Visualizing the randomized sham-controlled trial in orthopedic research: proposed steps to conducting a total knee arthroplasty randomized controlled trial.
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ABSTRACT:
SUBMITTER: Tran AA
PROVIDER: S-EPMC10288945 | biostudies-literature | 2023 Mar
REPOSITORIES: biostudies-literature
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Visualizing the randomized sham-controlled trial in orthopedic research: proposed steps to conducting a total knee arthroplasty randomized controlled trial.
Tran Audrey A AA Prasad Vinay V
Journal of comparative effectiveness research 20230227 3
Performed more than 600,000 times annually in the USA alone, total knee arthroplasty is the one of the most common and costly elective operations in the world. A primary total knee arthroplasty is generally an elective procedure, for which total index hospitalization costs are estimated around $30,000 USD. Roughly four in five patients declare they are satisfied postoperatively, justifying the procedure's frequency and high costs. It is sobering to realize, however, that the evidence base in fav ...[more]
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Project description:ObjectiveThis study aimed to evaluate the effectiveness and safety of auricular acupuncture (AA) on postoperative analgesia, the degree of postoperative nausea, and the effect of inflammation after total knee arthroplasty (TKA).MethodsThis was a single-center, placebo-controlled, randomized clinical trial. In total, 96 patients were randomly divided into an AA group with an indwelling intradermal needle (n = 48) and a sham auricular acupuncture (SAA) group with a non-penetrating placebo needle (n = 48). Intra-spinal anesthesia was adopted in both groups during surgery, and an epidural analgesic pump was implanted after surgery for 48 h. The primary outcome was the post-surgery visual analog score (VAS) of resting and movement states (at 6, 12 h and 1, 2, 3, 5, and 7 days). The secondary outcomes included additional doses of analgesic injection during the treatment, C-reactive protein (CRP) levels, erythrocyte sedimentation rate (ESR), and white blood cell (WBC) count on the 1st, 3rd, and 7th day after the operation, nausea on the 1st, 2nd, and 3rd day after the operation, the Hospital for Special Surgery Knee Score (HSS) on the 2nd and 12th week after the operation, and adverse events.ResultsThe VAS in the AA group at 6 h, 12 h, 2, 3, and 5 days after surgery were lower than those of the SAA group (p < 0.05). Among the secondary outcomes, the total dose of additional analgesic injection after surgery in the AA group was lower than that in the SAA group (p < 0.05). The serum CRP on the 1st day after operation in the AA group was lower than that in the SAA group (p < 0.05). The degree of nausea on 2nd day after surgery in the AA group was lower than that in the SAA group (p < 0.05). There was no significant difference in other outcomes (p > 0.05).ConclusionIn this study, AA was shown to be an effective and safe complementary and alternative therapy for pain relief after TKA, which was able to reduce the total postoperative dose of additional painkillers, decrease serum CRP 1 day after surgery, and improve the degree of postoperative nausea.Clinical trial registrationwww.chictr.org.cn, ChiCTR2100054403.
| S-EPMC10904590 | biostudies-literature
Project description:BackgroundPatients with fibromyalgia (FM) frequently resort to osteopathic or chiropractic treatment, despite very weak supporting evidence. We aimed to assess the efficacy of osteopathic manipulation in FM in a properly controlled and powered randomized clinical trial.MethodsPatients were randomized to osteopathic or sham treatment. Treatment was administered by experienced physical medicine physicians, and consisted of six sessions per patient, over 6 weeks. Treatment credibility and expectancy were repeatedly evaluated. Patients completed standardized questionnaires at baseline, during treatment, and at 6, 12, 24, and 52 weeks after randomization. The primary outcome was pain intensity (100-mm visual analog scale) during the treatment period. Secondary outcomes included fatigue, functioning, and health-related quality of life. We performed primarily intention-to-treat analyses adjusted for credibility, using multiple imputation for missing data.ResultsIn total, 101 patients (94% women) were included. Osteopathic treatment did not significantly decrease pain relative to sham treatment (mean difference during treatment: -2.2 mm; 95% confidence interval, -9.1 to 4.6 mm). No significant differences were observed for secondary outcomes. No serious adverse events were observed, despite a likely rebound in pain and altered functioning at week 12 in patients treated by osteopathy. Patient expectancy was predictive of pain during treatment, with a decrease of 12.9 mm (4.4-21.5 mm) per 10 points on the 0-30 scale. Treatment credibility and expectancy were also predictive of several secondary outcomes.ConclusionOsteopathy conferred no benefit over sham treatment for pain, fatigue, functioning, and quality of life in patients with FM. These findings do not support the use of osteopathy to treat these patients. More attention should be paid to the expectancy of patients in FM management.
