scholarly journals The efficacy of intraarticular viscosupplementation after arthroscopic partial meniscectomy: a randomized controlled trial

2022 ◽  
Vol 23 (1) ◽  
Author(s):  
Kyoung Ho Yoon ◽  
Woo Seung Wan ◽  
Yoon-Seok Kim ◽  
Jae-Young Park
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Arthroscopic Surgery ◽  
Partial Meniscectomy ◽  
Control Group ◽  
Arthroscopic Partial Meniscectomy ◽  
Level Of Evidence ◽  
Randomized Controlled ◽  
Link Type ◽  
Post Surgery

Abstract Background This study aimed to evaluate the efficacy of viscosupplementation after arthroscopic partial meniscectomy. Method A randomized controlled trial of 47 patients who underwent arthroscopic partial meniscectomy was conducted between March 2020 and March 2021. Patients were randomized into two groups: a viscosupplementation group (n = 23) and a control group (n = 24). A single-dose intraarticular hyaluronic acid injection was used as viscosupplementation. The 100 mm visual analogue scale (VAS) for pain assessment was measured at baseline and at 1 day, 2 weeks, 6 weeks, and 3 months post-surgery. The International Knee Documentation Committee (IKDC), Tegner, Lysholm, and Western Ontario and McMaster University Osteoarthritis Index (WOMAC) scores and range of motion (ROM) of the knee were measured at baseline, 2 weeks, 6 weeks, and 3 months. Results The 100 mm VAS score for pain was significantly lower in the viscosupplementation group at 2 weeks post-surgery (27.5 mm vs. 40.7 mm, P = 0.047). ROM was significantly greater in the viscosupplementation group than in the control group at 2 weeks (131.5° vs. 121.0°, P = 0.044) post-surgery. No significant differences were observed in the IKDC or in the Tegner, Lysholm, and WOMAC scores between the two groups. Conclusions Viscosupplementation after arthroscopic partial meniscectomy significantly reduced pain at 2 weeks post-surgery and improved ROM of the knee at 2 weeks post-surgery. There might be some benefits in terms of pain and functional recovery of viscosupplementation after arthroscopic surgery. Study design Randomized controlled trial; Level of evidence, 1. Trial registration This randomized controlled trial was registered at cris.nih.go.kr #KCT0004921.

scholarly journals Frequency of repositioning for preventing pressure ulcers in patients hospitalized in ICU: protocol of a cluster randomized controlled trial

BMC Nursing ◽  
2021 ◽  
Vol 20 (1) ◽  
Author(s):  
Olga L. Cortés ◽  
Mauricio Herrera-Galindo ◽  
Juan Carlos Villar ◽  
Yudi A. Rojas ◽  
María del Pilar Paipa ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Critical Care ◽  
Pressure Ulcers ◽  
Controlled Trial ◽  
Cluster Randomized Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Link Type ◽  
Cluster Randomized ◽  
The Impact

Abstract Background Despite being considered preventable, ulcers due to pressure affect between 30 and 50% of patients at high and very high risk and susceptibility, especially those hospitalized under critical care. Despite a lack of evidence over the efficacy in prevention against ulcers due to pressure, hourly repositioning in critical care as an intervention is used with more or less frequency to alleviate pressure on patients’ tissues. This brings up the objective of our study, which is to evaluate the efficacy in prevention of ulcers due to pressure acquired during hospitalization, specifically regarding two frequency levels of repositioning or manual posture switching in adults hospitalized in different intensive care units in different Colombian hospitals. Methods A nurse-applied cluster randomized controlled trial of parallel groups (two branches), in which 22 eligible ICUs (each consisting of 150 patients), will be randomized to a high-frequency level repositioning intervention or to a conventional care (control group). Patients will be followed until their exit from each cluster. The primary result of this study is originated by regarding pressure ulcers using clusters (number of first ulcers per patient, at the early stage of progression, first one acquired after admission for 1000 days). The secondary results include evaluating the risk index on the patients’ level (Hazard ratio, 95% IC) and a description of repositioning complications. Two interim analyses will be performed through the course of this study. A statistical difference between the groups < 0.05 in the main outcome, the progression of ulcers due to pressure (best or worst outcome in the experimental group), will determine whether the study should be put to a halt/determine the termination of the study. Conclusion This study is innovative in its use of clusters to advance knowledge of the impact of repositioning as a prevention strategy against the appearance of ulcers caused by pressure in critical care patients. The resulting recommendations of this study can be used for future clinical practice guidelines in prevention and safety for patients at risk. Trial registration PENFUP phase-2 was Registered in Clinicaltrials.gov (NCT04604665) in October 2020.

