Randomized Controlled Trial
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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.

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.

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.

2021 ◽  
Oliver Rumle Hovmand ◽  
Sidse Marie Arnfred ◽  
Nina Reinholt ◽  
Kirstine Dichmann ◽  
Radoslav Borisov

Abstract BackgroundEvasive personality disorder (EPD) and social phobia (SP) have substantial costs to the patients and their families, and great economic costs to the community. While psychotherapy can be an efficient treatment, a large percentage of patients drop-out during treatment. Little is known about what can be done in order to decrease dropout from psychotherapy in general, including how to increase a patient’s readiness for psychotherapy. MethodsWe describe a feasibility randomized controlled trial of 42 individuals with a clinical diagnosis of either SP or evasive personality disorder, who are to initiate psychotherapeutic treatment in Danish outpatient mental health services. They will be randomized in a 1:1 ratio to either assessment-as-usual and receive no further assessment, or to a Modified Collaborative Assessment (MCA) provided as a pre-treatment intervention before psychotherapy initiation. MCA will included a battery of psychological tests designed to thoroughly assess the patients’ psychopathology. The tests is administered in collaboration with the patient including a detailed oral and written feedback. We hypothesize that the patients randomized to MCA will reach higher levels of readiness for psychotherapy as assessed with the University of Rhode Island Change Assessment Scale (URICA) and have lower dropout-rates than assessment-as-usual. DiscussionThis protocol assess the feasibility, efficacy, acceptability, and safety of an intervention aimed at changing the readiness for participation in psychotherapy for patients with SP and EVP. Results from this feasibility study could guide the development of future large-scale trials of MCA and procedures for MCA treatment fidelity assessment.

BMC Medicine ◽  
2021 ◽  
Vol 19 (1) ◽  
Qi-Yue Chen ◽  
Qing Zhong ◽  
Ping Li ◽  
Jian-Wei Xie ◽  
Zhi-Yu Liu ◽  

Abstract Background Application of indocyanine green (ICG) fluorescence imaging is effective in guiding laparoscopic radical lymphadenectomy for gastric cancer. However, the optimal approach for indocyanine green injection is controversial. Therefore, the objective of this study was aimed to compare the efficacy and ICG injection between the preoperative submucosal and intraoperative subserosal approaches for lymph node (LN) tracing during laparoscopic gastrectomy. Method This randomized controlled trial (ClinicalTrials.gov, NCT04219332) included 266 patients with potentially resectable gastric cancer (cT1–T4a, N0/+, M0) enrolled from a tertiary teaching center between December 2019 and October 2020. The primary endpoint was total number of retrieved LNs. Results In total, 259 patients (n = 130 and n = 129 in the submucosal and subserosal groups, respectively) were included in the per-protocol analysis. There are no significant differences in total number of retrieved LNs between the two groups (49.8 vs. 49.2, P = 0.713). The rate of LN noncompliance in the submucosal group was comparable to that in the subserosal group (32.3% vs. 33.3%, P = 0.860). No significant difference was found between the submucosal and subserosal groups in terms of the incidence (17.7% vs. 16.3%; P = 0.762) or severity of postoperative complications. The mean fluorescence cost in the submucosal group was higher than that in the subserosal group ($335.3 vs. $182.4; P < 0.001). The overall treatment satisfaction score was lower in the submucosal group than in the subserosal group (70.5 vs. 76.1%, P = 0.048). Conclusion ICG administered by subserosal injection was comparable to that administered by submucosal injection for lymph node tracing in gastric cancer. However, the former approach imposed a lower economic and mental burden on patients undergoing laparoscopic D2 lymphadenectomy. Trial registration ClinicalTrials.gov, NCT04219332.

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