scholarly journals Comparative Effectiveness of Chuna Manipulative Therapy for Non-Acute Lower Back Pain: A Multi-Center, Pragmatic, Randomized Controlled Trial

2020 ◽  
Vol 9 (1) ◽  
pp. 144 ◽  
Author(s):  
Sun-Young Park ◽  
Eui-Hyoung Hwang ◽  
Jae-Heung Cho ◽  
Koh-Woon Kim ◽  
In-Hyuk Ha ◽  
...  
Keyword(s):  
Comparative Effectiveness ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Leg Pain ◽  
Manipulative Therapy ◽  
Pragmatic Randomized Controlled Trial ◽  
Randomized Controlled ◽  
Lower Back ◽  
Acute Lower Back Pain

Current evidence on the effectiveness and safety of Chuna manipulative therapy (CMT) for managing non-acute lower back pain (LBP) is insufficient. We investigated the comparative effectiveness and safety of CMT, a Korean style of manipulation, plus usual care (UC) compared to UC alone for non-acute LBP. We conducted a parallel, two-armed, multi-centered, assessor blinded, pragmatic, randomized controlled trial at four major Korean medical hospitals. Overall, 194 patients were randomly allocated to either CMT plus UC (n = 97) or UC alone (n = 97), for six weeks of treatment and six months follow-up. The primary outcome was measured using the numerical rating scale (NRS) of LBP intensity at 7 weeks. Secondary outcomes included NRS of leg pain, Oswestry Disability Index (ODI) for functional disability, patient global impression of change (PGIC) scale, and safety. A total of 194 patients were included in the intention-to-treat analysis, and 174 patients provided complete data for the primary outcome. At 7 weeks, clinically significant differences between groups were observed in the NRS of LBP (CMT + UC: −3.02 ± 1.72, UC: −1.36 ± 1.75, p < 0.001), ODI scores (CMT + UC: −5.65 ± 4.29, UC: −3.72 ± 4.63, p = 0.003), NRS of leg pain (CMT + UC: −2.00 ± 2.33, UC: −0.44 ± 1.86, p < 0.0001), and PGIC (CMT + UC: −0.28 ± 0.85, UC: 0.01 ± 0.66, p = 0.0119). Mild to moderate safety concerns were reported in 21 subjects. CMT plus UC showed higher effectiveness compared to UC alone in patients with non-acute LBP in reducing LBP and leg pain and in improving function with good safety results using a powered sample size and including mid-term follow-up.

Effect of ICT-Based Self-Management System DialBeticsLite on Treating Abdominal Obesity: Randomized Controlled Trial. (Preprint)

2021 ◽  
Author(s):  
Masahiro Kondo ◽  
Teru Okitsu ◽  
Kayo Waki ◽  
Toshimasa Yamauchi ◽  
Masaomi Nangaku ◽  
...  
Keyword(s):  
Abdominal Obesity ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Intervention Group ◽  
Metabolic Parameters ◽  
Control Group ◽  
Physical Parameters ◽  
Lifestyle Behavior ◽  
Randomized Controlled