scholarly journals Effectiveness of a psychological online training to promote physical activity among students: protocol of a randomized-controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Lena Violetta Krämer ◽  
Nadine Eschrig ◽  
Lena Keinhorst ◽  
Luisa Schöchlin ◽  
Lisa Stephan ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Mixed Model ◽  
Controlled Trial ◽  
Control Group ◽  
Web Based ◽  
Intention To Treat ◽  
Randomized Controlled ◽  
Link Type

Abstract Background Many students in Germany do not meet recommended amounts of physical activity. In order to promote physical activity in students, web-based interventions are increasingly implemented. Yet, data on effectiveness of web-based interventions in university students is low. Our study aims at investigating a web-based intervention for students. The intervention is based on the Health Action Process Approach (HAPA), which discriminates between processes of intention formation (motivational processes) and processes of intention implementation (volitional processes). Primary outcome is change in physical activity; secondary outcomes are motivational and volitional variables as proposed by the HAPA as well as quality of life and depressive symptoms. Methods A two-armed randomized controlled trial (RCT) of parallel design is conducted. Participants are recruited via the internet platform StudiCare (www.studicare.com). After the baseline assessment (t1), participants are randomized to either intervention group (immediate access to web-based intervention) or control group (access only after follow-up assessment). Four weeks later, post-assessment (t2) is performed in both groups followed by a follow-up assessment (t3) 3 months later. Assessments take place online. Main outcome analyses will follow an intention-to-treat principle by including all randomized participants into the analyses. Outcomes will be analysed using a linear mixed model, assuming data are missing at random. The mixed model will include group, time, and the interaction of group and time as fixed effects and participant and university as random effect. Discussion This study is a high-quality RCT with three assessment points and intention-to-treat analysis meeting the state-of-the-art of effectiveness studies. Recruitment covers almost 20 universities in three countries, leading to high external validity. The results of this study will be of great relevance for student health campaigns, as they reflect the effectiveness of self-help interventions for young adults with regard to behaviour change as well as motivational and volitional determinants. From a lifespan perspective, it is important to help students find their way into regular physical activity. Trial registration The German clinical trials register (DRKS) DRKS00016889. Registered on 28 February 2019

Enhanced early sensory outcome after nerve repair as a result of immediate post-operative re-learning: a randomized controlled trial

2014 ◽  
Vol 40 (6) ◽  
pp. 598-606 ◽  
Author(s):  
B. Rosén ◽  
P. Vikström ◽  
S. Turner ◽  
D. A. McGrouther ◽  
R. W. Selles ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Nerve Repair ◽  
Intervention Group ◽  
Control Group ◽  
Level Of Evidence ◽  
Test Part ◽  
Randomized Controlled ◽  
Identification Test

