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BACKGROUND: Chronic fatigue syndrome (CFS) is a debilitating multisystem disorder that can lead to various pathophysiological abnormalities and symptoms, including insomnia, gastrointestinal disorders, and anxiety. Due to the side effects of currently available drugs, there is a growing need for safe and effective nondrug therapies. The Prolong Life With Nine Turn (PLWNT) Qigong method is a system of mind-body exercise with restorative benefits that can alleviate the clinical symptoms of CFS and impart a significant inhibitory effect. Various studies have proven the treatment efficacy of PLWNT; however, the impact on insomnia, gastrointestinal disorders, and anxiety in patients with CFS has not yet been investigated. OBJECTIVE: This study aims to evaluate the efficacy and safety of the PLWNT method in terms of its effects on fatigue, insomnia, anxiety, and gastrointestinal symptoms in patients with CFS. METHODS: We will conduct a randomized, analyst-blinded, parallel-controlled trial with a 12-week intervention and 8-week follow-up. A total of 208 patients of age 20-60 years will be recruited. The patients will be randomly divided into a PLWNT Qigong exercise group (PLWNT Group) and a control group treated with cognitive behavioral therapy at a ratio of 1:1. Participants from the treatment groups will be taught by a highly qualified professor at the Shanghai University of Traditional Chinese Medicine once a week and will be supervised via web during the remaining 6 days at home, over 12 consecutive weeks. The primary outcome will be the Multidimensional Fatigue Inventory 20, while the secondary outcomes include the Pittsburgh Sleep Quality Index, Gastrointestinal Symptom Rating Scale, Hospital Anxiety and Depression Scale, functional magnetic resonance imaging, gut microbiota, and peripheral blood. RESULTS: The study was approved by the ethics committee of Shanghai Municipal Hospital of Traditional Chinese Medicine in March 2022 (Ethics Approval Number 2022SHL-KY-05). Recruitment started in July 2022. The intervention is scheduled to be completed in December 2024, and data collection will be completed by the end of January 2025. Over the 3-year recruitment period, 208 participants will be recruited. Data management is still in progress; therefore, data analysis has yet to be performed. CONCLUSIONS: This randomized trial will evaluate the effectiveness of the PLWNT method in relieving fatigue, insomnia, anxiety, and gastrointestinal symptoms in patients with CFS. If proven effective, it will provide a promising alternative intervention for patients with CFS. TRIAL REGISTRATION: China Clinical Trials Registry ChiCTR2200061229; https://www.chictr.org.cn/showproj.html?proj=162803. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/53347.
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INDRODUCTION: Primary dysmenorrhea (PD) is a very common issue in young women that reduces the quality of women's lives. Both Western medicine and traditional Chinese medicine (TCM) provide several ways to treat PD; however, TCM treatment exhibits fewer side effects for the patient. Tuina massage and Chinese herbal compresses are considered forms of external TCM therapy that have been widely used to treat PD, especially in China. Therefore, to provide the most effective and safe treatment for PD, we combined Tuina and Chinese herbal compresses together in this observational study. METHODS: A randomized controlled trial (RCT) consisting of 114 participants from the Shanghai University of Traditional Chinese Medicine who meet inclusion criteria will be divided into two groups in a 1:1 allocation ratio. The intervention group will receive Tuina combined with Chinese herbal compress therapy, while the control group will only receive Chinese herbal compress therapy. The treatment will be given 3 days before menstruation (once per day, 3 times per menstrual cycle). The primary outcome will be measured with the Visual Analog Scale (VAS). The secondary outcomes will be measured by the Dysmenorrhea Symptom Score, the Chinese Medical Dysmenorrhea Symptom Score, the Self-Rating Anxiety Scale (SAS), the Self-Rating Depression Scale (SDS), and the pain threshold at Guanyuan (CV4). CONCLUSION: This study will be the first RCT that will entail the combination of Tuina and Chinese herbal compresses to treat PD in the category of cold coagulation and blood stasis syndrome. If the results demonstrate that Tuina combined with a Chinese herbal compress is effective, we posit that this study will provide evidence-based references for a potential alternative treatment to treat PD in the future.
