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BackgroundPrimary dysmenorrhea is a common condition in women of reproductive age. A previous app-based study undertaken by our group demonstrated that a smartphone app supporting self-acupressure introduced by a health care professional can reduce menstrual pain. ObjectiveThis study aims to evaluate whether a specific smartphone app is effective in reducing menstrual pain in 18- to 34-year-old women with primary dysmenorrhea in a self-care setting. One group of women has access to the full-featured study app and will be compared with 2 control groups who have access to fewer app features. Here, we report the trial design, app development, user access, and engagement. MethodsOn the basis of the practical implications of the previous app-based study, we revised and reengineered the study app and included the ResearchKit (Apple Inc) framework. Behavior change techniques (BCTs) were implemented in the app and validated by expert ratings. User access was estimated by assessing recruitment progress over time. User evolution and baseline survey respondent rate were assessed to evaluate user engagement. ResultsThe development of the study app for a 3-armed randomized controlled trial required a multidisciplinary team. The app is accessible for the target population free of charge via the Apple App Store. In Germany, within 9 months, the app was downloaded 1458 times and 328 study participants were recruited using it without external advertising. A total of 98.27% (5157/5248) of the app-based baseline questions were answered. The correct classification of BCTs used in the app required psychological expertise. ConclusionsConducting an innovative app study requires multidisciplinary effort. Easy access and engagement with such an app can be achieved by recruitment via the App Store. Future research is needed to investigate the determinants of user engagement, optimal BCT application, and potential clinical and self-care scenarios for app use. Trial RegistrationClinicalTrials.gov NCT03432611; https://clinicaltrials.gov/ct2/show/NCT03432611 (Archived by WebCite at http://www.webcitation.org/75LLAcnCQ).

BACKGROUND: Many patients with cancer do not disclose complementary medicine use but want their physician's advice on this matter. This study evaluated whether using blended learning (e‐learning plus a workshop) to train oncology physicians in providing advice on complementary and integrative medicine (CIM) therapies to their patients with cancer, in addition to distributing an information leaflet on reputable CIM websites, had different effects on patient‐reported outcomes for the consultation than only distributing the leaflet. METHODS: In this multicenter, cluster‐randomized trial, patients from private practices/hospital departments, recruited by 48 oncology physicians randomly allocated to an intervention group (CIM consultation plus information leaflet) or a control group (information leaflet), received CIM information. Patient‐reported outcomes included satisfaction (Patient Satisfaction With Information on Cancer Treatment), readiness to make a decision (Preparation for Decision Making), and physician‐patient communication (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire and Communication 26 [EORTC QLQ‐COMU26]) for the consultation. Qualitative interviews were conducted with a physician subsample. RESULTS: A total of 291 patients (128 in the intervention group and 169 in the control group) advised by 41 physicians participated. Patients in the intervention group rated physician‐patient communication higher on all EORTC QLQ‐COMU26 scales (mean total score, 84.3 [95% CI, 79.5‐89.2] vs 73.6 [95% CI, 69.3‐78.0]; P =.002), were more satisfied with the advice (mean, 4.2 [95% CI, 4.0‐4.4] vs 3.7 [95% CI, 3.5‐3.8]; P <.001), and were readier to make a decision (mean, 63.5 [95% CI, 57.4‐69.6] vs 53.2 [95% CI, 47.8‐58.7]; P =.016) than the control group. Physicians who reported patients in both settings seemed satisfied with the advice given. CONCLUSIONS: This study evaluated a novel education intervention for training oncology physicians in providing CIM advice in routine care. Providing structured CIM consultations had positive effects on patient satisfaction, readiness to make decisions, and physician‐patient communication. This is the first study to implement and evaluate an evidence‐based complementary and integrative medicine (CIM) consultation in routine cancer treatment. Advising patients with cancer according to a structured, evidence‐based consultation manual has positive effects on patient satisfaction, preparation for decision‐making, and physician‐patient communication in comparison with only distributing an information leaflet about CIM. [ABSTRACT FROM AUTHOR]

Objective: Since recent studies suggested a role of the striatum and prefrontal cortex for multiple sclerosis (MS)-related fatigue, we investigated resting-state functional connectivity alterations of striatal subdivisions and the dorsolateral prefrontal cortex (dlPFC). Methods: Resting-state functional magnetic resonance imaging was acquired in 77 relapsing–remitting MS patients (38 fatigued (F-MS), 39 non-fatigued (NF-MS)) and 41 matched healthy controls (HC). Fatigue severity was assessed using the fatigue severity scale. Seed-based connectivity analyses were performed using subregions of the striatum and the dlPFC as regions of interest applying non-parametric permutation testing. Results: Compared to HC and NF-MS patients, F-MS patients showed reduced caudate nucleus and ventral striatum functional connectivity with the sensorimotor cortex (SMC) and frontal, parietal, and temporal cortex regions. Fatigue severity correlated negatively with functional connectivity of the caudate nucleus and ventral striatum with the SMC and positively with functional connectivity of the dlPFC with the rostral inferior parietal gyrus and SMC. Conclusion: MS-related fatigue is associated with reduced functional connectivity between the striatum and sensorimotor as well as attention and reward networks, in which the ventral striatum might be a key integration hub. Together with increased connectivity between the dlPFC and sensory cortical areas, these connectivity alterations shed light on the mechanisms of MS-related fatigue. [ABSTRACT FROM AUTHOR]

