Export selected to
Endnote
Reference Manager
Procite
Medlars Format
RefWorks Format
BibTex Format
  Access statistics : Table of Contents
   2016| January-March  | Volume 1 | Issue 1  
    Online since March 16, 2016

 
 
  Archives   Next Issue   Most popular articles   Most cited articles
 
Hide all abstracts  Show selected abstracts  Export selected to
  Viewed PDF Cited
STUDY PROTOCOL
Safety and efficacy of WeChat combined with Yi Jin Jing exercise for the treatment of cervical spondylosis in white-collar workers: study protocol for a prospective open label randomized controlled trial
Guang-hui An, Xiao-ting Tang, Guo-miao Zhu
January-March 2016, 1(1):31-37
DOI:10.4103/2468-5674.178853  
Background: Yi Jin Jing (changing tendon exercise) is a traditional Chinese exercise. Yi Jin Jing can reportedly prevent cervical spondylosis in financial professionals. In the absence of effective supervision and follow-up training, Yi Jin Jing self-exercise does not become habitual, reducing the efficacy of the technique. WeChat is an online text and voice messaging communication service developed by Tencent in China, and can be used as an interactive platform for doctors and patients. We hypothesized that WeChat could be used to guide Yi Jin Jing exercise, potentially enhancing the preventative and therapeutic benefits for cervical spondylosis in white-collar workers. Methods/Design: 120 financial professionals with cervical spondylosis working at the Bank Card Industrial Park in Pudong New Area, Shanghai, China will be enrolled in this prospective, open label, randomized controlled trial. Participants will be equally and randomly divided into two groups. In the intervention group, participants will undertake conventional Yi Jin Jing training followed by a group chat using WeChat to provide interactive guidance. In the control group, participants will undertake conventional Yi Jin Jing training alone. The primary ontcome will be the Cervical Spondylosis Symptoms scale measured 1, 3, 6 and 12 months after training. The secondary outcomes will be the 36-item Short Form Health Survey score, Visual Analog Scale score for pain intensity, medical expenses and the number of days absent from work. Discussion: This study will examine whether on-going interactive Yi Jin Jing exercise using the WeChat platform will improve outcomes in participants with cervical spondylosis. Trial registration: This trial was registered with the Chinese Clinical Trial Registry (identifier: ChiCTR-OCH-13003426) on 6 August 2013. Ethical approval: Written approval for this project was obtained from the Ethics Committee of Wanggang Community Health Center, Shanghai Pudong New Area, Shanghai, China (approval number WG2013 0709001). All patients will be informed of the protocols and will provide written informed consent.
  15,076 1,060 -
Femoral nerve block prevents deep venous thrombosis of the lower extremity after knee arthroplasty: a single-center randomized controlled trial
Yi Chen, Shen Qu, Gang Ma, Jin-hai Meng, Xin-li Ni
January-March 2016, 1(1):8-14
DOI:10.4103/2468-5674.178820  
Background: The use of tourniquets in knee arthroplasty can promote the release of abundant neutrophil elastase from neutrophils, which increases the risk of deep venous thrombosis of the lower extremity. Advanced femoral nerve blocks can decrease the risk of deep venous thrombosis of the lower extremity after knee arthroplasty, but their mechanism of action remains unclear. We assume that the femoral nerve block can effectively suppress the inflammatory reaction and prevent deep venous thrombosis of the lower extremity after knee arthroplasty. Methods/Design: A total of 120 patients undergoing total knee arthroplasty under general anesthesia in the General Hospital of Ningxia Medical University of China will be enrolled in this single-center randomized controlled trial. These patients will be equally and randomly assigned to three groups. In the advanced femoral nerve block group, ultrasound-guided femoral nerve block will be conducted 30 minutes before surgery. In the conventional femoral nerve block group, ultrasound-guided femoral nerve block will be carried out at consciousness after surgery. In the intravenous analgesia group, an analgesia pump will be used to relieve pain after surgery. The primary outcomes will be the changes in the levels of serum thrombosis-related inflammatory factors (neutrophil elastase, thrombin-antithrombin III complex, D-dimers, C-reactive protein, tumor necrosis factor-α, interleukin-1, interleukin-6, and interleukin-8) immediately after entering the operating room; 30 and 60 minutes after application of the tourniquet; 30 minutes after removal of the tourniquet; and 12, 24 and 48 hours after surgery. The secondary outcomes measures will be the Ramsay Sedation Scale score, visual analogue scale score, times until initial and complete effect of the block, muscle strength rating, blood loss, and color Doppler ultrasound examination results of the lower extremity veins. Discussion: We hope to identify the clinical advantages of advanced femoral nerve block for total knee arthroplasty and determine whether deep venous thrombosis of the lower extremity after knee arthroplasty can be prevented by inhibiting the release of abundant neutrophil elastase and suppressing the inflammatory reaction. Trial registration: ClinicalTrial.gov identifier: NCT02411097; registered on 20 March 2015. Ethical approval: Written approval for this project was obtained from the Ethics Committee of the General Hospital of Ningxia Medical University of China. All patients or their family members will be informed of the protocols and will provide written informed consent. Our study is in accordance with the guidelines of the Declaration of Helsinki, formulated by the World Medical Association.
