scholarly journals Auricular acupressure for adverse events following immunization related to COVID-19 vaccine injection: study protocol for a multicenter, three-arm, blinded randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Qinwei Fu ◽  
Hui Xie ◽  
Li Zhou ◽  
Xinrong Li ◽  
Yang Liu ◽  
...  

Abstract Background Some pain, fatigue, and gastrointestinal adverse events were observed in potential association with injection of COVID-19 vaccines, while there was no preventive intervention for it. We aim to investigate the efficacy of auricular acupressure (AA) therapy in preventing and relieving AEFI after injection of COVID-19 vaccine. Methods The study design is a randomized, multicentre, three-arm controlled, single-blind trial. Participants meeting the inclusion criteria will be advertised and enrolled and assigned in the medical institutions randomly for post-injection observation. No less than 360 participants will be randomized into one of three groups: auricular acupressure group, sham auricular acupressure group, and wait-list group. Interventions will be performed immediately and will happen 4 to 5 times per day for 5 days. The primary clinical outcomes will be quality and quantity evaluation among participants who reported any AEFI and who reported local pain at injection site. Secondary outcomes will concern headache, muscle and (or) joint pain, fatigue, nausea, vomiting, diarrhoea, and other potential events. All the outcomes will be assessed at baseline and 1, 3, 5, 7, and 14 days after the injection. Both intention-to-treat and per-protocol analyses will be performed, with significance level determined as 5%. Discussion Results of this trial will help to clarify the value of auricular acupressure therapy in preventing and relieving overall and certain adverse events following immunization after injection of COVID-19 vaccine. Trial registration China Clinical Trial Registry (ChiCTR) (ChiCTR2100043210). Registered on 8 February, 2021.

2021 ◽  
Author(s):  
Qinwei Fu ◽  
Hui Xie ◽  
Li Zhou ◽  
Xinrong Li ◽  
Yang Liu ◽  
...  

Abstract Background Some pain, fatigue, and gastrointestinal adverse reactions were observed in potential association with injection of COVID-19 vaccines. However, there were no preventive intervention for it. We aim to investigate efficacy of auricular acupressure (AA) therapy in preventing and (or) relieving AEFI after injection of COVID-19 vaccine. Methods/design: The study design is a randomized controlled, multicentre, three-arm, single-blind trial. Participants meeting the inclusion criteria will be advertised and enrolled, and assigned randomly in the medical institutions for post-injection observation. No less than 360 participants will be randomized into one of three groups: auricular acupressure group, sham auricular acupressure group and wait-list group. Interventions will be performed immediately, and will happen 4 to 5 times per day for 5 days. The primary clinical outcomes will be quality and quantity evaluation among participants who reported any AEFI and who reported local pain at injection site. Secondary outcomes will concern headache, muscle and (or) joint pain, fatigue, nausea, vomiting, diarrhoea, and other potential events. All the outcomes will be assessed at baseline, 1, 3, 5, 7, and 14 days after the injection. Both intention-to-treat and per-protocol analyses will be performed, with significance level determined at the 5 % level. Discussion Results of this trial will help clarify the value of auricular acupressure therapy in preventing and (or) relieving overall and certain adverse events following immunization after injection of COVID-19 vaccine. Trial registration: This trial was registered in the China Clinical Trial Registry (ChiCTR) (ChiCTR2100043210) on 8th February, 2021.


2020 ◽  
Author(s):  
Jianfu Zhou ◽  
Rongwu Lin ◽  
Xuehua Liu ◽  
Liguo Lv ◽  
Shusheng Wang ◽  
...  

