CONCLUSION: These findings indicate that the differences in the diameters of DBNs from 0.14 to 0.20 mm didn’t significantly affect the acupuncturist’s blinding.

Sickle cell disease (SCD) pain may have a neuropathic component. Adjuvant drugs used to treat neuropathic pain have not been studied for the treatment of adults with SCD. To determine the safety and feasibility of using pregabalin for chronic SCD pain. A randomized, controlled, double-blind pilot study. Based on random assignment, participants were treated with pregabalin or placebo control for 3 months with monthly follow-up visits. Participants were recruited from the University of Illinois Hospital and Health Sciences System outpatient SCD clinic. Participants/Subjects: A total of 22 participants with SCD (21 African American, 1 other) were included 16 women aged 18-82 (mean age 33.1 ± 9.9). PAINReportIt, Leeds Assessment of Neuropathic Signs and Symptoms, Neuropathic Pain Symptom Inventory, and Short Form 36 Health Survey were completed. Adverse effects were minimal. Mean scores for average pain intensity, composite pain index, and neuropathic pain revealed a reduction for pregabalin and placebo control groups. Although the between-group differences were not significant, sustained reduction in pain over time within the pregabalin group indicated promising effects of pregabalin for SCD pain. Mean quality-of-life scores increased slightly over time (representing better quality of life) in 7 of 8 domains for the pregabalin group and decreased in 4 of 8 domains for the placebo control group. Small sample size made it difficult to interpret quality-of-life findings. This pilot study provided sufficient evidence that further investigation of pregabalin's potential efficacy for treatment of chronic SCD pain in adults is warranted.

Purpose: Describe perceptions of patients with rheumatoid arthritis (RA) regarding disease-related pain, tendency to tell others about their pain, and treatments used since diagnosis. Design: Cross sectional, exploratory. Method: A total of 63 participants responded to telephone interview about their treatments and tendency to tell others about their RA pain. They also responded to McGill Pain Questionnaire and Health Assessment Questionnaire (HAQ) items. Participants marked pain location on mailed body outlines. Findings: RA diagnosis occurred an average of 11 years prior. Mean HAQ Standard Disability Index score was 1.26. Previous week symptoms were joint pain (97%), joint swelling (83%), decreased movement/function (83%), fatigue (70%), muscle weakness (65%). Mean morning stiffness duration was 120 ± 137 minutes. Mean pain intensity was 1.15 ± 0.6 at its least and 3.8 ± 1.1 at its worst. 65% were not satisfied with pain levels. 57% stated a tendency not to tell others about their pain; 43% tended to tell. 78% used medications and alternative therapies, none solely used alternative therapies, and 22% only used medications. Conclusions: RA patients reported high rates of alternative therapy use. Dissatisfaction with pain levels indicates need for improved pain management. Not talking about pain lends insights into the importance of teaching patients to communicate their pain to others.

Background: We assessed history of adverse pregnancy outcomes (APOs) and coronary microvascular dysfunction (CMD) in the Women's Ischemia Syndrome Evaluation—Coronary Vascular Dysfunction (WISE-CVD) cohort of women with signs and symptoms of ischemia without obstructive coronary artery disease (CAD). We hypothesized that women with CMD with symptoms and signs of ischemia, without obstructive CAD, are more likely to have a history of APO. Materials and Methods: WISE-CVD recruited women with suspected ischemia found to have no obstructive CAD (n = 324). A subset of these women underwent coronary reactivity testing, including coronary flow reserve (CFR) (n = 185). Relationship between history of any APO and CMD was assessed by multivariable linear regression analyses. APOs included any of the following: hypertension during pregnancy, preeclampsia, eclampsia, gestational diabetes, or intrauterine growth restriction (low-birth-weight child). Results: Overall, 79/324 (24%) women reported at least one APO. Women with APOs were younger (52 vs. 56 years, p = 0.001), were more likely obese (body mass index 32 vs. 29 kg/m(2), p = 0.004), and had a history of hypertension (56% vs 36%, p = 0.002), but otherwise had no additional differences in cardiac risk variables versus women without APOs. Among the subgroup who underwent invasive CFR testing (n = 185), those with an APO had lower CFR (2.53 vs. 2.76, p = 0.016) versus those without APO. Conclusions: History of APOs in women with signs and symptoms of ischemia without obstructive CAD is associated with lower CFR indicative of CMD. Whether common pathways involving diffuse microvascular dysfunction may account for this suggested association remains unclear. Further investigation is needed to expand on these exploratory findings.

