Single-joint Assessment for the Evaluation of Intraarticular Treatment: Responsiveness and Discrimination of the Composite Change Index

2015 ◽  
Vol 42 (9) ◽  
pp. 1672-1676 ◽  
Author(s):  
Caroline J. Aalbers ◽  
Danielle M. Gerlag ◽  
Margriet J. Vervoordeldonk ◽  
Paul P. Tak ◽  
Robert B. Landewé
Keyword(s):  
Effect Size ◽  
Controlled Trial ◽  
Rank Correlation ◽  
Joint Involvement ◽  
Spearman Rank Correlation ◽  
Analog Scale ◽  
Clinical Trial Registration ◽  
Randomized Controlled ◽  
Treatment Responsiveness ◽  
Joint Assessment

Objective.To investigate responsiveness, discrimination, and construct validity of a composite change index (CCI) for the assessment of single-joint involvement in inflammatory arthritis.Methods.Evaluation of standardized response means (SRM), Guyatt effect size, and Spearman rank correlation coefficient in a randomized controlled trial investigating the effect of an intraarticular etanercept injection.Results.The CCI showed a high SRM (1.68) and high Guyatt effect size (2.72). Both visual analog scale of pain and functionality had a moderate Guyatt effect size (2.06, 2.44) and high SRM (0.81, 0.97).Conclusion.This study supports the use of the CCI as a single-joint assessment after single-joint intervention. Clinical trial registration: NTR-1210.

The Effectiveness of the Mézières Method in Elite Rhythmic Gymnastics Athletes With Low Back Pain: A Randomized Controlled Trial

2020 ◽  
Vol 29 (7) ◽  
pp. 913-919
Author(s):  
Orges Lena ◽  
Jasemin Todri ◽  
Ardita Todri ◽  
José Luis Martínez Gil ◽  
Maria Gomez Gallego
Keyword(s):  
Randomized Controlled Trial ◽  
Low Back Pain ◽  
Back Pain ◽  
Visual Analog Scale ◽  
Effect Size ◽  
Controlled Trial ◽  
Low Back ◽  
Analog Scale ◽  
Randomized Controlled ◽  
Rhythmic Gymnastics

Context: One of the main reasons why athletes with a high physical condition suffer from low back pain disease is because they often participate in sports that involve disc compression movements during flexion, lifting loads, or torsion movement. Objectives: This study aims to examine the effectiveness of the postural treatment of the Mézières method on elite rhythmic gymnastics athletes with low back pain. Design: Double-blind, randomized, controlled trial. Setting: The sports hall of “Puente Tocinos,” Murcia, Spain. Participants: Ninety gymnastics athletes were randomized into 2 parallel groups (intervention: n = 39; control: n = 51), of whom 98.9% were women (women = 89; man = 1). Intervention: The Mézières method postural therapy was implemented. It lasted about 60 minutes in repeated sessions of 2 to 3 meetings per week by counting in overall 60 sessions during a 24-week period. Main Outcome Measures: Visual analog scale of pain, sit and reach flexibility test, Runtastic (pedometer performance android application), Roland–Morris Questionnaire for the physical disability, and the Health Status Questionnaire were used. Results: The univariate analysis of variance and independent sample t test revealed a significant improvement in the intervention group concerning the visual analog scale pain assessment scale (P < .05, ), and, also, the between-groups effect size was high during the 24 sessions of treatment (d > 0.8) compared with the control one. The same situation persists even for Roland–Morris Questionnaire (P < .05, ), physical score (P < .05, ), mental score (P < .05, ), sit and reach flexibility test (P < .05, ), and Runtastic performance (P < .05, ), where the between-groups effect size was high during the 24 sessions of treatment (d > 0.8). Conclusion: The Mézières method treatment performed on athletes with low back pain has caused positive effects on all the outcomes analyzed compared with the ones of control group.

