scholarly journals A multicenter, randomized, active-controlled, clinical trial study to evaluate the efficacy and safety of navigation guided balloon Eustachian tuboplasty

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Sung-Won Choi ◽  
Se-Joon Oh ◽  
Yehree Kim ◽  
Min Young Kwak ◽  
Myung-Whan Suh ◽  
...  
Keyword(s):  
Eustachian Tube ◽  
Valsalva Maneuver ◽  
Controlled Trial ◽  
Pure Tone Audiometry ◽  
Secondary Outcome ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Multicenter Rct ◽  
Balloon Eustachian Tuboplasty

AbstractTo assess the safety and efficacy of navigation-guided balloon Eustachian tuboplasty (BET) compared to medical management (MM) alone in patients with chronic Eustachian tube dilatory dysfunction (ETD). This is a prospective, multicenter, 1:1 parallel-group, randomized controlled trial (RCT). It aims to assess the efficacy of navigation-guided BET compared to MM alone in patients with chronic ETD. The primary outcome measure was an improvement in the Eustachian tube dysfunction questionnaire (ETDQ)-7 score at the 6-week follow-up compared with baseline. Secondary outcome measures included changes in the signs and symptoms during the follow-up, changes in the score for each subcategory of ETDQ-7, type of tympanometry, pure tone audiometry, and the availability of a positive modified Valsalva maneuver. Navigation-guided BET was safely performed in all patients. A total of 38 ears of 31 patients (19 ears of 16 patients in the BET group and 19 ears of 15 patients in the control group) completed the planned treatment and 6 weeks of follow-up. More patients in the BET group (1.99 ± 0.85) had less symptomatic dysfunction than in the control group (3.40 ± 1.29) at 6 weeks post-procedure (P = 0.001). More patients experienced tympanogram improvement in the BET group at 6 weeks compared to the control group (36.5% vs. 15.8%) with a positive modified Valsalva maneuver (36.6% vs. 15.8%, P = 0.014). Additionally, air–bone gap change was significantly decreased in the BET group compared to the control group at the 6-week follow-up visit (P = 0.037). This prospective, multicenter, RCT study suggests that navigation-guided BET is a safe and superior treatment option compared to MM alone in patients with chronic ETD.

scholarly journals Evaluating the Effectiveness and Safety of the Electroencephalogram-Based Brain-Machine Interface Rehabilitation System for Patients With Severe Hemiparetic Stroke: Protocol for a Randomized Controlled Trial (BEST-BRAIN Trial) (Preprint)

2018 ◽  
Author(s):  
Katsuhiro Mizuno ◽  
Takayuki Abe ◽  
Junichi Ushiba ◽  
Michiyuki Kawakami ◽  
Tomomi Ohwa ◽  
...  
Keyword(s):  
Occupational Therapy ◽  
Neural Plasticity ◽  
Controlled Trial ◽  
Brain Machine Interface ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Multicenter Rct ◽  
Machine Interface

