scholarly journals Cerebral Mechanism of Tuina Analgesia in Management of Knee Osteoarthritis using multimodal MRI: Study Protocol for a Randomized Controlled Trial

2021 ◽  
Author(s):  
Guangxin Guo ◽  
Yazhuo Kong ◽  
Qingguang Zhu ◽  
Zhiwei Wu ◽  
Shuaipan Zhang ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Chronic Pain ◽  
Randomized Controlled Trial ◽  
Short Form ◽  
Controlled Trial ◽  
Clinical Assessments ◽  
Randomized Controlled ◽  
Education Group ◽  
Multimodal Mri

Abstract Background: Chronic pain of patients with knee osteoarthritis (KOA) seriously affects the quality of life and leads to the heavy social and economic burden. As one of the representative non-drug therapies in Traditional Chinese Medicine (TCM), Tuina has been generally recognized as safe and effective for reducing the chronic pain of KOA, however the underlying central mechanisms of Tuina for improving the pain of KOA are not fully understood.Methods/design: This study is a randomized controlled trial with parallel-group design. In total, 60 eligible participants will be randomly assigned to a Tuina group and a health care education group (Education group) in a 1:1 ratio with gender and age matched. The interventions of both groups will last for 30 min per session and be conducted twice each week for 12 weeks. This study will focus on detecting the changes of brain gray matter structure (GM), white matter structure (WM), the cerebral functional connectivity (FC) elicited by Tuina treatment, e.g thalamus, hippocampus, anterior cingulate gyrus, S1, insula, the periaqueductal gray subregions (PAG) etc. The two groups of patients will be evaluated by clinical assessments and multimodal magnetic resonance imaging (MRI) at the baseline and the end of 6 and 12 weeks’ treatment, and still be evaluated by clinical assessments for 48 weeks of follow-up. The Visual Analog Scale (VAS) of current pain, Short-form McGill Pain Questionnaire (SF-MPQ), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), the 36-Item Short Form Health Survey (SF-36), Hamilton Depression Scale (HAMD) and the Hamilton Anxiety Scale (HAMA) will be used to evaluate the pain intensity, pain feeling, pain emotion, clinical symptoms and quality of life respectively. The evaluators and statisticians will be blinded to the group allocation. The repeated measures analysis of variance (2 groups × 6 time points ANOVA) will be employed to analyze numerical variables of the clinical and neuroimaging data obtained in the study. P<0.05 will be the statistical significance level. Discussion: The results of this randomized controlled trial with clinical assessments and multimodal MRI will help to reveal the influence of Tuina treatment on the potential morphological changes of cortical and subcortical brain structures, the white matter integrity and the functional activities and connectivity of brain regions of patients with KOA, which might provide scientific evidence for the clinical application of Tuina in management of KOA.Trial registration: Chinese Clinical Trial Registry: ChiCTR2000037966. Date of Registration: 8, Sep. 2020. http://www.chictr.org.cn/edit.aspx?pid=61083&htm=4

The Therapeutic Effects of Acupuncture on Patients with Chronic Neck Myofascial Pain Syndrome: A Single-Blind Randomized Controlled Trial

2010 ◽  
Vol 38 (05) ◽  
pp. 849-859 ◽  
Author(s):  
Mei-Yuan Sun ◽  
Ching-Liang Hsieh ◽  
Yung-Yen Cheng ◽  
Hung-Chang Hung ◽  
Tsai-Chung Li ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Myofascial Pain ◽  
Short Form ◽  
Controlled Trial ◽  
Pain Syndrome ◽  
Myofascial Pain Syndrome ◽  
Randomized Controlled ◽  
Single Blind

Chronic neck myofascial pain syndrome (MPS) is a common disorder seen in clinics. There is no gold standard method to treat myofascial pain. We investigated the effects of acupuncture on patients with chronic neck MPS by a single-blind randomized controlled trial. A total of 35 patients were randomly allocated to an acupuncture group (AG) or a sham acupuncture group (SG). Each subject received acupuncture treatment twice per week for three consecutive weeks. The primary outcome measure was quality of life as assessed with Short Form-36, and secondary outcome measures were neck range of motion (ROM), motion-related pain, and Short-Form McGill Pain Questionnaire (SF-MPQ), as determined by a blinded investigator. The clinical assessments were made before treatment (BT) and after six acupuncture treatments (AT), as well as four weeks (F1) and 12 weeks (F2) after the end of the treatment. A total of 34 patients completed the trial. The results indicated that there is no significant difference in the ROM, motion-related pain, and SF-MPQ scores between AG and SG at AT, F1 and F2 (all p > 0.05). However, AG has greater improvement in physical functioning and role emotional of Short Form-36 quality of life at F2. The results indicate that acupuncture may be used to improve the quality of life in patients with chronic neck MPS.