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Dismenorrea , Umbral del Dolor , Femenino , Humanos , Dismenorrea/tratamiento farmacológico , China , Ensayos Clínicos Controlados Aleatorios como Asunto , Estudios Observacionales como AsuntoRESUMEN
BACKGROUND: Chronic insomnia (CI) is a mind-body disease that is commonly defined as a state of having disturbed daytime activities due to poor nighttime sleep quality. Baduanjin qigong (BDJQG) is widely used for CI in China. However, there is little scientific evidence to evaluate its effects on the hyperarousal state, which is closely associated with improved sleep quality. OBJECTIVE: The objective of the trial is to assess the therapeutic effects of BDJQG on sleep quality in patients with CI. METHODS: A randomized controlled trial will be conducted on 86 patients, who will be divided into a BDJQG group and a cognitive behavioral therapy for insomnia group at a ratio of 1:1. Interventions in both groups will be given to the participants 7 times a week for 8 weeks, and the participants will be followed up for 4 weeks. The primary outcome is the change in the Pittsburgh Sleep Quality Index from baseline to week 8. The secondary outcomes are the changes in the Hyperarousal Scale, Insomnia Severity Index, Fatigue Scale-14, wrist actigraphy, salivary cortisol level, and functional magnetic resonance imaging from baseline to week 8. All main analyses will be carried out on the basis of the intention-to-treat principle. RESULTS: This study was funded from January 2023. As of the submission of the manuscript, there were 86 participants. Data collection began in April 2023 and will end in January 2024. Data analysis is expected to begin in January 2024, with the publication of results expected in February 2024. CONCLUSIONS: This study will present data concerning the clinical effects of BDJQG on CI. The results will help to demonstrate whether BDJQG is an effective therapy for improving sleep quality in association with a decreased hyperarousal level as a possible underlying mechanism. This study will provide much-needed knowledge for complementary and alternative therapy for patients with CI. TRIAL REGISTRATION: China Clinical Registration Agency ChiCTR2300069241; https://chictr.org.cn/bin/project/ChiCTR2300069241. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/53501.
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INTRODUCTION: Chronic fatigue syndrome (CFS) is a physical and mental disorder in which long-term fatigue is the main symptom. CFS patients are often accompanied by functional gastrointestinal diseases (FGIDs), which lead to decreased quality of life and increased fatigue. Prolong-life-with-nine-turn-method (PLWNT) is a kind of physical and mental exercise. Its operation includes adjusting the mind, breathing and cooperating with eight self-rubbing methods and one upper body rocking method. PLWNT was used to improve the digestive function in ancient China and to treat FGIDs such as functional dyspepsia and irritable bowel syndrome in modern times. Previous studies have shown that PLWNT can reduce fatigue in patients with CFS. But it is unclear whether the effect of PLWNT on CFS fatigue is related to gastrointestinal function. The aim of this study was to explore the relationship between PLWNT and fatigue and gastrointestinal function in patients with CFS. METHODS: This study is a non-inferiority randomized controlled trial (RCT). The whole study period is 38 weeks, including 2 weeks of baseline evaluation, 12 weeks of intervention and 6 months of follow-up. Ninety-six CFS patients will be stratified random assigned to the intervention group (PLWNT) and the control group (cognitive behavior treatment) in the ratio of 1:1 through the random number table generated by SPSS. In the evaluation of results, Multidimensional Fatigue Inventory-20 (MFI-20), Gastrointestinal Symptom Rating Scale (GSRS), Bristol Stool Form Scale (BSFS), and Short Form 36 item health survey (SF-36) will be evaluated at week 0 (baseline), week 6 (midterm), week 12 (endpoint) and month 9 (follow up). The intestinal flora will be evaluated at week 0 (baseline) and week 12 (endpoint). The data results will be processed by statistical experts. The data analysis will be based on the intention to treat principle and per-protocol analysis. In the efficacy evaluation, repeated measurement analysis of variance will be used for data conforming to normal distribution or approximate normal distribution. The data which do not conform to the analysis of repeated measurement variance will be analyzed by the generalized estimation equation Linear discriminant analysis will be used to clarify the difference species of intestinal flora. The significance level sets as 5%. The safety of interventions will be evaluated after each treatment session. DISCUSSION: This trial will provide evidence to PLWNT exerting positive effects on fatigue and gastrointestinal function of CFS. It will further explore whether the improvement of PLWNT on CFS fatigue is related to gastrointestinal function. TRIAL REGISTRATION: The trial was registered at Chinese Clinical Trial Registry http://www.chictr.org.cn/showproj.aspx?proj=151456 (Registration No.: ChiCTR2200056530). Date: 2022-02-07.