BACKGROUND We developed a brain-machine interface (BMI) system for poststroke patients with severe hemiplegia to detect event-related desynchronization (ERD) on scalp electroencephalogram (EEG) and to operate a motor-driven hand orthosis combined with neuromuscular electrical stimulation. ERD arises when the excitability of the ipsi-lesional sensorimotor cortex increases. OBJECTIVE The aim of this study was to evaluate our hypothesis that motor training using this BMI system could improve severe hemiparesis that is resistant to improvement by conventional rehabilitation. We, therefore, planned and implemented a randomized controlled clinical trial (RCT) to evaluate the effectiveness and safety of intensive rehabilitation using the BMI system. METHODS We conducted a single blind, multicenter RCT and recruited chronic poststroke patients with severe hemiparesis more than 90 days after onset (N=40). Participants were randomly allocated to the BMI group (n=20) or the control group (n=20). Patients in the BMI group repeated 10-second motor attempts to operate EEG-BMI 40 min every day followed by 40 min of conventional occupational therapy. The interventions were repeated 10 times in 2 weeks. Control participants performed a simple motor imagery without servo-action of the orthosis, and electrostimulation was given for 10 seconds for 40 min, similar to the BMI intervention. Overall, 40 min of conventional occupational therapy was also given every day after the control intervention, which was also repeated 10 times in 2 weeks. Motor functions and electrophysiological phenotypes of the paretic hands were characterized before (baseline), immediately after (post), and 4 weeks after (follow-up) the intervention. Improvement in the upper extremity score of the Fugl-Meyer assessment between baseline and follow-up was the main outcome of this study. RESULTS Recruitment started in March 2017 and ended in July 2018. This trial is currently in the data correcting phase. This RCT is expected to be completed by October 31, 2018. CONCLUSIONS No widely accepted intervention has been established to improve finger function of chronic poststroke patients with severe hemiparesis. The results of this study will provide clinical data for regulatory approval and novel, important understanding of the role of sensory-motor feedback based on BMI to induce neural plasticity and motor recovery. CLINICALTRIAL UMIN Clinical Trials Registry UMIN000026372; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi? recptno=R000030299 (Archived by WebCite at http://www.webcitation.org/743zBJj3D) INTERNATIONAL REGISTERED REPOR DERR1-10.2196/12339

Evaluating the effects of a mindfulness mobile application on student pharmacists’ stress, burnout, and mindfulness

2021 ◽  
Author(s):  
Angela Chu ◽  
Tyler M Rose ◽  
Danielle A Gundrum ◽  
Tressa E McMorris ◽  
Eytan A Klausner ◽  
...  
Keyword(s):  
Mobile Application ◽  
Controlled Trial ◽  
Intervention Group ◽  
Secondary Outcome ◽  
Control Group ◽  
Intervention Period ◽  
Entire Study ◽  
Positive Effects ◽  
Waitlist Control Group

Abstract Disclaimer In an effort to expedite the publication of articles, AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. Purpose Pharmacists report high levels of burnout. Mindfulness approaches have been demonstrated to have positive results in the general population and in other healthcare professions. However, limited studies have been performed evaluating mindfulness approaches in student pharmacists. The aim of this study was to evaluate the effectiveness of daily use of a mindfulness mobile application in improving student pharmacists’ perceived stress, burnout, and mindfulness. Methods This study was a randomized, longitudinal, waitlist-controlled trial. The intervention group was asked to meditate using the mindfulness application Headspace daily for at least 6 weeks. The waitlist control group was asked to abstain from using the application for the entire study. Stress, burnout, and mindfulness were assessed using validated survey instruments at baseline, 6 weeks, and 10 weeks. A secondary outcome was to assess the persistence of application use after the intervention period. Results Fifty-six participants completed the study. The intervention group reported significantly lower scores on stress and burnout at 6 weeks compared to the control group. The intervention group also reported significantly higher scores on mindfulness. The differences in stress, burnout, and mindfulness persisted at follow-up. The mean percentage of students in the intervention group who used the application each day was 90% over the intervention period and 62% over the follow-up period. Conclusion A mindfulness mobile application significantly improved student pharmacists’ stress, burnout, and mindfulness with daily use. Most participants continued to use the application for 4 weeks after the end of the intervention. Positive effects on stress and mindfulness persisted even with decreased use.

scholarly journals Long-Term Effectiveness of a Stress Management Intervention at Work: A 9-Year Follow-Up Study Based on a Randomized Wait-List Controlled Trial in Male Managers

2017 ◽  
Vol 2017 ◽  
pp. 1-11 ◽  
Author(s):  
Jian Li ◽  
Natalie Riedel ◽  
Amira Barrech ◽  
Raphael M. Herr ◽  
Birgit Aust ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Stress Management ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
External Control ◽  
Control Group ◽  
Wait List ◽  
Eri Model

