Effectiveness of customized insoles in patients with Morton’s neuroma: a randomized, controlled, double-blind clinical trial

2019 ◽  
Vol 33 (12) ◽  
pp. 1898-1907 ◽  
Author(s):  
Hilda Alcântara Veiga de Oliveira ◽  
Jamil Natour ◽  
Mariana Vassalli ◽  
Andre Rosenfeld ◽  
Fabio Jennings ◽  
...  
Keyword(s):  
Control Group ◽  
Morton’S Neuroma ◽  
Double Blind ◽  
Foot Health ◽  
Randomized Controlled ◽  
Sf 36 ◽  
Foot Function ◽  
Morton's Neuroma ◽  
Arch Support ◽  
Foot Health Status Questionnaire

Objective: To assess the effectiveness of customized insole in patients with Morton’s neuroma. Design: Double-blind randomized controlled trial with intent-to-treat analysis. Setting: Outpatients, University Hospital. Subjects: A total of 72 patients with Morton’s neuroma met the inclusion criteria and were randomly allocated to either the study group ( n = 36) or the control group ( n = 36). Interventions: The study group was assigned to use a customized insole with metatarsal and arch support made of ethyl vinyl acetate and the control group received a flat insole of the same material, color, and density. Main measures: The primary outcome measure was walking pain intensity measured by the visual analogue scale. The secondary outcomes were as follows: pain at rest, palpation, and paresthesia (visual analogue scale); functional disability (6-minute walk test, Foot Function Index, and Foot Health Status Questionnaire); quality of life (Health Survey Short Form-36 (SF-36)); and foot pressure (AM Cube FootWalk Pro program). Results: In the comparison between the groups over time, a statistically significant difference, with improvement in favor of the experimental group, was found for pain during walking ( P = 0.048); in the general health domains ( P < 0.001) and physical activity ( P = 0.025) of the Foot Health Status Questionnaire; in the general Foot Function Index score ( P = 0.012); and in the functional capacity domain of the SF-36 questionnaire ( P = 0.046). For the other parameters, no difference was found between groups. Conclusion: The study demonstrated that customized insole with metatarsal and arch support relieved walking pain and improved patient-reported measures of function in patients with Morton’s neuroma.

scholarly journals Neurofeedback for tinnitus: Study protocol for a double-blind randomized controlled trial assessing the specificity of an alpha/delta neurofeedback training protocol in alleviating both the sound perception and the psychological distress, in a cohort of chronic tinnitus sufferers

2019 ◽  
Author(s):  
Martin Jensen ◽  
Eva Hüttenrauch ◽  
Jennifer Schmidt ◽  
Gerhard Andersson ◽  
Mira-Lynn Chavanon ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Control Group ◽  
Neurofeedback Training ◽  
Double Blind ◽  
Sound Perception ◽  
Active Comparator ◽  
Randomized Controlled ◽  
Tinnitus Distress ◽  
Training Protocol

Abstract Background Tinnitus is a very common condition, which for some can have debilitating psychological consequences. Although some interventions are helpful in learning how to cope better with the tinnitus, at present there is no cure. Neurofeedback is an emerging treatment modality in tinnitus. Previous studies, utilizing an alpha/delta training protocol have shown promise. However, they were characterized by small sample sizes and lack of neurofeedback control conditions. Therefore, the aim of this study is to investigate, if an alpha/delta neurofeedback training protocol, compared to beta/theta neurofeedback or a diary control group, is effective in reducing, not only the tinnitus sound perception, but also the psychological symptoms associated with the condition. Methods The study is designed as a three-armed, single-blinded randomized controlled trial. Participants are randomly assigned to either an established neurofeedback protocol for tinnitus (alpha/delta training), another neurofeedback protocol as active comparator (beta/theta training) or diary control group. In the four-week intervention period, participants in both neurofeedback groups undergo ten sessions, whereas participants in the diary control group complete a diary bi-weekly. The primary outcomes are between group differences in tinnitus sound percept change, as measured with the Tinnitus Magnitude Index (TMI) and changes in tinnitus distress, measured with the Tinnitus Handicap Inventory (THI), four weeks post baseline. Secondary outcome measures include changes in tinnitus distress, sleep quality, depressive symptoms and whether neurofeedback leads to specific power changes in the trained frequency bands. Discussion This is the first double-blind, randomized controlled trial examining the efficacy of an alpha/delta neurofeedback training protocol in reducing the tinnitus sound percept and the distress associated with the condition. Compared to former studies, the present study is designed to assess both the specificity of an alpha/delta neurofeedback training protocol by including an active comparator, beta/theta neurofeedback training, and in addition to control for placebo effects by inclusion of a diary control group. We hope this study contributes not only to our understanding of the neurological underpinnings of tinnitus, but also to the potentiality of neurofeedback as a therapeutic agent.

