scholarly journals Evaluating the efficacy and safety of electro-acupuncture in patients with antipsychotic-related constipation: protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Fang-Ting Yu ◽  
Di-He Long ◽  
Guang-Xia Shi ◽  
Li-Qiong Wang ◽  
Jian-Feng Tu ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Rating Scale ◽  
Controlled Trial ◽  
Common Adverse Effect ◽  
Life Questionnaire ◽  
Efficacy And Safety ◽  
Patient Assessment ◽  
Randomized Controlled ◽  
Bowel Movements

Abstract Background Constipation is known as a common adverse effect of antipsychotics. Advice for its management remains inadequate. This study is designed to investigate the efficacy and safety of electro-acupuncture (EA) for antipsychotic-related constipation. Methods This is a single-centric, parallel-group, randomized controlled trial with blinded participants, outcome assessor, and statistician. One hundred twelve participants will be randomly assigned into the EA group or sham acupuncture (SA) group in a 1:1 ratio. The study will last for 22 weeks for each participant, including a 2-week baseline assessment period, an 8-week treatment period, and a follow-up for 12 weeks. The primary outcome is the change of mean weekly complete spontaneous bowel movements (CSBMs) during weeks 1 to 8 from baseline. Secondary outcomes include the change from baseline of mean weekly CSBMs during the follow-up period, mean weekly spontaneous bowel movements (SBMs), overall CSBM response rate, scores on Bristol Stool Form Scale (BSFS), straining level, Patient Assessment of Constipation Symptoms (PAC-SYM), Patient Assessment of Constipation Quality of life questionnaire (PAC-QOL), and Brief Psychiatric Rating Scale (BPRS). Adverse events and medicine use will be recorded as well. Discussion The study is designed based on a rigorous methodology to evaluate the efficacy and safety of EA for antipsychotic-related constipation. The finding will be published in peer-reviewed journals as reliable evidence. Trial registration ClinicalTrials.gov ChiCTR2000032582. Registered May 3, 2020, with the Chinese Clinical Trial Registry.

scholarly journals Oral dexamethasone for the prevention of acute migraine recurrence in pediatric patients presenting to the emergency department with migraine

2018 ◽  
Vol 1 ◽  
pp. 251581631880415
Author(s):  
Serena L Orr ◽  
Lawrence Richer ◽  
Nick Barrowman ◽  
Roger Zemek
Keyword(s):  
Emergency Department ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Recruitment Rate ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Oral Dexamethasone ◽  
Safety Outcomes

Objective: To assess the feasibility of a randomized controlled trial protocol that aims to determine the efficacy and safety of oral dexamethasone compared to placebo for the prevention of migraine recurrence in children and adolescents visiting the pediatric emergency department (ED) with migraine. Methods: This study was a two-arm, parallel-group, randomized, placebo-controlled, double-blind pilot trial of patients presenting to the pediatric ED with migraine. Eligible participants were randomized at 1:1 ratio to receive either oral dexamethasone 0.6 mg/kg (maximum 15 mg) or matched placebo as a single dose. Efficacy and safety outcomes were assessed at discharge, 48 h and 7 days after discharge. The primary outcome of the trial was feasibility and was assessed through participant recruitment rate, follow-up completion rates, participant satisfaction ratings and comparison of enrolled versus non-enrolled participants. Efficacy and safety outcomes were not analyzed given that this was a pilot study. Results: Twelve participants were enrolled over the 6-month recruitment period. This represents 60% of the planned sample size and a 10.5% recruitment rate. No other feasibility issues were identified and patients expressed high satisfaction rates with their treatment: 90.9% were satisfied with their treatment at discharge and at 48-h follow-up and 81.8% were satisfied with their treatment at 7-day follow-up (81.8%). There were no significant differences observed when comparing enrolled participants to those not enrolled. Conclusion: This pilot randomized controlled trial is the first to assess dexamethasone in the pediatric ED for the prevention of migraine recurrence. The protocol is feasible but recruitment in a single center was lower than expected. Future pediatric ED migraine studies may use innovative or pragmatic trial designs to maximize feasibility from a recruitment standpoint.

