Background: In December 2019, pneumonia associated with the 2019 novel coronavirus (COVID-19) emerged in Wuhan, China. The number of cases has increased rapidly. Patients with severe disease have a poor prognosis, and there are no effective therapies for COVID-19. Only rapid advice guidelines for symptomatic supportive care have been used. A traditional Chinese medicine rehabilitation (TCMR) program consisting of acupressure therapy and Liu Zi Jue Qigong can be used as a complementary therapy for COVID-19. Hence, we designed a randomized trial to evaluate the efficacy and advantages of TCMR for treating patients with severe COVID-19. Methods/design: This is a parallel-design, two-arm, analyst assessor-blinded, randomized controlled trial. A total of 128 patients with COVID-19 aged from 20 to 80 years will be recruited and assigned randomly into a guideline therapy group and a guideline therapy plus TCMR group at a 1:1 ratio. Patients in both groups will receive guideline therapy. The patients in the intervention group will perform acupressure therapy and Liu Zi Jue Qigong exercises in addition to conventional treatments twice a day and will be persistent from admission to discharge. The primary outcome will be measured with the Modified Medical Research Council Dyspnea Scale, and the secondary outcomes will include the Activities of Daily Living Barthel Index Scale, Patient Health Questionnaire-9 Scale, and the Respiratory Symptoms Scale. The assessments of the clinical scales will be performed at three points (before treatment, the 7th day during hospitalization, and the discharge day). Adverse events will be noted and recorded for the safety evaluation. Discussion: This trial will provide high-quality evidence of the value of TCMR, which consists of acupressure therapy and Liu Zi Jue Qigong exercises, for treating patients with severe COVID-19. Trial registration: Chinese Clinical Trial Registry ChiCTR2000029994. Registered on

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.

Low back pain (LBP) is one of the major concerns of the current health care. The guidelines for chronic LBP recommend traditional Chinese exercise as an effective treatment. As one of the representatives of traditional Chinese exercise, Wuqinxi has been famous in China for its effects on improving health and treating chronic diseases for thousands of years. The objectives of the study were to assess the effects of Wuqinxi in the patients with chronic LBP on pain intensity, trunk muscle strength, and quality of life. The primary outcome measure was assessed by the Short-Form McGill Pain Questionnaire (SF-MPQ), including the Visual Analog Scale (VAS) and Present Pain Intensity (PPI) as the subtables. The effects of Wuqinxi on the quality of life were also assessed by the Short-Form Health Survey (SF-36) and the Pittsburgh Sleep Quality Index (PSQI) from physical component summary (PCS), mental component summary (MCS), and sleep quality. Besides, the electrical activities of the rectus abdominis (RA), obliquus externus abdominis (OEA), lumbar erector spinae (ES), and multifidus (MF) were assessed by integrated electromyogram (iEMG) after the end of the intervention. Both the groups showed statistically significant improvement in SF-MPQ, SF-36, PSQI, and iEMG at 12 weeks and 24 weeks when compared with baseline (P<0.05). However, Wuqinxi demonstrated better effects in SF-MPQ and MCS after 24 weeks of intervention compared with the general exercise (P<0.05). The patients in the Wuqinxi group (WQXG) also showed a significantly higher iEMG on OEA than the general exercise group (GEG) in 30°/s and 90°/s (P<0.05). Our results showed that Wuqinxi had better effects on chronic LBP for a long time compared with general exercise, including pain intensity and quality of life. Thus, Wuqinxi should be recognized as a possible standalone therapy and self-management skill in chronic LBP, which is suitable for long-term practice.

Background: Low back pain is a common reason for medical care and carries a heavy social burden. The efficacy of Tuina or health care education for low back pain has been evaluated in previous systematic reviews. However, there is no evidence to support the superiority of one form of treatment over another. The aim of this study is to compare the efficacy of Tuina with health care education in the management of low back pain.Methods/design: This study is a randomized controlled trial with parallel-group design including two groups: a Tuina group and a health care education group. A total of 160 eligible participants will be randomly assigned to the groups in a 1:1 ratio. The interventions of both groups will last for 20 min and be carried out twice each week for a period of 12 weeks. The primary outcome is the Oswestry Disability Index. The secondary outcomes include a visual analogue scale and the 36-item Short Form Health Survey. They will be assessed at baseline, at the end of the intervention every month, and during 6 months and 9 months of follow-up by repeated measures analysis of variance. The significance level is 5%. The safety of Tuina and health care education will be evaluated after each treatment session. This study will focus on the value of Tuina and health care education for low back pain and will highlight any differences in the efficacy of the treatments.Discussion: This study will evaluate the efficacy and safety of Tuina intervention for low back pain, which could provide reliable evidence for clinical decision making for patients with low back pain.