Reanalyzing a Randomized Controlled Trial of Combination Antidepressant Treatment With Mirtazapine: Confidence Intervals Suggest Substantial Uncertainty

2011 ◽  
Vol 13 (2) ◽  
pp. 149-154 ◽  
Author(s):  
Jeffrey R. Lacasse
Keyword(s):  
Randomized Controlled Trial ◽  
Combination Therapy ◽  
Confidence Intervals ◽  
Effect Size ◽  
Antidepressant Treatment ◽  
Controlled Trial ◽  
Number Needed To Treat ◽  
Clinical Trial Registration ◽  
Randomized Controlled ◽  
Substantial Uncertainty

This article subjects a randomized controlled trial (RCT) published in the American Journal of Psychiatry to a methodological and statistical critique, including a reanalysis of the effect size statistics presented. The published trial tested the use of combination antidepressants (mirtazapine coprescribed with either bupropion, venlafaxine, or fluoxetine) at treatment initiation as compared with fluoxetine monotherapy. The authors report that combination therapy was effective, with a number-needed-to-treat (NNT) statistic of 3–5, a strong effect size. Scrutiny of the methodology and clinical trial registration shows that 4 of 6 preregistered outcomes were statistically nonsignificant, 1 outcome was not reported, and 1 unregistered outcome was published. The well-critiqued Hamilton Depression Inventory was the only positive outcome measure. Calculating confidence intervals for the reported NNT demonstrates substantial uncertainty (95% CI for NNT = 2.3–18.0). In an era of evidence-based psychiatric practice, there is insufficient evidence to recommend combination therapy at initiation of treatment.

scholarly journals Implementation of enhanced recovery after surgery in gynecological operations: a randomized controlled trial

2020 ◽  
Vol 12 (1) ◽  
Author(s):  
Amr Nady Abdelrazik ◽  
Ahmad Sameer Sanad
Keyword(s):  
Hospital Stay ◽  
Enhanced Recovery ◽  
Enhanced Recovery After Surgery ◽  
Controlled Trial ◽  
Length Of Hospital Stay ◽  
Gynecologic Surgery ◽  
Complication Rates ◽  
Control Groups ◽  
Analog Scale ◽  
Randomized Controlled

Abstract Background To investigate the effects of enhanced recovery after surgery (ERAS) in patients undergoing gynecologic surgery on length of hospital stay, pain management, and complication rate. Results The length of hospital stay was reduced in ERAS groups when compared with the control groups (3.46 days vs 2.28 days; P < 0.0001; CI − 1.5767 to − 0.7833 for laparotomy groups and 2.18 vs 1.76 days; P = 0.0115; CI − 0.7439 to − 0.0961 for laparoscopy groups respectively). Intraoperative fluid use was reduced in both ERAS groups compared to the two control groups (934 ± 245 ml and 832 ± 197 ml vs 1747 ± 257 ml and 1459 ± 304 respectively; P < 0.0001) and postoperative fluid use was also less in the ERAS groups compared to the control groups (1606 ± 607 ml and 1210 ± 324 ml vs 2682 ± 396 ml and 1469 ± 315 ml respectively; P < 0.0001). Pain score using visual analog scale (VAS) on postoperative day 0 was 4.8 ± 1.4 and 4.1 ± 1.2 (P = 0.0066) for both laparotomy control and ERAS groups respectively, while in the laparoscopy groups, VAS was 3.8 ± 1.1 and 3.2 ± 0.9 (P = 0.0024) in control and ERAS groups respectively. Conclusion Implementation of ERAS protocols in gynecologic surgery was associated with significant reduction in length of hospital stay, associated with decrease intravenous fluids used and comparable pain control without increase in complication rates.

scholarly journals Adherence to a Lifestyle Exercise and Nutrition Intervention in University Employees during the COVID-19 Pandemic: A Randomized Controlled Trial

2021 ◽  
Vol 18 (14) ◽  
pp. 7510
Author(s):  
Guillermo García Pérez de Sevilla ◽  
Olga Barceló Guido ◽  
María de la Paz De la Cruz ◽  
Ascensión Blanco Fernández ◽  
Lidia B. Alejo ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Effect Size ◽  
Exercise Intervention ◽  
Controlled Trial ◽  
Intervention Group ◽  
Nutrition Intervention ◽  
Sitting Time ◽  
Post Intervention ◽  
University Employees ◽  
Randomized Controlled

