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 ◽  
...  

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

2020 ◽  
Author(s):  
Ricard Carrillo Muñoz ◽  
Jose Luis Ballve Moreno ◽  
Ivan Villar Balboa ◽  
Yolanda Rando Matos ◽  
Oriol Cunillera Puertolas ◽  
...  

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


2021 ◽  
Vol 19 (Sup9) ◽  
pp. S30-S37
Author(s):  
Eugenia Rodriguez González ◽  
Carmen del Pino Zurita ◽  
Gemma Arrontes Caballero ◽  
Araceli Hoyo Rodríguez ◽  
Eugenia Zapatero Rodríguez ◽  
...  

Aim: The Convexity in Ostomy (ECOS) study measured the impact of soft convex ostomy appliances on leakage frequency, peristomal skin health, and patient satisfaction, as well as stomal protrusion and body profile. Methods: This prospective non-randomised controlled trial included people with a stoma, divided into a control group using a convex appliance throughout (Alterna Confort Convex or Easiflex Confort Convex Light, Coloplast A/S, Humlebæk, Denmark), and an intervention group who were using a flat appliance at baseline before switching to a convex appliance for the rest of the study. Leakage frequency was counted within the past 2 weeks; peristomal skin health was assessed using the discolouration, erosion and tissue overgrowth (DET) Ostomy Skin Tool; and patient satisfaction was measured with a 0-10 Likert scale of self-reported satisfaction with the appliance. Measurements were taken at three visits: baseline (V1), 2-8 weeks (V2) and 6 months (V3). The Kruskal-Wallis and analysis of variance (ANOVA) tests were used for comparison. Multiple regression analysis was used to evaluate the effect of independent variables on the change in leakage frequency and DET score between baseline and 6 months. Findings: Of 253 participants screened, 245 completed the follow-up, with 151 in the intervention group and 94 in the control group. Mean leakage frequency period went from 5.85 ± 5.55 (V1) to 0.63 ± 1.42 (V2) and 0.23 ± 0.75 (V3) (p<.0001). Mean DET score changed from 4.8 ± 3.47 (V1) to 1.41 ± 2.17 (V2) and 0.54 ± 1.57 (V3) (p<.0001). Mean satisfaction changed from 6.0 ± 2.25 (V1) to 8.6 ± 1.14 (V2) and 9.17 ± 0.93 (V3) (p<.0001). From V1 to V3, the proportion of patients with a depressed peristomal area went from 45.7% to 31.4%, a normal peristomal area went from 45.3% to 65.3%, stoma protrusion went from 31.4% to 47.3% and stoma retraction went from 28.6% to 15.5%. By group, mean leakage frequency decreased in the intervention group by 7.65, from 7.57 to 0.11, and in the control group by 2.37, from 2.94 to 0.46 (p<0.0001). Multiple ANOVA analysis confirmed independent variables in reducing leakage to be initiating convexity and appliance coupling. By group, mean DET score decreased in the intervention group by 4.82, from 5.24 to 0.42, and in the control group by 3.52, from 4.34 to 0.76. Multiple ANOVA analysis showed independent variables for DET score to be initiating convexity, emergency surgery and stoma siting. Conclusion: People with a stoma experiencing repeated leakage benefitted from shifting from a flat to a soft convex appliance in terms of leakage frequency, peristomal skin health, stomal protrusion and body profile.


Circulation ◽  
2012 ◽  
Vol 125 (suppl_10) ◽  
Author(s):  
Jaime Céspedes ◽  
German Briceño ◽  
Michael Farkouh ◽  
Rajesh Vedanthan ◽  
Martha Leal ◽  
...  