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Síndrome de Fatiga Crónica , Qigong , Humanos , Síndrome de Fatiga Crónica/diagnóstico , Calidad de Vida , Ejercicio Físico , Pacientes , Resultado del Tratamiento , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
BACKGROUND: Knee osteoarthritis (KOA) is a common public health problem and a leading cause of long-term pain, decreased muscle strength, and even disability. Tai Chi has been proved effective and highly recommended for KOA management worldwide. However, little is known about its benefits on quadriceps strength which is closely associated with relieving knee pain. This trial is designed to evaluate the efficacy and safety of Tai Chi on knee pain and muscle strength in middle-aged and older adults with KOA. METHODS: A total of 100 participants will be randomly divided into a Tai Chi group (TC group) (1x/week for 12 weeks) and a control group with a health education and stretching program (1x/week for 12 weeks) with a follow-up period of 6 weeks. The primary outcome is the change of Western Ontario and McMaster Universities (WOMAC) pain subscale at week 12 compared with baseline. Secondary outcomes include WOMAC stiffness and function subscales, data from isokinetic dynamometry, gait analysis with electromyography (EMG), and a 36-item short form health survey (SF-36). The daily dose of pain-relieving medication will also be recorded. All adverse effects will be assessed by the Treatment Emergent Symptom Scale (TESS). DISCUSSION: We expect this randomized trial to evaluate the effectiveness of Tai Chi on relieving pain and increasing quadriceps strength in KOA patients. This protocol, if proven effective, will contribute to providing a promising alternative intervention for middle-aged and older adults with KOA. TRIALS REGISTRATION NUMBER: This trial has been registered in the China Clinical Trials Registry (registration number: ChiCTR2300069339).
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Osteoartritis de la Rodilla , Taichi Chuan , Persona de Mediana Edad , Humanos , Anciano , Osteoartritis de la Rodilla/terapia , Resultado del Tratamiento , Dolor , Fuerza Muscular , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
Background: Traditional Chinese exercise has been shown to be effective in relieving long-term chronic pain, physical dysfunction, decreased ability to participate in society and decreased quality of life in musculoskeletal diseases. In recent years, there has been a steady increase in publications on the treatment of musculoskeletal disorders by traditional Chinese exercises. The purpose of this study is to review the characteristics and trends of Chinese traditional exercise studies on musculoskeletal diseases published since 2000 through bibliometric analysis, and identify current research hotspots, so as to guide the direction of future research. Methods: Publications regarding traditional Chinese exercises for musculoskeletal disorders from 2000 to 2022 were downloaded from the Web of Science Core Collection. VOSviewer 1.6.18 and CiteSpace V software were used for bibliometric analyses. Bibliometric visualization and comparative analysis were conducted for authors, cited authors, journals, co-cited journals, institutions, countries, references, and keywords. Results: A total of 432 articles were obtained, with an upward trend over time. The most productive countries and institutions in this field are the USA (183) and Harvard University (70). Evidence-based Complementary and Alternative Medicine (20) was the most prolific journal, Cochrane Database System Review (758) was the most commonly cited journal. Wang Chenchen published the largest number of articles (18). According to high frequency keywords, the hot spot musculoskeletal disorder and the type of traditional Chinese exercise are knee osteoarthritis and Tai Chi. Conclusion: This study provides a scientific perspective for the research of traditional Chinese exercises for musculoskeletal disorders and provides valuable information for researchers to discover the current research status, hot spots and new trends of future research.