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Project description:Repetitive transcranial magnetic stimulation (rTMS) is emerging as a non-invasive therapeutic strategy in the battle against Alzheimer's disease. Alzheimer's disease patients primarily show alterations of the default mode network for which the precuneus is a key node. Here, we hypothesized that targeting the precuneus with TMS represents a promising strategy to slow down cognitive and functional decline in Alzheimer's disease patients. We performed a randomized, double-blind, sham-controlled, phase 2, 24-week trial to determine the safety and efficacy of precuneus stimulation in patients with mild-to-moderate Alzheimer's disease. Fifty Alzheimer's disease patients were randomly assigned in a 1:1 ratio to either receive precuneus or sham rTMS (mean age 73.7 years; 52% female). The trial included a 24-week treatment, with a 2-week intensive course in which rTMS (or sham) was applied daily five times per week, followed by a 22-week maintenance phase in which stimulation was applied once weekly. The Clinical Dementia Rating Scale-Sum of Boxes was selected as the primary outcome measure, in which post-treatment scores were compared to baseline. Secondary outcomes included score changes in the Alzheimer's Disease Assessment Scale-Cognitive Subscale, Mini-Mental State Examination and Alzheimer's Disease Cooperative Study-Activities of Daily Living scale. Moreover, single-pulse TMS in combination with EEG was used to assess neurophysiological changes in precuneus cortical excitability and oscillatory activity. Our findings show that patients that received precuneus repetitive magnetic stimulation presented a stable performance of the Clinical Dementia Rating Scale-Sum of Boxes score, whereas patients treated with sham showed a worsening of their score. Compared with the sham stimulation, patients in the precuneus stimulation group also showed also significantly better performances for the secondary outcome measures, including the Alzheimer's Disease Assessment Scale-Cognitive Subscale, Mini-Mental State Examination and Alzheimer's Disease Cooperative Study-Activities of Daily Living scale. Neurophysiological results showed that precuneus cortical excitability remained unchanged after 24 weeks in the precuneus stimulation group, whereas it was significantly reduced in the sham group. Finally, we found an enhancement of local gamma oscillations in the group treated with precuneus stimulation but not in patients treated with sham. We conclude that 24 weeks of precuneus rTMS may slow down cognitive and functional decline in Alzheimer's disease. Repetitive TMS targeting the default mode network could represent a novel therapeutic approach in Alzheimer's disease patients.