  12,742 1,060 -
Cubital tunnel syndrome treated with ulnar nerve simple decompression, anterior intramuscular or subcutaneous transposition: a parallel randomized controlled clinical trial
Qian-qian Liu, Rui Li
January-March 2016, 1(1):15-21
DOI:10.4103/2468-5674.178845  
Background: Simple decompression and anterior transposition of the ulnar nerve are surgical methods commonly used for treating moderate and severe cubital tunnel syndrome. It is generally thought that anterior transposition effectively eliminates ulnar nerve compression, but simple decompression cannot improve symptoms. However, studies have also shown that the therapeutic effects of the two procedures are identical. The advantages and disadvantages of the two surgical methods have been described in a small number of cases. Thus, we will conduct a parallel-group randomized controlled clinical trial to determine the optimal surgical intervention. Methods/Design: The trial will be conducted at the Center for Hand and Foot Surgery and Reparative and Reconstructive Surgery, Orthopedics Hospital, the Second Hospital, Jilin University, China. Moderate and severe cubital tunnel syndrome patients will be equally and randomly divided into simple decompression, anterior intramuscular transposition, and anterior subcutaneous transposition groups. In the simple decompression group, adhesions will be completely removed around the ulnar nerve. In the anterior intramuscular transposition group, the ulnar nerve and its accompanying nutrient vessels will be removed in the tunnel of the forearm flexor, pronator teres muscle membrane, and a small portion of muscle fibers below it. In the anterior subcutaneous transposition group, the ulnar nerve in the cubital tunnel will be dissociated and placed in the subcutaneous tissue of the forearm flexor and pronator teres. Two primary outcomes will be determined, sensory disturbance, tested with Semmes-Weinstein filaments, and muscle strength, evaluated using the Medical Research Council's grading system. The secondary outcomes of pain will be assessed with the Visual Analogue Scale and the function of the ulnar nerve with electromyography. Discussion: Trial results will provide a reference for selecting an effective surgical method for treating moderate and severe cubital tunnel syndrome. Trial registration: ClinicalTrial.gov identifier: NCT01893164; registered on 2 July 2013. Ethical approval: Written approval for this project was obtained from the Ethics Committee of the Orthopedics Hospital, the Second Hospital, Jilin University of China. Our study is in accordance with the guidelines of the Declaration of Helsinki, formulated by the World Medical Association.
  12,625 978 -
Iodophor-impregnated versus iodophor-free adhesive drapes for prevention and healing of wound infections after total hip arthroplasty: study protocol for a randomized controlled trial
Zhuo Wu, Zhi Wang, Zeng-bing Xia
January-March 2016, 1(1):38-43
DOI:10.4103/2468-5674.178854  
Background: Surgical adhesive drapes can be used to create an aseptic area around the operative wound to reduce bacterial infection. However, the efficacy of such drapes in preventing wound infection remains unclear. Few studies have examined the effects of iodophor-impregnated and iodophor-free adhesive drapes on bacteria in the deeper layers of the epidermis. We therefore plan to compare the effects of 3M iodophor-impregnated antibacterial adhesive drapes and 3M aseptic iodophor-free adhesive drapes on the incidence of wound infection and wound healing after total hip arthroplasty. Methods/Design: We will perform a single-center, randomized, double-blinded, parallel-cohort controlled trial at the Hospital of Bone Injury, Guangzhou University of Traditional Chinese Medicine, China. A total of 120 patients scheduled for total hip arthroplasty will be numbered according to their sequence of admission to the operating room and sex, in a single-blinded manner: men, nos. 1-60 and women, nos. 1-60. Odd-numbered patients will be operated on using iodophor-impregnated adhesive drapes, and even-numbered with iodophor-free adhesive drapes at the surgical site. Peri-articular tissue will be harvested for bacterial culture after disinfection and again between the end of surgery and prior to skin suturing. The primary outcomes will be Bacterial culture results, wound healing time and grade, The secondary outcomes will be pain score (Visual Analog Scale), Harris score, and X-ray results. Discussion: The trial outcomes will support the rational use of iodophor-impregnated surgical adhesive drapes for preventing wound infections after total hip arthroplasty. Trial registration: ClinicalTrial.gov identifier: NCT02707302. Ethical approval: This study protocol acquired written approval from Ethics Committee of Hospital of Bone Injury, Guangzhou University of Traditional Chinese Medicine, China (approval No. 2016-001-01), and will be performed in accordance with the Declaration of Helsinki developed by the World Medical Association.