A randomized controlled trial with 4-month follow-up of adjunctive repetitive transcranial magnetic stimulation of the left prefrontal cortex for depression

2007 ◽  
Vol 38 (3) ◽  
pp. 323-333 ◽  
Author(s):  
A. Mogg ◽  
G. Pluck ◽  
S. V. Eranti ◽  
S. Landau ◽  
R. Purvis ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Magnetic Stimulation ◽  
Sham Group ◽  
Rating Scale ◽  
Repetitive Transcranial Magnetic Stimulation ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Real Group ◽  
The Mean

BackgroundEffectiveness of repetitive transcranial magnetic stimulation (rTMS) for major depression is unclear. The authors performed a randomized controlled trial comparing real and sham adjunctive rTMS with 4-month follow-up.MethodFifty-nine patients with major depression were randomly assigned to a 10-day course of either real (n=29) or sham (n=30) rTMS of the left dorsolateral prefrontal cortex (DLPFC). Primary outcome measures were the 17-item Hamilton Depression Rating Scale (HAMD) and proportions of patients meeting criteria for response (⩾50% reduction in HAMD) and remission (HAMD⩽8) after treatment. Secondary outcomes included mood self-ratings on Beck Depression Inventory-II and visual analogue mood scales, Brief Psychiatric Rating Scale (BPRS) score, and both self-reported and observer-rated cognitive changes. Patients had 6-week and 4-month follow-ups.ResultsOverall, Hamilton Depression Rating Scale (HAMD) scores were modestly reduced in both groups but with no significant group×time interaction (p=0.09) or group main effect (p=0.85); the mean difference in HAMD change scores was −0.3 (95% CI −3.4 to 2.8). At end-of-treatment time-point, 32% of the real group were responders compared with 10% of the sham group (p=0.06); 25% of the real group met the remission criterion compared with 10% of the sham group (p=0.2); the mean difference in HAMD change scores was 2.9 (95% CI −0.7 to 6.5). There were no significant differences between the two groups on any secondary outcome measures. Blinding was difficult to maintain for both patients and raters.ConclusionsAdjunctive rTMS of the left DLPFC could not be shown to be more effective than sham rTMS for treating depression.

scholarly journals Evaluation on Immediate Analgesic Efficacy and Safety of Kai-Hou-Jian Spray (Children 'S Type) In Treating Sore Throat Caused By Acute Pharyngitis and Tonsillitis In Children: Study Protocol For A Randomized Controlled Trial

2021 ◽  
Author(s):  
Yan-ning Ma ◽  
Cheng-liang Zhong ◽  
Siyuan Hu ◽  
Qiu-han Cai ◽  
Sheng-xuan Guo
Keyword(s):  
Randomized Controlled Trial ◽  
Sore Throat ◽  
Rating Scale ◽  
Controlled Trial ◽  
Analgesic Efficacy ◽  
Effective Rate ◽  
Efficacy And Safety ◽  
Acute Pharyngitis ◽  
Randomized Controlled ◽  
Parallel Group

Abstract Background: Acute pharyngitis and tonsillitis are common respiratory diseases for which children seek medical care. Their main clinical manifestation is sore throat which interferes with patients’ quality of life. However, there is no proven effective or safe method to treat it. It is necessary to find an excellent strategy to reduce sore throat and reduce the burden of acute illness. We designed the randomized controlled trial with the characteristics of traditional Chinese medicine (TCM) to determine the clinical positioning of Kai-Hou-Jian spray (children 's type) (KHJS) through evidence-based research. This trial aims to evaluate the immediate analgesic efficacy of KHJS on sore throat caused by acute pharyngitis and tonsillitis (wind-heat syndrome/heat exuberance in lung and stomach syndrome) in children, and to observe its safety. Methods/design: This is a prospective, multicenter, randomized, double-blind, parallel-group, placebo-controlled trial. It will include 240 children with acute pharyngitis/tonsillitis from 7 study sites across China. All participants are randomly assigned to two parallel treatment groups, one with KHJS and the other with placebo sprays, for 5 consecutive days. The primary outcome is the time of analgesic onset. Secondary outcomes include duration of analgesic effect, area under time curve of 0-3 hours Wong-Baker FACES Pain Rating Scale (WBS) score (AUC0-3h), rate of analgesic onset, rate of disappearance of sore throat, changes of WBS score (in days), effective rate of pharyngeal signs, and effective rate of TCM syndrome. The incidence of adverse events during the trial is the primary safety outcome. In addition, vital signs and laboratory tests before and after medication are monitored.Discussion: To our knowledge, this will be the first clinical trial to explore the immediate analgesic efficacy of a Chinese patent medicine spray for acute pharyngitis/tonsillitis induced sore throat in children in a multicenter, randomized, double-blinded, parallel-group, placebo-controlled manner. Not only might it prove the efficacy and safety of KHJS in the treatment of sore throat caused by acute pharyngitis/tonsillitis in children, but it might also provide evidence for the treatment of acute sore throat with Chinese herbal medicine.Trial registration: ChiCTR2000031599. Registered on 5 April 2020, http://www.chictr.org.cn/showproj.aspx?proj=50385