| S-EPMC9679166 | biostudies-literature
Project description:BackgroundTelemedicine consultations using real-time videoconferencing has the potential to improve access and quality of care, avoid patient travels, and reduce health care costs.ObjectiveThe aim of this study was to examine the cost-effectiveness of an orthopedic videoconferencing service between the University Hospital of North Norway and a regional medical center in a remote community located 148 km away.MethodsAn economic evaluation based on a randomized controlled trial of 389 patients (559 consultations) referred to the hospital for an orthopedic outpatient consultation was conducted. The intervention group (199 patients) was randomized to receive video-assisted remote orthopedic consultations (302 consultations), while the control group (190 patients) received standard care in outpatient consultation at the hospital (257 consultations). A societal perspective was adopted for calculating costs. Health outcomes were measured as quality-adjusted life years (QALYs) gained. Resource use and health outcomes were collected alongside the trial at baseline and at 12 months follow-up using questionnaires, patient charts, and consultation records. These were valued using externally collected data on unit costs and QALY weights. An extended sensitivity analysis was conducted to address the robustness of the results.ResultsThis study showed that using videoconferencing for orthopedic consultations in the remote clinic costs less than standard outpatient consultations at the specialist hospital, as long as the total number of patient consultations exceeds 151 per year. For a total workload of 300 consultations per year, the annual cost savings amounted to €18,616. If costs were calculated from a health sector perspective, rather than a societal perspective, the number of consultations needed to break even was 183.ConclusionsThis study showed that providing video-assisted orthopedic consultations to a remote clinic in Northern Norway, rather than having patients travel to the specialist hospital for consultations, is cost-effective from both a societal and health sector perspective. This conclusion holds as long as the activity exceeds 151 and 183 patient consultations per year, respectively.Trial registrationClinicalTrials.gov NCT00616837; https://clinicaltrials.gov/ct2/show/NCT00616837 (Archived by WebCite at http://www.webcitation.org/762dZPoKX).
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Project description:BackgroundChatGPT is a natural language processing model developed by OpenAI, which can be iteratively updated and optimized to accommodate the changing and complex requirements of human verbal communication.ObjectiveThe study aimed to evaluate ChatGPT's accuracy in answering orthopedics-related multiple-choice questions (MCQs) and assess its short-term effects as a learning aid through a randomized controlled trial. In addition, long-term effects on student performance in other subjects were measured using final examination results.MethodsWe first evaluated ChatGPT's accuracy in answering MCQs pertaining to orthopedics across various question formats. Then, 129 undergraduate medical students participated in a randomized controlled study in which the ChatGPT group used ChatGPT as a learning tool, while the control group was prohibited from using artificial intelligence software to support learning. Following a 2-week intervention, the 2 groups' understanding of orthopedics was assessed by an orthopedics test, and variations in the 2 groups' performance in other disciplines were noted through a follow-up at the end of the semester.ResultsChatGPT-4.0 answered 1051 orthopedics-related MCQs with a 70.60% (742/1051) accuracy rate, including 71.8% (237/330) accuracy for A1 MCQs, 73.7% (330/448) accuracy for A2 MCQs, 70.2% (92/131) accuracy for A3/4 MCQs, and 58.5% (83/142) accuracy for case analysis MCQs. As of April 7, 2023, a total of 129 individuals participated in the experiment. However, 19 individuals withdrew from the experiment at various phases; thus, as of July 1, 2023, a total of 110 individuals accomplished the trial and completed all follow-up work. After we intervened in the learning style of the students in the short term, the ChatGPT group answered more questions correctly than the control group (ChatGPT group: mean 141.20, SD 26.68; control group: mean 130.80, SD 25.56; P=.04) in the orthopedics test, particularly on A1 (ChatGPT group: mean 46.57, SD 8.52; control group: mean 42.18, SD 9.43; P=.01), A2 (ChatGPT group: mean 60.59, SD 10.58; control group: mean 56.66, SD 9.91; P=.047), and A3/4 MCQs (ChatGPT group: mean 19.57, SD 5.48; control group: mean 16.46, SD 4.58; P=.002). At the end of the semester, we found that the ChatGPT group performed better on final examinations in surgery (ChatGPT group: mean 76.54, SD 9.79; control group: mean 72.54, SD 8.11; P=.02) and obstetrics and gynecology (ChatGPT group: mean 75.98, SD 8.94; control group: mean 72.54, SD 8.66; P=.04) than the control group.ConclusionsChatGPT answers orthopedics-related MCQs accurately, and students using it excel in both short-term and long-term assessments. Our findings strongly support ChatGPT's integration into medical education, enhancing contemporary instructional methods.Trial registrationChinese Clinical Trial Registry Chictr2300071774; https://www.chictr.org.cn/hvshowproject.html ?id=225740&v=1.0.