Abstract BackgroundHot flashes, characterized by intense heat sensation and diaphoresis, are common side effects resulted from hormonotherapy in patients with prostate cancer. Cumulated studies have revealed beneficial role of acupuncture as complementary and alternative recipe for the management of hot flashes. However, little is known about the auricular acupressure (AA), a micro-acupuncture technique whose therapeutic purpose is similar with conventional acupuncture. Therefore, this current study aims to explore the effects and determine the feasibility of AA for hot flashes in patients with prostate cancer.Methods/DesignThis proposed pilot study is a two-arm parallel, single-blinded, randomized sham-controlled trial. A total of 72 participants of prostate cancer suffered with hot flashes will be recruited and randomly allocated into two groups in a 1:1 ratio. Equal randomization is conducted using a computer-generated random allocation sequence. Sheng Zhi Qi (TF2), Nei Fen Mi (CO18), Shen Men (TF4), Shen (CO10) and Pi Zhi Xia (AT4) are selected as experimental acupressure points, and five helix points (HX 8-12) are used as sham control acupressure points. Participants in the experimental group and control group will receive AA and sham-AA treatment, respectively. The duration of the treatment is 6 weeks with two sessions per week, and the follow-up period is 12 weeks. The primary outcome is Hot Flash Score (HFS). The secondary outcomes include Quality of Life (QoL), Pittsburgh Sleep Quality Index (PSQI) and Hamilton Anxiety Scale (HAS). All outcomes measurement will be conducted before and through treatment period as well as follow-up period. Safety assessment will be carried out through treatment and follow-up period.DiscussionThis pilot study will for the first time advance our knowledge on feasibility of AA in alleviating hot flashes in patients of prostate cancer and provide preliminary evidence for a further full-scale trial.Trial registrationChinese Clinical Trial Registry, ChiCTR1900026694. Registered on 19 October 2019.


Stroke ◽  
2013 ◽  
Vol 44 (suppl_1) ◽  
Author(s):  
Maria Ranner ◽  
Ann-Sofie Bertilsson ◽  
Susanne Guidetti ◽  
Ulla Johansson ◽  
Gunilla Eriksson ◽  
...  

A goal for rehabilitation after stroke is to regain the ability to manage activities of daily living (ADL). The Swedish health care legislation recognizes that individuals bring unique sets of needs and preferences to encounters with the health care system, which should impact the services delivered. Consequently rehabilitation needs to be designed to meet each individual’s concern i.e., be client-centered. This implies interventions tailored to the client’s ability and perceived needs, services that take the client’s unique life-world experiences as the point of departure for goals and collaboration during the rehabilitation. However, studies on such services are scarce. Thus the aim was to compare a client-centered ADL intervention (CADL) to usual ADL training (UADL) regarding perceived participation, independence in ADL and life satisfaction at 3 months after inclusion. Methods: Sixteen rehabilitation units in Stockholm, Uppsala and Gävleborg, Sweden were randomly assigned to deliver either CADL or UADL to people in need of ADL rehabilitation after stroke. The occupational therapists (OT) who delivered the CADL were specifically trained. At 3 months perceived participation was assessed with the Stroke impact scale (SIS) and the Occupational Gaps questionnaire (OGQ), self-reported dependence in ADL with the Barthel Index (BI) and the Katz Extended ADL Index (KE), and life satisfaction with the LiSat-11. Number of contacts with an OT was collected in the clients’ medical records. Intention-to-treat analysis was applied. The significance level was set to 0.05. ClinicalTrials.gov identifier: NCT01417585 . Results: Two hundred and eighty persons with stroke were included (CADL n=126, UADL n=154). The mean number of OT sessions in the CADL was 19 and 14 in the UADL group. There were no differences regarding SIS (p=0.64), OGQ (p=0.15), BI (p=0.06), KE (p=0.78) or in LiSat-11 (p=0.77). Conclusion: Albeit people with stroke who receive CADL tend to be more independent in ADL at 3 months it is likely that differences in perceived participation and life satisfaction will not be present until later. Thus there is a need to evaluate such services in the long term, their impact on significant others and qualitative studies of the clients’ experiences.