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BACKGROUND: Chronic fatigue syndrome (CFS) is a chronic disease characterized by various symptoms such as pathological fatigue, cognitive dysfunction, and inability to recover energy after waking up. The Yijinjing, a kind of health care practice from ancient China, consists of 12 movements, and it is considered as one of the complementary and alternative medicine (CAM) for health maintenance, health care, and disease healing. In this study, multiple scales were used to evaluate the effects of Yijinjing intervention on the clinical symptoms of CFS. PATIENTS AND METHODS: Forty patients with CFS were randomly assigned to Yijinjing group and the cognitive behavior therapy (CBT) group separately. The Yijinjing intervention was practiced 6 times per week, among which one exercise should be guided by the teacher of the faculty in the university, and another 5 times should be finished at home over 12 consecutive weeks. Similarly, the control group received cognitive education, including popular science lectures and psychological counseling related to CFS prevention and treatment for 12 weeks. Multidimensional Fatigue Inventory-20 (MFI-20), Short Form 36-item Health Survey (SF-36), and Pittsburgh Sleep Quality Index (PSQI) were assessed before and after intervention. RESULTS: Intra-group analysis showed that the differences in MFI-20, SF-36, and PSQI were statistically significant (p < 0.05) after the intervention of 12 weeks Yijinjing intervention. Compared with the CBT group, the differences in MFI-20 and PSQI of the Yijinjing group were statistically significant (p < 0.05), but SF-36 was superior to the CBT group in terms of physical function, bodily pain, general health, and vitality (p < 0.05). CONCLUSION: Yijinjing can significantly improve sleep disorders, fatigue, and quality of life in patients with CFS and is superior to behavioral cognitive education in pain and vitality. The study was registered with Chinese Clinical Trial Registry: ChiCTR-INR-17010694.
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Síndrome de Fatiga Crónica , Calidad de Vida , Humanos , Síndrome de Fatiga Crónica/terapia , Calidad del Sueño , Depresión/terapia , Estado de SaludRESUMEN
Importance: Both tuina therapy and yijinjing exercise were beneficial to patients with nonspecific chronic neck pain, but the evidence for this combination is limited. Objective: To investigate the effectiveness of tuina therapy combined with yijinjing exercise compared with tuina therapy alone for patients with nonspecific chronic neck pain. Design, Setting, and Participants: A 12-week, open-label, analyst-blinded randomized clinical trial (8-week intervention plus 4-week observational follow-up) was conducted from September 7, 2020, to October 25, 2021. A total of 102 participants with nonspecific chronic neck pain were recruited, and data were analyzed from December 10, 2021, to March 26, 2022. Interventions: Participants in the tuina group or tuina combined with yijinjing group received 3 sessions of tuina therapy per week for 8 weeks, for a total of 24 sessions. Participants in the tuina combined with yijinjing group practiced yijinjing 3 times a week for 8 weeks, including an instructor-guided exercise at the hospital and 2 self-practice exercises at home. Main Outcomes and Measures: The primary outcome was change in visual analog scale (VAS) score from baseline to week 8. Secondary outcomes included Neck Disability Index scores, Self-rating Anxiety Scale scores, tissue hardness, and active range of motion. Results: This randomized clinical trial recruited 102 patients (mean [SD] age, 36.5 [4.9] years; 69 [67.6%] female) who were randomized to 2 groups. All 102 patients (100%) completed all the outcome measurements. The mean difference in VAS scores from baseline at week 8 for the tuina combined with yijinjing group was -5.4 (95% CI, -5.8 to -5.1). At week 8, the difference in VAS score was -1.2 (95% CI, -1.6 to -0.8; P < .001) between the tuina group and the tuina combined with yijinjing group. The effectiveness of tuina combined with yijinjing in treating nonspecific chronic neck pain remained at the 12-week follow-up. Conclusions and Relevance: In this randomized clinical trial, for patients with nonspecific chronic neck pain, tuina combined with yijinjing was more effective than tuina therapy alone in terms of pain, functional recovery, and anxiety at week 8, and effectiveness remained at week 12. A combination of tuina and yijinjing should be considered in the management of nonspecific chronic neck pain. Trial Registration: Chinese Clinical Trial Registry: ChiCTR2000036805.