Xingnao Kaiqiao (XNKQ) acupuncture is an acupuncture technique used for stroke patients. In 24 healthy volunteers, we applied this complex acupuncture intervention, which consists of a manual needle-stimulation on five acupuncture points (DU26 unilaterally, PC6, and SP6 bilaterally). XNKQ was compared to three control conditions: (1) insertion of needles on the XNKQ acupuncture points without stimulation, (2) manual needle-stimulation on five nearby non-acupuncture points, and (3) insertion of needles on the non-acupuncture points without stimulation. In a within-subject design, we investigated functional connectivity changes in resting-state functional magnetic resonance imaging (fMRI) by means of the data-driven eigenvector centrality (EC) approach. With a 2 × 2 factorial within-subjects design with two-factor stimulation (stimulation vs. non-stimulation) and location (acupuncture points vs. non-acupuncture points), we found decreased EC in the precuneus after needle-stimulation (stimulation

Acupuncture is widely applied all over the world. Although the neurobiological underpinnings of acupuncture still remain unclear, accumulating evidence indicates significant alteration of brain activities in response to acupuncture. In particular, activities of brain regions in the default mode network (DMN) are modulated by acupuncture. DMN is crucial for maintaining physiological homeostasis and its functional architecture becomes disrupted in various disorders. But how acupuncture modulates brain functions and whether such modulation constitutes core mechanisms of acupuncture treatment are far from clear. This Perspective integrates recent literature on interactions between acupuncture and functional networks including the DMN, and proposes a back-translational research strategy to elucidate brain mechanisms of acupuncture treatment. [ABSTRACT FROM AUTHOR]

Introduction Fatigue plays an important role in the daily activity of patients with multiple sclerosis (MS) and strongly influences their quality of life. Numerous clinical trials evaluating various interventions for fatigue in MS have shown only minor benefits. The main aim of the present trial is to evaluate whether 1) acupuncture or 2) mindfulness-based stress reduction (MBSR) in addition to usual care are effective in reducing fatigue in MS patients compared to usual care alone. Methods Within a randomized, three-arm, controlled trial we aim to include 141 MS patients aged 18–65 years with fatigue for at least 3 months and an average score of ≥4 on the Fatigue Severity Scale (FSS). Patients will be randomized into three groups: an acupuncture group receiving 12 weeks of acupuncture in addition to usual care, a MBSR group receiving 12 weeks of MBSR in addition to usual care, and a usual care group continuing their previous treatment. Primary outcome is the Fatigue Severity Scale (FSS) after 12 weeks. To assess the trial’s characteristics regarding efficacy and effectiveness we used the pragmatic explanatory continuum summary (PRECIS-2). Discussion This trial addresses new therapeutic approaches for fatigue in MS. The resulting design is a compromise between scientific rigor and pragmatism. Due to difficulties with recruitment we had to scale down our trial to the groups of usual care and acupuncture. The trial's results will give first evidence whether acupuncture is effective in patients with MS associated fatigue. Trial registration ClinicalTrials.gov identifier NCT01864707, registered on 2 April 2013. [ABSTRACT FROM AUTHOR]

Acupuncture can have instant and sustained effects, however, its mechanisms of action are still unclear. Here, we investigated the sustained effect of acupuncture by evaluating centrality changes in resting-state functional magnetic resonance imaging after manually stimulating the acupuncture point ST36 at the lower leg or two control point locations (CP1 same dermatome, CP2 different dermatome). Data from a previously published experiment evaluating instant BOLD effects and S2-seed-based resting state connectivity was re-analyzed using eigenvector centrality mapping and degree centrality mapping. These data-driven methods might add new insights into sustained acupuncture effects on both global and local inter-region connectivity (centrality) by evaluating the summary of connections of every voxel. We found higher centrality in parahippocampal gyrus and middle temporal gyrus after ST36 stimulation in comparison to the two control points. These regions are positively correlated to major hubs of the default mode network, which might be the primary network affected by chronic pain. The stronger integration of both regions within the whole-brain connectome after stimulation of ST36 might be a potential contributor to pain modulation by acupuncture. These findings highlight centrality mapping as a valuable analysis for future imaging studies investigating clinically relevant outcomes associated with physiological response to acupuncture stimulation. Clinical trial registration: NCT01079689, ClinicalTrials.gov. [ABSTRACT FROM AUTHOR]

