Randomized Controlled
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2021 ◽  
Zhengting He ◽  
Xin Cao ◽  
Duan Zhao ◽  
Zemin Tang ◽  
Jiayu Zhao ◽  

Abstract Background Among rural Chinese patients with non-communicable diseases (NCDs), low socioeconomic status increases the risk of developing NCDs and associated financial burdens in paying for medicines and treatments. Despite the chronic disease medicine reimbursement policy of the local government in Nantong City, China, various barriers prevent patients from registering for and benefitting from the policy. This study aims to develop a behavior-science based intervention program for promoting the adoption of the policy and to evaluate the effectiveness of the program compared with usual practices. Methods Barriers and opportunities affecting stakeholders in adopting the policy were identified through contextual research and summarized through behavior mapping. The intervention targets these barriers and opportunities through behavior science theories and will be evaluated through a 6-month cluster randomized controlled trial in Tongzhou District, Nantong, China. A total of 30 villages from two townships are randomized in a 1:1 ratio to either the intervention or the control arm (usual practices). Village doctors in the intervention arm (1) receive systematic training on policy details, registration procedures, and intervention protocol, (2) promote the policy and encourage registration, (3) follow-up with patients in the first, third and sixth month after the intervention, and (4) receive financial incentives based on performance. The primary outcome is policy registration rate and the secondary outcomes include the number of patients registering for the policy, medical costs saved, frequency of village doctor visits, and health conditions such as blood pressure and glucose levels. Discussion This study is one of very few that aims to promote adoption of NCDs outpatient medication reimbursement policies, and the first study to evaluate the impact of these policies on patients’ financial and physical wellbeing in China. The simple, feasible, and scalable intervention is designed based on the theories of behavior science and are applicable to similar low-income regions nationwide where outpatient medical costs remain a financial burden for patients. Trial registration: ClinicalTrials.gov, NCT04731194, registered on 29 January 2021, https://clinicaltrials.gov/ct2/show/NCT04731194?term=PAPMed&draw=2&rank=1; Chinese Clinical Trial Registry, ChiCTR2100042152, registered on 14 January 14 2021, http://www.chictr.org.cn/showproj.aspx?proj=65987.

BMC Neurology ◽  
2021 ◽  
Vol 21 (1) ◽  
Anna Zaheer ◽  
Arshad Nawaz Malik ◽  
Tahir Masood ◽  
Sahar Fatima

Abstract Background The objective of the current study is to evaluate the effects of phantom exercises on phantom limb pain, mobility status, and quality of life in lower limb amputees treated with mirror therapy and routine physiotherapy. Methods It is a randomized controlled trial in which 24 unilateral lower limb amputees (above and below the knee) were randomly assigned to two equal groups i.e., control group (mirror therapy and conventional physical therapy) and experimental group in which, phantom exercises were given, additionally. Physical therapy included conventional therapeutic exercises while phantom exercises include imagining the movement of the phantom limb and attempting to execute these movements Data were collected at baseline, after 2 and 4 weeks of intervention using VAS (pain), AMP (mobility) and RAND SF-36 Version 1.0 (QOL) questionnaires. All statistical analyses were done with IBM SPSS 25.0 with 95% CI. Results Twenty-four amputees (17 males and 7 females) participated in this trial. The Mean age of the participants in experimental and control groups was 45.3 ± 11.1 years and 40.5 ± 12.5 years respectively. After the intervention, the pain (VAS score) was significantly lower in the experimental group (p = 0.003). Similarly, the experimental group demonstrated a significantly better score in the “bodily pain” domain of SF-36 (p = 0.012). Both groups significantly (p < 0.05) improved in other domains of SF-36 and ambulatory potential with no significant (p > 0.05) between-group differences. Conclusions The Addition of phantom exercises resulted in significantly better pain management in lower limb amputees treated with mirror therapy and routine physiotherapy. Trial registration This study is registered in the U.S National Library of Medicine. The clinical trials registration number for this study is NCT04285138 (ClinicalTrials.gov Identifier) (Date: 26/02/2020).

