scholarly journals The Clinical Efficacy, Safety and Biomechanical Mechanism of Tai Chi in Patients with Knee Osteoarthritis: Study Protocol for a Randomized Controlled Trial

Author(s):  
PAN FUWEI ◽  
Min Zhang ◽  
Guoqing Du ◽  
Yuanchuan Chen ◽  
Guangyue Yang ◽  
...  

Abstract Background: Knee osteoarthritis (KOA), one of the most common degenerative joint disease, is the leading cause of disability among elder people. Many previous studies demonstrated that Tai chi is an effective treatment in the management of KOA, but there has been a lack of study evaluated the effect of Tai chi on both clinical and biomechanical outcomes in individuals with KOA. The purpose of the study is to identify the clinical and biomechanical effect of the Tai chi, the results will help to improve the understanding of possible underlying biomechanical effects of the Tai chi. Methods: We will conduct a prospective, randomized controlled trials of 72 individuals with medial KOA. The participants with medial KOA will be randomly divided into Tai chi group or a control group. The Tai chi group will participant in Tai chi twice a week for eight weeks. The control group will receive health care education. After the 8-week intervention period there will be a 16-week follow-period with no active intervention in either group. The primary and secondary outcomes will be assessed at baseline, 4 weeks, 8 weeks, 12 weeks and 24 weeks. The primary measure will be Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The secondary outcome measures will include the kinetics, kinematics changing of the knee joint at sagittal, frontal, and transverse plane, the muscle co-contraction.Discussion: This study aims to investigate the clinical and biomechanical effect of the Tai chi, and the results will help to improve the understanding of possible underlying biomechanical effects of the Tai chi in the management of KOA. Trail Registration: The study was approved by China registered clinical trial ethics review committee with No.ChiECRCT20200335. The study plan was registered on the website of China Registered Clinical Trial Registration Center with No.ChiCTR2000040769 .Registered 09 December 2020, http://www.chictr.org.cn/showprojen.aspx?proj=65571

2022 ◽  
Vol 8 ◽  
Author(s):  
Shuaipan Zhang ◽  
Guangxin Guo ◽  
Xing Li ◽  
Fei Yao ◽  
Zhiwei Wu ◽  
...  

Background: Although traditional Chinese Yijinjing Qigong Exercise (YJJQE) is popularly used in China, to alleviate symptoms of people with knee osteoarthritis (KOA), no randomized controlled trials (RCTs) are available to evaluate the effects of YJJQE in patients with KOA. The purpose of this trial is to assess the clinical efficacy of YJJQE for patients with KOA.Methods: A total of 50 participants clinically diagnosed with KOA are randomly (1:1) assigned to the YJJQE group (n = 25) and to the stretching training exercise (STE) group (n = 25), for a 40-min exercise session twice a week for 12 weeks. All outcome measures are collected at baseline and at 12-week ending intervention, which includes the primary outcomes of Western Ontario and McMaster Universities Osteoarthritis Index Scale (WOMAC), the secondary outcomes of visual analog scale (VAS), mental component summary (MCS), physical component summary (PCS), Beck depression inventory (BDI), perceived stress scale (PSS), Berg balance scale (BBS), and the Gait functional mobility data.Results: The YJJQE group did not have any significant changes compared to the control group on the WOMAC score after the 12-week intervention (P > 0.05), though the YJJQE group demonstrated better performance in MCS, BDI, and PSS (P = 0.002, P = 0.001, and P = 0.026, respectively) than the control group. No serious adverse events occurred in either group, and only mild muscle soreness was reported during both exercise treatments.Conclusion: Because no difference between both groups was shown, with regards to the primary outcome measurement (WOMAC), it can hardly explain that the YJJQE had an advantageous effect on patients experiencing the pain and dysfunction of knee osteoarthritis. However, compared to the control group, YJJQE appeared to be associated with improvements in psychological well-being including reduced stress, anxiety, depression, and mood disturbance to manage KOA. Further trials with larger sample sizes and follow-up studies will be required.Clinical Trial Registration:https://www.chictr.org.cn/edit.aspx?pid=60357&htm=4, ChiCTR2000037256.