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Dolor Crónico , Terapia por Ejercicio , Dolor de Cuello , Adulto , Femenino , Humanos , Masculino , Dolor Crónico/terapia , Dolor de Cuello/terapia , Dimensión del Dolor , Resultado del TratamientoRESUMEN
Background: Chronic fatigue syndrome (CFS) is characterized by persistent fatigue, which often leads to physical and psychological damage. The Prolong Life with Nine Turn method (PLWNT) Qigong is considered as one of the complementary treatments for improving symptoms in patients with CFS. In this study, we used functional magnetic resonance imaging (fMRI) to explore the effects of PLWNT intervention on the subjects with CFS. Methods: Thirty four CFS patients were randomly divided into PLWNT group and cognitive behavioral therapy (CBT) group. Both groups were taught by a highly qualified professor at the Shanghai University of Traditional Chinese Medicine once a week and were supervised online during the remaining 6 days at home, over 12 consecutive weeks. We calculated the regional rs-fMRI index amplitude of low-frequency fluctuations (ALFF) for all subjects. To study the changes of the brain network, we used the brain regions with significant differences in ALFF as the regions of interest for whole-brain functional connectivity (FC) analysis. The Multi-dimensional Fatigue Inventory 20 (MFI-20) and Short Form 36-item Health Survey (SF-36) were used for clinical symptom assessment to explore the possible correlation between the rs-fMRI indicators and clinical variations. Results: The ALFF values of the right superior frontal gyrus (SFG), and left median cingulate gyrus (DCG) were increased, whereas those of the left middle occipital gyrus (OG), right middle OG and left middle temporal gyrus (MTG) were decreased in PLWNT group. The FC values between the DCG and middle temporal gyrus (MTG), and those between the left OG and the right OG were enhanced. In addition, the SF-36 were positively with the left OG (r = 0.524), SFG (r = 0.517), and DCG (r = 0.533), MFI-20 were negatively with the SFG (r = -0.542) and DCG (r = -0.578). These results were all corrected by FWE (voxel level p < 0.001, cluster level p < 0.05). Conclusion: CFS patients have abnormal regional spontaneous neuronal activity and abnormal functional connections between regions after PLWNT intervention. PLWNT can relieve the fatigue symptoms of CFS patients and improve their quality of life. The study was registered in the American Clinical Trial Registry (12/04/2018). Registration Number is NCT03496961.
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Background: Chronic fatigue syndrome (CFS) is a complex disease of unknown etiology and mechanism. The purpose of this study was to investigate the effect of Prolong Life with Nine Turn Method (PLWNT) Qigong exercise on CFS focusing on fatigue, sleep quality, depression, and anxiety. Methods: A total of 90 participants diagnosed with CFS were randomly assigned into two parallel groups: PLWNT and cognitive behavioral therapy (CBT). The participants in the PLWNT or CBT group participated in qigong exercise or cognitive behavior education program, respectively, once a week in-person and were supervised online during the remaining 6 days at home, over 12 consecutive weeks. The primary outcome was fatigue (Multi-dimensional Fatigue Inventory 20 [MFI-20]), and secondary outcomes were sleep quality (Pittsburgh Sleep Quality Index [PSQI]), anxiety, depression (Hospital Anxiety and Depression Scale [HADS]), and changes in the Neuropeptide Y (NPY) of peripheral blood. Results: The within-group comparisons of the PLWNT and CBT groups revealed significant improvement in both groups in MFI-20, PSQI, and HADS scores (P < 0.05). No significant difference were found between the PLWNT and CBT groups, even though the effective rate of the PLWNT group was 62.22%, which is slightly than 50.00% of the CBT group. The fatigue scores in the PLWNT group were positively correlated with sleep degree (r = 0.315) and anxiety degree (r = 0.333), only anxiety degree (r = 0.332) was found to be positively correlated with fatigue in the CBT group. The analysis of peripheral blood showed that NPY decreased after PLWNT intervention but increased significantly in the CBT. Conclusion: The PLWNT qigong exercise has potential to be an effective rehabilitation method for CFS symptoms including fatigue, sleep disturbance, anxiety, and depression. Future studies should expand study sample size for in-depth investigation to determine the optimal frequency and intensity of PLWNT qigong intervention in CFS patients. The study was registered in the ClinicalTrials.gov database on April 12, 2018, with registration number NCT03496961.