Objective. Short- and medium-term effectiveness (up to 3 years) of individual level stress management interventions (SMI) at work were demonstrated, yet long-term effectiveness remains unexplored. We therefore aimed to address this research gap. Methods. 94 male middle managers participated in a randomized wait-list controlled trial between 2006 and 2008 and in a post-trial-follow-up survey in 2015. During the first two years, all received an 18-hour psychotherapeutic SMI intervention which was based on the Effort-Reward Imbalance (ERI) model: tackling stressor on mismatch between effort and reward and promoting recovery on overcommitment. Work stress (i.e., ERI indicators) was the primary outcome, and the secondary outcome was depressive symptoms. The long-term effectiveness of the SMI was examined by mixed modeling, using an external control group (n=94). Results. Effort and reward were substantially improved with significant intervention ⁎ time interaction effects (p<0.001) compared to the external control group; effects on overcommitment and depressive symptoms were also significant (p<0.05 and p<0.01, resp.), though their trajectories in the intervention group were less sustainable. Conclusions. The effectiveness of this psychotherapeutic SMI at work based on the ERI model was observed over a 9-year period, particularly on the effort-reward ratio.

scholarly journals Impact of Epley manoeuvre on self-perceived disability: A randomised controlled trial in primary care

2020 ◽  
Author(s):  
Ricard Carrillo Muñoz ◽  
Jose Luis Ballve Moreno ◽  
Ivan Villar Balboa ◽  
Yolanda Rando Matos ◽  
Oriol Cunillera Puertolas ◽  
...  
Keyword(s):  
Primary Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Perceived Disability ◽  
Randomised Controlled ◽  
The Impact

Abstract Background: Posterior canal benign paroxysmal positional vertigo (pc-BPPV) causes physical, functional, and emotional impairment. The treatment of choice is the Epley manoeuvre (EM). The purpose of the study was to compare the impact of the EM and a sham manoeuvre in primary care on self-perceived disability.Method: Randomised, double-blind, sham-controlled clinical trial conducted in primary care with a follow-up of 1 year. Patients aged ≥18 years old diagnosed with pc-BPPV according to the Dix-Hallpike test (DHT) were randomised to an intervention (EM) group or a control (sham manoeuvre) group. The main study covariables were age, sex, history of depression and anxiety, presence of nystagmus in the DHT, patient-perceived disability assessed with the Dizziness Handicap Inventory-screening version (DHI-S). Data were analyzed using bivariate and multivariate mixed Tobit analyses. Results: Overall, 134 patients were studied: 66 in the intervention group and 68 in the control group. Median age was 52 years (interquartile range [IQR], 38.25–68.00 years) and 76.12% of the patients were women. The DHT triggered nystagmus in 40.30% of patients. The median total DHI-S score for the overall sample at baseline was 16 (IQR, 8.00–22.00); 16 [IQR, 10.5–24.0] vs 10 [6.0–14.0] for women vs men (P<0.001) and 16 [IQR, 10.0-24.0] vs 12 [IQR, 8.0–18.0] for patients without nystagmus vs those with nystagmus (P=0.033).Patients treated with the EM experienced a mean reduction of 2.03 points in DHI-S score over the follow-up period compared with patients in the sham group. Conclusion: Pc-BPPV affects the quality of life of primary care patients. A single EM can improve self-perceptions of disability by around 2 points on the DHI-S scale, Trial registration: ClinicalTrials.gov Identifier: NCT01969513. Retrospectively registered. First Posted: October 25, 2013. https://clinicaltrials.gov/ct2/show/NCT01969513

scholarly journals Effect of Balloon Eustachian Tuboplasty in Adults That Only Have Symptoms of Chronic Eustachian Tube Dysfunction, With a 1-Year Follow-Up: Prospective Clinical Trial

2020 ◽  
pp. 014556132098019
Author(s):  
Martin Formánek ◽  
Debora Formánková ◽  
Lukáš Školoudík ◽  
Karol Zeleník ◽  
Viktor Chrobok ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Eustachian Tube ◽  
Pure Tone Audiometry ◽  
Adult Patients ◽  
Eustachian Tube Dysfunction ◽  
Prospective Clinical Trial ◽  
Patient Reported ◽  
Tube Dysfunction ◽  
Balloon Eustachian Tuboplasty