Acupuncture can be regarded as a complex somatosensory stimulation. Here, we evaluate whether the point locations chosen for a somatosensory stimulation with acupuncture needles differently change the brain activity in healthy volunteers. We used EEG, event-related fMRI, and resting-state functional connectivity fMRI to assess neural responses to standardized needle stimulation of the acupuncture point ST36 (lower leg) and two control point locations (CP1 same dermatome, CP2 different dermatome). Cerebral responses were expected to differ for stimulation in two different dermatomes (CP2 different from ST36 and CP1), or stimulation at the acupuncture point vs. the control points. For EEG, mu rhythm power increased for ST36 compared to CP1 or CP2, but not when comparing the two control points. The fMRI analysis found more pronounced insula and S2 (secondary somatosensory cortex) activation, as well as precuneus deactivation during ST36 stimulation. The S2 seed-based functional connectivity analysis revealed increased connectivity to right precuneus for both comparisons, ST36 vs. CP1 and ST36 vs. CP2, however in different regions. Our results suggest that stimulation at acupuncture points may modulate somatosensory and saliency processing regions more readily than stimulation at non-acupuncture point locations. Also, our findings suggest potential modulation of pain perception due to acupuncture stimulation. [ABSTRACT FROM AUTHOR]

Background Chronic low back pain (LBP) and neck pain (NP) are highly prevalent conditions resulting in high economic costs. Treatment guidelines recommend relaxation techniques, such as progressive muscle relaxation, as adjuvant therapies. Self-care interventions could have the potential to reduce costs in the health care system, but their effectiveness, especially in a usual care setting, is unclear. The aim of these two pragmatic randomized studies is to evaluate whether an additional app-delivered relaxation is more effective in the reduction of chronic LBP or NP than usual care alone. Methods/design Each pragmatic randomized two-armed study aims to include a total of 220 patients aged 18 to 65 years with chronic (>12 weeks) LBP or NP and an average pain intensity of ≥ 4 on a numeric rating scale (NRS) in the 7 days before recruitment. The participants will be randomized into an intervention and a usual care group. The intervention group will be instructed to practice one of these 3 relaxation techniques on at least 5 days/week for 15 minutes/day over a period of 6 months starting on the day of randomization: autogenic training, mindfulness meditation, or guided imagery. Instructions and exercises will be provided using a smartphone app, baseline information will be collected using paper and pencil. Follow-up information (daily, weekly, and after 3 and 6 months) will be collected using electronic diaries and questionnaires included in the app. The primary outcome measure will be the mean LBP or NP intensity during the first 3 months of intervention based on daily pain intensity measurements on a NRS (0 = no pain, 10 = worst possible pain). The secondary outcome parameters will include the mean pain intensity during the first 6 months after randomization based on daily measurements, the mean pain intensity measured weekly as the average pain intensity of the previous 7 days over 3 and 6 months, pain acceptance, 'LBP- and NP-related' stress, sick leave days, pain medication intake, adherence, suspected adverse reaction, and serious adverse events. Discussion The designed studies reflect a usual self-care setting and will provide evidence on a pragmatic self-care intervention that is easy to combine with care provided by medical professionals. [ABSTRACT FROM AUTHOR]

Background: Multiple sclerosis (MS) preferentially affects females at childbearing age. For this reason patients and treating physicians were frequently confronted with questions concerning family planning, pregnancy and birth. Objective: The aim of this study was to evaluate the expertise about pregnancy related topics in multiple sclerosis of neurologists in private practice. Methods: We developed a survey with 16 multiple choice questions about pregnancy related topics and sent it to neurologists in private practice in Berlin, Germany. Results: 56 completed questionnaires were sent back. 54% of all questions were answered correctly, 21% of the questions were answered with “I don’t know”. Correct answers were more often given by physicians who treat more than 400 MS patients per year (p = 0.001). Further positive associations were found for assumed relevance of the topic (p = 0.002) and the degree of counseling (p<0.001). Conclusion: To provide a comprehensive counseling, MS patients with desire for children should be counseled by physicians with a lot of experience in MS treatment. [ABSTRACT FROM AUTHOR]

Acupuncture can have instant and sustained effects, however, its mechanisms of action are still unclear. Here, we investigated the sustained effect of acupuncture by evaluating centrality changes in resting-state functional magnetic resonance imaging after manually stimulating the acupuncture point ST36 at the lower leg or two control point locations (CP1 same dermatome, CP2 different dermatome). Data from a previously published experiment evaluating instant BOLD effects and S2-seed-based resting state connectivity was re-analyzed using eigenvector centrality mapping and degree centrality mapping. These data-driven methods might add new insights into sustained acupuncture effects on both global and local inter-region connectivity (centrality) by evaluating the summary of connections of every voxel. We found higher centrality in parahippocampal gyrus and middle temporal gyrus after ST36 stimulation in comparison to the two control points. These regions are positively correlated to major hubs of the default mode network, which might be the primary network affected by chronic pain. The stronger integration of both regions within the whole-brain connectome after stimulation of ST36 might be a potential contributor to pain modulation by acupuncture. These findings highlight centrality mapping as a valuable analysis for future imaging studies investigating clinically relevant outcomes associated with physiological response to acupuncture stimulation.