2017 ◽  
Vol 2017 ◽  
pp. 1-7 ◽  
Author(s):  
Masafumi Maruyama ◽  
Naoki Tanaka ◽  
Daisuke Kubota ◽  
Masayuki Miyajima ◽  
Takefumi Kimura ◽  
...  

Background. A new agent, potassium-competitive acid blocker vonoprazan (VPZ) has potent acid-inhibitory effects and may offer advantages over conventionalH. pylorieradication therapies. We aimed to compare the eradication rate between VPZ-based treatment and PPI-based one.Methods. This randomized controlled trial was designed to assign 141 patients withH. pylori-positive gastritis to VPZ group (VPZ 20 mg, amoxicillin 750 mg, and clarithromycin 200 or 400 mg twice daily for 7 days) or PPI group (rabeprazole 20 mg or lansoprazole 30 mg, amoxicillin 750 mg, and clarithromycin 200 or 400 mg twice daily for 7 days). Primary endpoints were eradication rates and adverse events.Results. Seventy of 72 patients in VPZ group and 63 of 69 patients in PPI group completed the treatment after 7 days. The eradication rate was significantly higher in VPZ group than PPI group by intention-to-treat analysis (95.8% versus 69.6%,P=0.00003, 95% confidence interval [CI] 88.3-99.1% versus 57.3-80.1%) and per-protocol analysis (95.7% versus 71.4%,P=0.0002, 95% CI 88.0-99.1% versus 58.7-82.1%). The incidence of adverse events was not different between the groups (26.3% in VPZ group versus 37.7% in PPI group,P=0.15).Conclusion. VPZ-based regimen is more useful than that PPI-based regimen as a first-lineH. pylorieradication therapy.


2021 ◽  
Author(s):  
Gustavo Gomes Resende ◽  
Ricardo da Cruz Lage ◽  
Samara Quadros Lobe ◽  
Amanda Fonseca Medeiros ◽  
Alessandra Dias Costa e Silva ◽  
...  

Background: Patients with severe COVID-19 seem to have a compromised antiviral response and hyperinflammation. Neutrophils are critical players in COVID-19 pathogenesis. IL-17A plays a major role in protection against extracellular pathogens and neutrophil attraction and activation. We hypothesized that secukinumab, an anti-IL17A monoclonal antibody, could mitigate the deleterious hyperinflammation in COVID-19. Methods: BISHOP was an open-label, single-center, phase-II controlled trial. Fifty adults hospitalized Covid-19 patients, confirmed by a positive SARS-CoV-2 RT-PCR, were randomized 1:1 to receive 300mg of secukinumab subcutaneously at day-0 (group A) plus standard of care (SoC: antiviral drugs, antimicrobials, corticosteroids, and/or anticoagulants) or SoC alone (group B). A second dose of 300mg of secukinumab could be administered on day-7, according to staff judgment. The primary endpoint was ventilator-free days at day-28 (VFD-28). Secondary efficacy and safety outcomes were also explored. Findings: An intention-to-treat analysis showed no difference in VFD-28: 23.7 (95%CI 19.6-27.8) in group A vs. 23.8 (19.9-27.6) in group B, p=0.62; There was also no difference in hospitalization time, intensive care unit demand, the incidence of circulatory shock, acute kidney injury, fungal or bacterial co-infections, and severe adverse events. Pulmonary thromboembolism was less frequent in group A (4.2% vs. 26.2% p=0.04). There was one death in each group. Viral clearance, defined by the viral load fold change (2-ΔΔCT) in upper airways, between day-0 and day-7, was also similar: 0.17 (0.05-0.56) in group A vs. 0.24 (0.10-0.57) in group B. Interpretation: The efficacy of secukinumab in the treatment of Covid19 was not demonstrated. No difference between groups in adverse events and no unexpected events were observed. Funding: Novartis Brazil supported this research providing expert input in the development of the project, drug supply, data management, and monitoring.