ObjectiveAlthough Traditional Chinese Yijinjing Qigong Exercise (YJJQE) as mind–body intervention is popularly used among adults to ameliorate depressive symptoms in China, no randomized controlled trials (RCTs) are available to evaluate the effects of YJJQE in patients with poststroke depression (PSD). This study aims to explore the clinical efficacy and the neurological and psychiatric mechanism in brain network functional connectivity underlying electroencephalography (EEG).Materials and methodsA total of 60 patients, diagnosed with mild PSD, were randomly (1:1) assigned to YJJQE group (n = 30) and control group of routine segmental rehabilitation training group (n = 30) for a 60-min exercise session once a day for 3 weeks. All outcome measures were collected at baseline and 3-weeks ending intervention. The primary outcome was the 24-item Hamilton Depression Scale (HAMD-24) score, evaluation at more time points for 1 month of follow-up. The secondary outcomes were EEG data in four frequency domains (δ, θ, α, and β), global efficiency (GE), local efficiency (LE), GE/LE curve [areas under the curve (AUC)], Phase Lag Index (PLI), (HAMD-24) Score and EEG correlation analysis.ResultsAll patients showed no significant differences in baseline data. After 3 weeks and 1 month of follow-up, the YJJQE group demonstrated significant decreasing changes compared to the control group on the HAMD-24 scores (p &lt; 0.001). Furthermore, the YJJQE group also showed a significant reduction in θ wave, and an increase in both GE and LE. Compared to the control group, the YJJQE Qigong group showed significantly greater functional connectivity in the δ, θ, and β frequency bands in the brain network of the degree of phase synchronization (p &lt; 0.001). HAMD-24 Score and EEG correlation analysis negative correlation in the Qigong group θ wave (p &lt; 0.001).ConclusionOur findings demonstrated that YJJQE is estimated to effectively alleviate the depressed mood of patients with PSD by promoting the efficiency in information transmission of network functional connectivity and its integration ability in different brain regions. Therefore, the YJJQE would be useful as a non-pharmacological treatment to prevent PSD.Clinical trial registration[http://www.chictr.org.cn/showproj.aspx?proj=55789], identifier [ChiCTR2000035588].

ObjectiveTo investigate the effectiveness and functional magnetic resonance imaging (fMRI) outcomes of Tuina therapy in patients with post-stroke depression (PSD).MethodsThis was a single-center, randomized, two-armed, controlled trial. Eighty-four patients with PSD were selected and randomly assigned to a Tuina therapy group or a routine rehabilitation control group. The patients underwent five 20-min treatment sessions per week over a period of 2 weeks. The primary outcome measure was change in Hamilton Depression Rating Scale (HAMD) score over the 2 weeks of intervention, whereas the secondary outcome measures were changes in Fugl-Meyer Assessment (FMA) score, Modified Barthel index (MBI), and Mini Mental State Examination (MMSE) score.ResultsThe Tuina group showed significantly improved HAMD scores compared to the routine rehabilitation control group (5.85, [2.54, 9.16]). For the secondary outcomes, the Tuina group showed better MMSE scores than the routine rehabilitation group (1.97, [1.19, 2.76]); however, there were no significant differences between the other secondary outcomes of both groups (P &gt; 0.05). After 2 weeks, both groups showed a significant decrease in HAMD score compared to baseline. In addition, the Tuina group showed a significant decrease in MMSE score compared to baseline (2.35, [1.8, 2.9]); however, there were no significant differences in the MBI and FMA scores of the two group after the intervention (P &gt; 0.05). Regarding fMRI results, the zALFF values of the right caudate nucleus, right putamen, right insula, left superior temporal gyrus, right parahippocampal gyrus, right hippocampus, left middle temporal gyrus, left angular gyrus, and left thalamus were higher in the Tuina group. In the Tuina group, the functional connectivity between the hippocampus and thalamus, and the thalamus and caudate nucleus, were significantly different (P &lt;0.01). In addition, the zALFF value of the hippocampus was significantly negatively correlated with HAMD score. No serious adverse events were observed in both groups.ConclusionTuina therapy administered 10 times within 2 weeks is safe and can effectively relieve depression and improve cognitive function in patients with PSD. This finding may be closely related to the effect of Tuina therapy on the activation and functional connectivity of the hippocampus.Clinical Trial Registrationhttp://www.chictr.org.cn/showproj.aspx?proj=55151, identifier ChiCTR200003388.