Keesha L Powell-Roach,1 Yingwei Yao,2 Julienne N Rutherford,3 Judith M Schlaeger,3 Crystal L Patil,3 Marie L Suarez,4 David Shuey,4 Veronica Angulo,4 Jesus Carrasco,4 Miriam O Ezenwa,2 Roger B Fillingim,1 Zaijie J Wang,5 Robert E Molokie,5–7 Diana J Wilkie1,21Department of Community Dentistry and Behavioral Science, College of Dentistry, University of Florida, Gainesville, FL, USA; 2Department of Biobehavioral Nursing Science, College of Nursing, University of Florida, Gainesville, FL, USA; 3Department of Women, Children and Family Health Science, College of Nursing, University of Illinois at Chicago, Chicago, IL, USA; 4Department of Biobehavioral Health Science, College of Nursing, University of Illinois at Chicago, Chicago, IL, USA; 5Department of Biopharmaceutical Sciences, College of Pharmacy, Cancer Center, University of Illinois at Chicago, Chicago, IL, USA; 6Division of Hematology/Oncology, University of Illinois at Chicago College of Medicine, Chicago, IL, USA; 7Department of Hematology/Oncology, Jessie Brown Veteran’s Administration Medical Center, Chicago, IL, USAPurpose: Only a few studies have reported quantitative sensory testing (QST) reference values for healthy African Americans, and those studies are limited in sample size and age of participants. The study purpose was to characterize QST values in healthy, pain-free African American adults and older adults whose prior pain experiences and psychological status were also measured. We examined the QST values for differences by sex, age, and body test site.Patients and methods: A cross-sectional sample of 124 pain-free African American adults (age 18–69years, 49% female) completed demographic and self-reported pain, fatigue and psychosocial measures. QST was performed to obtain thermal and mechanical responses and associated pain intensity levels.Results: We found thermal detection values at the anterior forearm were (29.2°C±1.6) for cool detection (CD) and (34.5°C±1.2) for warm detection (WD). At that site the sample had cold pain threshold (CPTh) (26.3°C±5.0), heat pain threshold (HPTh) (37.8°C±3.6), and mechanical pain thresholds (MPTH) (16.7±22.2grams of force, gF). There was a significant between sex difference for WD, with women being more sensitive (q=0.027). Lower body sites were less sensitive than upper body sites across all thermal modalities (q

Evidence supports, but is inconclusive that sensitization contributes to chronic pain in some adults with sickle cell disease (SCD). We determined the prevalence of pain sensitization among adults with SCD pain compared with pain-free healthy adults. In a cross sectional, single session study of 186 African American outpatients with SCD pain (age 18–74 years, 59% female) and 124 healthy age, gender, and race matched control subjects (age 18–69 years, 49% female), we compared responses to standard thermal (Medoc TSA II) and mechanical stimuli (von Frey filaments). Although we observed no significant differences in thermal thresholds between controls and patients, patients with SCD had lower pain thresholds to mechanical stimuli and reported higher pain intensity scores to all thermal and mechanical stimuli at a non-painful body site. Compared with controls, about twice as many patients with SCD showed sensitization: 12% versus 23% at the anterior forearm site (P = .02), and 16% versus 32% across 3 tested sites (P = .004). Among patients with SCD, 18% exhibited some element of central sensitization. Findings indicate that persistent allodynia and hyperalgesia can be part of the SCD pain experience and should be considered when selecting therapies for SCD pain. Perspective Compared with matched healthy controls, quantitative sensory testing in adults with pain and sickle cell disease (SCD) demonstrates higher prevalence of sensitization, including central sensitization. The findings of allodynia and hyperalgesia may indicate neuropathic pain and could contribute to a paradigm shift in assessment and treatment of SCD pain.

