Study protocol for a prospective, randomized, multicenter trial to investigate the influence of peripheral nerve stimulation on patients with chronic sacroiliac joint syndrome (SILENCING)
The prevalence of sacroiliac joint pain (SIJP) is estimated to be 10 –30% in patients with chronic low back pain. Numerous conservative and surgical treatment modalities for SIJP have been described with limite... (Source: Trials)
Source: Trials - March 28, 2024 Category: General Medicine Authors: Tarik Alp Sargut, Dimitri Tkatschenko, Anton Fr üh, Jochen Tüttenberg, Alexander Heckert, Steffen Fleck, Anja Kuckuck and Simon Heinrich Bayerl Tags: Study protocol Source Type: research
Current usage of explainer animations in trials: a survey of the UKCRC registered clinical trial units in the UK
Explainer animations are a means to communicate aspects of clinical trials to participants in a more engaging and accessible way. Delivered well these have the potential to enhance recruitment and retention. T... (Source: Trials)
Source: Trials - March 28, 2024 Category: General Medicine Authors: Vicki S. Barber, Clare Calvert, Duncan Appelbe, Kirsty Sprange, Claire Nollett, Samantha Tanner and Duncan B. Richards Tags: Research Source Type: research
Design and evaluation of mobile application for adolescents ’ self-care: protocol for a randomized controlled field trial
Adolescence is a critical stage for the development of self-care. Many adolescents use mobile apps to monitor and improve their health. Health information technology plays a significant role in the field of se... (Source: Trials)
Source: Trials - March 28, 2024 Category: General Medicine Authors: Razieh Rezaee, Mohtasham Ghaffari, Reza Rabiei, Amir Kavousi and Sakineh Rakhshanderou Tags: Study protocol Source Type: research
Design and evaluation of mobile application for adolescents ’ self-care: protocol for a randomized controlled field trial
This study will be done in three stages: The first stage is the design and evaluation of a mobile application for adolescent self-care. The second stage is, designing and evaluating the psychometric properties of the “Questionnaire for Measuring Adolescent Self-Care Performance.” This questionnaire will be used before and after using the application in the third stage. The third stage is determining the effectiveness of self-care interventions based on mobile applications among adolescents. The target group will be adolescents aged 10–19 from the schools of Amol City. In the first stage, the opinions of 30 people ado...
Source: Trials - March 28, 2024 Category: Research Source Type: clinical trials
Current usage of explainer animations in trials: a survey of the UKCRC registered clinical trial units in the UK
ConclusionsThe survey showed that a high proportion of the UKCRC CTUs have used explainer animations to provide information to participants about clinical studies. For those not using the technology yet, the most common reasons cited were a lack of expertise, lack of resources and costs to produce them. One of the desired outcomes of this project is the creation of a free-to-use library of animations to encourage wider uptake and avoid duplication. (Source: Trials)
Source: Trials - March 28, 2024 Category: Research Source Type: clinical trials
Study protocol for a prospective, randomized, multicenter trial to investigate the influence of peripheral nerve stimulation on patients with chronic sacroiliac joint syndrome (SILENCING)
DiscussionWe have described the protocol for a prospective, multicenter, randomized trial evaluating the influence of PNS on patients with chronic sacroiliac joint syndrome. We believe that PNS on patients with chronic sacroiliac joint syndrome will show promising results regarding pain relief and quality of life in comparison to BMT after 12 months. The design of this trial promises high evidence in comparison to the data to date.Trial registrationClinicalTrials.gov, NCT05357300. Registered on April 26, 2022. (Source: Trials)
Source: Trials - March 28, 2024 Category: Research Source Type: clinical trials
Cost-effectiveness and cost-utility of the ball-and-socket trapeziometacarpal prosthesis compared to trapeziectomy and ligament reconstruction: study protocol for a randomized controlled clinical trial
Trapeziometacarpal (TMC) osteoarthritis (OA) is a common cause of pain and weakness during thumb pinch leading to disability. There is no consensus about the best surgical treatment in unresponsive cases. The ... (Source: Trials)
Source: Trials - March 27, 2024 Category: General Medicine Authors: Seraf ín Lirola-Palmero, Guillem Salva-Coll, Aina María Yáñez-Juan and Eduardo Sánchez-Iriso Tags: Study protocol Source Type: research
The REPAIR study: oral antibiotics to prevent infection and wound dehiscence after obstetric perineal tear —a double-blinded placebo controlled randomized trial