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BACKGROUND: Insomnia is a common sleeping disorder which affects the quality of life which can bring harms to physical and mental health of human beings and even economic development. Traditional Chinese medicine (TCM) plays an outstanding role in treating chronic diseases and alleviating their symptoms. Therefore, the purpose of this study is to assess the treatment efficacy in patients with insomnia treated with abdomen-rubbing qigong exercise (ARQE). In addition, the brain function changes of patients will be explored by resting state functional magnetic resonance imaging (rs-fMRI). METHOD/DESIGN: This trial is a randomized, single-blind, controlled study planned to transpire between July 1, 2020, and July 31, 2021. A sample size of 114 participants (57 per group) with chronic insomnia will be randomly assigned to receive ARQE or CBTI for 8 weeks. The study duration will be 13 weeks, including a 1-week screening period, 8 weeks of intervention, and another 4 weeks of follow-up. The primary outcome is the Pittsburgh sleep quality index scores. Secondary outcomes include insomnia severity index, gastrointestinal symptom rating scale, the Hamilton Depression Scale, and rs-fMRI scan. The adverse events will be in control. DISCUSSION: The results of this study will help to clarify the efficacy of ARQE in the treatment of insomnia and try to use rs-fMRI technology to explore the brain function changes of ARQE in improving sleep quality in patients with insomnia disorder. If the results are as expected, this study will provide high-quality evidence for the treatment of insomnia with ARQE. TRIAL REGISTRATION: China Clinical Registration Agency ChiCTR1900028009 . Registered on 19 December 2019.
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Qigong , Trastornos del Inicio y del Mantenimiento del Sueño , Abdomen , Humanos , Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como Asunto , Método Simple Ciego , Trastornos del Inicio y del Mantenimiento del Sueño/diagnóstico , Trastornos del Inicio y del Mantenimiento del Sueño/terapia , Resultado del TratamientoRESUMEN
BACKGROUND: Non-specific chronic neck pain (NCNP) is a common musculoskeletal disorder which has caused a huge economic burden due to its expensive health costs and high re-occurrence rate. Yijinjing and Tuina are widely used for non-specific chronic neck pain in China. But there is little scientific evidence to evaluate their efficacy for NCNP. The aim of this research is to compare the efficacy of Yijinjng combined with Tuina versus Tuina for patients with NCNP. METHODS/DESIGN: A randomized controlled trial in which 102 patients with non-specific chronic neck pain will be recruited and randomly allocated to either the Tuina group or the Yijinjng combined with Tuina group in a 1:1 ratio. The interventions for both groups will be carried out three times a week for 8 weeks. The patients in the two groups will receive follow-up 1 month after the intervention. The primary outcome will be the changes in the visual analog scale (VAS). Secondary outcomes will be measured by the Neck Disability Index (NDI), Self-Rating Anxiety Scale (SAS), and Tissue Hardness and Active Range of Motion (AROM). The data will be analyzed at the baseline, 4 weeks during the intervention, at the end of the intervention, and 1 month after the intervention. The significance level sets as 5%. The safety of interventions will be evaluated after each treatment session. DISCUSSION: The purpose of this trial is to determine whether Yijinjing combined with Tuina is not inferior to Tuina for patients with NCNP. This study will provide clinicians and stakeholders much-needed knowledge for a complementary and alternative therapy for patients with non-specific chronic neck pain. TRIAL REGISTRATION: ChiCTR registry (ChiCTR) 2000036805 . Registered on August 25, 2020.