2021 ◽  
Author(s):  
Jie Wang ◽  
Lei Qiao ◽  
Long Yu ◽  
Yanmin Wang ◽  
Ying Zhang ◽  
...  

Abstract Background: Insoles were considered to be a beneficial adjunctive treatment option for gait rehabilitation, which could provide a proper basic support for walking. The purpose of this study was to evaluate the effect of customized insoles (Jiangsu Suyun Medical Equipment Co. Ltd, Jiangsu, China) on the gait of patients with hemiplegia.Methods: This randomized controlled trial was set in the rehabilitation department of a hospital. A total of 50 stroke patients were randomized into an experimental group (n=25) or a control group (n=25). Both groups received 40-min conventional gait training, which was conducted 5 times a week, for 4 weeks and patients in the experimental group were required to wear customized insoles for at least 1 h per day for 4 weeks. The primary outcome measure was Tinetti Gait Scale (TGS), which was assessed three times(baseline[T0], 4 weeks from baseline[T1] and 4 weeks after completion of the intervention[T2]), and the secondary outcome measures were the plantar pressure test, 6-min walking test (6MWT), Lower Extremity Fugl-Meyer assessment (FMA-LE), Berg Balance Scale (BBS) and Barthel Index (BI), which was assessed twice(baseline[T0] and 4 weeks from baseline[T1]).Results: Compared to the control group, there were significant increases in the experimental group after 4 weeks(P = 0.014) and 4 weeks follow-up(P = 0.001) in the change of TGS, weight-bearing on the involved side (P = 0.012) or forefoot (P =0.028) when standing, weight-bearing on the involved side (P = 0.016) or forefoot (P = 0.043) when walking, early stance phase (P = 0.023) and mid stance phase (P = 0.013) on the involved side, FMA-LE (P = 0.029), BBS (P = 0.005) and BI (P = 0.009), but no difference in late stance phase (P = 0.472) on the involved side when walking and in the 6MWT (P = 0.069).Conclusions: Customized insoles had great efficacy in enhancing gait performance.Clinical Trial Registration: ChiCTR1900024843.Registered 30 July 2019,http://www.chictr.org.cn/edit.aspx?pid=41003&htm=4.


Author(s):  
Kari Bø ◽  
Lene Anette H. Haakstad ◽  
Gøran Paulsen ◽  
Anne Mette Rustaden

Abstract Introduction and hypothesis Urinary incontinence (UI) is common in women who exercise. We aimed to investigate new onset UI in formerly inactive, overweight or obese women (BMI > 25) participating in three different strength training modalities compared with a non-exercising control group. Methods This was a secondary analysis of an assessor blinded randomized controlled trial investigating the effect of 12 weeks of three strength training concepts for women on muscle strength and body composition. None of the programs included pelvic floor muscle training. International Consensus on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI-SF) was used to investigate primary outcome; new onset UI, and secondary outcome; ICIQ-UI-SF sum score. Suissa and Shuster’s exact unconditional test was used to analyze difference in new onset UI. Difference in ICIQ-UI-SF sum score is presented as mean with 95% CI. Results At baseline 40 out of 128 (31.2%) participants reported UI. Three out of 27, 2 out of 17, 2 out of 23, and 0 out of 21 women in the three training and control groups respectively had new onset UI. There were no statistically significant differences in new onset UI across the groups or when collapsing new onset UI in the intervention groups compared with the controls (7 out of 67 vs 0 out of 21), p = 0.124. After the intervention the control group reported worse ICIQ-UI-SF sum score than any of the training groups; mean difference − 6.6 (95% CI: −11.9, −1.27), p = 0.012, but there was no difference in change from baseline to 12 weeks between the groups p = 0.145). Conclusions There was no statistically significant change in UI after strength training.