Approximately 85% of women experience an obstetric tear at delivery and up to 25% subsequently experience wound dehiscence and/or infection. Previous publications suggest that intravenous antibiotics administr... (Source: Trials)
Source: Trials - March 27, 2024 Category: General Medicine Authors: Kathrine Perslev, Niels Klarskov, Thomas Bergholt and Hanna Jang ö Tags: Study protocol Source Type: research
Individual Placement and Support for persons with alcohol and drug addiction in a Swedish context (IPS-ADAS): study protocol for a randomised controlled trial
Employment is a vital source for experiencing well-being and lowering the risk of long-term social marginalisation and poverty. For persons with alcohol and drug addiction, it may also improve sobriety. Howeve... (Source: Trials)
Source: Trials - March 27, 2024 Category: General Medicine Authors: Ulrika Bejerholm, Anders H åkansson, Marcus Knutagård and Helene Hillborg Tags: Study protocol Source Type: research
The REPAIR study: oral antibiotics to prevent infection and wound dehiscence after obstetric perineal tear —a double-blinded placebo controlled randomized trial
DiscussionReducing the risk of wound dehiscence and/or infection would decrease the number of control visits, prevent the need for longer antibiotic treatment, and possibly also decrease both short-term and long-term symptoms. This would be of great importance so the mother, her partner, and the baby could establish and optimize their initial family relation.Trial registrationThe conduction of this study is approved the 2/2 –2023 with the EU-CT number: 2022–501930-49–00. ClinicalTrials.gov Identifier: NCT05830162. (Source: Trials)
Source: Trials - March 27, 2024 Category: Research Source Type: clinical trials
Cost-effectiveness and cost-utility of the ball-and-socket trapeziometacarpal prosthesis compared to trapeziectomy and ligament reconstruction: study protocol for a randomized controlled clinical trial
DiscussionThis is the first randomized study that investigates the effectiveness and cost-utility of trapeziectomy and ligament reconstruction arthroplasty and Ma ïa prosthesis. We expect the findings from this trial to lead to new insights into the surgical approach to TMC OA.Trial registrationClinicalTrials.gov NCT04562753. Registered on June 15, 2020. (Source: Trials)
Source: Trials - March 27, 2024 Category: Research Source Type: clinical trials
Individual Placement and Support for persons with alcohol and drug addiction in a Swedish context (IPS-ADAS): study protocol for a randomised controlled trial
DiscussionA primary study on the effectiveness of IPS on employment for the new target group of addictions will add to the international IPS knowledge base and inform national policy to include the underrepresented group in working life.Trial registrationWHO International Clinical Trials Registry Platform ISRCTN10492363. Registered on 14 August 2023. (Source: Trials)
Source: Trials - March 27, 2024 Category: Research Source Type: clinical trials
Pneumococcal conjugate vaccination schedules in infants —acquisition, immunogenicity, and pneumococcal conjugate and yellow fever vaccine co-administration study: statistical analysis plan
The effectiveness of immunisation with pneumococcal conjugate vaccine (PCV) has been demonstrated in many countries. However, the global impact of PCV is limited by its cost, which has prevented its introducti... (Source: Trials)
Source: Trials - March 26, 2024 Category: General Medicine Authors: Grant A. Mackenzie, Isaac Osei, Rasheed Salaudeen, Paul V. Licciardi, Brian Greenwood, Kim Mulholland and Cattram Nguyen Tags: Update Source Type: research
Implementing and evaluating group interpersonal therapy for postnatal depression in Lebanon and Kenya —individually randomised superiority trial
Depression ranks as the foremost mental health concern among childbearing women. Within low- and middle-income countries (LMICs), between 20 and 25% of women encounter depression during pregnancy or soon after... (Source: Trials)
Source: Trials - March 26, 2024 Category: General Medicine Authors: Peter Fonagy, Rabih El Chammay, Carol Ngunu, Manasi Kumar, Lena Verdeli, Elizabeth Allison, Ghida Anani, Pasco Fearon, Fouad Fouad, Zoe Hoare, Lucina Koyio, Henrietta Moore, Andrew Nyandigisi, Stephen Pilling, Hannah Sender, Jolene Skordis & hellip; Tags: Study protocol Source Type: research
Clinical statistical analysis plan for the ACCURE trial: the effect of appendectomy on the clinical course of ulcerative colitis, a randomised international multicentre trial
The primary treatment of ulcerative colitis (UC) is medical therapy using a standard step-up approach. An appendectomy might modulate the clinical course of UC, decreasing the incidence of relapses and reducin... (Source: Trials)
Source: Trials - March 26, 2024 Category: General Medicine Authors: Eva Visser, Lianne Heuthorst, Shri Pathmakanthan, Willem A. Bemelman, Geert R. D ’Haens, Kelly Handley, Apostolos Fakis, Thomas D. Pinkney, Christianne J. Buskens and Marcel G. W. Dijkgraaf Tags: Update Source Type: research