Is a combined programme of manual therapy and exercise more effective than usual care in patients with non-specific chronic neck pain? A randomized controlled trial

2019 ◽  
Vol 33 (12) ◽  
pp. 1908-1918 ◽  
Author(s):  
Lucia Domingues ◽  
Fernando Manuel Pimentel-Santos ◽  
Eduardo Brazete Cruz ◽  
Ana Cristina Sousa ◽  
Ana Santos ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Neck Pain ◽  
Usual Care ◽  
Pain Intensity ◽  
Manual Therapy ◽  
Rating Scale ◽  
Controlled Trial ◽  
Chronic Neck Pain ◽  
Randomized Controlled

Objective: The aim of this study was to compare the effectiveness of a combined intervention of manual therapy and exercise (MET) versus usual care (UC), on disability, pain intensity and global perceived recovery, in patients with non-specific chronic neck pain (CNP). Design: Randomized controlled trial. Setting: Outpatient care units. Subjects: Sixty-four non-specific CNP patients were randomly allocated to MET ( n = 32) or UC ( n = 32) groups. Interventions: Participants in the MET group received 12 sessions of mobilization and exercise, whereas the UC group received 15 sessions of usual care in physiotherapy. Main measures: The primary outcome was disability (Neck Disability Index). The secondary outcomes were pain intensity (Numeric Pain Rating Scale) and global perceived recovery (Patient Global Impression Change). Patients were assessed at baseline, three weeks, six weeks (end of treatment) and at a three-month follow-up. Results: Fifty-eight participants completed the study. No significant between-group difference was observed on disability and pain intensity at baseline. A significant between-group difference was observed on disability at three-week, six-week and three-month follow-up (median (P25–P75): 6 (3.25–9.81) vs. 15.5 (11.28–20.75); P < 0.001), favouring the MET group. Regarding pain intensity, a significant between-group difference was observed at six-week and three-month follow-up (median (P25–P75): 2 (1–2.51) vs. 5 (3.33–6); P < 0.001), with superiority of effect in MET group. Concerning the global perceived recovery, a significant between-group difference was observed only at the three-month follow-up ( P = 0.001), favouring the MET group. Conclusion: This study’s findings suggest that a combination of manual therapy and exercise is more effective than usual care on disability, pain intensity and global perceived recovery.

scholarly journals Percutaneous Electrolysis in the Treatment of Lateral Epicondylalgia: A Single-Blind Randomized Controlled Trial

2020 ◽  
Vol 9 (7) ◽  
pp. 2068 ◽  
Author(s):  
Manuel Rodríguez-Huguet ◽  
Jorge Góngora-Rodríguez ◽  
Rafael Lomas-Vega ◽  
Rocío Martín-Valero ◽  
Ángeles Díaz-Fernández ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Eccentric Exercise ◽  
Rating Scale ◽  
Controlled Trial ◽  
Exercise Program ◽  
Randomized Controlled ◽  
Pressure Pain Thresholds ◽  
Lateral Epicondylalgia ◽  
Mean Differences

Few studies have considered the effects of percutaneous electrolysis (PE) in the treatment of lateral epicondylalgia (LE). For this reason, the objective of this study was to compare the effects of PE with an evidence-based approach—trigger point dry needling (TDN)—in patients with LE. A randomized controlled trial was conducted in which 32 participants with LE were randomly assigned to two treatment groups, the PE group (n = 16) and the TDN group (n = 16). Both groups received four therapy sessions and an eccentric exercise program to be performed daily. The numerical pain rating scale (NPRS), pressure pain thresholds (PPT), quality of life, and range of motion were measured before treatment, at the end of treatment, and at one- and three-month follow-ups. Significant between-group mean differences were found after treatment for NPRS (p < 0.001) and flexion movement (p = 0.006). At one-month follow-up, significant mean differences between groups were found for NPRS (p < 0.001), PPT (p = 0.021), and flexion (p = 0.036). At three-months follow-up, significant mean differences between groups were found for NPRS (p < 0.001), PPT (p = 0.004), and flexion (p = 0.003). This study provides evidence that PE could be more effective than TDN for short- and medium-term improvement of pain and PPTs in LE when added to an eccentric exercise program.

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