2020 ◽  
Author(s):  
Juan Jose Gonzalez-Gerez ◽  
Carlos Bernal Utrera ◽  
Ernesto Anarte ◽  
Cleofas Rodriguez-Blanco

Abstract Background: Numerous publications have showed the biomechanical influence of thoracic spine on cervical spine. Recently, some authors have pointed out the role of other physiological systems in this relationship, what have been calle interdependence regional model. It has been studies that interventions applied over thoracic spine have a neurophysiological influence on cervical spine and respiratory system. Our study evaluates the influence of bilateral manipulative technique of first rib on pain and pulmonary function in subjects with chronic non-specific neck pain.Methods: The immediate changes produced by bilateral direct manipulation (HVLA) of first rib in subjects with non-specific chronic neck pain will be studied. The sample will be randomly divided into two groups, experimental and placebo. As dependent variables of the study, we will measure the peak expiratory flow and cervical rom. Findings will be analyzed statistically considering a 5% significance level (p ≤ 0.05)Discussion: Our study aims to provide knowledge about the influence of bilateral manipulative technique of first rib in pain and pulmonary capacity in subjects with non-specific chronic neck pain. The efficacy of this technique may entail an easy access and low cost strategy in patients with pain and a reduction in pulmonary function. Trial registration Brazilian Clinical Trial Registry, RBR-4dsvfy. Registered on 17 March 2020.


2019 ◽  
Author(s):  
Carlos Bernal-Utrera ◽  
Juan Jose Gonzalez-Gerez ◽  
Manuel Saavedra-Hernandez ◽  
Miguel Angel Lerida-Ortega ◽  
Cleofas Rodriguez-Blanco

Abstract • Background: Underlying mechanisms of non-specific chronic neck pain relapses are not clear, but it could be associated with a deficit and alteration of neck muscles propioception that play a decisive role in cervical joint position, motor control of the head and postural stability. Numerous treatments for non-specific chronic neck pain have been described in the scientific literature. However, few studies analyze its influence on postural stability, since these alterations are not fully described, and various theories emerge about the reasons that cause it. Our mainly aim is analyze the differences in postural stability, pain, cervical disability and the relation between them produced by a treatment based on manual therapy and other based on therapeutic exercise. • Methods: The short-term and mid-term changes produced by different therapies on subjects with non-specific chronic neck pain will be studied. The sample will be randomly divided into three groups, manual therapy, therapeutic exercise and placebo. As dependent variables of the study, we will take: a) overall balance index, measured through a dynamic stabilometric platform; b) pain, based on the visual analog scale and the pressure pain threshold; c) cervical disability, through the cervical disability index. The findings will be analyzed statistically considering a 5% significance level (p ≤ 0.05) • Discussion: Our study aims to provide knowledge about postural stability and its relationship with pain in subjects with non-specific chronic neck pain. Analyzing the results produced by different types of therapy will allow us to draw conclusions about the mechanisms that may elicit these alterations, structural or central mechanisms. • Trial registration: Brazilian Clinical Trial Registry, RBR-2vj7sw. Registered on 28 November 2018.


2021 ◽  
Vol 8 ◽  
Author(s):  
John McCoy ◽  
Andy Goren ◽  
Flávio Adsuara Cadegiani ◽  
Sergio Vaño-Galván ◽  
Maja Kovacevic ◽  
...  

