Fighting for menstrual equity through period product pantries.

BACKGROUND: Menstruators facing period poverty often struggle with menstrual hygiene and waste management, which can result in harmful short- and long-term health outcomes such as urinary tract infections, yeast infections, and vulvar contact dermatitis. Research indicates that 42% of menstruators in the United States have difficulty affording period products. Traditional methods of distributing period products through social services may unintentionally undermine menstruators' agency, leading to disempowerment and inefficient resource allocation. Period product pantries are a novel approach aimed at addressing period poverty, inequity, and inadequate menstrual health education in the United States. OBJECTIVES: This paper aims to examine the development, organization, and implementation of two distinct period product pantry networks in Ohio and New York. It seeks to compare the advantages and challenges of grassroots versus nonprofit-led models and to provide practical insights for future pantry operators. DESIGN: The study examines two models of period product pantries: a grassroots effort led by three local residents in Ohio and an initiative spearheaded by a nonprofit organization in New York. The design includes a comparative analysis of both models' organization, funding methods, and operational structures. METHODS: The authors gathered data on the construction, operation, and usage of two pantry networks, focusing on factors such as accessibility, community engagement, and sustainability. The study employed a combination of qualitative methods, including interviews with organizers, and a review of organizational documents to analyze the effectiveness and scalability of each model. RESULTS: Both pantry networks increased accessibility to period products in low socioeconomic neighborhoods, which are disproportionately affected by period poverty. The grassroots model, while resource-limited, fostered strong community ties and local engagement. The nonprofit-led model benefited from dedicated staff and a more stable funding structure but faced bureaucratic challenges. Despite their differences, both models demonstrated the potential to empower menstruators by preserving their dignity and autonomy. CONCLUSIONS: Period product pantries represent an innovative and equitable approach to addressing period poverty and inequity. The analysis of the two models offers valuable insights for organizations and individuals interested in establishing similar initiatives. While each model has its unique benefits and challenges, both are effective in empowering menstruators and providing accessible menstrual hygiene products to those in need. REGISTRATION: Not applicable.

Fighting for menstrual equity through period product pantriesPeriod product pantries are a new way to help people who can't afford period products and don't have enough education about menstrual health in the U.S. Many people who experience period poverty, or trouble getting products like pads and tampons, also face barriers to staying clean and managing period waste. This can cause health issues like infections. About 42% of people who get periods in the U.S. say they've had trouble paying for these products. Period product pantries are different from older methods of getting free products, like through social services, because they let people get what they need without feeling embarrassed or losing their sense of control. This paper looks at two types of period pantries: one started by three local people in Ohio and another run by a nonprofit group in New York. Both help people in neighborhoods where it's hard to afford period products. The paper talks about how these pantries were set up, how they are funded, and what worked well or didn't. The goal is to show how these pantries can be a good, fair way to help people while giving advice to others who might want to start their own pantries.

Trajectory of Postpartum Cervical Remodeling in Women Delivering Full-Term and Spontaneous Preterm: Sensitivity to Quantitative Ultrasound Biomarkers.

OBJECTIVE: Women with a history of spontaneous preterm birth (sPTB) face an increased risk of recurrence. Yet, the factors contributing to the increased risk are unknown, hampering the development of targeted interventions. Noninvasive quantitative ultrasound (QUS) has been validated in the characterization of cervical tissue and has the potential to provide information about postpartum cervical remodeling. The objective of this study was to determine the postpartum cervical remodeling trajectories of women over 12 mo post-delivery and to determine whether there were differences between women who delivered full-term and spontaneous preterm that were sensitive to QUS biomarkers. METHODS: Data were collected prospectively from 55 women: 41 who delivered full-term and 14 who delivered spontaneously preterm at 6 wk, 3, 6, 9 and 12 mo (±2 wk) postpartum. Data from QUS biomarkers: Attenuation Coefficient; Backscatter Coefficient; Shear Wave Speed; and Lizzi-Feleppa Slope, Intercept and Midband were analyzed from the acquired radiofrequency data using a Siemens S2000 ultrasound system with a transvaginal MC 9-4 MHz probe. The biomarkers were analyzed using descriptive statistics and linear mixed-effects models. RESULTS: QUS biomarkers, Backscatter Coefficient and Lizzi-Feleppa Intercept showed significant differences during the year after delivery between women who had a full-term birth and sPTB (p < 0.05), suggesting that there are differences in the cervical remodeling trajectories between the two groups. All QUS biomarkers demonstrated significant variations between the full-term birth and sPTB groups over time (p < 0.05), indicating ongoing cervical remodeling for both groups during the 12-mo postpartum period. CONCLUSION: QUS biomarkers identified cervical microstructure differences and trajectories in the year after delivery between women who delivered full-term and spontaneous preterm.