Introduction: Educational programs for children can increase uptake of healthy lifestyle behaviors. However, the impact of educational programs in preschool-aged children in low- and middle-income countries is not known. We conducted a five month educational intervention in preschool facilities (PF) in Bogota, Colombia, to assess changes in preschooler’s knowledge, attitudes and habits (KAH) towards healthy eating and living an active lifestyle. Methods: We conducted a cluster, randomized, controlled trial, and randomly assigned 14 PF in Bogota to a five-month educational intervention (7 PF) or to usual curriculum (7 PF). The intervention included classroom activities and use of printed material and videos. A total of 1216 pre-school children, 928 parents, and 120 teachers participated. A structured survey was used to evaluate changes in KAH with a weighted total score (WTS). The primary outcome was change in children's WTS, and the secondary outcomes were change in parents’ and teachers' WTS. The control PF were provided the intervention after the initial evaluation. To assess sustainability, we evaluated both intervention and control groups at 18 months. Results: At 6 months, children in the intervention group showed 10.9% increase in WTS vs. 5.3% in controls, p<0.001, after adjustment for cluster, sex, age and teachers' educational level. Among parents, the equivalent results were 8.9% and 3.1%, respectively, p< 0.001, and among teachers 9.4% and 2.5%, p=0.06. At the 18-month extended follow-up, both the intervention and control children showed a significant further increase in WTS, p<0.001 (Figure 1). In parents and teachers in the intervened group, there was no significant increase in WTS, p=0.7417, and p=0.1197. In the control group, there was an increase in WTS in teachers but not in parents, p=0.001, and p=0.4239. Conclusion: A preschool based intervention, aimed at changing KAH related to healthy diet and active lifestyle, is feasible, efficacious and sustainable up to 18 months in very young children in Colombia.


Author(s):  
Iñaki Aguirrezabal ◽  
Maria Soledad Pérez de San Román ◽  
Raquel Cobos-Campos ◽  
Estibalitz Orruño ◽  
Arturo Goicoechea ◽  
...  

Abstract Aim: The aim of this study was to assess the effectiveness of a primary care-based group educational intervention about concepts of pain neuroscience for the management of migraine compared to the routine medical care delivered to patients with this condition. Background: The way pain is understood has been radically changed in recent decades, thanks to developments in the field of neuroscience. Thus, migraine may develop as a result of an exaggerated perception of threat that activates the pain neuromatrix, which might be modifiable, from a learning perspective, by adjusting the beliefs and behaviours that favour the onset of an attack. Methods: A randomised controlled trial was carried out in five primary care health centres of Vitoria-Gasteiz (Basque Country, Spain). The follow-up period was 12 months. The main outcome measure was the reduction in days lost due to migraine-related disability according to the Migraine Disability Assessment Test (MIDAS) score. Secondary outcome measures included the intensity and frequency of the pain and the number of analgesic drugs taken in the previous three months. A positive response to treatment was considered when the MIDAS score decreased by at least 50% from baseline. Findings: Days lost due to migraine-related disability decreased by at least 50% in 68.9% (n = 37) of patients in the intervention group and 34.6% of patients in the control group (n = 18) (P < 0.001). The intensity of the headache [odds ratio (OR) 9.116; P = 0.005] and the medication intake (OR 13.267; P < 0.001) were also significantly reduced with the intervention. Conclusions: The provision of suitable information through a group educational intervention delivered in primary care appears to be effective in preventing migraine attacks. Moreover, the intervention could offer a new cost-effective management alternative that seems to reduce the need for pharmacological treatment in patients with migraine.


2020 ◽  
Author(s):  
Mostafa Hemamy ◽  
Naseh Pahlavani ◽  
Gholamreza Askari ◽  
Mahsa Malekahmadi

Abstract Background: Attention-Deficit / Hyperactivity Disorder (ADHD) is a neurodevelopmental disorder, characterized by varying severity in attention deficit and hyperactivity. Studies have shown deficiencies in the serum level of magnesium and vitamin D in ADHD. The aim of this study is to determine the effect of Vitamin D and magnesium supplementation on mental health in children with ADHD.Method: This double‑blind, randomized controlled trial was performed on 66 ADHD children. participants were randomly allocated to receive both Vitamin D (50,000 IU/week) and magnesium (6 mg/kg/day) supplements (n = 33) or placebos (n = 33) for 8 weeks. Strengths and difficulties questionnaire were used to evaluate children’s mental health at baseline and at the end of the study.Results: After 8 weeks of intervention, the serum levels of 25‑hydroxy‑Vitamin D3 and magnesium increased significantly in the intervention group compared with the control group. Also a significant decrease in changes of emotional problems (p=0.001), conduct problems (p=0.002), peer problems (p=0.001), prosocial score (p=0.007), total difficulties (p=0.001), externalizing score (p=0.001), and internalizing score (p=0.001) was seen in intervention group at the end of study.Conclusion: Vitamin D (50,000 IU/week) and magnesium (6 mg/kg/day) co-supplementation during 8-week could improve the behavioral function and mental health in ADHD. Although further well-designed studies with a larger sample size are needed.the IRCT registration: IRCT2016030326886N1.


BMC Medicine ◽  
2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Daphne M. Stol ◽  
Eelco A. B. Over ◽  
Ilse F. Badenbroek ◽  
Monika Hollander ◽  
Mark M. J. Nielen ◽  
...  