We aimed to compare the effectiveness of standardized and individualized acupuncture treatment in patients with chronic low back pain. A single-center randomized controlled single-blind trial was performed in a general medical practice in Germany run by a Chinese-born medical doctor trained in western and Chinese medicine. One hundred and fifty outpatients with chronic low back pain were randomly allocated to two groups (78 standardized and 72 individualized acupuncture). Patients received either standardized acupuncture or individualized acupuncture. Treatment encompassed between 10 and 15 treatments based on individual symptoms with two treatments per week. The main outcome measure was the area under the curve (AUC) summarizing eight weeks of daily rated pain severity measured with a visual analogue scale (0 mm = no pain, 100 mm = worst imaginable pain). No significant differences between groups were observed for the AUC (individualized acupuncture mean: 1768.7 (95% CI, 1460.4; 2077.1); standardized acupuncture 1482.9 (1177.2; 1788.7); group difference, 285.8 (-33.9; 605.5) P = 0.080). In this single-center trial, individualized acupuncture was not superior to standardized acupuncture for patients suffering from chronic pain. As a next step, a multicenter noninferiority study should be performed to investigate whether standardised acupuncture treatment for chronic low back pain might be applicable in a broader usual care setting. This trial is registered with ClinicalTrials.gov NCT00758017. [ABSTRACT FROM AUTHOR]

Background: One in five children visiting a homeopathic physician suffers from atopic eczema. Objectives: We aimed to examine the long-term effectiveness, safety and costs of homoeopathic vs. conventional treatment in usual medical care of children with atopic eczema. Methods: In this prospective multi-centre comparative observational non-randomized rater-blinded study, 135 children (48 homoeopathy, 87 conventional) with mild to moderate atopic eczema were included by their respective physicians. Depending on the specialisation of the physician, the primary treatment was either standard conventional treatment or individualized homeopathy as delivered in routine medical care. The main outcome was the SCORAD (SCORing Atopic Dermatitis) at 36 months by a blinded rater. Further outcomes included quality of life, conventional medicine consumption, safety and disease related costs at six, 12 and 36 months after baseline. A multilevel ANCOVA was used, with physician as random effect and the following fixed effects: age, gender, baseline value, severity score, social class and parents' expectation. Results: The adjusted mean SCORAD showed no significant differences between the groups at 36 months (13.7 95% CI [7.9- 19.5] vs. 14.9 [10.4-19.4], p = 0.741). The SCORAD response rates at 36 months were similar in both groups (33% response: homoeopathic 63.9% vs. conventional 64.5%, p = 0.94; 50% response: 52.0% vs. 52.3%, p = 0.974). Total costs were higher in the homoeopathic versus the conventional group (months 31-36 200.54 Euro [132.33-268.76] vs. 68.86 Euro [9.13-128.58], p = 0.005). Conclusions: Taking patient preferences into account, while being unable to rule out residual confounding, in this long- term observational study, the effects of homoeopathic treatment were not superior to conventional treatment for children with mild to moderate atopic eczema, but involved higher costs. [ABSTRACT FROM AUTHOR]

Objective: To create a German version of the Southampton Needle Sensation Questionnaire (SNSQ) in order to measure deqi (needling sensation) in subjects receiving different forms of acupuncture and to evaluate the translated questionnaire in an acupuncture study. Methods: A forward and backward translation procedure was applied to create a German version of the SNSQ. Discrepancies between translations were resolved by consensus. Healthy participants from an experimental acupuncture trial were asked to fill in the resulting questionnaire comprising of 17 items (none (0) to intense (3)) and a visual analogue scale (VAS) for pain (0-100 mm) after receiving either sham or real acupuncture with or without stimulation. The questionnaire was validated using factor analysis and correlation analysis. Results: Questionnaires from 63 subjects (mean 27.1 years; 69.8% female) were included in the analysis. Participants tended to score toward the low end of each of the 17 items (mean sum score (± SD): 8.9 ± 7.0). Four factors with eigenvalues > 1 were identified using exploratory factor analysis. Both of the original subscales, aching deqi (AD) and tingling deqi (TD), showed good internal consistency (Cronbach's α: AD: 0.71; TD: 0.78) and medium test-retest reliability (AD: r = 0.538, p = 0.002; TD: r = 0.603, p < 0.001). AD feeling (r = 0.574, p < 0.001) and TD feeling (r = 0.496, p < 0.001) correlated with the VAS for pain. Conclusion: Factor structure of the original questionnaire could not be reproduced with the German version of the SNSQ in an experimental setting. The questionnaire could not discriminate between pain and deqi. Further research is needed to create a German tool which is more suitable to measure deqi. Copyright © 2011 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]