2021 ◽  
Vol 3 ◽  
Jae M. Sevelius ◽  
Torsten B. Neilands ◽  
Cathy J. Reback ◽  
Danielle Castro ◽  
Samantha E. Dilworth ◽  

Introduction: Transgender women (assigned “male” at birth but who do not identify as male) are disproportionately impacted by HIV and experience unique barriers and facilitators to HIV care engagement. In formative work, we identified culturally specific and modifiable barriers to HIV treatment engagement among transgender women living with HIV (TWH), including prioritizing transition-related healthcare over HIV treatment, avoiding HIV care settings due to gender-related and HIV stigma, concerns about potential drug interactions with hormones, and inadequate social support. Grounded in the investigators' Models of Gender Affirmation and Health Care Empowerment, we developed the Healthy Divas intervention to optimize engagement in HIV care among TWH at risk for treatment failure and consequential morbidity, mortality, and onward transmission of HIV.Methods and Analysis: We conducted a 2-arm randomized controlled trial (RCT) of the intervention's efficacy in Los Angeles and San Francisco to improve engagement in care among TWH (N = 278). The primary outcome was virologic control indicated by undetectable HIV-1 level (undetectability = &lt; 20 copies/mL), at baseline and follow-up assessment for 12 months at 3-month intervals.Ethics and Dissemination: This study was approved by University of California, San Francisco Institutional Review Board (15-17910) and Western Institutional Review Board (20181370). Participants provided informed consent before enrolment in the study. We are committed to collaboration with National Institutes of Health officials, other researchers, and health and social services communities for rapid dissemination of data and sharing of materials. The results will be published in peer-reviewed academic journals and scientific presentations. We will make our results available to researchers interested in transgender health to avoid unintentional duplication of research, as well as to others in health and social services communities, including HIV clinics, LGBT community-based organizations, and AIDS service organizations.Clinical Trial Registration:Clinicaltrials.gov, identifier NCT03081559.

Antonia Kohlert ◽  
Katharina Wick ◽  
Jenny Rosendahl

Abstract Background Autogenic training (AT) is frequently used as therapeutic approach in multimodal pain therapy. The aim of this systematic review and meta-analysis is to investigate the efficacy of AT in individuals suffering from chronic pain in comparison to passive and active control groups. Methods A comprehensive literature search in Medline, Web of Science, PsycInfo, and PubPsych and manual searches (last search April 7, 2021) were conducted to locate randomized controlled trials (RCTs). Treatment guidelines and references of relevant articles and previous reviews were checked. ProQuest Dissertations and Theses Full Text database, DART-Europe E-theses Portal, Networked Digital Library of Theses and Dissertations (NDLTD), and the Theses Database of the German National Library were screened to identify any unpublished material. Results A total of 13 eligible studies (k = 15 comparisons) including 576 participants were identified. Random-effects meta-analyses revealed a significantly positive, moderate effect of AT on the primary outcome pain compared to passive control groups (g = 0.58, 95% CI [0.36; 0.79], k = 9, I2 = 0%). In comparison with other psychological interventions, no difference was found (g = − 0.05, 95% CI [− 0.30; 0.20], k = 6, I2 = 0%). Sensitivity analyses proved the robustness of findings. Overall risk-of-bias judgment was ‘some concerns’ in the majority of studies. Conclusions Beneficial effects of AT on pain reduction were demonstrated, but findings are prone to bias. Furthermore, high methodological quality RCTs are needed to strengthen the promising evidence of AT for individuals with chronic pain.

2021 ◽  
Vol 21 (1) ◽  
Ronya Rezaie ◽  
Sakineh Mohammad-Alizadeh-Charandabi ◽  
Fatemeh Nemati ◽  
Mojgan Mirghafourvand

Abstract Background Pregnancy and childbirth at an early age are associated with potential risks and complications for adolescent mothers. Health practices are behaviors that can positively affect maternal and fetal health. This study aimed to investigate the effects of self-care counseling on health practices (main outcome), attitudes towards motherhood and pregnancy, and pregnancy symptoms (secondary outcomes) in adolescent pregnant women. Methods In this randomized controlled trial, 54 adolescent pregnant women admitted to the health centers of Bukan, Iran in 2020 were enrolled. Using randomized block design, the participants were randomly assigned to the counseling (n=27) and control (n=27) groups. Those in the intervention group attended 6 self-care group counseling sessions. The Health Practices Questionnaire-II (HPQ-II), Attitudes towards Motherhood and Pregnancy Questionnaire (PRE-MAMA), and Pregnancy Symptoms Inventory (PSI) were completed before and 4 weeks after the intervention. Results Based on the results of ANCOVA with controlled baseline values, after the intervention the mean health practices score of the participants in the intervention group was significantly higher than those in the control group (adjusted mean difference (AMD): 36.34; 95% CI: 34.69 to 37.98; P<0.001). The mean attitude towards motherhood score of the participants in the intervention group was significantly higher than those in the control group (AMD: 1.01; 95% CI: 0.06 to 1.96; P= 0.038). However, the mean pregnancy symptoms score of the participants in the intervention group was partially lower than those in the control group (AMD: -1.37; 95% CI: -4.32 to 1.58; P= 0.354). Conclusion Self-care counseling sessions can improve the health practices of adolescent pregnant women and enhance their attitudes towards maternal role and pregnancy. Therefore, planners are recommended to organize self-care counseling programs for all pregnant women, especially for adolescent pregnant women. Trial registration Iranian Registry of Clinical Trials (IRCT): IRCT20120718010324N54. Date of registration: 2/3/2020. URL: https://en.irct.ir/user/trial/42571/view; Date of first registration: February 3, 2020.