Abstract Background Cardiometabolic diseases (CMD) are the major cause of death worldwide and are associated with a lower quality of life and high healthcare costs. To prevent a further rise in CMD and related healthcare costs, early detection and adequate management of individuals at risk could be an effective preventive strategy. The objective of this study was to determine long-term cost-effectiveness of stepwise CMD risk assessment followed by individualized treatment if indicated compared to care as usual. A computer-based simulation model was used to project long-term health benefits and cost-effectiveness, assuming the prevention program was implemented in Dutch primary care. Methods A randomized controlled trial in a primary care setting in which 1934 participants aged 45–70 years without recorded CMD or CMD risk factors participated. The intervention group was invited for stepwise CMD risk assessment through a risk score (step 1), additional risk assessment at the practice in case of increased risk (step 2) and individualized follow-up treatment if indicated (step 3). The control group was not invited for risk assessment, but completed a health questionnaire. Results of the effectiveness analysis on systolic blood pressure (− 2.26 mmHg; 95% CI − 4.01: − 0.51) and total cholesterol (− 0.15 mmol/l; 95% CI − 0.23: − 0.07) were used in this analysis. Outcome measures were the costs and benefits after 1-year follow-up and long-term (60 years) cost-effectiveness of stepwise CMD risk assessment compared to no assessment. A computer-based simulation model was used that included data on disability weights associated with age and disease outcomes related to CMD. Analyses were performed taking a healthcare perspective. Results After 1 year, the average costs in the intervention group were 260 Euro higher than in the control group and differences were mainly driven by healthcare costs. No meaningful change was found in EQ 5D-based quality of life between the intervention and control groups after 1-year follow-up (− 0.0154; 95% CI − 0.029: 0.004). After 60 years, cumulative costs of the intervention were 41.4 million Euro and 135 quality-adjusted life years (QALY) were gained. Despite improvements in blood pressure and cholesterol, the intervention was not cost-effective (ICER of 306,000 Euro/QALY after 60 years). Scenario analyses did not allow for a change in conclusions with regard to cost-effectiveness of the intervention. Conclusions Implementation of this primary care-based CMD prevention program is not cost-effective in the long term. Implementation of this program in primary care cannot be recommended. Trial registration Dutch Trial Register NTR4277, registered on 26 November 2013


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Karen Alterhaug Bjøntegaard ◽  
Signe Nilssen Stafne ◽  
Siv Mørkved ◽  
Kjell Åsmund Salvesen ◽  
Kari Anne I. Evensen

Abstract Background There are limited data on long-term outcomes of children whose mothers have followed exercise interventions during pregnancy. The aim of this paper was to investigate whether regular moderate intensity exercise during pregnancy affected the children’s body mass index (BMI) and physical activity (PA) at 7 years of age, and determine the relationship between children’s and mothers’ BMI and PA. Methods This was a follow-up of a multicentre randomised controlled trial, carried out at St. Olavs Hospital, Trondheim University Hospital, and Stavanger University Hospital, Norway (2007–2009 and 2014–2016). Women were randomised to follow a 12-week structured exercise protocol or standard antenatal care during pregnancy. At the 7-year follow-up, parents reported their child’s height, weight, and PA. The mothers also reported their own weight and PA. Main outcome variables were BMI, frequency and duration of moderate to vigorous PA (MVPA), and intensity of PA. Results A total of 855 women were randomised to exercise (n = 429) or standard antenatal care (n = 426) during pregnancy. At follow-up, 164 (38.2%) children and mothers in the intervention group and 117 (27.5%) in the control group participated. We found no group differences in the children’s iso-BMI or PA. Findings were similar when we performed stratified analyses by sex, except boys in the control group spent more time on electrical devices than boys in the intervention group. Subgroup analyses of children of mothers who adhered to the exercise protocol and sensitivity analyses excluding children born preterm, children admitted to the neonatal intensive care unit, and children with diseases or health problems at the 7-year follow-up, did not change the results. Children’s BMI, weekly leisure time MVPA and intensity of PA correlated with mothers’ BMI, daily exercise, and intensity of exercise. Conclusions Regular moderate intensity exercise during pregnancy did not affect BMI or PA of the children at 7 years. Good maternal health should be encouraged as it may influence the health of the next generation. Trial registration The initial RCT study was registered in ClinicalTrials.govNCT00476567.