Background: The effectiveness of injection therapy for low-back pain is still debatable. We compared the efficacy of local injections of the homeopathic preparation Disci/Rhus toxicodendron compositum (verum) with placebo injections and with no treatment in patients with chronic low back pain. Methodology/Principal Findings: In a randomized controlled partly double blind multicenter trial patients with chronic low back pain from 9 German outpatient clinics were enrolled and randomly allocated in a 1:1:1 ratio to receive subcutaneous injections (verum or placebo) into painful sites on the lower back over 12 treatment sessions within eight weeks, or no treatment (rescue pain medication with paracetamol or NSAIDs). All trial personnel and participants were masked to treatment allocation. The primary outcome measure was the average pain intensity over the last seven days on a visual analogue scale (0-100 mm, 0 = no pain, 100 = worst imaginable pain) after eight weeks. Follow-up was 26 weeks. Primary analysis was by intention to treat. Between August 2007 and June 2008, 150 patients were randomly allocated to three groups (51 verum, 48 placebo and 51 no treatment). The mean baseline-adjusted low back pain intensity at week eight was: verum group 37.0 mm (97.5% CI 25.3;48.8), no treatment group 53.0 (41.8;64.2), and placebo group 41.8 (30.1;53.6). The verum was significantly superior to no treatment (P = 0.001), but not to placebo (P = 0.350). No significant side effects were reported. Conclusions/Significance: The homeopathic preparation was not superior to placebo. Compared to no treatment injections resulted in significant and clinical relevant chronic back pain relief. [ABSTRACT FROM AUTHOR]

The article presents a study on the effect of qigong exercises on chronic neck pain. It references a study by Daniel Rendant and colleagues published in "Spine" in 2011. It discusses the qigong tradition as a component of Chinese medicine. It discusses the result of a randomized controlled trial to evaluate the effectiveness of qigong in alleviating chronic neck pain compared to no treatment and exercise therapy.

The article presents a randomised controlled trial which compared the efficacy of hot dry air application over dry air at room temperature to the throat of patients with recently-acquired common cold. Researchers conducted the randomised controlled trial for both controlled groups in hot sauna in Berlin, Germany. The results of the study revealed the absence of significant difference between the two groups and concluded that inhaling dry hot air while inside a sauna facility has no therapeutic effect on symptom severity of common cold.

Background: One of five children visiting a homoeopathic physician is suffering from atopic eczema. Objective: To examine the effectiveness, safety and costs of homoeopathic versus conventional treatment in usual care. Methods: In a prospective multicentre comparative observational non-randomised study, 135 children (homoeopathy n = 48 vs. conventional n = 87) with mild to moderate atopic eczema were included. The primary outcome was the SCORAD (Scoring Atopic Dermatitis) at 6 months. Further outcomes at 6 and 12 months also included quality of life of parents and children, use of conventional medicine, treatment safety and disease-related costs. Results: The adjusted SCORAD showed no significant differences between the groups at both 6 months (homoeopathy 22.49 ± 3.02 [mean ± SE] vs. conventional 18.20 ± 2.31, p = 0.290) and 12 months (17.41 ± 3.01 vs. 17.29 ± 2.31, p = 0.974). Adjusted costs were higher in the homoeopathic than in the conventional group: for the first 6 months EUR 935.02 vs. EUR 514.44, p = 0.026, and for 12 months EUR 1,524.23 vs. EUR 721.21, p = 0.001. Quality of life was not significantly different between both groups. Conclusion: Taking patient preferences into account, homoeopathic treatment was not superior to conventional treatment for children with mild to moderate atopic eczema. Copyright © 2009 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]

Objective: Descriptions of the interventions used in acupuncture studies are often incomplete. The aim of this paper is to describe participating trial physicians and interventions in a randomised trial of acupuncture for low back pain. Design: Three-armed, randomized, controlled multicenter trial with 1-year follow-up. A total of 301 patients with low-back pain were randomized to 12 sessions of semistandardized acupuncture (at least six local and two distant points needled bilaterally from a selection of predefined points, but individual choice of additional body or ear acupuncture points possible), minimal acupuncture (superficial needling of at least 6 of 10 predefined, bilateral, distant nonacupuncture points), or a waiting list control (2 months no acupuncture followed by semistandardised acupuncture described above). Outcome measures: Participating trial physicians and interventions. Results: Forty-five (45) physicians specializing in acupuncture (mean age 44 ± 7.8 years, 23 (51%) female) in 30 outpatient centers in Germany provided the interventions. The median duration of acupuncture training of trial physicians was 350 hours (range 140–2508). The most frequently reported Chinese diagnosis was Kidney deficiency (39%), followed by qi and Blood stagnation (24%), and bi syndrome (20%). The total number of needles used was 17.3 ± 4.2 in the acupuncture group compared to 12.3 ± 1.2 in the minimal acupuncture group. In total, 40 physicians (89%) stated that they would have treated patients similarly or in exactly the same way outside of the trial, whereas 5 (11%) stated that they would have treated patients differently. Conclusions: For most trial physicians, the semistandardized acupuncture strategy used in this trial was an acceptable compromise for an efficacy study. However, a relevant minority of participating trial physicians stated that they would have treated patients differently outside of the trial. [ABSTRACT FROM AUTHOR]

