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  Access statistics : Table of Contents
   2016| January-March  | Volume 1 | Issue 1  
    Online since April 5, 2016

 
 
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STUDY PROTOCOL
Chinese medicine packet plus wax therapy for periarthritis of the shoulder: study protocol for a multi-center, randomized controlled trial
Ye Wang
January-March 2016, 1(1):25-31
Background: Periarthritis of the shoulder clinically manifests as pain and functional disorder of the shoulder joint. Although there is a tendency to self-heal, results are unsatisfactory. Nonsurgical treatments often used for clinical treatment of periarthritis, including simple closure, massage and acupuncture, do not improve symptoms. Chinese medicine packets and wax treatment effectively improves the local micro-circulation and regulates body functions. Therefore, this study aims to develop a new Chinese medicine wax treatment for periarthritis of the shoulder using these two techniques, and to observe its safety and efficacy. Methods/Design: A prospective, multi-center randomized, double-blind, placebo-controlled clinical trial will enroll patients with periarthritis of the shoulder who will be randomized into treatment and control groups. In the treatment group, packets will be immersed in a decoction of Chinese medicine. Prepared packets will be placed onto the shoulder joint followed by warm paraffin cake, once a day for 20 minutes, for 4 weeks. In the control group, Chinese medicine packets will be replaced by placebo; all other procedures will be identical. Outcome measures will be assessed at baseline and 1, 2, and 4 weeks after treatment. Primary outcome is the McGill Pain Questionnaire score. Secondary outcomes include shoulder disability questionnaire score, Oxford shoulder score, American Shoulder and Elbow Surgeons score, University of California, Los Angeles shoulder score, the efficacy in treating Traditional Chinese Medicine syndromes, visual analog scale score, and Constant-Murley shoulder score. Discussion: This trial will provide a quantitative basis to establish therapeutic guidelines and technical standards for Chinese medicine packet plus wax therapy for the treatment of periarthritis of the shoulder. Trial registration: Chictr.org.cn identifier: ChiCTR-IOR-15006149; registered on 11 March 2015. Written approval for this protocol was obtained from the Ethics Committee of the Affiliated Hospital of Liaoning University of Traditional Chinese Medicine in China (approval No. 2014ZX (KT)-010-02).
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Safety and efficacy of human umbilical cord-derived mesenchymal stem cells in patients with Alzheimer's disease: study protocol for an open-label self-control trial
Jing-wen Niu, Bin Zhang, Hu Chen
January-March 2016, 1(1):1-8
Background: Animal model experiments have demonstrated the efficacy and safety of human umbilical cord-derived mesenchymal stem cells (hUC-MSCs) in the treatment of Alzheimer's disease. However, the clinical efficacy of hUC-MSCs in the treatment of Alzheimer's disease in humans remains unclear. This study protocol for a phase I/II clinical trial was designed to investigate the clinical safety (primary outcome) and efficacy (secondary outcome) of hUC-MSCs in the clinical treatment of Alzheimer's disease. Methods/Design: This open-label, self-control, single-center prospective phase I/II clinical trial will be performed at the Department of Hematopoietic Stem Cell Transplantation, Cell and Gene Therapy Center, the 307 th Hospital of Chinese People's Liberation Army, China. Thirty patients with moderate to severe Alzheimer's disease will be included. The primary outcome is the number of patients who have adverse events at 10 weeks and 1 year after hUM-MSCs therapy. Secondary outcomes include cognitive function, overall clinical status, daily living activities, neuropsychiatric symptoms, blood biochemical Alzheimer's disease markers. Discussion: The findings from this trial will provide valuable evidence for the use of hUM-MSCs in the clinical treatment of Alzheimer's disease. Trial registration: ClinicalTrial.gov identifier: NCT01547689; registered on 5 March 2012. This study protocol was approved by the Ethics Committee of the 307 th Hospital of Chinese People's Liberation Army.
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Safety of intrathecal transplantation of human umbilical cord mesenchymal stem cells for treating hereditary cerebellar ataxia: study protocol for a randomized controlled trial
Yi-hua An
January-March 2016, 1(1):9-16
Background: Intrathecal transplantation of human umbilical cord mesenchymal stem cells (hUCMSCs) has been shown to be effective for treating spinocerebellar ataxia and can improve patient's neurological function to a certain degree without safety concerns. However, further validation by randomized controlled trials is needed. The present study aims to fill this gap. Methods/Design: A single-center, parallel group, open-label, randomized controlled trial will be performed at General Hospital of Chinese Armed Police Forces, China. A total of 100 patients with hereditary cerebellar ataxia will undergo hUCMSC transplantation in the subarachnoid space through lumbar puncture (hUCMSCs transplantation group) or not (control group). The outcome observation time will be designated within 1 week before transplantation, as well as 1, 3, 6, and 12 months after transplantation. Primary outcomes include neurological function evaluation (International Cooperative Ataxia Rating Scale, Modified Falls Efficacy Scale, Berg Balance Assessment, Tremor Rating Scale, and the Timed Up and Go test) and blood tests. Secondary outcomes include electrophysiology examination, mental state evaluation, and urine testing. Discussion: This trial protocol is designed to provide reference data for the safety and rational use of hUCMSC transplantation in the treatment of hereditary cerebellar ataxia. Trial registration: ClinicalTrials.gov identifier: NCT01489267; registered on 30 October 2011. The study protocol has been approved by the ethics committee of the General Hospital of Chinese Armed Police Forces, China (approval No. 201117).