2021 ◽  
Vol 22 (1) ◽  
Anders Galaasen Bakken ◽  
Andreas Eklund ◽  
Anna Warnqvist ◽  
Søren O’Neill ◽  
Iben Axén

Abstract Background Recurrent or persistent neck pain affects a vast number of people globally, leading to reduced quality of life and high societal costs. Clinically, it is a difficult condition to manage, and treatment effect sizes are often moderate at best. Activity and manual therapy are first-line treatment options in current guidelines. We aimed to investigate the combination of home stretching exercises and spinal manipulative therapy in a multicentre randomized controlled clinical trial, carried out in multidiscipline ary primary care clinics. Methods The treatment modalities utilized were spinal manipulative therapy and home stretching exercises compared to home stretching exercises alone. Both groups received 4 treatments for 2 weeks. The primary outcome was pain, where the subjective pain experience was investigated by assessing pain intensity (NRS − 11) and the quality of pain (McGill Pain Questionnaire). Neck disability and health status were secondary outcomes, measured using the Neck Disability Indexthe EQ-5D, respectively. One hundred thirty-one adult subjects were randomized to one of the two treatment groups. All subjects had experienced persistent or recurrent neck pain the previous 6 months and were blinded to the other group intervention. The clinicians provided treatment for subjects in both group and could not be blinded. The researchers collecting data were blinded to treatment allocation, as was the statistician performing data analyses. An intention-to-treat analysis was used. Results Sixty-six subjects were randomized to the intervention group, and sixty-five to the control group. For NRS − 11, a B-coefficient of − 0,01 was seen, indication a 0,01 improvement for the intervention group in relation to the control group at each time point with a p-value of 0,305. There were no statistically significant differences between groups for any of the outcome measures. Conclusion Based on the current findings, there is no additional treatment effect from adding spinal manipulative therapy to neck stretching exercises over 2 weeks for patients with persistent or recurrent neck pain. Trial registration The trial was registered 03/07/2018 at ClinicalTrials.gov, registration number: NCT03576846.

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Rasmus Kramer Mikkelsen ◽  
Lars Blønd ◽  
Lisbeth Rosenkrantz Hölmich ◽  
Cecilie Mølgaard ◽  
Anders Troelsen ◽  

Abstract Background Osteoarthritis is a destructive joint disease that leads to degeneration of cartilage and other morphological changes in the joint. No medical treatment currently exists that can reverse these morphological changes. Intra-articular injection with autologous, micro-fragmented adipose tissue has been suggested to relieve symptoms. Methods/Design The study is a blinded randomized controlled trial with patients allocated in a 1:1 ratio to 2 parallel groups. Patients suffering from pain and functional impairment due to osteoarthritis Kellgren-Lawrence grades 2–3 in the tibiofemoral joint are eligible for inclusion. The intervention group is treated with an intra-articular injection with autologous, micro-fragmented adipose tissue prepared using the Lipogems® system. The control group receives an intra-articular injection with isotonic saline. In total, 120 patients are to be included. The primary outcome is The Knee injury and Osteoarthritis Outcome Score (KOOS4) evaluated at 6 months. Secondary outcomes are KOOS at 3, 12 and 24 months; the Tegner activity score; treatment failure; and work status of the patient. The analysis will be conducted both as intention-to-treat and per-protocol analysis. Discussion This trial is the first to investigate the efficacy of autologous, micro-fragmented adipose tissue in a randomized controlled trial. The study uses the patient-reported outcome measure Knee Injury and Osteoarthritis Outcome Score (KOOS4) after 6 months as the primary outcome, as it is believed to be a valid measure to assess the patient’s opinion about their knee and associated problems when suffering from osteoarthritis.

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