Background: Clinical research on mobile health (mHealth) interventions is too slow in comparison to the rapid speed of technological advances, thereby impeding sustainable research and evidence-based implementation of mHealth interventions. Objective: We aimed to establish practical lessons from the experience of our working group, which might accelerate the development of future mHealth interventions and their evaluation by randomized controlled trials (RCTs). Methods: This paper is based on group and expert discussions, and focuses on the researchers' perspectives after four RCTs on mHealth interventions for chronic pain. Results: The following five lessons are presented, which are based on practical application, increase of speed, and sustainability: (1) explore stakeholder opinions, (2) develop the mHealth app and trial simultaneously, (3) minimize complexity, (4) manage necessary resources, and (5) apply behavior change techniques. Conclusions: The five lessons developed may lead toward an agile research environment. Agility might be the key factor in the development and research process of a potentially sustainable and evidence-based mHealth intervention. JMIR Mhealth Uhealth 2021;9(2):e20630 doi:10.2196/20630 [ABSTRACT FROM AUTHOR]

An abstract of the study "Qigong Versus Exercise Therapy for Chronic Low Back Pain in Adults--A Randomized Controlled Non-Inferiority Trial" by Susanne Blodt, Daniel Pach, Theresa Kaster, Rainer Ludke, Anett Reishauer and Claudia M. Witt is presented.

Background: Self-care acupressure might be successful in treating menstrual pain, which is common among young women. There is a need for comparative effectiveness research with stakeholder engagement in all phases seeking to address the needs of decision-makers. Our aim was to design a study on the effectiveness of additional self-care acupressure for menstrual pain comparing usual care alone using different methods of stakeholder engagement.Methods: The study was designed using multiple mixed methods for stakeholder engagement. Based on the results of a survey and focus group discussion, a stakeholder advisory group developed the study design.Results: Stakeholder engagement resulted in a two-arm pragmatic randomized trial. Two hundred and twenty women aged 18 to 25 years with menstrual pain will be included in the study. Outcome measurement will be done using electronic questionnaires provided by a study specific mobile application (App). Primary outcome will be the mean pain intensity at the days of pain during the third menstruation after therapy start.Conclusion: Stakeholder engagement helped to develop a study design that better serves the needs of decision makers, including an App as a modern tool for both intervention and data collection in a young target group.Trial Registration: Clinicaltrials.gov identifier http://NCT01582724. [ABSTRACT FROM AUTHOR]

Traditional medical practice has suffered from male bias, which can lead to sub-optimal treatment options for female patients and increase the incidence of severe side-effects in this population. Mobile health applications, mHealth apps, represent one essential component of the shift towards consumer-centered self-administered individualized health. To prevent sex-specific bias it is important that trials consider sex and gender when developing mHealth apps. We evaluated the inclusion and reporting of sex and gender at all levels in mHealth randomized controlled trials (RCTs). To this end, we conducted a secondary analysis of a large study database addressing the effectiveness of app interventions on clinical outcomes in patients with chronic medical conditions. We followed the 5 steps described in the framework by Arksey and O'Malley and the guidelines of the PRISMA-ScR. Of the 72 app-based RCTs which reported information about sex overall, 62 included individuals of both sexes. The concept of gender was not addressed in any of the studies. The consideration of sex aspects in the design, execution and reporting of mHealth RCTs was minimal or absent. To adequately address the health and preventative needs of the mHealth user population, sex and gender should be systematically included in the research, development and evaluation of mHealth applications. [ABSTRACT FROM AUTHOR]

Aim: To explore the current practice of stakeholder engagement in clinical trials and its evaluation in North America (USA and Canada), DACH countries (Germany, Austria and Switzerland) and China. Participants & methods: We conducted a web-based, anonymous, international, cross-sectional online survey for clinical researchers. Data were analyzed using descriptive and explorative statistical analysis including analysis of variance and analysis of covariance. Results: Stakeholder engagement is more prominent and higher accepted among researchers in North America. Researchers in DACH countries have less knowledge of the stakeholder engagement method and are less likely to apply it. Conclusion: Stakeholder engagement is perceived very differently among participants from DACH countries, North America and China. For a broader acceptance and implementation institutional support and motivational conditions might be needed.

Background: Clinical research on mobile health (mHealth) interventions is too slow in comparison to the rapid speed of technological advances, thereby impeding sustainable research and evidence-based implementation of mHealth interventions., Objective: We aimed to establish practical lessons from the experience of our working group, which might accelerate the development of future mHealth interventions and their evaluation by randomized controlled trials (RCTs)., Methods: This paper is based on group and expert discussions, and focuses on the researchers' perspectives after four RCTs on mHealth interventions for chronic pain., Results: The following five lessons are presented, which are based on practical application, increase of speed, and sustainability: (1) explore stakeholder opinions, (2) develop the mHealth app and trial simultaneously, (3) minimize complexity, (4) manage necessary resources, and (5) apply behavior change techniques., Conclusions: The five lessons developed may lead toward an agile research environment. Agility might be the key factor in the development and research process of a potentially sustainable and evidence-based mHealth intervention., (©Daniel Pach, Alizé A Rogge, Jiani Wang, Claudia M Witt. Originally published in JMIR mHealth and uHealth (http://mhealth.jmir.org), 08.02.2021.)