BackgroundAcupuncture has demonstrated physiologic analgesic effects in Chinese patients with stable angina. One proposed mechanism of action for these analgesic effects is the downregulation of M1 macrophages, interleukin 1 beta, interleukin-6, interleukin-18, and tumor necrosis factor alpha.ObjectiveThis study aims to test a 10-session, 5-week acupuncture treatment protocol as a complementary therapy for symptoms of stable angina for American patients, who vary from Chinese patients in health care systems and other salient variables.MethodsWe are conducting a randomized controlled trial (RCT) of 69 adults (35 assigned to initial acupuncture and 34 to an attention control condition) with a medically confirmed diagnosis of stable angina, whose pain and associated symptoms have not been controlled to their satisfaction with guideline-directed medical management. Participants in the experimental group will receive a standardized traditional Chinese medicine point prescription. The attention control group will view non–pain-related health education videos over 5 weeks equal to the 10 hours of treatment for the acupuncture group. Participants will complete the McGill Pain Questionnaire and the Seattle Angina Questionnaire-7, as well as have inflammatory cytokines measured at baseline and study completion. The primary outcomes are anginal pain and quality of life.ResultsThis study has been funded over 2 years by the National Institutes of Health, National Institute for Nursing Research. We are currently recruiting and expect to have initial results by December 2020.ConclusionsWe will generate data on feasibility, acceptability, effect sizes, and protocol revisions for a future fully powered RCT of the protocol. Findings will help determine if patients with persistent ischemic symptoms experience a proinflammatory state and hyperalgesia caused by multiple neural and immune processes not always relieved with medication.International Registered Report Identifier (IRRID)DERR1-10.2196/14705

BACKGROUND We sought to refine a screening measure for discriminating a sensitized or normal sensation pain phenotype among African American adults with sickle cell disease (SCD). OBJECTIVE To develop scoring schemes based on sensory pain quality descriptors; evaluate their performance on classifying patients with SCD who had sensitization or normal sensation, and compare with scores on the Self-report Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS) and the Neuropathic Pain Symptom Inventory (NPSI). METHODS Participants completed PAINReportIt, quantitative sensory testing (QST), S-LANSS, and NPSI. Conventional binary logistic regression and least absolute shrinkage and selection operator (lasso) regression were used to obtain 2 sets of weights resulting in 2 scores: the PR-Logistic (PAINReportIt score weighted by conventional binary logistic regression coefficients) and PR-Lasso (PAINReportIt score weighted by lasso regression coefficients). Performance of the proposed scores and the existing scores were evaluated. RESULTS Lasso regression resulted in a parsimonious model with non-zero weights assigned to 2 neuropathic descriptors, cold and spreading. We found positive correlations between the PR-Lasso and other scores: S-LANSS (r = 0.22, P

Individuals with pain from sickle cell disease (SCD) are often treated for nociceptive pain, but recent findings indicate they may also have neuropathic pain. PAIN ReportIt, a computerized version of the McGill Pain Questionnaire, provides a potential subscale that is the summed number of selected neuropathic pain quality words (PR-NNP), but it lacks construct validity. The study purpose was to ascertain PR-NNP construct validity in adults with SCD and chronic pain. In an outpatient setting, 186 participants completed the PAIN ReportIt, Neuropathic Pain Symptom Inventory (NPSI), and Leeds Assessment for Neuropathic Symptoms and Signs (S-LANSS). PR-NNP was moderately correlated with NPSI ( r = .33, p < .001) and S-LANSS ( r = .40, p < .001). Regression analysis indicated that PR-NNP and pain intensity, but not a nociceptive pain subscale, were significant predictors of NPSI and S-LANSS. Findings support construct validity of PR-NNP, which may be useful as a screening tool for neuropathic pain in patients with SCD.

Background Numerous randomized controlled trials on the effects of electro-acupuncture have been conducted to treat dysphagia as a sequela of stroke. However, the normal physiological mechanisms of swallowing and the pathological mechanisms of dysphagia are not fully understood. The purpose of this study is to investigate whether lateralization of the human swallowing motor cortex excitability in healthy subjects will be influenced by electro-acupuncture to Lianquan (CV 23) and Fengfu (GV 16), which may provide insight into the pathological mechanisms of dysphagia after stroke. Methods We designed a single-blind, randomized, sham-controlled trial in which 40 healthy subjects will be recruited. Subjects will be randomized 1:1 into two groups: the electro-acupuncture group and the sham-control electro-acupuncture group. The swallowing motor cortex will be located in both groups using a neuroimaging navigation system. Then left and right cortical stimulation will be measured by transcranial magnetic stimulation (TMS) before and after electro-acupuncture or sham electro-acupuncture. The electro-acupuncture or sham electro-acupuncture interventions will last for 15 min. The primary outcome measure will be percent change in the resting motor threshold (RMT) of the mylohyoid. The secondary outcome measures will be the amplitude (μV) and latency (ms) of the motor evoked potential (MEP) of the mylohyoid as a proxy for the TMS evoked potential. All outcomes will be measured at baseline and after the electro-acupuncture or sham electro-acupuncture treatment. Discussion The aim of this trial is to explore whether lateralization of the human swallowing motor cortex excitability in healthy subjects is present, and to determine if electro-acupuncture to acupuncture points Lianquan (CV 23) and Fengfu (GV 16) will exert an effect on it under normal physiological conditions. Trial registration Chinese Clinical Trial Registry, ChiCTR-IOR-17011359. Registered on 11 May 2017. Electronic supplementary material The online version of this article (10.1186/s13063-019-3267-x) contains supplementary material, which is available to authorized users.