scholarly journals Taking Charge after Stroke: A randomized controlled trial of a person-centered, self-directed rehabilitation intervention

2020 ◽  
Vol 15 (9) ◽  
pp. 954-964 ◽  
Author(s):  
Vivian Fu ◽  
Mark Weatherall ◽  
Kathryn McPherson ◽  
William Taylor ◽  
Anna McRae ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Physical Component Summary ◽  
Short Form ◽  
Controlled Trial ◽  
Short Form 36 ◽  
Randomized Controlled ◽  
Rehabilitation Intervention ◽  
Related Quality

Background and purpose “Take Charge” is a novel, community-based self-directed rehabilitation intervention which helps a person with stroke take charge of their own recovery. In a previous randomized controlled trial, a single Take Charge session improved independence and health-related quality of life 12 months following stroke in Māori and Pacific New Zealanders. We tested the same intervention in three doses (zero, one, or two sessions) in a larger study and in a broader non-Māori and non-Pacific population with stroke. We aimed to confirm whether the Take Charge intervention improved quality of life at 12 months after stroke in a different population and whether two sessions were more effective than one. Methods We randomized 400 people within 16 weeks of acute stroke who had been discharged to institution-free community living at seven centers in New Zealand to a single Take Charge session (TC1, n = 132), two Take Charge sessions six weeks apart (TC2, n = 138), or a control intervention (n = 130). Take Charge is a “talking therapy” that encourages a sense of purpose, autonomy, mastery, and connectedness with others. The primary outcome was the Physical Component Summary score of the Short Form 36 at 12 months following stroke comparing any Take Charge intervention to control. Results Of the 400 people randomized (mean age 72.2 years, 58.5% male), 10 died and two withdrew from the study. The remaining 388 (97%) people were followed up at 12 months after stroke. Twelve months following stroke, participants in either of the TC groups (i.e. TC1 + TC2) scored 2.9 (95% confidence intervals (CI) 0.95 to 4.9, p = 0.004) points higher (better) than control on the Short Form 36 Physical Component Summary. This difference remained significant when adjusted for pre-specified baseline variables. There was a dose effect with Short Form 36 Physical Component Summary scores increasing by 1.9 points (95% CI 0.8 to 3.1, p < 0.001) for each extra Take Charge session received. Exposure to the Take Charge intervention was associated with reduced odds of being dependent (modified Rankin Scale 3 to 5) at 12 months (TC1 + TC2 12% versus control 19.5%, odds ratio 0.55, 95% CI 0.31 to 0.99, p = 0.045). Conclusions Confirming the previous randomized controlled trial outcome, Take Charge—a low-cost, person-centered, self-directed rehabilitation intervention after stroke—improved health-related quality of life and independence. Clinical trial registration-URL http://www.anzctr.org.au . Unique identifier: ACTRN12615001163594

scholarly journals Consumption of OLL1073R-1 yogurt improves psychological quality of life in women healthcare workers: secondary analysis of a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Tetsu Kinoshita ◽  
Koutatsu Maruyama ◽  
Keiko Suyama ◽  
Mariko Nishijima ◽  
Kimiko Akamatsu ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Healthcare Workers ◽  
Short Form ◽  
Controlled Trial ◽  
Lactobacillus Delbrueckii ◽  
Control Group ◽  
Randomized Controlled ◽  
Psychological Quality Of Life

Abstract Background We conducted a randomized controlled trial to investigate the effects of consumption of yogurt fermented with Lactobacillus delbrueckii ssp. bulgaricus OLL1073R-1 in women healthcare workers. In a previous study we used these data to investigate hypothesized preventive effects against flu, however any effects on improving mental quality of life were not analyzed at that time. In the present study, we focus on that aspect. Methods The participants (961 women; mainly nurses, aged 20–71 years) were randomly allocated to either the yogurt group (n = 479) or the control group (n = 482). Participants in the yogurt group drank 112 mL of OLL1073R-1 yogurt for 16 weeks, while those in the control group did not consume any yogurt. All participants were prohibited from consuming other yogurt or fermented dairy products during the study period. The participants answered the Pittsburgh Sleep Quality Index (PSQI), Short Form-8 Health Survey (SF-8), and Gastrointestinal Symptom Rating Scale (GSRS) questionnaires at baseline and after 16 weeks. Results The PSQI score showed significant improvement after the intake of yogurt (p < 0.01). SF-8 results showed significant intervention effects in the General Health and Vitality scores (p = 0.02 and p = 0.01, respectively). In other subscales of SF-8, we did not observe significant effects of the yogurt. In the GSRS, daily intake of yogurt exerted a preventive effect on constipation (p = 0.03). Conclusions Consumption of yogurt fermented with Lactobacillus delbrueckii ssp. bulgaricus OLL1073R-1 enhances subjective psychological quality of life by improving quality of sleep and gastrointestinal condition among women healthcare workers.