Acupuncture is a complementary and nonpharmacological intervention that can be effective for the management of chronic pain in addition to or instead of medication. Various animal models for neuropathic pain, inflammatory pain, cancer-related pain, and visceral pain already exist in acupuncture research. We used a newly validated human pain model and examined whether acupuncture can influence experimentally induced dental pain. For this study, we compared the impact of manual acupuncture (real acupuncture), manual stimulation of a needle inserted at nonacupuncture points (sham acupuncture) and no acupuncture on experimentally induced dental pain in 35 healthy men who were randomized to different sequences of all 3 interventions in a within-subject design. BORG CR10 pain ratings and autonomic responses (electrodermal activity and heart rate variability) were investigated. An initial mixed model with repeated measures included preintervention pain ratings and the trial sequence as covariates. The results showed that acupuncture was effective in reducing pain intensity when compared to no acupuncture (β = -.708, P = .002), corresponding to a medium Cohen's d effect size of .56. The comparison to the sham acupuncture revealed no statistically significant difference. No differences in autonomic responses between real and sham acupuncture were found during the intervention procedures. PERSPECTIVE: This study established a dental pain model for acupuncture research and provided evidence that experimentally induced dental pain can be influenced by either real acupuncture or manual stimulation of needles at nonacupuncture points. The data do not support that acupoint specificity is a significant factor in reducing experimental pain., (Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.)

Objective: Since recent studies suggested a role of the striatum and prefrontal cortex for multiple sclerosis (MS)-related fatigue, we investigated resting-state functional connectivity alterations of striatal subdivisions and the dorsolateral prefrontal cortex (dlPFC)., Methods: Resting-state functional magnetic resonance imaging was acquired in 77 relapsing-remitting MS patients (38 fatigued (F-MS), 39 non-fatigued (NF-MS)) and 41 matched healthy controls (HC). Fatigue severity was assessed using the fatigue severity scale. Seed-based connectivity analyses were performed using subregions of the striatum and the dlPFC as regions of interest applying non-parametric permutation testing., Results: Compared to HC and NF-MS patients, F-MS patients showed reduced caudate nucleus and ventral striatum functional connectivity with the sensorimotor cortex (SMC) and frontal, parietal, and temporal cortex regions. Fatigue severity correlated negatively with functional connectivity of the caudate nucleus and ventral striatum with the SMC and positively with functional connectivity of the dlPFC with the rostral inferior parietal gyrus and SMC., Conclusion: MS-related fatigue is associated with reduced functional connectivity between the striatum and sensorimotor as well as attention and reward networks, in which the ventral striatum might be a key integration hub. Together with increased connectivity between the dlPFC and sensory cortical areas, these connectivity alterations shed light on the mechanisms of MS-related fatigue.

Objective: To evaluate whether tuina is more effective and cost-effective in reducing pain compared to no intervention in patients with chronic neck pain., Design: Single-center randomized two-armed controlled trial., Setting: University outpatient clinic specialized in Integrative Medicine., Subjects: Outpatients with chronic neck pain were randomly allocated to tuina or no intervention., Intervention: Six tuina treatments within 3 weeks., Outcome Measures: The primary outcome was the mean neck pain intensity during the previous 7 days on a visual analogue scale after 4 weeks (VAS, 0-100 mm, 0 = no pain, 100 = worst imaginable pain). Secondary outcomes included Neck Pain and Disability Scale (NPDS), Neck Disability Index (NDI), health-related quality of life (12-item quality-of-life questionnaire [SF-12]), medication intake, and cost-effectiveness after 4 and 12 weeks. Statistical analysis included analysis of covariance adjusted for baseline values and a full economic analysis from a societal perspective., Results: Altogether, 92 outpatients were included (46 in both groups, 87% female, mean age 45.4 [standard deviation ±9.7], and mean VAS 57.7 ± 11.5). Tuina treatment led to a clinically meaningful reduction in neck pain intensity (group differences, 4 weeks: -22.8 mm [95% confidence interval, -31.7 to -13.8]; p < 0.001 and 12 weeks: -17.9 mm [-27.1 to -8.8], p < 0.001). No serious adverse events were observed. Total costs as well as quality-adjusted life years (QALYs) did not differ significantly between the groups. When taking group differences into account independently from their statistical significance, costs per QALY gained (incremental cost-effectiveness ratio) would range within a cost-effective area from €7,566 (for costs €10.28 per session) to €39,414 (cost €35 per session)., Conclusion: An additional treatment with six tuina sessions over 3 weeks was effective, safe and relatively cost-effective for patients with chronic neck pain. A future trial should compare tuina to other best care options.