Healthy lifestyles should be encouraged in the workplace through the occupational health teams of the companies. The objective of the present study was to evaluate the adherence to a lifestyle intervention carried out in university employees during the COVID-19 pandemic and its impact on health-related quality of life (HrQoL). A randomized controlled trial following the CONSORT guidelines was performed, consisting of three supervised interventions lasting for 18 weeks: an educational intervention on healthy habits, a nutritional intervention, and a telematic aerobic and strength exercise intervention. Lifestyle and HrQoL were analyzed six months post-intervention to assess adherence. Twenty-three middle-aged participants completed the study. The intervention group significantly improved their lifestyle according to the Health Promoting Lifestyle Profile II questionnaire, especially in the categories of Health Responsibility, Physical Activity, and Nutrition, with a large effect size. Sitting time was reduced by 2.5 h per day, with a moderate effect size. Regarding HrQoL, the intervention group showed a clinically significant improvement in the Physical Component Summary. Despite the lockdown and the mobility restrictions caused by the COVID-19 pandemic, this intervention performed on university employees achieved adherence to a healthier lifestyle and improved their HrQoL, which is of great clinical relevance.

scholarly journals The effect of therapeutic listening on anxiety and fear among surgical patients: randomized controlled trial

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 ◽  
...  
Keyword(s):  
Heart Rate ◽  
Randomized Controlled Trial ◽  
State Anxiety ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Clinical Trial Registration ◽  
Physiological Variables ◽  
Randomized Controlled ◽  
Therapeutic Listening

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.

scholarly journals The Effectiveness of Traditional Chinese Yijinjing Qigong Exercise for the Patients With Knee Osteoarthritis on the Pain, Dysfunction, and Mood Disorder: A Pilot Randomized Controlled Trial

2022 ◽  
Vol 8 ◽  
Author(s):  
Shuaipan Zhang ◽  
Guangxin Guo ◽  
Xing Li ◽  
Fei Yao ◽  
Zhiwei Wu ◽  
...  
Keyword(s):  
Knee Osteoarthritis ◽  
Outcome Measurement ◽  
Controlled Trial ◽  
Well Being ◽  
Functional Mobility ◽  
Exercise Session ◽  
Control Group ◽  
Serious Adverse Events ◽  
Clinical Trial Registration ◽  
Randomized Controlled

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 &gt; 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&amp;htm=4, ChiCTR2000037256.

scholarly journals A randomized controlled trial of combination of peppermint, lavender, and turmeric oil for antipruritic agent in pregnant women

2021 ◽  
Vol 30 (1) ◽  
pp. 39-44
Author(s):  
Fransisca Retno Asih ◽  
Farid Husin ◽  
Oki Suwarsa ◽  
Irda Fidrianny ◽  
Dany Hilmanto
Keyword(s):  
Pregnant Women ◽  
Controlled Trial ◽  
Control Groups ◽  
Analog Scale ◽  
Chi Square ◽  
Herbal Products ◽  
Randomized Controlled ◽  
Level I ◽  
And Control ◽  
Single Blind

BACKGROUND Pruritus is the most common dermatological complaint that occurs during pregnancy, which is around 14–20%. No research related to herbal products to reduce some of the characteristics of pruritus at once has been conducted. This study aimed to assess the effect of blending oil to reduce pruritus based on visual analog scale (VAS). METHODS This was a single-blind, randomized clinical trial that included 57 pregnant women who were at 25–38 weeks of gestation, had a pruritus during pregnancy, a single pregnancy, a level I and II pruritus and a moderate to severe pruritus based on VAS. Pruritus scores were measured using VAS in both the treatment and control groups. The treatment and control groups applied blending oil and placebo, respectively, twice a day after bathing for 2 weeks. Mann–Whitney U, paired t, and chi-square tests were used for the analysis. RESULTS Pruritus reduction in pregnant women who received blending oil was higher than those using placebo (61.08% versus 12.41%, p<0.05). 83% of subjects using blending oils had a reduction of pruritus by >25 mm. Pregnant women who used placebo had a six times greater risk of experiencing pruritus than those who used blending oil (RR = 5.8, 95% CI = 2.613–12.874). CONCLUSIONS Blending oil can be used topically to treat a pruritus in pregnant women.

scholarly journals The Effect of Proprioceptive Neuromuscular Facilitation on Joint Position Sense: A Systematic Review