scholarly journals A Psychosocial Intervention’s Impact on Quality of Life in AYAs with Cancer: A Post Hoc Analysis from the Promoting Resilience in Stress Management (PRISM) Randomized Controlled Trial

Children ◽  
2019 ◽  
Vol 6 (11) ◽  
pp. 124 ◽  
Author(s):  
Angela Steineck ◽  
Miranda C. Bradford ◽  
Nancy Lau ◽  
Samantha Scott ◽  
Joyce P. Yi-Frazier ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Stress Management ◽  
Short Form ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Cancer Module ◽  
Related Quality ◽  
Post Hoc

Promoting Resilience in Stress Management (PRISM), a psychosocial intervention for adolescents and young adults (AYAs) with serious illness, enhances resilience resources via four skills-based training sessions. A recent randomized controlled trial showed PRISM improved health-related quality of life (HRQOL) compared to usual care (UC). This post hoc exploratory analysis aimed to better understand the effect of PRISM on HRQOL by describing changes in HRQOL subdomain scores. English-speaking AYAs (12–25 years) with cancer were randomized to PRISM or UC. At enrollment and six months later, HRQOL was assessed using the Pediatric Quality of Life Inventory (PedsQL) Generic Short Form (SF-15) and Cancer Module. Scores at each time point were summarized descriptively and individual HRQOL trajectories were categorized (<70 vs. ≥70). “Positive” trajectories indicate participants maintained scores ≥70 or improved from <70 to ≥70 during the study period. Baseline assessments were completed by 92 participants (48 PRISM, 44 UC); six-month assessments were completed by 74 participants (36 PRISM, 38 UC). For the SF-15, positive trajectories in psychosocial domains were more common with PRISM; trajectories in the physical subdomain were similar across groups. For the Cancer Module, positive trajectories were more common with PRISM in the following subdomains: nausea, treatment anxiety, worry, cognitive, physical appearance, and communication. From this, we conclude PRISM may improve HRQOL, especially in psychosocial domains of wellbeing.

scholarly journals Consumption of OLL1073R-1 Yogurt Improves Psychological Quality of Life in Women Healthcare Workers: A Randomized Controlled Trial

2021 ◽  
Author(s):  
Tetsu Kinoshita ◽  
Koutatsu Maruyama ◽  
Keiko Suyama ◽  
Mariko Nishijima ◽  
Kimiko Akamatsu ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Healthcare Workers ◽  
Short Form ◽  
Controlled Trial ◽  
Lactobacillus Delbrueckii ◽  
Control Group ◽  
Randomized Controlled ◽  
Psychological Quality Of Life

Abstract Background To investigate the effects of yogurt consumption fermented with Lactobacillus delbrueckii ssp. bulgaricus OLL1073R-1 on improving mental quality of life of women healthcare workers, a randomized controlled trial was conducted. The 961 women (mainly nurses, aged 20–71 years) agreed to participate in this trial, and were randomly allocated to either the yogurt group (n = 479) or the control group (n = 482). Participants of the yogurt group drank 112 mL of OLL1073R-1 yogurt for 16 weeks, meanwhile those of the control group did not consume the yogurt. All participants were prohibited from consuming other yogurt or fermented dairy products during the study period. The participants answered the Pittsburgh Sleep Quality Index (PSQI), Short Form-8 Health Survey (SF-8), and Gastrointestinal Symptom Rating Scale (GSRS) questionnaires at baseline and after 16 weeks.Results The PSQI score showed significant improvement after the intake of yogurt (p < 0.01). SF-8 results showed significant intervention effects in the General Health and Vitality scores (p = 0.02 and p = 0.01, respectively). In other subscales of SF-8, we did not observe significant effects of the yogurt. In the GSRS, daily intake of the yogurt exerted a preventive effect on constipation (p = 0.03). Conclusions Consumption of yogurt fermented with Lactobacillus delbrueckii ssp. bulgaricus OLL1073R-1 enhances subjective psychological quality of life by improving quality of sleep and gastrointestinal condition among women healthcare workers.

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