  11,766 1,119 1
Local application of mitomycin C for prevention of epidural fibrosis: study protocol for a prospective randomized controlled double-blinded trial
Tao Sui, Lei Liu, Xiao-tao Wu, Xiao-jian Cao
January-March 2016, 1(1):22-30
DOI:10.4103/2468-5674.178847  
Background: Interventions including lumbar discectomy are a primary treatment method for degenerative disc disease. However, after surgery, scar adhesion often forms at the spinal dura mater or adventitial nerves in the defective vertebral plate region and affects recovery. Our previous animal experiments showed that mitomycin C applied topically could safely protect against epidural fibrosis at an optimal dose of 0.5 mg/mL. However, randomized controlled clinical studies have shown that 1 mg/mL mitomycin C does not show obvious therapeutic effects on epidural fibrosis in patients after lumbar discectomy. Methods/Design: This prospective, randomized, controlled, double-blinded, single-center clinical trial will be performed at the Affiliated Zhongda Hospital of Southeast University in China. Seventy-five patients with single-level lumbar disc protrusion will be included in this study and undergo microendoscopic discectomy. The site of discectomy will be topically treated with cotton wool impregnated with 0.5 mg/mL mitomycin C (treatment group) or 0.9% physiological saline (control group) for 5 minutes. Contrast-enhanced MRI score of the lumbar spine will be the primary outcome measure used to evaluate epidural scar proliferation and adhesion, and Lumbar Spine Outcomes Questionnaire score will be the secondary outcome used to evaluate epidural fibrosis-related clinical symptoms. Discussion: This study protocol will try to establish an imaging method to precisely grade epidural fibrosis data acquired after microendoscopic discectomy via a prospective, randomized, controlled, double-blinded trial. A safe and effective mitomycin C dose, 0.5 mg/mL, will be topically applied, and the efficacy and safety of mitomycin C for the prevention of epidural fibrosis will be investigated to provide evidence for the clinical use of mitomycin C. Trial registration: This protocol was registered at Chinese Clinical Trial Registry (identifier: ChiCTR-TRC-10001079) on 6 September 2010. Ethical approval: The study protocol has acquired written approval from Ethics Committee of the First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University, China (approval No. 2010-SR-088) and will be performed in accordance with the guidelines of the Declaration of Helsinki, formulated by the World Medical Association.
  11,610 876 -
Clinical efficacy of tranexamic acid administration via different routes during total hip arthroplasty: study protocol for a prospective randomized controlled trial
Kai-di Zhou, Hong-yi Wang, Yu-fei Yan, Wei-xiang Hong, Jian-min Feng
January-March 2016, 1(1):1-7
DOI:10.4103/2468-5674.178819  
Background: Intravenous injection or topical application of tranexamic acid during total hip arthroplasty has been shown to effectively reduce blood loss. There is no consensus on differences in clinical efficacy and safety between these two administration methods. To determine the optimal clinical efficacy of tranexamic acid during hip replacement, we will compare differences between these two administration methods during total hip arthroplasty. Methods/Design: The study protocol is a prospective, paired (1:1:1), double-blind, randomized controlled clinical trial. A total of 174 patients who will receive hip replacement at Ruijin Hospital, Shanghai Jiao Tong University, China will be randomly divided into three groups, with 58 patients per group. Before the end of surgery, in the placebo group, 60 mL of physiological saline will be used to soak the articular cavity for at least 3 minutes and then be sucked away; in the topical tranexamic acid group, 60 mL of physiological saline containing 3 g tranexamic acid will be used and then sucked away; in the intravenous tranexamic acid group, 100 mL of physiological saline containing 10 mg/kg tranexamic acid will be intravenously administered 15 minutes before surgery and then again 3 hours later. The primary outcome is total blood loss on postoperative day 3, which is calculated using Nadler's and Gross's formula. Secondary outcomes include blood transfusion rates, drainage output within 2 days postoperation, amount of human serum albumin used during hospitalization, postoperative blood coagulation indices, and incidences of deep venous thrombosis and other thromboembolic events during postoperative day 1-week 6. Discussion: This protocol is powered to provide reference information for the rational use of tranexamic acid by comparing clinical efficacy of the drug between intravenous and topical administration routes. Trial registration: ClinicalTrials.gov identifier: NCT02312440; registered on 28 November 2014. Ethical approval: This study protocol was approved by the Ethics Committee of Ruijin Hospital, Shanghai Jiao Tong University, China (permission No. (2014)-47-2) and will be performed in accordance with the Declaration of Helsinki.
  11,095 1,086 1