2020 ◽  
Vol 29 (4) ◽  
pp. 488-497 ◽  
Author(s):  
Hiroshi Takasaki ◽  
Yu Okubo ◽  
Shun Okuyama
Keyword(s):  
Randomized Controlled Trial ◽  
Effect Size ◽  
Methodological Quality ◽  
Controlled Trial ◽  
Position Sense ◽  
Joint Position Sense ◽  
Joint Position ◽  
Healthy Individuals ◽  
Randomized Controlled ◽  
Proprioceptive Neuromuscular Facilitation

Context: Accurate joint position sense (JPS) is necessary for effective motor learning and high performance in activities that require fine motor control. Proprioceptive neuromuscular facilitation (PNF) can be a promising intervention. Objective: To examine existing peer-reviewed original studies that have investigated the effect of PNF techniques on the JPS in terms of the methodological quality, PNF techniques, outcomes, and participant characteristics. Evidence Acquisition: A systematic literature search was performed using PubMed, EMBASE, MEDLINE, CINAHL, SocINDEX, Scopus, and Cochrane Library from inception to January 2018. The following inclusion criteria were used: (1) assessment of the JPS; (2) peer-reviewed original studies with a randomized controlled trial or quasi-randomized controlled trial design; (3) participants with musculoskeletal disorders or healthy individuals (ie, neither animal studies nor those involving neurological problems); and (4) no cointervention with PNF, except for warm-up procedures. The methodological quality was assessed using PEDro scale and 5 additional criteria. Effect size (η2) was calculated where a positive value indicated an increased JPS after PNF as compared with other approaches including the wait-and-see method. Evidence Synthesis: Nine studies were examined for their methodological quality, and only one study scored >6 on the PEDro scale. Positive and large effect size (η2 > .14) was detected in 2 studies where JPS of the knee with contract-relax and replication techniques was assessed in healthy individuals. However, the methodological quality of these studies was poor (PEDro scores of 3 and ≤5 in the total quality score out of 16, respectively). Conclusions: The current study did not find multiple studies with high methodological quality and similar PNF techniques, outcomes, and characteristics of participants. More high-quality studies are required to achieve a comprehensive understanding of the effect of PNF on the JPS.

scholarly journals Moxibustion as a Therapy for Breast Cancer–Related Lymphedema in Female Adults: A Preliminary Randomized Controlled Trial

2019 ◽  
Vol 18 ◽  
pp. 153473541986691 ◽  
Author(s):  
Chunhui Wang ◽  
Ming Yang ◽  
Yingyi Fan ◽  
Xiaohua Pei
Keyword(s):  
Breast Cancer ◽  
Scale Score ◽  
Controlled Trial ◽  
Visual Analog Scale Score ◽  
Control Group ◽  
Analog Scale ◽  
Randomized Controlled ◽  
Arm Circumference ◽  
Breast Cancer Related Lymphedema ◽  
And Control

Objective: To evaluate the effect of moxibustion on relieving breast cancer–related lymphedema. Materials and Methods: A randomized controlled trial was conducted in our institution from March 2016 to March 2017. All patients (N = 48) with cancer-related lymphedema were allocated to 2 groups: a treatment group, in which moxibustion was performed, and a control group, in which pneumatic circulation was performed with compression garments worn every day. Therapeutic efficacy was evaluated by measuring arm circumference (wrist crease, 10 cm proximal to wrist crease, elbow crease, and 10 cm proximal to elbow crease) and determining the Revised Piper Fatigue Scale score and Visual Analog Scale score for swelling before and after treatment. Results: All patients were treated for 4 consecutive weeks. Compared with 0 week after treatment, the affected-side arm circumference after 4 weeks’ treatment decreased in both treatment and control groups; the difference value in the treatment group was superior to that in the control group. Compared with the controls, moxibustion resulted in a lower Visual Analog Scale score. The Revised Piper Fatigue total scores were improved in both the moxibustion and control group, and there was no significant difference between the 2 groups. Moxibustion reduced the behavioral, sensory, emotional, and cognitive Revised Piper Fatigue scores, but only the behavioral and sensory scores improved in the control group. Conclusion: Moxibustion has potential effect on breast cancer–related lymphedema. We present promising preliminary data for larger randomized trials to enable accurate evaluation of moxibustion as a lymphedema treatment.

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