Objectives: Balloon eustachian tuboplasty (BET) is a promising therapeutic option for eustachian tube (ET) dysfunction. However, data are lacking on the effect of BET in adults with symptoms of chronic ET dysfunction but without a contributing pathology. This study investigated the effect of BET in adult patients with only symptoms of chronic ET dysfunction. Methods: This prospective clinical trial included adult patients with aerated physiological middle ears and symptoms of ET dysfunction for more than 6 months. Compliance with follow-up was 93.3%. We evaluated the effects of BET with tympanometry, assessment of the Valsalva or Toynbee maneuver with tympanometry verification, a Eustachian Tube Dysfunction Questionnaire (ETDQ-7), and pure-tone audiometry. Data were recorded 1 day before surgery and 2, 6, and 12 months after BET. Therapy was considered successful when the patient exhibited a newly acquired ability to perform the Valsalva or Toynbee maneuver or when the ETDQ-7 score improved by 20% or more. Results: We included 14 ears in the analysis. After 2, 6, and 12 months, therapy was successful, according to the ETDQ-7, in 11/14 (78.6%; 95% CI: 48.8-94.3), 13/14 (92.9%; 95% CI: 64.2-99.6), and 12/14 (85.7%; 95% CI: 56.2-97.5) ears, respectively. These results were statistically significant. The ETDQ-7 scores also significantly decreased at 2, 6, and 12 months after the BET, when any change was observed. All patients experienced improvement. Only 1 patient reported temporary deterioration after 2 months. Treatment was more frequently successful in patients without nasal polyps or pollinosis. Conclusions: Adults with only symptoms of chronic ET dysfunction benefitted more and had longer lasting results from BET, compared to patients with pathologies caused by ET dysfunction. Balloon eustachian tuboplasty could be recommended for these patients.

The effectiveness of a non-guided mindfulness application on perceived stress in a non-clinical Dutch population: a Randomized Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Leonieke W Kranenburg ◽  
Jamie Gillis ◽  
Birgit Mayer ◽  
Witte JG Hoogendijk
Keyword(s):  
Randomized Controlled Trial ◽  
Perceived Stress ◽  
Psychological Symptoms ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Control Group ◽  
Dutch Population ◽  
Randomized Controlled ◽  
Experimental Group

BACKGROUND Mindfulness has become increasingly popular and positive outcomes have been reported for mindfulness-based interventions (MBIs) to reduce stress. These findings make room for innovative perspectives on how MBIs could be applied, for instance through mHealth. OBJECTIVE The aim of this study is to investigate if a non-guided mindfulness mobile phone application can decrease perceived stress in a non-clinical Dutch population over the course of eight weeks, with follow-up at six months. METHODS A randomized controlled trial (RCT) was performed, comparing the experimental group that made use of a structured 8-week mHealth mindfulness program and a control group after 8 weeks, with follow-up after six months. Participants were recruited via a national television program. The primary outcome measure was perceived stress as measured by the Perceived Stress scale (PSS), secondary outcomes were symptoms of burnout (VAS) and psychological symptoms (measured by the four-dimensional symptom questionnaire ; 4DSQ at follow-up). Outcomes were analyzed using a multilevel regression model. RESULTS At baseline, 587 respondents were included. Results showed no differences between groups for the level of perceived stress. With regard to the secondary outcome measures, the VAS for emotional exhaustion and physical exhaustion showed statistically significant lower scores for the experimental group after 8 weeks (resp. p=.04 and p= .01), but not at follow-up. There were also no differences between groups found for psychological symptoms. CONCLUSIONS These findings do not support our hypothesis that using the mindfulness app would reduce stress levels. However, findings with regard to diminished exhaustion at 8 weeks are encouraging and require further investigation.