2019 ◽  
Vol 25 (3) ◽  
pp. 102-108
Author(s):  
Mengyang Di ◽  
Chen Mao ◽  
Zuyao Yang ◽  
Hong Ding ◽  
Qu Liu ◽  
...  

ObjectiveTo evaluate whether evidence-based, individualised (EBI) counselling regarding hypertension and the treatment would affect medication use in insured patients with mild hypertension in China.MethodsWe conducted a parallel-group, randomised controlled trial in two primary care centres in Shenzhen, a metropolitan city in China. Patients with mild primary hypertension, 10-year risk of cardiovascular diseases (CVDs) lower than 20% and no history of CVDs were recruited and randomly allocated to two groups. EBI plus general counselling was provided to the intervention group and general counselling alone to the control group. EBI counselling included information on the 10-year CVD risk and treatment benefit in terms of absolute risk reduction estimated for each individual and information on average side effects and costs of antihypertensive drugs. The outcomes included use of antihypertensive drugs and adherence to the treatment at 6-month follow-up, with the former being primary outcome.ResultsTwo hundred and ten patients were recruited, with 103 and 107 allocated to the intervention and control groups, respectively. At baseline, 62.4% of the patients were taking antihypertensive drugs that were all covered by health insurance. At the end of 6-month follow-up, there was no statistically significant difference in the rate of medication use between the intervention group and the control group (65.0% vs 57.9%; OR=1.35, 95% CI: 0.77 to 2.36). The difference in adherence rate between the two groups was not statistically significant either (43.7% vs 40.2%; OR=1.15, 95% CI 0.67 to 2.00]). The results were robust in sensitivity analyses that used different cutoffs to define the two outcomes.ConclusionsThe EBI counselling by health educators other than the caring physicians had little impact on treatment choices and drug-taking behaviours in insured patients with mild primary hypertension in this study. It remains unclear whether EBI counselling would make a difference in uninsured patients, especially when conducted by the caring physicians.Trial registration numberChiCTR-TRC-14004169.


2012 ◽  
Vol 2012 ◽  
pp. 1-7 ◽  
Author(s):  
Torunn Askim ◽  
Birgitta Langhammer ◽  
Hege Ihle-Hansen ◽  
Jon Magnussen ◽  
Torgeir Engstad ◽  
...  

Background. There are no evidence-based strategies that have been shown to be superior in maintaining motor function for months to years after the stroke. The LAST study therefore intends to assess the effect of a long-term follow-up program for stroke patients compared to standard care on function, disability and health.Design. This is a prospective, multi-site randomised controlled trial, with blinded assessment 18 months after inclusion. A total of 390 patients will be recruited and randomised to a control group, receiving usual care, or to an intervention group 10 to 16 weeks after onset of stroke. Patients will be stratified according to stroke severity, age above 80, and recruitment site. The intervention group will receive monthly coaching on physical activity by a physiotherapist for 18 consecutive months after inclusion.Outcomes. The primary outcome is motor function (Motor Assessment Scale) 18 months after inclusion. Secondary outcomes are: dependency, balance, endurance, health-related quality of life, fatigue, anxiety and depression, cognitive function, burden on caregivers, and health costs. Adverse events and compliance to the intervention will be registered consecutively during follow-up.


2009 ◽  
Vol 195 (4) ◽  
pp. 308-317 ◽  
Author(s):  
Hans-Helmut König ◽  
Anja Born ◽  
Dirk Heider ◽  
Herbert Matschinger ◽  
Sven Heinrich ◽  
...  

BackgroundIndividuals with anxiety disorders often do not receive an accurate diagnosis or adequate treatment in primary care.AimsTo analyse the cost-effectiveness of an optimised care model for people with anxiety disorders in primary care.MethodIn a cluster randomised controlled trial, 46 primary care practices with 389 individuals positively screened with anxiety were randomised to intervention (23 practices, 201 participants) or usual care (23 practices, 188 participants). Physicians in the intervention group received training on diagnosis and treatment of anxiety disorders combined with the offer of a psychiatric consultation–liaison service for 6 months. Anxiety, depression, quality of life, service utilisation and costs were assessed at baseline, 6-month and 9-month follow-up.ResultsResultsNo significant differences were observed between intervention and control group on the Beck Anxiety Inventory, Beck Depression Inventory and EQ–5D during follow-up. Total costs were higher in the intervention group (€4911 v. €3453, P = 0.09). The probability of an incremental cost-effectiveness ratio <€50 000 per quality-adjusted life year was below 10%.ConclusionsThe optimised care model did not prove to be cost-effective.


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