Antiandrogens have demonstrated a protective effect for COVOD-19 patients in observational and interventional studies. The goal of this study was to determine if proxalutamide, an androgen receptor antagonist, could be an effective treatment for men with COVID-19 in an outpatient setting. A randomized, double-blinded, placebo-controlled clinical trial was conducted at two outpatient centers (Brasilia, Brazil). Patients were recruited from October 21 to December 24, 2020 (clinicaltrials.gov number, NCT04446429). Male patients with confirmed COVID-19 but not requiring hospitalization (COVID-19 8-point ordinal scale <3) were administered proxalutamide 200 mg/day or placebo for up to 7 days. The primary endpoint was hospitalization rate at 30 days post-randomization. A total of 268 men were randomized in a 1:1 ratio. 134 patients receiving proxalutamide and 134 receiving placebo were included in the intention-to-treat analysis. The 30-day hospitalization rate was 2.2% in men taking proxalutamide compared to 26% in placebo, P < 0.001. The 30-day hospitalization risk ratio was 0.09; 95% confidence interval (CI) 0.03–0.27. Patients in the proxalutamide arm more frequently reported gastrointestinal adverse events, however, no patient discontinued treatment. In placebo group, 6 patients were lost during follow-up, and 2 patients died from acute respiratory distress syndrome. Here we demonstrate the hospitalization rate in proxalutamide treated men was reduced by 91% compared to usual care.


2019 ◽  
Author(s):  
Zainab Alimoradi ◽  
farideh kazemi ◽  
Mahboubeh Valiani ◽  
Maryam Gorji

Abstract Background labor pain is one of the leading causes for fear of childbirth. Acupressure is a non-pharmacological pain relief method which showed promising results. Comparing the effect of body acupressure at multiple points and auricular acupressure on the pain and duration of labor, the present study is designed. Methods/Design In a randomized controlled trial, 90 primigravida women who attend for childbirth would be randomly assigned to three groups (interventions: body acupressure and auricular acupressure, control: routine care). In order to determine the allocation sequence with 1:1:1 ratio, the computer-generated 6-block randomization techniques would be used. To hide the allocation, the type of intervention will be written based on the generated sequence and put in opaque enveloped pockets; then, the pockets as well as questionnaires are encoded respectively. The pain score of all the participants would be measured at the peak uterine contraction at the 4cm cervical dilation and at 10 cm dilation based on visual analog scale (VAS). Duration of the active phase of labor in these groups are recorded too. Data are imported into SPSS-16 software. First, normality of the data distribution will be investigated. To compare the labor duration among the research groups, ANOVA would be used, which will be followed, in case of significance, by the Scheffe post-hoc test. Furthermore, Chi-squared test would be used to compare the categorized demographic variables and ANOVA or Kruskal-Wallis tests will be used to compare the quantitative variables in the studied groups. significance level of 0.05 is considered significant. Discussion In this study the effect of auricular acupressure and body acupressure on pain and duration of first stage of labor will be compared. Trial registration number IRCT20180218038789N1 in 2018-03-04; pre result.


2020 ◽  
Author(s):  
Juan Jose Gonzalez-Gerez ◽  
Carlos Bernal Utrera ◽  
Ernesto Anarte ◽  
Cleofas Rodriguez-Blanco

Abstract Background: Numerous publications have showed the biomechanical influence of thoracic spine on cervical spine. Recently, some authors have pointed out the role of other physiological systems in this relationship, what have been calle interdependence regional model. It has been studies that interventions applied over thoracic spine have a neurophysiological influence on cervical spine and respiratory system. Our study evaluates the influence of bilateral manipulative technique of first rib on pain and pulmonary function in subjects with chronic non-specific neck pain. Methods: The immediate changes produced by bilateral direct manipulation (HVLA) of first rib in subjects with non-specific chronic neck pain will be studied. The sample will be randomly divided into two groups, experimental and placebo. As dependent variables of the study, we will measure the peak expiratory flow and cervical rom. Findings will be analyzed statistically considering a 5% significance level (p ≤ 0.05) Discussion: Our study aims to provide knowledge about the influence of bilateral manipulative technique of first rib in pain and pulmonary capacity in subjects with non-specific chronic neck pain. The efficacy of this technique may entail an easy access and low cost strategy in patients with pain and a reduction in pulmonary function. Trial registration Brazilian Clinical Trial Registry, RBR-4dsvfy. Registered on 17 March 2020. Retrospectively registered


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