Efficacy of an online intervention for treatment of depressive disorders: a three-arm randomized controlled trial comparing guided and unguided self-help with waitlist control (Preprint)

2021 ◽  
Author(s):  
Krämer Rico
Keyword(s):  
Depressive Symptoms ◽  
Depressive Disorders ◽  
Depressive Symptomatology ◽  
Controlled Trial ◽  
Intervention Group ◽  
Online Intervention ◽  
Self Report ◽  
Secondary Outcome ◽  
Control Group

BACKGROUND Digital health applications are efficacious treatment options for mild-to-moderate depressive disorders. However, the extent to which psychological guidance increases the efficacy of these applications is controversial. OBJECTIVE We evaluated the efficacy of the online intervention “Selfapy” for unipolar depression. We also investigated differences between a psychotherapist-guided vs. unguided version compared with those from a control group. METHODS A cohort of 401 participants with mild-to-severe depressive disorders were assigned randomly to either participate in a guided version of Selfapy (involving weekly telephone calls of 25-min duration), an unguided version of Selfapy, or to the waiting list (control group). Selfapy is a cognitive behavioral therapy-based intervention for depressive disorders of duration 12 weeks. Symptom assessment was undertaken at T1 (before study entrance), T2 (after 6 weeks), T3 (post-treatment, after 12 weeks), and T4 (follow-up, after 6 months). The main outcome was reduction in depressive symptoms in the Beck Depression Inventory (BDI-II) from T1 to T3. Secondary-outcome parameters were the Quick Inventory of Depressive Symptomatology – Self Report (QIDS-SR 16) and Beck Anxiety Inventory (BAI). RESULTS A total of 297 out of 401 participants (74.06%) completed the post-measurement at T3. In the primary analysis, both intervention groups showed a significantly higher reduction in depressive symptoms (BDI-II) from T1 to T3 compared with that in the control group, with high within-effect sizes (guided: d = 1.46; unguided d = 1.36). No significant differences were found for guided vs. unguided treatment groups. The response rate (BDI-II) for intention-to-treat data in the guided version was 46.4%, 40.0% for the unguided version, and 2.0% in the control group. After 6 months (T4), treatment effects could been maintained for both intervention groups (BDI-II) without differences between either intervention group. CONCLUSIONS Conclusions: Selfapy can help to reduce depressive symptoms in guided or unguided version. Follow-up data suggest that these effects could be maintained. The guided version was not superior to the unguided version. CLINICALTRIAL Trial Registration: Current Controlled Trial DRKS00017191 Date of registration: 14 May 2019 INTERNATIONAL REGISTERED REPORT RR2-https://doi.org/10.1186/s13063-021-05218-4

scholarly journals Effectiveness of a mindfulness-oriented substance use prevention program for boys with mild to borderline intellectual disabilities: study protocol for a randomised controlled trial

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Lucie Waedel ◽  
Anne Daubmann ◽  
Antonia Zapf ◽  
Olaf Reis
Keyword(s):  
Substance Use ◽  
Randomised Controlled Trial ◽  
Intellectual Disabilities ◽  
Controlled Trial ◽  
Intervention Group ◽  
Secondary Outcome ◽  
Control Group ◽  
Post Intervention ◽  
Randomised Controlled

Abstract Background Boys with mild to borderline intellectual disabilities (MBID) are at particular risk to drink in harmful ways once they start to consume alcohol. Interventions based on mindfulness have been proven to be effective in preventing substance use, but mostly for adults with MBID. A mindfulness oriented intervention targeting 11–17 years old boys will be tested in a randomised controlled trial. Study aim is to investigate the benefits of this new intervention compared to an active control condition within a 12 months follow-up. Methods In this randomised controlled proof of concept study, 82 boys with MBID who consumed any alcohol during the last year will be randomised either to the 6 week mindfulness oriented intervention or the control group receiving a control intervention equal in dose and length. The intervention group undergoes mindfulness training combined with interactive drug education, while the control group completes a health training combined with the same education. In the intention-to-treat analysis the primary outcome is the self-reported delay of first post-intervention drunkeness within a 12 months follow-up time span, measured weekly with a short app-based questionnaire. Secondary outcome is the use of alcohol, tobacco and other drugs within 30 days post-intervention. Changes in neurobiological behavioural parameters, such as impulse control, reward anticipation, and decision making, are also investigated. Other secondary outcomes regard trait mindfulness, emotion regulation, psychopathological symptoms, peer networks, perceived stress, and quality of life. In addition, a prospective registry will be established to record specific data on the population of 11–17 year old boys with MBID without any alcohol experience. Discussion This study offers the opportunity to gain first evidence of the effectiveness of a mindfulness-oriented program for the prevention of substance use for boys with MBID. Trial registration German Clinical Trials Register, DRKS00014042. Registered on March 19th 2018.