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Transcutaneous electrical acupoint stimulation with different acupoint combinations on opioid consumption in patients undergoing off-pump coronary artery bypass grafting: study protocol for a randomized double-blind controlled trial
Hui Zhang, Chong Lei, Tao-yuan Zhang, Li-hong Hou, Qiang Wang, Hai-long Dong, Jian-ge Han, Li-ze Xiong
January-March 2016, 1(1):17-24
Background: The demand for improved anesthesia during off-pump coronary artery bypass grafting (OP-CABG) is continually increasing. Ensuring stable hemodynamics and balanced myocardial oxygen supply during OP-CABG are key issues that remain to be resolved. There is evidence that acupuncture anesthesia can decrease mortality after OP-CABG, while reducing the dose of anesthesia required, minimizing surgical complications, and decreasing medical costs. Acupuncture at distal-proximal acupoints in combination is the most commonly used method requiring acupoint compatibility. We hypothesize that electroacupuncture at distal-proximal and regional acupoints prior to OP-CABG will reduce the dosage of anesthesia required during OP-CABG, and minimize postoperative complications. Methods/Design: This prospective, randomized, double-blind, controlled trial will be performed at the Departments of Anesthesiology at Xijing Hospital, Fourth Military Medical University, and Tianjin Chest Hospital, China. A total of 186 patients scheduled for OP-CABG in these two hospitals will be included in the study. The patients will be divided into three groups: distal-proximal acupoints group (acupuncture at the Danzhong (CV17) and Hegu (LI4) acupoints); regional acupoints group (acupuncture at the Danzhong (CV17) and Juque (CV14) acupoints); and non-acupoint group (acupuncture at a site 2 cm lateral from the Danzhong (CV17) and Juque (CV14) acupoints). All interventions will start 30 minutes prior to anesthesia and continue until the beginning of anesthesia. The primary outcome is the dose of sufentanil used for anesthesia. Secondary outcomes are cardiac troponin I content, inotropic score, dose of propofol used for anesthesia, duration of mechanical ventilation, duration of stay in the intensive care unit, length of postoperative hospital stay, incidence of overall complications within 30 days of surgery, and incidence of overall mortality within 30 days of surgery. Adverse events will be also evaluated. Discussion: This trial protocol will determine whether acupuncture at distal-proximal or regional acupoints can reduce anesthetic dose and postoperative complications in OP-CABG surgery, with the purpose of ensuring patient safety in the perioperative phase. Trial registration: ClinicalTrals.gov identifier: NCT02443220; registered on 18 August 2014. Ethical approval: The protocol was approved by the Ethics Committee on Clinical Trials of Drugs, Xijing Hospital, and the Ethics Committee on Clinical Trials, Tianjin Chest Hospital, China. Written informed consent regarding trial procedure and treatment protocol will be obtained from each subject.
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Local administration of enriched mononuclear cells, platelets and zoledronic acid for preventing collapse of the femoral head in the early stage of osteonecrosis: study protocol for a prospective randomized parallel-controlled clinical trial
Ning Ma, Jiang Peng, Quan-yi Guo
January-March 2016, 1(1):32-37
Background: Although there are many treatments for osteonecrosis of the femoral head, conservative treatment is often ineffective. Once collapse of the femoral head occurs, the damage is irreversible. Our previous animal studies have shown that local administration of zoledronic acid prevents collapse of the osteonecrotic femoral head. Additionally, bone marrow mononuclear cell therapy has a good short-term clinical effect on osteonecrosis of the femoral head. Currently, it is unclear whether a combination of bone marrow mononuclear cells and platelet-rich plasma may have efficacy in preventing early-stage collapse of the osteonecrotic femoral head. Methods/Design: A prospective, randomized, parallel-controlled, single-center clinical trial will be completed at the Chinese PLA General Hospital, China. One hundred patients with Ficat I-II osteonecrosis of the femoral head will be recruited and equally randomized into treatment and control groups. The treatment group will be given injection of enriched autologous mononuclear cells and zoledronic acid into the necrotic area following core decompression by drilling. In the control group, core decompression by drilling will be done, but no treatment will be given. Patients will be followed up at 3, 6, 12 and 18 months. Dynamic perfusion MR imaging, three-dimensional CT reconstruction, and anteroposterior and lateral X-ray observations of the hip joint will be performed to observe blood supply, bone formation and femoral appearance in the necrotic area. Harris score of the hip joint and a numeric rating scale score will be used to evaluate hip function and pain. These indicators will be used as primary outcome measures. Scores from the 36-Item Short-Form Health Survey and activity of daily living scale will be used as secondary outcome measures. Discussion: The outcomes of this trial will provide quantitative data and related information for evaluating the efficacy of local administration of enriched bone marrow mononuclear cells, platelets and zoledronic acid for the clinical prevention of collapse of the early-stage osteonecrotic femoral head. Trial registration: ClinicalTrial.gov identifier: NCT02721940. Written approval for this protocol was obtained from the ethics committee of the Chinese PLA General Hospital in China (approval No. S2015-082-01).
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