2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Shicheng Wang ◽  
Wensheng Wang ◽  
Long Shao ◽  
Jing Ling

Abstract Background Postoperative residual knee pain after total knee arthroplasty (TKA) is a significant factor that contributes to patient dissatisfaction. Patients with preoperative central sensitization (CS) may be more susceptible to unexplained chronic pain after TKA, and duloxetine has been reported to be effective in post-TKA pain control in patients with CS. However, there remains limited evidence to support this off-label use in routine clinical practice. Hence, we designed this randomized, placebo-controlled, triple-blind clinical trial to evaluate the effects of preoperative screening and targeted duloxetine treatment of CS on postoperative residual pain compared with the care-as-usual control group. Methods This randomized controlled trial includes patients with knee osteoarthritis on a waiting list for primary unilateral TKA. Patients with preoperative CS will be randomly allocated to the perioperative duloxetine treatment group (duloxetine group) or the care-as-usual control group (placebo group). Patients in the duloxetine group will receive a half-dose of preemptive duloxetine (30 mg/day) for a week before surgery and a full-dose of duloxetine (60 mg/day) for six weeks after surgery. The primary outcome is the intensity of residual pain at six months after TKA, including the visual analogue scale, 11-point numeric rating scale, the sensory dimension of the brief pain inventory, and the pain subscale of the Knee injury and Osteoarthritis Outcome Score. The secondary outcome measures will include the pain and function related outcomes. All of the patients will be followed up at one, three, and six months after surgery. All adverse events will be recorded and immediately reported to the primary investigator and ethics committee to decide if the patient needs to drop out from the trial. Discussion This clinical trial will convey the latest evidence of the efficacy and safety of the application of duloxetine in postoperative pain control in CS patients who are scheduled for TKA. The study results will be disseminated at national and international conferences and published in peer-reviewed journals. Trial registration Chinese Clinical Trial Registry (http://www.chictr.org.cn) registration number: ChiCTR2000031674. Registered 07 April 2020.


2018 ◽  
Vol 26 (0) ◽  
Author(s):  
Ana Cláudia Mesquita Garcia ◽  
Talita Prado Simão-Miranda ◽  
Ana Maria Pimenta Carvalho ◽  
Paula Condé Lamparelli Elias ◽  
Maria da Graça Pereira ◽  
...  

ABSTRACT Objective: To investigate the effect of therapeutic listening on state anxiety and surgical fears in preoperative colorectal cancer patients. Method: A randomized controlled trial with 50 patients randomly allocated in the intervention group (therapeutic listening) (n = 25) or in the control group (n = 25). The study evaluated the changes in the variables state anxiety, surgical fears and physiological variables (salivary alpha-amylase, salivary cortisol, heart rate, respiratory rate and blood pressure). Results: In the comparison of the variables in the control and intervention groups in pre- and post-intervention, differences between the two periods for the variables cortisol (p=0.043), heart rate (p=0.034) and surgical fears (p=0.030) were found in the control group, which presented reduction in the values of these variables. Conclusion: There was no reduction in the levels of the variables state anxiety and surgical fears resulting from the therapeutic listening intervention, either through the physiological or psychological indicators. However, the contact with the researcher during data collection, without stimulus to reflect on the situation, may have generated the results of the control group. Clinical Trial Registration: NCT02455128.


2020 ◽  
Author(s):  
Shanshan Li ◽  
Qing Zhang ◽  
Xuan Yin ◽  
Hongyu Yue ◽  
Wei Zhang ◽  
...  

Abstract Background: Postoperative pain is a common disorder that interferes with the quality of sleep after nasal endoscopic surgery and delays postoperative recovery. Acupuncture is an effective tool for pain management. However, electroacupuncture specifically for the relief of postoperative pain after nasal endoscopic surgery has not yet been studied through a randomized controlled trial. Method/Design: A pilotrandomized, sham-controlled, patient- and- assessor-blind trial is designed to evaluate the efficacy and safety of electroacupuncturein managing postoperative pain following nasal endoscopic surgery of sinusitis with nasal polyps. There will be 30participants randomly allocated to an electroacupuncture or non-invasive sham control in a 1:1 ratio. Treatment will be done within 2 hours before operation, immediately after the operation upon arrival to the recovery ward, and once daily for 3 days. The primary outcome of the Pain Numerical Rating Scale (NRS) will be analyzed using the area-under-the-curve (AUC) method. The secondary outcome measures include Heart Rate (HR) and Blood Pressure (BP) after operation, the sleep quality during the hospital stay (Actigragh),Quality of Recovery-15 (QoR-15), and the MOS item short form health survey (SF-36). ITT analysis will be used in this RCT. Discussion: This pilot randomized controlled trial will explore the feasibility of further clinical application for the management of postoperative pain using electroacupuncture treatment, and it will inform the design of a further full-scale trial. Trial Registration: Chinese Clinical Trial Registry, ChiCTR1900024183, Date: 2019-06-29. URL: http://www.chictr.org.cn/showproj.aspx?proj=40573 Keywords: Electroacupuncture; postoperative pain;nasal endoscopic surgery; RCT; randomized controlled trial; clinical trial