scholarly journals The Effect of Selective Retina Therapy with Automatic Real-Time Feedback-Controlled Dosimetry for Chronic Central Serous Chorioretinopathy: A Randomized, Open-Label, Controlled Clinical Trial

2021 ◽  
Vol 10 (19) ◽  
pp. 4295
Author(s):  
Ji-young Lee ◽  
Min-hee Kim ◽  
Seung-hee Jeon ◽  
Seung-hoon Lee ◽  
Young-jung Roh
Keyword(s):  
Real Time ◽  
Central Serous Chorioretinopathy ◽  
Controlled Trial ◽  
Subretinal Fluid ◽  
Post Treatment ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Chronic Central Serous Chorioretinopathy ◽  
Selective Retina Therapy

This prospective randomized controlled trial evaluated the safety and efficacy of real-time feedback-controlled dosimetry (RFD)-guided selective retina therapy (SRT) in chronic central serous chorioretinopathy (CSC). Forty-four participants with chronic CSC were included and randomly assigned to the control group or SRT group. The SRT laser system with RFD-guidance was applied to cover the entire leakage area. If SRF remained at the 6-week follow-up visit, re-treatment and rescue SRT was performed for the SRT group and crossover group, respectively. The rate of complete resolution of subretinal fluid (SRF), mean SRF height, and mean retinal sensitivity were compared between the two groups at 6-weeks post-treatment. The complete SRF resolution rate in all SRT-treated eyes was evaluated at 12-weeks post-treatment. The rate of complete SRF resolution was significantly higher in the SRT group (63.6%) than in the control group (23.8%) at 6-weeks post-treatment (p = 0.020). The mean SRF height at 6 weeks after SRT was significantly lower in the SRT group (p = 0.041). Overall, SRT-treated eyes showed complete SRF resolution in 70.3% of eyes at 12-weeks post-treatment. RFD-guided SRT was safe and effective to remove SRF in chronic CSC patients during the 3-month follow-up period.

scholarly journals Comparison of efficacy of needling and a combination of needling and platelet rich plasma in relieving pain and improving function in patients of tennis elbow: a prospective, randomized, double blinded, placebo controlled clinical trial

2021 ◽  
Vol 7 (2) ◽  
pp. 258
Author(s):  
Vikram Sharma ◽  
Vivek Chandak
Keyword(s):  
Tennis Elbow ◽  
Platelet Rich Plasma ◽  
Controlled Trial ◽  
Lateral Epicondylitis ◽  
Secondary Outcome ◽  
Controlled Clinical Trial ◽  
Group A ◽  
Group B ◽  
Double Blinded

<p><strong>Background: </strong>Lateral epicondylitis is a common musculoskeletal disorder for which an effective treatment strategy remains unknown. Aim of the study was to examine whether a single injection of platelet-rich plasma (PRP) with needling is more effective than needling with placebo in reducing pain in adults with lateral epicondylitis. Study design used was randomized controlled trial.    </p><p><strong>Methods: </strong>A total of 66 patients with chronic lateral epicondylitis were randomized (1:1) to receive either a blinded injection of PRP (group A) or saline (placebo) group B. The primary end point was a change in pain using the VAS and patient-rated tennis elbow evaluation (PRTEE) questionnaire. The secondary outcome being improvement in function (PRTEE scores).<strong></strong></p><p><strong>Results: </strong>The VAS score and PRTEE score improved significantly in both the groups at all 3 follow-up examinations. Group A had significantly better results than the group B.</p><p><strong>Conclusions: </strong>PRP injection are safe and effective management strategy for lateral epicondylitis</p>

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