BACKGROUND Mobile health interventions, a more cost-effective approach compared to traditional methods of delivering lifestyle coaching in person, have been shown to improve physical parameters and lifestyle behavior among overweight populations. It is useful to know the efficacy of mobile apps in treating abdominal obesity, as it is a known risk factor for metabolic disorders and type 2 diabetes. OBJECTIVE This study aimed to determine whether a mobile self-management app (DialBeticsLite) could be used by patients with abdominal obesity to achieve a reduction in visceral fat area (VFA) and other physical parameters. METHODS This study was an open-label, 2-arm parallel-design randomized controlled trial. We recruited 122 people in September 2017, and randomly assigned them into either the intervention group or the control group. All participants attended an educational group session, which delivered information regarding diet and exercise. Additionally, participants in the intervention group were asked to use DialBeticsLite for 3 months. DialBeticsLite facilitated the daily recording of several physical parameters and lifestyle behavior, and provided feedback to encourage an improvement in behavior. The primary outcome was the change in VFA from baseline to the 3-month follow-up. Secondary outcomes included changes in both physical and metabolic parameters, from baseline to the 3-month follow-up. Welch t test was conducted to analyze the effects of DialBeticsLite on both the primary outcome and the secondary outcomes. RESULTS Out of the 122 participants recruited, 75 participants were analyzed due to 47 participants being excluded: 37 due to ineligibility and 10 due to withdrawal of consent. The mean age was 49.3 (standard deviation: SD 6.1) in the intervention group (n=41) and 48.5 (SD 5.3) in the control group (n=34), and all participants were male, though unintentionally. Baseline characteristics did not differ significantly between the intervention and control group, except for VFA. The averaged change of VFA was -23.5cm2 (SD 20.6) in the intervention group and +1.9cm2 (SD 16.2) in the control group (P<.001). Statistically significant differences were also found for the change of body weight, BMI and waist circumference. These findings did not change after adjusting for VFA at baseline. The intervention had no significant effect on any of the metabolic parameters. An exploratory analysis showed significant associations between the change in VFA and steps per day, and between the change in VFA and calorie intake per day within the intervention group. CONCLUSIONS Our findings indicate that although unsuccessful in improving metabolic parameters, a mobile health intervention facilitating the daily monitoring of several physical parameters and lifestyle behavior, can be highly effective in inducing visceral fat loss and weight loss among adults with abdominal obesity. CLINICALTRIAL Trial Registration: University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) UMIN000042045 Retrospectively Registered; https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&recptno=R000046495&type=summary&llanguag=J

Life review therapy for older adults with moderate depressive symptomatology: a pragmatic randomized controlled trial

2011 ◽  
Vol 42 (6) ◽  
pp. 1163-1173 ◽  
Author(s):  
J. Korte ◽  
E. T. Bohlmeijer ◽  
P. Cappeliez ◽  
F. Smit ◽  
G. J. Westerhof
Keyword(s):  
Mental Health ◽  
Depressive Symptoms ◽  
Controlled Trial ◽  
Life Review ◽  
Positive Mental Health ◽  
Anxiety Symptoms ◽  
Pragmatic Randomized Controlled Trial ◽  
Randomized Controlled ◽  
Life Review Therapy

BackgroundAlthough there is substantial evidence for the efficacy of life review therapy as an early treatment of depression in later life, its effectiveness in natural settings has not been studied. The present study evaluates an intervention based on life review and narrative therapy in a large multi-site, pragmatic randomized controlled trial (RCT).MethodLife review therapy was compared with care as usual. The primary outcome was depressive symptoms; secondary outcomes were anxiety symptoms, positive mental health, quality of life, and current major depressive episode (MDE). To identify groups for whom the intervention was particularly effective, moderator analyses were carried out (on sociodemographic variables, personality traits, reminiscence functions, clinically relevant depressive and anxiety symptoms, and past MDEs).ResultsCompared with care as usual (n=102), life review therapy (n=100) was effective in reducing depressive symptoms, at post-treatment (d=0.60, B=−5.3, p<0.001), at 3-month follow-up (d=0.50, B=−5.0, p<0.001) and for the intervention also at 9-month follow-up (t=5.7, p<0.001). The likelihood of a clinically significant change in depressive symptoms was significantly higher [odds ratio (OR) 3.77, p<0.001 at post-treatment; OR 3.76, p<0.001 at the 3-month follow-up]. Small significant effects were found for symptoms of anxiety and positive mental health. Moderator analyses showed only two significant moderators, the personality trait of extraversion and the reminiscence function of boredom reduction.ConclusionsThis study shows the effectiveness of life review therapy as an early intervention for depression in an ecologically valid context, supporting its applicability to a broad target group. The intervention is also effective in reducing anxiety symptoms and strengthening positive mental health.

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