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Project description:BackgroundIn recent years, many studies focused on the use of robotic devices for both the assessment and the neuro-motor reeducation of upper limb in subjects after stroke, spinal cord injuries or affected by neurological disorders. Contrarily, it is still hard to find examples of robot-aided assessment and rehabilitation after traumatic injuries in the orthopedic field. However, those benefits related to the use of robotic devices are expected also in orthopedic functional reeducation.MethodsAfter a wrist injury occurred at their workplace, wrist functionality of twenty-three subjects was evaluated through a robot-based assessment and clinical measures (Patient Rated Wrist Evaluation, Jebsen-Taylor and Jamar Test), before and after a 3-week long rehabilitative treatment. Subjects were randomized in two groups: while the control group (n = 13) underwent a traditional rehabilitative protocol, the experimental group (n = 10) was treated replacing traditional exercises with robot-aided ones.ResultsFunctionality, assessed through the function subscale of PRWE scale, improved in both groups (experimental p = 0.016; control p < 0.001) and was comparable between groups, both pre (U = 45.5, p = 0.355) and post (U = 47, p = 0.597) treatment. Additionally, even though groups' performance during the robotic assessment was comparable before the treatment (U = 36, p = 0.077), after rehabilitation the experimental group presented better results than the control one (U = 26, p = 0.015).ConclusionsThis work can be considered a starting point for introducing the use of robotic devices in the orthopedic field. The robot-aided rehabilitative treatment was effective and comparable to the traditional one. Preserving efficacy and safety conditions, a systematic use of these devices could lead to decrease human therapists' effort, increase repeatability and accuracy of assessments, and promote subject's engagement and voluntary participation. Trial Registration ClinicalTrial.gov ID: NCT04739644. Registered on February 4, 2021-Retrospectively registered, https://www.clinicaltrials.gov/ct2/show/study/NCT04739644 .
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Project description:BackgroundOpposing needling is a unique method used in acupuncture therapy to relieve pain, acting on the side contralateral to the pain. Although opposing needling has been used to treat pain in various diseases, it is not clear how opposing needling affects the activity of the central nervous system to relieve acute pain. We herein present the protocol for a randomized sham-controlled clinical trial aiming to explore the cerebral mechanism of opposing needling for managing acute pain after unilateral total knee arthroplasty (TKA).MethodsThis is a randomized sham-controlled single-blind clinical trial. Patients will be allocated randomly to two parallel groups (A: opposing electroacupuncture group; B: sham opposing electroacupuncture group). The Yinlingquan (SP9), Yanglingquan (GB34), Futu (ST32), and Zusanli (ST36) acupoints will be used as the opposing needling sites in both groups. In group A, the healthy lower limbs will receive electroacupuncture, while in group B, the healthy lower limbs will receive sham electroacupuncture. At 72 h after unilateral TKA, patients in both groups will begin treatment once per day for 3 days. Functional magnetic resonance imaging will be performed on all patients before the intervention, after unilateral TKA, and at the end of the intervention to detect changes in brain activity. Changes in pressure pain thresholds will be used as the main outcome for the improvement of knee joint pain. Secondary outcome indicators will include the visual analogue scale (including pain during rest and activity) and a 4-m walking test. Surface electromyography, additional analgesia use, the self-rating anxiety scale, and the self-rating depression scale will be used as additional outcome indices.DiscussionThe results will reveal the influence of opposing needling on cerebral activity in patients with acute pain after unilateral TKA and the possible relationship between cerebral activity changes and improvement of clinical variables, which may indicate the central mechanism of opposing needling in managing acute pain after unilateral TKA.Trial registrationStudy on the brain central mechanism of opposing needling analgesia after total kneearthroplasty based on multimodal MRI ChiCTR2100042429 . Registered on January 21, 2021.