Acupuncture and acupressure, 2 modalities of Traditional Chinese Medicine, are based on reducing pain and symptoms of disease through balancing yin and yang. Acupuncture and acupressure have been used in China for reduction of labor pain, labor augmentation, and other intrapartum indications for more than 2 millennia. This article presents a review of the current literature that has addressed the effects of acupuncture and acupressure on intrapartum events. Studies of acupuncture have demonstrated that acupuncture may reduce labor pain, the use of pharmacologic agents, the use of forceps and vacuum-assisted births, and the length of labor. Studies that examined the effect of acupuncture on labor that is induced or augmented for premature rupture of membranes have found that acupuncture may increase the degree of cervical ripening but does not reduce the amount of oxytocin or epidural analgesia administration, nor does it shorten length of induced labor. Acupressure may reduce labor pain and labor duration, but acupressure has not been found to increase cervical ripening or induce labor. There are insufficient studies about acupuncture and acupressure and their effects on labor at this time, and there is need for further research. Areas of uncertainty include efficacy, optimal point selection, best techniques, and length of time for point stimulation.

Introduction. Vulvar pain can be a symptom of vulvar cancer, which is frequently detected at late stage for elderly women, and has racial disparities. Better documentation, detection, and monitoring of vulvar pain, may eventually lead to early detection of vulvar cancer to reduce age and racial disparities in this cancer. Unfortunately, typical body outline drawings for measuring pain location do not allow documentation of the specific details of vulvar pain. Our study purpose was to compare two measures of pain location for patients with another vulvar pain condition, vulvodynia. Methodology. Using baseline data from an ongoing randomized clinical trial conducted in Chicago, 62 women with vulvodynia marked their pain on a genital specific outline and 59 of those also marked their pain on a full body outline. The women’s ages ranged from 20-62 years (31.8±9.4 years). Their education levels were high school (10%), some college (9%), bachelors degree (43%), and advanced leveled education (38%). 11% were Asian, 7% were Black, 74% were White, and 9% were other race. They completed PAINReportIt, an electronic version of the McGill Pain Questionnaire, which allowed women to mark the region of their pain and describe their pain intensity. ImageJ software was used to isolate and analyze the surface area included within the markings on a full body outline with a total of 48 segments and on a genital area outline with a total of 22 segments. Descriptive statistics and Pearson’s correlation were used to analyze the number of segments marked and the number of pixels marked on each segment of both outlines. Results. As a context for women’s pain experience, the average pain intensity was 3.9±2.6. On the full body outline, 41 women marked the genital area only contrary to 18 women who marked both the genital area and elsewhere. On the full body outline, 24/48 segments were marked and the most frequent were segments near the vulvar region: left anterior thigh (n=59), right anterior thigh (n=54), left lumbar/iliac region (n=49), and right lumbar/iliac region (n=47). Some women also marked regions in the gluteal and posterior thigh region: left gluteal region (n=13), right gluteal region (n=9), and left hamstrings (n=10). On the genital specific outline, 22/22 body areas were marked. The most frequent vulvar specific areas marked were: vestibular fossa (n=51), left labia minora (n= 52)and vagina (n=55). There was a moderate correlation (r=.43, p=.001) between the body surface area marked on the full-body outline and the body surface area marked on the genital area outline. Conclusion. Study findings support the validity of the body surface area as a measure of pain location using either outline. The genital area outline provides more specific information about pain in the vulvar region, and implications for its use have the potential to eliminate disparities of vulvar cancer through the improved detection and monitoring of vulvar pain. Citation Format: Guettchina Telisnor, Rishabh Garg, Yingwei Yao, Judith Schlaeger, Diana J. Wilkie. Documentation methods for vulvar pain: Implications for detection of vulvar cancer, a cancer with known disparities [abstract]. In: Proceedings of the AACR Virtual Conference: Thirteenth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2020 Oct 2-4. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(12 Suppl):Abstract nr PO-269.