Barriers and Facilitators to Integrating Acupuncture into the U.S. Health Care System: A Scoping Review.

Background: Acupuncture is a widely practiced complementary and integrative health modality that has multiple clinical applications. The use of acupuncture in the United States is rapidly increasing. Although studies have shown the efficacy and effectiveness of acupuncture for various ailments, the integration of acupuncture into the U.S. health care system remains a challenge. Little is known about the factors affecting this integration. Objective: To provide a systematic review of the barriers and facilitators affecting the integration of acupuncture into the U.S. health care system. Methods: Four electronic databases were searched. Three independent reviewers were involved in the screening and data charting processes. Findings were synthesized and categorized into four levels based on the Social Ecological Model. Results: A total of 22 studies were included in the final review. The barriers and facilitators affecting the integration of acupuncture were mapped into four levels (individual, interpersonal, organizational, and policy). The most frequently reported barriers and facilitators were mapped into the Social Ecological Model constructs within the "Individual" level (i.e., beliefs and attitudes of acupuncture, and practical issues) and the "Organizational" level (i.e., credentialing, space and facility, referral system). Conclusion: This review has identified and synthesized the breadth of evidence on the barriers and facilitators to the integration of acupuncture into the U.S. health care system. Results of this review will guide future implementation studies to develop and test implementation strategies to integrate acupuncture into the U.S. health care system.

Integration of a Community Opioid Treatment Program into a Federally Qualified Health Center.

OBJECTIVES: With the increasing rates of opioid overdose deaths in the United States, barriers to treatment access for patients seeking medications for opioid use disorder (OUD), and challenges of initiating buprenorphine in patients who use fentanyl, it is essential to explore novel approaches to expanding access to methadone treatment. An opioid treatment program (OTP) and a federally qualified health center (FQHC) partnered to develop and implement an innovative integrated methadone and primary care treatment model. The process for integrating an OTP and FQHC to provide methadone treatment in the primary care setting will be discussed. METHODS: An OTP methadone dispensing site was co-located in the FQHC, utilizing a staffing matrix built on the expertise of each stakeholder. The OTP managed DEA and state regulatory processes, whereas the FQHC physicians provided medical treatment, including methadone treatment protocols, treatment plans, and primary care. Patient demographics, medical history, and retention data for those who entered the program between January 2021 and February 2023 were collected through chart review and analyzed with descriptive statistics. RESULTS: A total of 288 OTP-FHQC patients were enrolled during the study. Retention rates in methadone treatment at 90 and 180 days were similar to partner clinics. CONCLUSIONS: Collaboration between FQHCs and OTPs is operationally feasible and can be achieved utilizing the current staffing model of the FQHC and OTP. This model can increase access to treatment for OUD and primary care for an urban, underserved patient population.

Lack of Diversity in Research on Females with Ehlers-Danlos Syndromes: Recruitment Protocol for a Quantitative Online Survey.

BACKGROUND: Ehlers-Danlos syndromes (EDS) are a group of connective tissue disorders caused by fragile lax collagen. Current EDS research lacks racial and ethnic diversity. The lack of diversity may be associated with the complexities of conducting a large international study on an underdiagnosed condition and a lack of EDS health care providers who diagnose and conduct research outside of the United States and Europe. Social media may be the key to recruiting a large diverse EDS sample. However, studies that have used social media to recruit have not been able to recruit diverse samples. OBJECTIVE: This study aims to discuss challenges, strategies, outcomes, and lessons learned from using social media to recruit a large sample of females with EDS. METHODS: Recruitment on social media for a cross-sectional survey examining dyspareunia (painful sexual intercourse) in females was examined. Inclusion criteria were (1) older than 18 years of age, (2) assigned female at birth, and (3) diagnosed with EDS. Recruitment took place on Facebook and Twitter (now X), from June 1 to June 25, 2019. RESULTS: A total of 1178 females with EDS were recruited from Facebook (n=1174) and X (n=4). On Facebook, participants were recruited via support groups. A total of 166 EDS support groups were identified, 104 permitted the principal investigator to join, 90 approved posting, and the survey was posted in 54 groups. Among them, 30 of the support groups posted in were globally focused and not tied to any specific country or region, 21 were for people in the United States, and 3 were for people outside of the United States. Recruitment materials were posted on X with the hashtag #EDS. A total of 1599 people accessed the survey and 1178 people were eligible and consented. The average age of participants was 38.6 (SD 11.7) years. Participants were predominantly White (n=1063, 93%) and non-Hispanic (n=1046, 92%). Participants were recruited from 29 countries, with 900 (79%) from the United States and 124 (11%) from Great Britain. CONCLUSIONS: Our recruitment method was successful at recruiting a large sample. The sample was predominantly White and from North America and Europe. More research needs to be conducted on how to recruit a diverse sample. Areas to investigate may include connecting with more support groups from outside the United States and Europe, researching which platforms are popular in different countries, and translating study materials into different languages. A larger obstacle to recruiting diverse samples may be the lack of health care providers that diagnose EDS outside the United States and Europe, making the pool of potential participants small. There needs to be more health care providers that diagnose and treat EDS in countries that are predominantly made up of people of color as well as research that specifically focuses on these populations. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/53646.