Background: The mechanisms of action underlying acupuncture, including acupuncture point specificity, are not well understood. In the previous decade, an increasing number of studies have applied fMRI to investigate brain response to acupuncture stimulation. Our aim was to provide a systematic overview of acupuncture fMRI research considering the following aspects: 1) differences between verum and sham acupuncture, 2) differences due to various methods of acupuncture manipulation, 3) differences between patients and healthy volunteers, 4) differences between different acupuncture points., Methodology/principal Findings: We systematically searched English, Chinese, Korean and Japanese databases for literature published from the earliest available up until September 2009, without any language restrictions. We included all studies using fMRI to investigate the effect of acupuncture on the human brain (at least one group that received needle-based acupuncture). 779 papers were identified, 149 met the inclusion criteria for the descriptive analysis, and 34 were eligible for the meta-analyses. From a descriptive perspective, multiple studies reported that acupuncture modulates activity within specific brain areas, including somatosensory cortices, limbic system, basal ganglia, brain stem, and cerebellum. Meta-analyses for verum acupuncture stimuli confirmed brain activity within many of the regions mentioned above. Differences between verum and sham acupuncture were noted in brain response in middle cingulate, while some heterogeneity was noted for other regions depending on how such meta-analyses were performed, such as sensorimotor cortices, limbic regions, and cerebellum., Conclusions: Brain response to acupuncture stimuli encompasses a broad network of regions consistent with not just somatosensory, but also affective and cognitive processing. While the results were heterogeneous, from a descriptive perspective most studies suggest that acupuncture can modulate the activity within specific brain areas, and the evidence based on meta-analyses confirmed some of these results. More high quality studies with more transparent methodology are needed to improve the consistency amongst different studies.

Objective: To create a German version of the Southampton Needle Sensation Questionnaire (SNSQ) in order to measure deqi (needling sensation) in subjects receiving different forms of acupuncture and to evaluate the translated questionnaire in an acupuncture study., Methods: A forward and backward translation procedure was applied to create a German version of the SNSQ. Discrepancies between translations were resolved by consensus. Healthy participants from an experimental acupuncture trial were asked to fill in the resulting questionnaire comprising of 17 items (none (0) to intense (3)) and a visual analogue scale (VAS) for pain (0-100 mm) after receiving either sham or real acupuncture with or without stimulation. The questionnaire was validated using factor analysis and correlation analysis., Results: Questionnaires from 63 subjects (mean 27.1 years; 69.8% female) were included in the analysis. Participants tended to score toward the low end of each of the 17 items (mean sum score (± SD): 8.9 ± 7.0). Four factors with eigenvalues > 1 were identified using exploratory factor analysis. Both of the original subscales, aching deqi (AD) and tingling deqi (TD), showed good internal consistency (Cronbach's α: AD: 0.71; TD: 0.78) and medium test-retest reliability (AD: r = 0.538, p = 0.002; TD: r = 0.603, p < 0.001). AD feeling (r = 0.574, p < 0.001) and TD feeling (r = 0.496, p < 0.001) correlated with the VAS for pain., Conclusion: Factor structure of the original questionnaire could not be reproduced with the German version of the SNSQ in an experimental setting. The questionnaire could not discriminate between pain and deqi. Further research is needed to create a German tool which is more suitable to measure deqi., (Copyright © 2011 S. Karger AG, Basel.)

Background: To evaluate the safety of acupuncture in a large number of patients receiving conventional health care and, based on these results, to develop a new medical consent form for acupuncture., Methods: The prospective observational study included patients who received acupuncture treatment for chronic osteoarthritis pain of the knee or hip, low back pain, neck pain or headache, allergic rhinitis, asthma, or dysmenorrhoea. After treatment, all patients documented adverse events associated with acupuncture (defined as adverse effects). Patients who reported a need for treatment due to an adverse effect completed an additional standardised questionnaire on the most important adverse effect. Based on this data and considering ethical and legal aspects a new consent form was developed., Results: A total of 229,230 patients received on average 10.2 +/- 3.0 acupuncture treatments. Altogether, 19,726 patients (8.6%) reported experiencing at least one adverse effect and 4,963 (2.2%) reported one which required treatment. Common adverse effects were bleedings or haematoma (6.1% of patients, 58% of all adverse effects), pain (1.7%) and vegetative symptoms (0.7%). Two patients experienced a pneumothorax (one needed hospital treatment, the other observation only). The longest duration of a side effect was 180 days (nerve lesion of the lower limb). The resulting medical consent form consists of five modules: Introduction to acupuncture and moxibustion, Risks of acupuncture treatment, Conditions which can increase the risk, Doctor's statement, and Consent., Conclusion: Acupuncture provided by physicians is a relatively safe treatment and the proposed consent form could support both patients and professionals in the process of obtaining informed consent., (Copyright (c) 2009 S. Karger AG, Basel.)