Background: In December, 2019, a pneumonia associated with the 2019 novel coronavirus (COVID-19) emerged in Wuhan, China. The number of cases has increased rapidly, severe patients have a poor prognosis and there are no effective therapies or vaccines for it. Only one rapid advice guideline for symptomatic supportive care has been used for it. A Traditional Chinese medicine Rehabilitation（TCMR） program consisting of acupressure therapy and Liuzijue Qigong can be used as a complementary therapy for COVID-19.Hence, we designed a randomized trial to evaluate the efficacy and advantages of TCMR for treating severe patients with COVID-19.Methods/design: This is a parallel-design, two-arm, analyst-assessor blinded, randomized controlled trial. A total of 120 patients with COVID-19 aged from 20 to 80 will be recruited and assigned randomly into a guideline therapy group and a guideline therapy plus TCMR group at a 1:1 ratio. Patients in both groups will receive guideline therapy. The patients in intervention group will perform acupressure therapy and Liuzijue Qigong exercise on the basis of conventional treatments, twice a day, and have been persistent from admission to discharge. The primary outcomes are measured with Modified Dyspnea Scale (MDS) and Activities of Daily Living (ADL). The secondary outcomes include Patient Health Questionnaire-9 (PHQ-9), Length of Hospital Stay (LHS), Respiratory Symptoms (RS), Liver function test, Renal function test and lung CT. Clinical assessments will at three points (before treatment, 7th day during hospitalization and the discharge day). Adverse events will be noted and recorded for the safety evaluation.Discussion: This trail will provide a high-quality evidence of the value of TCMR, which is consist of acupressure therapy and Liuzijue Qigong exercise for treating severe patients with COVID-19.Trial registration: Chinese Clinical Trial Registry, ChiCTR2000029994 Registered 18 February 2020, http://www.chictr.org.cn/showproj.aspx?proj=49309

BackgroundHerniation of the nucleus pulposus caused by disc degeneration and other reasons can cause low back pain and disability. In China, traditional Chinese exercises (TCEs) and traditional Chinese massage (TCM) are widely used to improve symptoms of pain and disability in patients with lumbar disc herniation (LDH). The safety and efficacy of combination therapy have not been studied.ObjectivesTo assess the effect of traditional Chinese exercise combined with massage vs. traditional Chinese massage alone on pain, disability, lumbar mobility and gait performance in patients with LDH.MethodsMulti-center, randomized clinical trial conducted at 4 hospitals in China and enrolling 272 patients with LDH. Participants were randomly assigned to TCEs plus TCM group or TCM alone group. The combined therapy group received 18 Tai Chi training sessions (30-min sessions 3 times a week) and regular TCM treatments over 6 weeks. The control group received TCM therapy alone and was instructed to maintain their usual daily physical activity. Outcome variables measured included Visual Analog Scale (VAS), Short Form of McGill Pain Questionnaire (SF-MPQ), Oswestry Disability Index (ODI), lumbar spine range of motion (ROM) and gait performance.ResultsAmong the 272 randomized participants, 259 completed the study. The mean VAS score was 51.77 mm at baseline in the TCEs plus TCM group, and 50.93 mm for the TCM alone group. The reduction in the VAS score at week 6 was greater in the TC group than in the TCM group with a mean difference of 4.05 (95% CI, 2.15–5.95; P &lt; 0.001), and the ODI score with between-group differences of 3.57 points (95% CI, 2.84–4.30 points; P &lt; 0.001). Similar significantly different results were observed in SF-MPQ, walking speed, cadence, and lumbar ROM. No serious adverse events were reported throughout the study period.ConclusionCompared with TCM alone, TCEs combined with TCM treatment performed better in reducing pain and improving disability. The combination therapy could be considered a valuable treatment option for LDH patients, with potential therapeutic utility for middle-aged and elderly patients with LDH.