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Dolor Crónico , Dolor de Cuello , Dolor Crónico/diagnóstico , Dolor Crónico/terapia , Humanos , Dolor de Cuello/diagnóstico , Dolor de Cuello/terapia , Dimensión del Dolor , Ensayos Clínicos Controlados Aleatorios como Asunto , Rango del Movimiento Articular , Resultado del TratamientoRESUMEN
BACKGROUND: Chronic fatigue syndrome (CFS) is characterized by persistent fatigue, which often leads to physical and psychological damage. Cognitive behavioral therapy (CBT) is considered to be one of the most effective treatments. Prolong life with nine turn method (PLWNT) Qigong is a combination of complex two-way traffic path connecting the cognitive center and the enteric nerves. In this study protocol, we will explore the effectiveness of PLWNT for physical and mental fatigue, gastrointestinal function, depression, and sleep quality in patients with CFS using clinical effectiveness scales and functional magnetic imaging (fMRI). METHODS: A randomized controlled trial (RCT) consisting of 90 patients will be divided into a CBT and PLWNT group. Both of the groups will include a supervised intervention at the Shanghai University of Traditional Chinese Medicine once a week, and the remaining six days will be completed at home over 12 consecutive weeks. The primary outcome variable will be the Multidimensional Fatigue Inventory (MFI20). Secondary outcomes will evaluate the Short Form 36-item Health Survey (SF-36), the Pittsburgh Sleep Quality Index (PSQI), the Hospital Anxiety and Depression Scale (HADS), and brain activation will be explored using fMRI. RESULTS: This will be the first randomized controlled clinical trial to introduce the PLWNT method for the treatment of CFS. If these results demonstrate that CBT or PLWNT interventions are effective, they will provide a quality treatment plan for patients with chronic fatigue and optimize their guidance. TRIAL REGISTRATION: Clinical Trials Registry, NCT03496961, Registered on April 12, 2018.
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Terapia Cognitivo-Conductual , Síndrome de Fatiga Crónica , Qigong , China , Terapia por Ejercicio , Síndrome de Fatiga Crónica/terapia , Humanos , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
BACKGROUND: A disturbance in the level of consciousness is a classical clinical sign of several seizure types. Recent studies have shown that altered states of consciousness in seizures are associated with structural and functional changes of several brain regions. Prominent among these are the thalamus, the brain stem and the default mode network, which is part of the consciousness system. Our study used diffusion tensor imaging (DTI) to evaluate these brain regions in patients with three different types of epilepsies that are associated with altered consciousness: complex partial seizures (CPS), primary generalized tonic-clonic seizures (PGTCS) or secondary generalized tonic-clonic seizures (SGTCS). Additionally, this study further explores the probable mechanisms underlying impairment of consciousness in seizures. MATERIALS AND METHODS: Conventional MRI and DTI scanning were performed in 51 patients with epilepsy and 51 healthy volunteers. The epilepsy group was in turn subdivided into three subgroups: CPS, PGTCS or SGTCS. Each subgroup comprised 17 patients. Each subject involved in the study underwent a DTI evaluation of the brain to measure the apparent diffusion coefficient (ADC) and fractional anisotropy (FA) values of nine regions of interest: the postero-superior portion of midbrain, the bilateral dorsal thalamus, the bilateral precuneus/posterior cingulate, the bilateral medial pre-frontal gyri and the bilateral supramarginalgyri. The statistical significance of the measured ADC and FA values between the experimental and control groups was analysed using the paired t-test, and one-way analysis of variance was performed for a comparative analysis between the three subgroups. RESULTS: Statistically significantly higher ADC values ( p < 0.01) were observed in the bilateral dorsal thalamus and postero-superior aspect of the midbrain in the three patient subgroups than in the control group. There were no significant changes in the ADC values ( p > 0.05) in the bilateral precuneus/posterior cingulate, bilateral medial pre-frontal gyri or bilateral supramarginalgyri in the experimental group. Among the three patient subgroups and the ADC values of corresponding brain regions, there were no statistically significant changes. Statistically significantly lower FA values ( p < 0.05) were observed in the bilateral dorsal thalamus of the patients in the three subgroups than in the control group. Significantly lowered FA values from the postero-superior aspect of the mid brain ( p < 0.01) were observed in patients with PGTCS compared with the control group. There were no significant changes in the FA values ( p > 0.05) from the bilateral precuneus/posterior cingulate, bilateral medial frontal gyri or bilateral supramarginalgyri in the experimental group. Among the three patient subgroups and the FA values of the corresponding brain regions, there were no statistically significant changes. CONCLUSION: In epileptic patients with CPS, PGTCS or SGTCS, there seems to be a long-lasting neuronal dysfunction of the bilateral dorsal thalamus and postero-superior aspect of the midbrain. The thalamus and upper brain stem are likely to play a key role in epileptic patients with impaired consciousness.