Feasibility of implementing acupuncture in medically underserved breast cancer survivors (FAB): A protocol.

Nearly 94% of breast cancer survivors experience one or more symptoms or side effects during or after endocrine therapy. Joint pain, hot flashes, sleep disturbance, fatigue, depression, and anxiety are the most common concurrent symptoms, some of which can persist for 5 to 10 years. Acupuncture is a holistic modality that addresses multiple symptoms and side effects in a single therapy. Acupuncture has not yet been investigated for its effectiveness in treating the multiple symptoms experienced by breast cancer survivors receiving endocrine therapy. Medically underserved breast cancer survivors typically have limited access to acupuncture. The barriers limiting access to acupuncture need to be removed to enable equal access to breast cancer survivors for this evidence-based treatment. Thus, we developed a randomized controlled trial with a 5-week acupuncture intervention versus usual care for medically underserved breast cancer survivors. Mixed methods (semi-structured interviews, surveys, study notes) will be used to obtain in-depth understanding of barriers and facilitators for eventual implementation of the acupuncture intervention. This study will facilitate the widespread implementation, dissemination, and sustained utilization of acupuncture for symptom management among medically underserved breast cancer survivors receiving endocrine therapy.

Collecting patient-reported outcome measures in the electronic health record: Lessons from the NIH pragmatic trials Collaboratory.

The NIH Pragmatic Trials Collaboratory supports the design and conduct of 27 embedded pragmatic clinical trials, and many of the studies collect patient reported outcome measures as primary or secondary outcomes. Study teams have encountered challenges in the collection of these measures, including challenges related to competing health care system priorities, clinician's buy-in for adoption of patient-reported outcome measures, low adoption and reach of technology in low resource settings, and lack of consensus and standardization of patient-reported outcome measure selection and administration in the electronic health record. In this article, we share case examples and lessons learned, and suggest that, when using patient-reported outcome measures for embedded pragmatic clinical trials, investigators must make important decisions about whether to use data collected from the participating health system's electronic health record, integrate externally collected patient-reported outcome data into the electronic health record, or collect these data in separate systems for their studies.

Monitoring and responding to signals of suicidal ideation in pragmatic clinical trials: Lessons from the GRACE trial for Chronic Sickle Cell Disease Pain.

Sickle cell disease (SCD) is a hemoglobin disorder and the most common genetic disorder that affects 100,000 Americans and millions worldwide. Adults living with SCD have pain so severe that it often requires opioids to keep it in control. Depression is a major global public health concern associated with an increased risk in chronic medical disorders, including in adults living with sickle cell disease (SCD). A strong relationship exists between suicidal ideation, suicide attempts, and depression. Researchers enrolling adults living with SCD in pragmatic clinical trials are obligated to design their methods to deliberately monitor and respond to symptoms related to depression and suicidal ideation. This will offer increased protection for their participants and help clinical investigators meet their fiduciary duties. This article presents a review of this sociotechnical milieu that highlights, analyzes, and offers recommendations to address ethical considerations in the development of protocols, procedures, and monitoring activities related to suicidality in depressed patients in a pragmatic clinical trial.

Potential bias and lack of generalizability in electronic health record data: reflections on health equity from the National Institutes of Health Pragmatic Trials Collaboratory.

Embedded pragmatic clinical trials (ePCTs) play a vital role in addressing current population health problems, and their use of electronic health record (EHR) systems promises efficiencies that will increase the speed and volume of relevant and generalizable research. However, as the number of ePCTs using EHR-derived data grows, so does the risk that research will become more vulnerable to biases due to differences in data capture and access to care for different subsets of the population, thereby propagating inequities in health and the healthcare system. We identify 3 challenges-incomplete and variable capture of data on social determinants of health, lack of representation of vulnerable populations that do not access or receive treatment, and data loss due to variable use of technology-that exacerbate bias when working with EHR data and offer recommendations and examples of ways to actively mitigate bias.