scholarly journals Efficacy and Safety of Ejiao (Asini Corii Colla) in Women With Blood Deficient Symptoms: A Randomized, Double-Blind, and Placebo-Controlled Clinical Trial

2021 ◽  
Vol 12 ◽  
Author(s):  
Li Zhang ◽  
Zhongju Xu ◽  
Tao Jiang ◽  
Jialu Zhang ◽  
Pinxian Huang ◽  
...  
Keyword(s):  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Blood Cell ◽  
Control Group ◽  
Placebo Control ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Placebo Control Group ◽  
Sf 36

Equus asinus L [Equidae; Asini Corii Colla] (donkey-hide gelatin, Ejiao), a well-known traditional Chinese medicine, has been widely used to nourish the blood, especially for women. The aim of this study was to assess the efficacy and safety of Ejiao in blood-deficient patients. A total of 210 participants were recruited and randomly allocated into the placebo control group and Ejiao-treated group (6 g/day). The primary outcomes on the efficacy of Ejiao included traditional Chinese medicine symptom scores, blood indicators, and SF-36. The secondary outcomes were changes in fireness and safety evaluation. Results showed that Ejiao treatment for 8 weeks had significantly improved dizziness symptoms. Among the tested 24 blood biochemical parameters, the hematocrit and red blood cell numbers decreased in the placebo control group, but decreased significantly less in the Ejiao treatment group. The white blood cell and neutrophil counts increased in the Ejiao group but were within the normal range. In addition, the quality of life improved as the scores in SF-36 domains were significantly higher in the Ejiao group. At the same time, there was no significant change in the fire–heat symptoms score or other safety parameters. Considering all these, our study showed that Ejiao has a promising effect in women suffering from blood deficiency without obvious adverse effects.

scholarly journals Foot Health Status Questionnaire (FHSQ) in Spanish People with Type 2 Diabetes Mellitus: Preliminary Values Study

2020 ◽  
Vol 17 (10) ◽  
pp. 3643
Author(s):  
Francisco Javier Domínguez-Muñoz ◽  
Miguel Angel Garcia-Gordillo ◽  
Rodrigo Anibal Diaz-Torres ◽  
Miguel Ángel Hernandez-Mocholi ◽  
Santos Villafaina ◽  
...  
Keyword(s):  
Physical Activity ◽  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Type 2 Diabetes Mellitus ◽  
Health Status ◽  
Foot Pain ◽  
Foot Health ◽  
Foot Function ◽  
Foot Health Status Questionnaire

Background and objectives: Type 2 Diabetes Mellitus (T2DM) is a chronic disease characterized by hyperglycemia. T2DM affects millions of people, and has a lot of complications such as impaired sensation in the feet. Moreover, it is important to know the health of the feet of people with T2DM. The aim of this study is to know the preliminary values of the Foot Health Status Questionnaire (FHSQ) in people with T2DM. Materials and Methods: A total of 87 patients with T2DM with an average age of 65.56 years, divided in 54 men and 33 women, participated in this cross-sectional study. The main outcome was the health of the foot as measured by the FHSQ questionnaire. This questionnaire collects data on eight dimensions: Foot Pain, Foot Function, Shoe, General Foot Health, General Health, Physical Activity, Social Capacity, and Vigor. Results: Patients with T2DM have lower values in Foot Pain; median values in General Foot Health and high values in Foot Function, Shoe, Physical Activity and Social Capacity. Some of these dimensions are affected by age, diabetes control, Body Mass Index (BMI), and years of diagnosis. Females with T2DM have more problems than males in the Shoe, General Foot Health, Physical Activity and Vigor dimensions. Conclusions: this research gives us preliminary values of the FHSQ in Spanish patients with T2DM and divided by gender, age, diabetes control, BMI, and years of diagnosis in people with T2DM.