Circulation ◽  
2018 ◽  
Vol 137 (suppl_1) ◽  
Author(s):  
Yao Jie Xie ◽  
Stanley Sai-chuen Hui ◽  
Suzanne C. Ho ◽  
Lorna Kwai Ping Suen

Background: Tai Chi is a body-mind exercise. It’s prophylactic efficacy on migraine attack remains largely unknown. The purpose of this study was to examine the effect of a 12-week Tai Chi training on the migraine attack days per month, body composition, and blood pressure (BP) in a sample of Chinese women with episodic migraine. Method: A two-arm randomized controlled trial was designed. Eighty-two local women aged 18 to 65 years and diagnosed with episodic migraine were randomized to the Tai Chi group or the waiting list control group. A modified 32-short form Yang-style Tai Chi training with 1 hour per day, 5 days per week for 12 weeks was adopted as intervention. An additional 12 weeks follow was conducted. The control group received a “delayed” Tai Chi training at the end of the trial. The difference in migraine days between 1 month before baseline, 3rd month (12nd week) and 6th month (24th week) after the randomization were examined. The changes in weight, body fat, and BP before and after the intervention were also analyzed. Results: Of 189 women screened, 82 eligible women completed the baseline assessment. After randomization, 9 women withdrew immediately, finally 40 in Tai Chi group and 33 in control group were involved in the analysis. On average, women in Tai Chi group had 3.6 (95% CI: -4.7 to -2.5, P<0.01) days reduction of migraine attack. Compared with control group, the difference was statistically significant (P<0.001). Tai Chi group also lost 0.6 kg of body weight and 0.6% of body fat at the 3rd month, and 10.8 mmHg systolic BP at the 6th month, respectively (all p<0.001). The between-group difference of systolic BP was -6.9 mmHg (95% CI: -11.6 mmHg to -2.1mmHg, p<0.05), whereas no significant differences were observed regarding weight and body fat at the 3rd month (all p>0.05). Among Tai Chi group, change in systolic BP was significantly correlated to the change in migraine days (P<0.05). Conclusion: The 12-week Tai Chi training significantly decreased the frequency of migraine attack and improved the systolic BP. The association between migraine attack reduction and BP improvement needs further investigations.


2019 ◽  
Vol 130 (2) ◽  
pp. 622-628 ◽  
Author(s):  
Julian Prell ◽  
Grit Schenk ◽  
Bettina-Maria Taute ◽  
Christian Scheller ◽  
Christian Marquart ◽  
...  

OBJECTIVEThe term “venous thromboembolism” (VTE) subsumes deep venous thrombosis (DVT) and pulmonary embolism. The incidence of DVT after craniotomy was reported to be as high as 50%. Even clinically silent DVT may lead to potentially fatal pulmonary embolism. The risk of VTE is correlated with duration of surgery, and it appears likely that it develops during surgery. The present study aimed to evaluate intraoperative use of intermittent pneumatic compression (IPC) of the lower extremity for prevention of VTE in patients undergoing craniotomy.METHODSA total of 108 patients undergoing elective craniotomy for intracranial pathology were included in a single-center controlled randomized prospective study. In the control group, conventional compression stockings were worn during surgery. In the treatment group, IPC of the calves was used in addition. The presence of DVT was evaluated by Doppler sonography pre- and postoperatively.RESULTSIntraoperative use of IPC led to a significant reduction of VTE (p = 0.029). In logistic regression analysis, the risk of VTE was approximately quartered by the use of IPC. Duration of surgery was confirmed to be correlated with VTE incidence (p < 0.01); every hour of surgery increased the risk by a factor of 1.56.CONCLUSIONSIntraoperative use of IPC significantly lowers the incidence of potentially fatal VTE in patients undergoing craniotomy. The method is easy to use and carries no additional risks.■ CLASSIFICATION OF EVIDENCE Type of question: therapeutic; study design: randomized controlled trial; evidence: class I.Clinical trial registration no.: DRKS00011783 (https://www.drks.de)


BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e041121
Author(s):  
Yago Tavares Pinheiro ◽  
Germanna Medeiros Barbosa ◽  
Hilmaynne Renaly Fonseca Fialho ◽  
César Augusto Medeiros Silva ◽  
Jaciara de Oliveira Anunciação ◽  
...  

ObjectiveTo analyse the short-term effects of kinesio taping (KT) with tension (KTT) or without tension (KTNT) in older women with knee osteoarthritis (KOA), and compare them to controls who did not receive KT.DesignRandomised controlled trial.SettingUniversity physiotherapy school clinic.ParticipantsForty-five older women (fifteen participants per group) with 66.8 (±5.6) years and clinical diagnosis of KOA were assessed pre, post and 3 days after intervention.InterventionsParticipants were randomly allocated to KTT, who received two simultaneous applications of KT with tension on the knee and rectus femoris; KTNT, who received the same application as the KTT group, but without tension and a control group that attended a class on KOA.Primary and secondary outcome measuresPrimary outcome was pain intensity and secondary outcomes were knee-related health status, functional capacity, muscle strength and global rating of change.ResultsNo between-group differences were observed in pain after the first intervention (KTT vs KTNT: mean difference (MD), −1.8 points; 95% CI −4.2 to 0.5; KTT vs control: MD, −1.2 points; 95% CI −3.6 to 1.2; KTNT vs control: MD, 0.66 points; 95% CI −1.7 to 3.0) or 3 days later (KTT vs KTNT: MD, −1.3 points; 95% CI −3.7 to 1.0; KTT vs control: MD, 0.13 points; 95% CI −2.2 to 2.5; KTNT vs control: MD, 1.4 points; 95% CI −0.9 to 3.8). The lack of between-group differences was also found for secondary outcomes.ConclusionThe short-term use of KT with or without tension in older woman with KOA had no beneficial effects on pain and function. These findings call into question the clinical use of KT as a non-pharmacological therapy for this population.Trial registration numberNCT03624075.


2019 ◽  
Vol 17 (1) ◽  
pp. 46-53
Author(s):  
Kaori Ichihara ◽  
Sayako Ouchi ◽  
Sachiko Okayama ◽  
Fukiko Kinoshita ◽  
Mitsunori Miyashita ◽  
...  

AbstractObjectiveTo obtain preliminary knowledge to design a randomized controlled trial to clarify the effects of spiritual care using the Spiritual Pain Assessment Sheet (SpiPas).MethodThe study was designed as a nonrandomized controlled trial. The study took place between January 2015 and July 2015 in a hematology and oncology ward and two palliative care units in Japan. Among 54 eligible patients with advanced cancer, 46 were recruited (24 in the control group vs. 22 in the intervention group). The intervention group received spiritual care using SpiPas and usual care; the control group received usual care. The primary outcome was the Functional Assessment of Chronic Illness Therapy-Spiritual (FACIT-Sp). The secondary outcomes were the Hospital Anxiety and Depression Scale (HADS) and Comprehensive Quality of Life Outcome (CoQoLo).ResultA total of 33 (72%) and 23 (50%) patients completed 2- and 3-week follow-up evaluations, respectively. The differences in the changes during 2 weeks in total scores of FACIT-Sp and HADS were significant (95% confidence intervals, 3.65, 14.4, p < 0.01; –11.2 to –1.09, p = .02, respectively). No significant changes were observed in the total score of CoQoLo.Significance of resultsSpiritual care using the SpiPas might be useful for improving patient spiritual well-being. This controlled clinical trial could be performed and a future clinical trial is promising if outcomes are obtained within 2 weeks.


Sign in / Sign up

Export Citation Format

Share Document