Developing an Implementation Blueprint for the NIH HEAL Initiative GRACE Trial: Perspectives on Acupuncture and Guided Relaxation for Chronic Sickle Cell Disease Pain.

Objective: This study aimed to explore perspectives of people living with sickle cell disease (SCD) and SCD clinic providers and staff about the use of acupuncture and guided relaxation for treating chronic SCD pain. Data obtained were to inform an implementation blueprint for an effectiveness implementation clinical trial (GRACE Trial) testing whether acupuncture or guided relaxation reduces chronic pain when compared with usual care. Design: Qualitative research design. Methods: We conducted 33 semistructured interviews with people with SCD and SCD clinic providers and staff. Interviews were transcribed and coded. A deductive content analysis process was used to identify themes. Results: Four themes were identified: Receptivity to Acupuncture and Guided Relaxation, Limited Awareness, Complementary and Integrative Health (CIH) Therapy Preference, and Access Barriers. Both patients and clinic providers and staff were open to the use of acupuncture and guided relaxation for chronic pain treatment. After learning about these CIH therapies, some patients expressed a preference for one therapy over the other. They also discussed their ability to successfully engage with each therapy. There is a need to dispel misconceptions about the therapies by increasing understanding of how each therapy is implemented and functions to reduce pain. We identified several potential barriers that might affect the success of the trial and future health system integration, including time, transportation, and technology. Conclusion: This study is one of the first to present perspectives of both patients with SCD and clinic providers and staff on the use of acupuncture and guided relaxation for chronic SCD pain. Stakeholders' early input and perspectives highlighted that they welcome nonpharmacological CIH therapies. Implementation of a clinical trial and future health system integration will require the addressing misinformation and identifying strategies to overcome access barriers. Clinical trial registration number: NCT04906447.

Equity and bias in electronic health records data.

Embedded pragmatic clinical trials (ePCTs) are conducted during routine clinical care and have the potential to increase knowledge about the effectiveness of interventions under real world conditions. However, many pragmatic trials rely on data from the electronic health record (EHR) data, which are subject to bias from incomplete data, poor data quality, lack of representation from people who are medically underserved, and implicit bias in EHR design. This commentary examines how the use of EHR data might exacerbate bias and potentially increase health inequities. We offer recommendations for how to increase generalizability of ePCT results and begin to mitigate bias to promote health equity.

Hybrid effectiveness-implementation trial of guided relaxation and acupuncture for chronic sickle cell disease pain (GRACE): A protocol.

Background: People with sickle cell disease frequently use complementary and integrative therapies to cope with their pain, yet few studies have evaluated their effectiveness. The 3-arm, 3-site pragmatic Hybrid Effectiveness-implementation Trial of Guided Relaxation and Acupuncture for Chronic Sickle Cell Disease Pain (GRACE) has 3 priorities: (1) evaluate guided relaxation and acupuncture to improve pain control; (2) determine the most appropriate and effective treatment sequence for any given patient based on their unique characteristics; and (3) describe the processes and structures required to implement guided relaxation and acupuncture within health care systems. Methods: Participants (N = 366) are being recruited and randomized 1:1:1 to one of 2 intervention groups or usual care. The acupuncture intervention group receives 10 sessions over approximately 5 weeks. The guided relaxation intervention group receives access to video sessions ranging from 2 to 20 min each viewed daily over 5 weeks. The usual care group receives the standard of clinical care for sickle cell disease. Participants are re-randomized at 6 weeks depending on their pain impact score. Assessments occur at 6 weeks, 12 weeks, and 24 weeks. The primary outcome is the change in pain impact score and secondary measures include opioid use, anxiety, depression, sleep, pain catastrophizing, substance use, global impression of change, constipation, and hospitalizations. The GRACE study uses the Consolidated Framework for Implementation Research to plan, execute, and evaluate the associated implementation processes. Conclusion: The results from GRACE will represent a critical step toward improving management of pain affecting patients with sickle cell disease.ClinicalTrials.gov Identifier: NCT04906447.

Feasibility of Acupuncture and Exploration of Metabolomic Alterations for Psychoneurological Symptoms Among Breast Cancer Survivors.

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 <0.05). Pathway analysis indicated that glutathione metabolism (p = 0.002, q = 0.071), and arginine and proline metabolisms (p = 0.009, q = 0.166) were potentially involved in mechanisms of acupuncture. 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.

Tryptophan and Kynurenine Pathway Metabolites and Psychoneurological Symptoms Among Breast Cancer Survivors.