We assessed the use of guided plasticity training to improve the outcome in the first 6 months after nerve repair. In a multicentre randomized controlled trial, 37 adults with median or ulnar nerve repair at the distal forearm were randomized to intervention, starting the first week after surgery with sensory and motor re-learning using mirror visual feedback and observation of touch, or to a control group with re-learning starting when reinnervation could be detected. The primary outcome at 3 and 6 months post-operatively was discriminative touch (shape texture identification test, part of the Rosen score). At 6 months, discriminative touch was significantly better in the early intervention group. Improvement of discriminative touch between 3 and 6 months was also significantly greater in that group. There were no significant differences in motor function, pain or in the total score. We conclude that early re-learning using guided plasticity may have a potential to improve the outcomes after nerve repair. Level of evidence: II

scholarly journals Pharmacist-guided pre-emptive pharmacogenetic testing in antidepressant therapy (PrePGx): study protocol for an open-label, randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Céline K. Stäuble ◽  
Markus L. Lampert ◽  
Samuel Allemann ◽  
Martin Hatzinger ◽  
Kurt E. Hersberger ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Antidepressant Treatment ◽  
Controlled Trial ◽  
Response Rates ◽  
Control Group ◽  
Open Label ◽  
Randomized Controlled ◽  
Link Type ◽  
Increased Risk ◽  
Antidepressant Pharmacotherapy

Abstract Background It is known that only 50% of patients diagnosed with major depressive disorders (MDD) respond to the first-line antidepressant treatment. Accordingly, there is a need to improve response rates to reduce healthcare costs and patient suffering. One approach to increase rates of treatment response might be the integration of pharmacogenetic (PGx) testing to stratify antidepressant drug selection. The goal of PGx assessments is to identify patients who have an increased risk to experience adverse drug reactions or non-response to specific drugs. Especially for antidepressants, there is compiling evidence on PGx influencing drug exposure as well as response. Methods This study is an open-label, randomized controlled trial conducted in two study centers in Switzerland: (1) the Psychiatric Clinic of Solothurn and (2) the Private Clinic Wyss in Münchenbuchsee. Adult inpatients diagnosed with a unipolar moderate or severe depressive episode are recruited at clinic admission and are included in the study. If the adjustment to a new antidepressant pharmacotherapy is necessary, the participants are randomized to either Arm A (intervention group) or Arm B (control group). If no new antidepressant pharmacotherapy is introduced the participants will be followed up in an observational arm. The intervention is the service of pharmacist-guided pre-emptive PGx testing to support clinical decision making on antidepressant selection and dosing. As a comparison, in the control group, the antidepressant pharmacotherapy is selected by the treating physician according to current treatment guidelines (standard of care) without the knowledge of PGx test results and support of clinical pharmacists. The primary outcome of this study compares the response rates under antidepressant treatment after 4 weeks between intervention and control arm. Discussion The findings from this clinical trial are expected to have a direct impact on inter-professional collaborations for the handling and use of PGx data in psychiatric practice. Trial registration ClinicalTrials.govNCT04507555. Registered on August 11, 2020. Swiss National Clinical Trials Portal SNCTP000004015. Registered August 18, 2020.

How Does the Presence of Unstable Chondral Lesions Affect Patient Outcomes After Partial Meniscectomy? The ChAMP Randomized Controlled Trial

2017 ◽  
Vol 46 (3) ◽  
pp. 590-597 ◽  
Author(s):  
Leslie J. Bisson ◽  
Melissa A. Kluczynski ◽  
William M. Wind ◽  
Marc S. Fineberg ◽  
Geoffrey A. Bernas ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Knee Injury ◽  
Short Form ◽  
Controlled Trial ◽  
Partial Meniscectomy ◽  
Postoperative Outcomes ◽  
Level Of Evidence ◽  
Chondral Lesions ◽  
Randomized Controlled ◽  
Outcome Score