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Project description:Rationale: Sepsis patients suffer from severe metabolic and immunologic dysfunction that may be amplified by standard carbohydrate-based nutritional regimes. We therefore hypothesize that a ketogenic diet improves sepsis treatment. Objectives: We investigated the safety and feasibility of a ketogenic diet in sepsis patients. Methods: We conducted a monocentric open-labeled randomized controlled trial (DRKS00017710) enrolling adult sepsis patients randomly assigned to either ketogenic or standard high-carbohydrate diet for 14 days with follow-up until day 30. The primary outcome measure was β-hydroxybutyrate serum concentration on day 14. Secondary outcomes included safety, clinical and immunological changes. Measurements and Main Results: 40 critically ill septic patients were assigned to the study groups. Increase in β-hydroxybutyrate concentrations from baseline to day 14 was markedly greater under ketogenic diet (1.2 ±0.9) compared to controls (-0.3 ±0.4); estimated mean difference 1.4 (95%-CI 1.0-1.8; p<0.0001). During ketogenic diet, no patient required insulin treatment beyond day 4, whereas 35% to 60% of control patients did (p=0.0095). Metabolic side effects were not observed under ketogenic diet. Ventilation-free (IRR 1.7; 95%-CI: 1.5 to 2.1; p<0.0001), vasopressor-free (IRR 1.7; 95%-CI: 1.5 to 2.0; p<0.0001), dialysis-free (IRR 1.5; 95%-CI: 1.3 to 1.8; p<0.0001), and ICU-free days (IRR 1.7; 95%-CI: 1.4 to 2.1; p<0.0001) significantly increased in patients under ketogenic diet. There was no difference in 30-day mortality. Analyses indicated favorable changes towards immune homeostasis. Conclusions: Ketogenic diet is a feasible and safe nutritional regimen in septic patients promoting recovery from sepsis-related organ dysfunction and could become a new tool in modern treatment concepts.
2024-06-13 | PXD046061 | Pride
Project description:IntroductionFrontotemporal dementia (FTD) is a progressive disease for which no curative treatment is currently available. We aimed to determine whether transcranial direct current stimulation (tDCS) can modulate intracortical connectivity and improve cognition in symptomatic FTD patients and presymptomatic FTD subjects.MethodsWe performed a double-blind, randomized, sham-controlled trial with anodal tDCS or sham stimulation over the left prefrontal cortex in 70 participants (15 presymptomatic and 55 symptomatic FTD).ResultsWe observed a significant increase of intracortical connectivity (short interval intracortical inhibition and facilitation) and improvement in clinical scores and behavioral disturbances in both symptomatic FTD patients and presymptomatic carriers after real tDCS but not after sham stimulation.DiscussionA 2-weeks' treatment with anodal left prefrontal tDCS improves symptoms and restores intracortical inhibitory and excitatory circuits in both symptomatic FTD patients and presymptomatic carriers. tDCS might represent a promising future therapeutic and rehabilitative approach in patients with FTD.
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Project description:This study aimed to evaluate the effectiveness of supervised exercise among nurses conducting shift work for health promotion.A total of 30 healthy female nurses conducting shift work participated in this study and they were randomly assigned to one of the following 2 groups: The supervised exercise group (SG; participants exercised under the supervision of a physical therapist (PT)) and the voluntary exercise group (VG; participants exercised without supervision). The study participants were asked to exercise twice/week for 12 weeks for 24 sessions. The primary outcome was aerobic fitness, and the secondary outcomes were muscle strength, anthropometric data, biochemical parameters, and mental health. We compared all the outcomes before and after the intervention within each group and between both groups at follow-up.Aerobic fitness increased in the SG whereas it decreased in the VG, but these changes were not statistically significant (p=0.053 and 0.073, respectively). However, the between-group difference was significant in the intervention effect (p=0.010). Muscle strength, high-density lipoprotein cholesterol and metabolic profile (high-molecular weight adiponectin), and depressive symptom significantly improved in the SG over time, even though the SG exercised less as compared with the VG. Moreover, significant differences in muscle strength, and low-density lipoprotein cholesterol and reactive oxygen metabolite levels were observed between both groups, and these parameters were better in the SG than in the VG.Our data-suggest the effectiveness of exercise supervised by a PT at the workplace of nurses conducting shift work for health promotion.
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