BACKGROUND: 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. AIMS: This study investigated the relationship between the metabolites involved in the tryptophan-kynurenine pathway and psychoneurological symptoms among breast cancer survivors. DESIGN: Cross-sectional study. SETTING: Participants were recruited at the oncology clinic at the University of Illinois Hospital & Health Sciences System. PARTICIPANTS/SUBJECTS: 79 breast cancer survivors after major cancer treatment. METHODS: 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. RESULTS: 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. CONCLUSION: The tryptophan-kynurenine pathway and impaired tryptophan availability may contribute to the development of psychoneurological symptoms.

Women's Experience of Living with Vulvodynia Pain: Why They Participated in a Randomized Controlled Trial of Acupuncture.

Introduction: Vulvodynia is vulvar pain lasting at least 3-months without clear identifiable cause that may have other associated factors. The aim, to explore motivations of women participating in a double-blind randomized controlled trial of acupuncture for vulvodynia. Methods: Responses to the question: "Tell me about why you decided to participate in this study" were analyzed using conceptual content analysis to identify patterns in motivation for study participation. Results: Four patterns emerged: 1) desire to address uncontrolled pain, 2) desire for understanding, 3) wish to contribute to knowledge generation, and 4) need to remove cost barriers. Conclusion: Motivations indicate vulvodynia-specific aspects of acceptability of acupuncture. Clinical Trial Registration: NCT03364127.

Evaluation and Treatment of Vulvodynia: State of the Science.

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.

Exploration of Japanese women seeking acupuncture for menopausal symptoms: a preliminary study.

Menopausal symptoms may affect every aspect of women's lives. There are no studies that examine the rate of menopausal women who seek acupuncture for their complaints, particularly muscle stiffness and aches, headaches, fatigue, and depression, which are indications for acupuncture, in Japan. The aim of this preliminary study was to explore the rate of Japanese women in menopause who sought acupuncture for the treatment of their general complaints, and to what extent acupuncture reduced their menopausal symptoms. 29 Japanese women, ages 40 to 59, received three individualized acupuncture treatments at 7 acupuncture clinics in Tokyo and surrounding suburbs. Menopausal symptoms were assessed by the Simple Menopause Index (SMI) which consisted of 10 symptoms from three categories: vasomotor, psychoneurological and musculoskeletal symptoms to determine if women were in menopause. Fifteen of 29 Japanese women had an SMI score greater than or equal to 26, suggesting that they were in menopause. Menopausal symptoms were reduced with individualized acupuncture treatments, exclusively due to improvement of musculoskeletal symptoms. Vasomotor and psychoneurological symptoms were not improved. These results suggest Japanese women in menopause seeking acupuncture may benefit from musculoskeletal symptom relief such as fatigue, chronic neck pain, and low back pain. Considering these results, acupuncturists may advise them to be evaluated by and inform gynecologists of their intention to use acupuncture to treat menopausal symptoms. Future studies focused on improvement of musculoskeletal symptoms and possibly vasomotor and psychoneurological symptoms with larger sample sizes are necessary.

Protocol for double-blind RCT of acupuncture for vulvodynia.

Background: Vulvodynia, vulvar pain of unknown origin lasting at least 3 months, affects 7% of American women. Dyspareunia, its frequent companion, renders sexual intercourse virtually impossible. Although few therapies are efficacious and rapid pain relief is rarely possible, there have been no sham/placebo-controlled studies of acupuncture for vulvodynia. Aims are to: 1) determine efficacy of acupuncture for vulvodynia, 2) explore duration of the acupuncture effect. Methods: In a pretest/posttest randomized controlled, double-blind (practitioner-patient) efficacy trial of a standardized acupuncture protocol, we will randomize 80 participants 1:1 to either penetrating needle or skin-touch placebo needle groups. Both types of needles are designed to blind both the acupuncturist and participant. Participants with vulvodynia will insert and remove a tampon as a standardized stimulus and complete primary measures of vulvar pain (pain intensity) and secondary measures of dyspareunia (Female Sexual Function Index, FSFI dyspareunia subscale score) and sexual function (FSFI total score) pretreatment, after the 10th acupuncture session, and pain measures weekly until return to pretest levels. Upon study completion control group participants will be offered 10 free real acupuncture sessions. Discussion: This is the first multi-needle multi-session RCT using double-blind acupuncture needles as a reliable sham. We hypothesize that controlling for baseline, at posttest there will be statistically significant less vulvar pain and dyspareunia and more sexual function over five weeks in the penetrating needle group compared to the skin touch placebo group. Conclusion: This study is responsive to the need for efficacious pain management for women with vulvodynia.ClinicalTrials.gov Identifier: NCT03364127.