Urokinase-Containing Locking Solution in the Prevention of Dialysis Catheter Dysfunction: A Double Blind Randomized Controlled Trial

2017 ◽  
Vol 18 (5) ◽  
pp. 436-442 ◽  
Author(s):  
Florence Bonkain ◽  
Freya Van Hulle ◽  
Peter Janssens ◽  
Concetta Catalano ◽  
Mandelina Allamani ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Incidence Rate ◽  
Controlled Trial ◽  
Recombinant Tissue Plasminogen Activator ◽  
Hemodialysis Patients ◽  
Control Group ◽  
Double Blind ◽  
Systemic Thrombolysis ◽  
Randomized Controlled ◽  
History Of

Introduction The prophylactic use of recombinant tissue plasminogen activator once weekly reduces the incidence rate of tunneled cuffed catheter (TCC) malfunction and bacteremia as compared to the exclusive use of heparin as locking solution. Restricting the use of prophylactic thrombolytic agents to patients with a history of thrombotic TCC malfunction could be more cost effective. We conduct a multicenter, double-blind, randomized controlled trial and test the hypothesis that weekly use of urokinase lock will reduce the incidence of thrombotic malfunction by 50% in prevalent hemodialysis patients with a history of thrombotic malfunction. Methods Patients with a history of at least two separate TCC thrombotic dysfunctions treated with urokinase lock during the 6 months preceding inclusion are recruited in eight Belgian dialysis units. Patients are randomized in two groups: the control group receiving Taurolock™-HEP500 (heparin 500 IU/mL, taurolidine, citrate 4%) after each hemodialysis session and the treatment group receiving Taurolock-U 25,000 (urokinase 25,000, taurolidine, citrate 4%) once a week and the standard Taurolock-HEP500 at the end of the two others sessions. The primary outcome is the incidence rate of TCC thrombotic dysfunction defined by the use of urokinase. The secondary outcomes are the incidence rate of TCC removal and systemic thrombolysis. For the study, both patients and healthcare staff are blinded to treatment allocation. Conclusions The present trial is the first to investigate the effect of Taurolock-U 25,000 catheter lock once a week as secondary prevention in hemodialysis patients with the highest risk of TCC-related thrombotic dysfunction. Trial Registration ClinicalTrials.gov Identifier: NCT02036255

scholarly journals Effectiveness of Hydrogalvanic Bath on Improving Pain, Disability, and Quality of Life in Individuals with Chronic Nonspecific Neck Pain: A Randomized Controlled Trial

2020 ◽  
Vol 2020 ◽  
pp. 1-7
Author(s):  
Mastour Saeed Alshahrani ◽  
Jaya Shanker Tedla ◽  
Ravi Shankar Reddy ◽  
Faisal Asiri
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Pain Disability ◽  
Sf 36 ◽  
Neck Disability ◽  
Experimental Group

Background. Neck pain is one of the world’s leading factors in years lived with disability. Ambiguity in the effect of electrotherapy modalities for the treatment of chronic nonspecific neck pains (CNSNP) needs to be examined further. This study sought to elucidate the effectiveness of hydrogalvanic bath on improving pain, disability, and quality of life among individuals with CNSNP. Methods. Thirty-four individuals with a diagnosis of CNSNP were selected through convenient sampling and randomly divided into two groups by block randomization. The control group treatment underwent low Transcutaneous Electrical Nerve Stimulation (TENS) and exercise, and the experimental group was subjected to hydrogalvanic bath therapy (HGBT) and exercise. Individuals were evaluated for pain using a visual analog scale (VAS), disability with the Neck Disability Index (NDI), and quality of life with Short Form-36 (SF-36). These measures were applied at baseline and after 12 weeks of treatment. Results. The pretreatment and posttreatment results for VAS, NDI, and SF-36 were compared for both control and experimental groups. We found that all the three variables showed significant differences between the two time points with p < 0.05 in both the groups but the experimental group improvements were more significant than the control group with p < 0.05 . Conclusion. Twelve weeks of low TENS or HGBT along with exercises can decrease pain and neck disability and increase the quality of life in individuals with CNSNP. However, HGBT along with exercise has superior effects relative to low TENS along with exercise. This randomized controlled trial was registered in the International Standard Randomized Controlled Trials Number-ISRCTN29695190 and registered on 05/02/2020. This study is a retrospective registration.

scholarly journals Effects of Bupropion on Cognitive Function in Schizophrenia: A Double Blind Randomized Controlled Trial

2016 ◽  
Vol 9 (5) ◽  
pp. 67
Author(s):  
Mansoureh Mirzadeh ◽  
Najmeh Shahini ◽  
Masoud Kashani Lotf Abadi ◽  
Maryam Tavakoli ◽  
Arash Javanbakht ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cognitive Function ◽  
Rating Scale ◽  
Controlled Trial ◽  
Control Group ◽  
P Value ◽  
Double Blind ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Schizophrenic Patients