Background: Chondral lesions are commonly encountered during arthroscopic partial meniscectomy (APM); however, it is unknown how these lesions affect postoperative outcomes. Purpose: The authors compared postoperative outcomes among patients with and without unstable chondral lesions 1 year after APM. Study Design: Cohort study; Level of evidence, 3. Methods: The authors conducted a secondary analysis of data from the ChAMP (Chondral Lesions and Meniscus Procedures) randomized controlled trial. They compared the following outcomes for patients with unstable chondral lesions that were left in situ and observed (CL-noDeb) versus patients without unstable chondral lesions (NoCL) at 1 year after APM: Western Ontario and McMaster Universities Osteoarthritis Index, Knee injury and Osteoarthritis Outcome Score, visual analog scale for pain, the Short Form Health Survey, range of motion, quadriceps circumference, and effusion. Multivariate linear regression was used to obtain mean differences (MDs) with corresponding 95% CIs adjusted for age, body mass index, and preoperative score (for postoperative scores). Results: Compared with the CL-noDeb group, the NoCL group had greater improvement in Western Ontario and McMaster Universities Osteoarthritis Index for pain (MD, 7.9, 95% CI: 2.7-13.1), stiffness (MD, 9.1, 95% CI: 1.9-16.3), and physical function (MD, 4.6, 95% CI: 0.1-9.0) and Knee injury and Osteoarthritis Outcome Score for pain (MD, 8.4, 95% CI: 2.7-14.0), function in sport and recreation (MD, 11, 95% CI: 3.0-19.1), and quality of life (MD, 10.4, 95% CI: 2.3-18.5). The NoCL group was less likely than the CL-noDeb group to have an effusion ( P = .02) 1 year after surgery. Conclusion: Patients undergoing APM without unstable chondral lesions had better outcomes than patients with unstable chondral lesions.

scholarly journals The effect of self-care counseling on health practices of adolescent pregnant women: a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Ronya Rezaie ◽  
Sakineh Mohammad-Alizadeh-Charandabi ◽  
Fatemeh Nemati ◽  
Mojgan Mirghafourvand
Keyword(s):  
Randomized Controlled Trial ◽  
Pregnant Women ◽  
Controlled Trial ◽  
Intervention Group ◽  
Self Care ◽  
Control Group ◽  
Health Practices ◽  
Randomized Controlled ◽  
Link Type ◽  
The Mean

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.

scholarly journals Effects of a Rehabilitation Program on Perceived Environmental Barriers in Older Patients Recovering from Hip Fracture: A Randomized Controlled Trial

2013 ◽  
Vol 2013 ◽  
pp. 1-8 ◽  
Author(s):  
Erja Portegijs ◽  
Merja Rantakokko ◽  
Johanna Edgren ◽  
Anu Salpakoski ◽  
Ari Heinonen ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Hip Fracture ◽  
Controlled Trial ◽  
Rehabilitation Program ◽  
Community Dwelling ◽  
Outdoor Environment ◽  
Control Group ◽  
Environmental Barriers ◽  
Randomized Controlled ◽  
Link Type

Objectives. To study effects of a one-year multicomponent intervention on perceived environmental barriers in hip fracture patients.Design. Randomized controlled trial of a 12-month home-based rehabilitation aiming to improve mobility and function (ISRCTN53680197); secondary analyses.Subjects. Community-dwelling hip fracture patients on average 70 days after trauma (n=81).Methods. Assessments at baseline, 3, 6, and 12 months later included perceived entrance-related barriers (e.g., indoor/outdoor stairs, lighting, floor surfaces, and storage for mobility devices) and perceived barriers in the outdoor environment (poor street condition, hilly terrain, long-distances, and lack of resting places). Sum scores for entrance-related and outdoor barriers were analyzed using general estimating equation models.Results. At baseline, 48% and 37% of the patients perceived at least one entrance-related barrier, and 62% and 60% perceived at least one outdoor barrier in the intervention and control group, respectively. Over time, (P=0.003) the number of entrance-related barriers decreased in both groups (groupP=0.395; interactionP=0.571). For outdoor barriers, time (P=0.199), group (P=0.911), and interaction effect (P=0.430) were not significant.Conclusion. Our intervention had no additional benefit over standard care in hip fracture patients. Further study is warranted to determine whether perceived environmental barriers can be reduced by interventions targeted at the older individual. This trial is registered withISRCTN53680197.

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