The McGill Pain Questionnaire (MPQ) pain quality descriptors have been analyzed to characterize the sensory, affective, and evaluative domains of pain, but have not been differentiated by pain location.To examine MPQ pain quality descriptors by pain location in outpatients with lung or prostate cancer.Cross sectional.Eleven oncology clinics or patients' homes.264 adult outpatients (80% male; mean age 62.2 ± 10.0 years, 85% White).Subjects completed a 100 mm visual analogue scale of pain intensity and MPQ clinic or home visit, marking sites where they had pain on a body outline and circling from 78 verbal descriptors those that described their pain. A researcher noted next to the descriptor spontaneous comments about sites feeling like a selected word and queried the subjects about any other words to obtain the site(s).Pain quality descriptors were assigned to all 7 pain locations marked by ≥ 20% of 198 lung or 66 prostate cancer patients. Four pain locations were marked with pain quality descriptors significanlty (p.05) more frequently for lung cancer (53% chest-aching, burning; 58% back-aching, stabbing; 48% head-aching, sharp; and 19% arms-aching, stabbing) than for prostate cancer, which had significantly more frequent pain locations in the abdomen (64%-aching, burning) and lower back/buttocks (55%-aching, burning).This type of pain characterization is innovative and has the potential to help implement targeted treatments for patients with cancer and other chronic pain conditions.

Background Efficacy of acupuncture is difficult to demonstrate without a feasible double-blind milieu. Double-blind acupuncture needles have been validated in single session protocols with one or two needles but not been tested in a protocol requiring many needles and repeated sessions. Methods We determined the feasibility of a 13-needle, 10-session study protocol. Feasibility focused on (1) enrolling and retaining participants; (2) two acupuncturists accurately implementing a double-blind, multi-needle, multi-session protocol; (3) participants completing measures; and (4) protocol acceptability to participants. In this double-blind randomized controlled pilot study, participants were randomized 1:1 to a penetrating needle group or a skin-touch placebo control group. Results Six women with vulvodynia (mean age 31.5 ± 8 years; five white, non-Latina, one black/African American) met the eligibility requirements, consented to participation, and were enrolled. All six participants (100%) completed the 10-session study protocol in 5 weeks without missing any treatment sessions. Per observed checklist documented technique, two acupuncturists flawlessly administered the 13-needle, 10-session acupuncture protocol; no needles malfunctioned. Six participants attended all sessions and completed 99% of measurement items. One participant did not like acupuncture (60% acceptability score) and five liked acupuncture (100% acceptability scores); the mean acceptability score was 93.3%. Conclusion Study feasibility was supported. This protocol can be used in a double-blind efficacy trial of acupuncture for vulvodynia. Trial registration ClinicalTrials.gov, NCT02704234. Registered 30 November 2015. Electronic supplementary material The online version of this article (10.1186/s40814-018-0265-9) contains supplementary material, which is available to authorized users.

Adults with sickle cell disease (SCD) have episodic crisis pain and chronic pain. Little is known about SCD chronic pain phenotypes. Quantitative sensory testing (QST) identifies the objective contribution of allodynia and hyperalgesia to chronic SCD pain phenotypes. However, self-report measures are needed to further characterize SCD chronic pain phenotypes. Our aim was to determine associations among QST-determined sensitization and anxiety, depression, and fatigue among outpatients with SCD. In a cross-sectional study, subjects (N=186, mean age 36.6 ± 11.7 years [19-74 years], 97% African American, 59% female; SC type 72% SS, 18% SC, 5% S-β thal+, 4% unknown) completed thermal and mechanical QST [heat/cold/mechanical pain thresholds and levels]) at three body sites. They completed pain intensity (API [average of pain now, least, and worst pain in the past 24 hours]) on a scale of 0 [no pain] to 10 [pain as bad as it could be] and the PROMIS anxiety (α=.90), depression (α=.94), and fatigue (α=.83) scales (higher scores represent more of the concept being measured). Descriptive analysis, Independent t-tests, and multiple linear logistic regression were conducted. QST findings indicated that 58 (31%) patients had sensitization and 126 (68%) did not have sensitization (two had missing data). Bivariate analysis for sensitized vs not sensitized groups were API, 5.3 ± 2.2 vs. 4.0 ± 2.4 (p= 0.001); anxiety, 56.2 ± 8.5 vs 52.6 ± 9.1 (p= 0.01); depression, 55.1 ± 10.2 vs 51.0 ± 9.2 (p= 0.01); and fatigue, 59.8 ± 9.1 vs 54.9 ± 8.6 (p=.001). API, fatigue, depression, and anxiety were not significant in the logistic regression model including all four as predictors of sensitization. Focus of future studies should be on factors that are associated with sensitization in adults with SCD. Supported by grant #: R01 HL124945-01 (MPIs: Wilkie, Molokie, Wang).