<p>Smoking habits are common in schizophrenic patients. Nicotine can suppress negative symptoms and cognitive impairments. The aim of this study was to determine the efficacy of bupropion on cognitive function in schizophrenic patients.<strong> </strong>This study is a double blind randomized controlled trial in a large referral psychiatric university hospital in Iran. Ninety smoker schizophrenic patients were randomly allocated (based on DSM -IV TR criteria) in two groups (46 patients for case group and 44 patients in control group). They get risperidone up to 6 mg/d and bupropion up to 400 mg/d .clinical assessment (Positive and Negative Syndrome Scale (PANSS), Brief psychiatric rating scale (BPRS) were taken in beginning of study, 14<sup>th</sup> and 28<sup>th</sup> days of study. Cognitive assessment (Stroop, Digit Span, and Wechsler, Wisconsin) were taken in begging of study, the days 2<sup>nd</sup>, 7<sup>th</sup>, 14<sup>th</sup>, 28<sup>th</sup>. All data were analyzed by SPSS Ver. 17 with analytic and descriptive tests. Mean age of patients was 37.66±1.01. Mean duration of disorder was 11.63±.98 years. The scores were significantly lower at the day 28<sup>th</sup> compared to the beginning of the study in both groups in Wechsler, Stroop color word , Stroop word , Stroop color , BPRS, PANSS p value ≤0.05 .The difference between the two treatments was not significant as indicated by the effect of group, the between-subjects factor<strong> </strong><strong>p </strong>value ≥0.05. In this study, the side effects were examined and there was no significant difference between the two groups p value ≥0.05.<strong> </strong>Augmentation of bupropion to routine treatment improves cognitive symptoms of schizophrenia in abstinence of tobacco.</p>

Morton's neuroma: Clinical testing and imaging in 76 feet, compared to a control group

2011 ◽  
Vol 17 (3) ◽  
pp. 197-200 ◽  
Author(s):  
R. Owens ◽  
N. Gougoulias ◽  
H. Guthrie ◽  
A. Sakellariou
Keyword(s):  
Control Group ◽  
Clinical Testing ◽  
Morton’S Neuroma ◽  
Morton's Neuroma

scholarly journals Tranexamic Acid has no Effect on Post-Operative Hemarthrosis or Pain Control Following ACL Reconstruction Using Bone Patella Tendon Bone Autograft: A Double-Blind Randomized Controlled Double-Blind Trial (169)

2021 ◽  
Vol 9 (10_suppl5) ◽  
pp. 2325967121S0029
Author(s):  
Jordan Fried ◽  
David Bloom ◽  
Samuel Baron ◽  
Eoghan Hurley ◽  
Jovan Popovic ◽  
...  
Keyword(s):  
Blood Loss ◽  
Tranexamic Acid ◽  
Acl Reconstruction ◽  
Control Group ◽  
Patella Tendon ◽  
Double Blind ◽  
Randomized Controlled ◽  
Perioperative Blood Loss ◽  
Significant Difference ◽  
Experimental Group

Objectives: Tranexamic acid (TXA) is a commonly used medication in orthopaedic procedures, reducing perioperative bleeding and need for transfusion. The purpose of this double-blind randomized controlled study was to evaluate if IV TXA for primary anterior cruciate ligament (ACL) reconstruction with bone-patella tendon-bone (BTB) could reduce perioperative blood loss or postoperative intra-articular hemarthrosis without postoperative drains. Methods: A controlled, randomized, double-blinded trial was conducted in 110 patients who underwent ACLR with BTB autograft. Patients were equally randomized to the control and experimental groups. The experimental group received two 1-gram boluses of IV TXA, one prior to tourniquet inflation and one prior to wound closure; the control group did not receive TXA. If a clinically significant hemarthrosis was evident, the knee was aspirated, and the volume of blood (ml) was recorded. Additionally, perioperative blood loss (ml); Visual Analog Scale (VAS) on postoperative days (POD) 1-7 and post-operative weeks (POW) 1, 6 and 12; postoperative opioid consumption POD 1-7; range of motion (ROM) and ability to straight leg raise (SLR) at POW 1, 6, 12; and pre and postoperative thigh circumference ratio (TCR). Results: There was no significant difference in perioperative blood loss between the experimental and control groups (32.5ml v. 35.6ml, p=0.47). The experimental group had 23 knees aspirated; control group had 26 knees aspirated (p=0.56). No significant difference seen in postoperative hemarthrosis volume with IV TXA (26.7ml v. 37.3ml, p=0.12). There was no significant difference in VAS score between the two groups (p=0.15), additionally, there was no difference in postoperative opioid consumption (p=0.33). There was no significant difference in ROM or ability to SLR, or pre- nor post-operative TCR (p > 0.05 for all). Conclusions: IV TXA in patients who undergo ACLR with BTB autograft does not significantly impact perioperative blood loss, postoperative hemarthrosis, or postoperative pain levels. Additionally, no significant differences were seen in early post-operative recovery regarding ROM or quadriceps reactivation.

Sign in / Sign up

Export Citation Format

Share Document