scholarly journals Is an individually tailored programme of intense leg resistance and dynamic exercise acceptable to adults with an acute lateral patellar dislocation? A feasibility study

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Colin Forde ◽  
Mark Haddad ◽  
Shashivadan P. Hirani ◽  
David J. Keene
Keyword(s):  
Patellar Dislocation ◽  
Pilot Trial ◽  
Exercise Adherence ◽  
Outcome Data ◽  
Recruitment Rate ◽  
Home Exercise ◽  
Future Research ◽  
Link Type ◽  
Lateral Patellar Dislocation ◽  
Intervention Acceptability

Abstract Background Lateral patellar dislocations mainly affect active teenagers and young adults. To help people recover, non-surgical exercise-based treatment is often recommended but the optimal exercise-based treatment is unknown. Currently, treatment outcomes after this injury are variable. Common problems include recurrent dislocation, reduced activity levels, and later surgery. A programme of intense leg resistance exercises, and dynamic exercises related to participants’ activity-related goals, has rationale, but has not been previously reported. In line with the Medical Research Council guidance, this study aimed to assess the acceptability of a novel evidence-based exercise programme for adults after acute lateral patellar dislocation and the feasibility of future research evaluating this treatment. Methods A single-group prospective study was conducted at the John Radcliffe Hospital, Oxford, UK. Participants were 16 years or older with an acute first-time or recurrent lateral patellar dislocation. Participants received up to six face-to-face, one-to-one, physiotherapy sessions, over a maximum of 3 months, and performed intensive home exercises independently at least three times per week. Strategies to increase exercise adherence were used. Primary objectives were to determine the number of eligible patients, the recruitment rate (proportion of eligible patients that provided written informed consent), participant adherence to scheduled physiotherapy sessions and self-reported adherence to prescribed exercise, and intervention acceptability to participants measured by attrition and a study-specific questionnaire. Data were analysed using descriptive statistics. Results Fifteen of 22 (68%) patients with a lateral patellar dislocation were eligible. All eligible (100%) were recruited. Two of 15 (13%) participants provided no outcome data, 2/15 (13%) provided partial outcome data, and 11/15 (73%) provided all outcome data. Questionnaire responses demonstrated high intervention acceptability to participants. Participants attended 56/66 (85%) physiotherapy sessions and 10/11 (91%) participants reported they ‘always’ or ‘often’ completed the prescribed exercise. One participant redislocated their patella; another experienced knee pain or swelling lasting more than one week after home exercise on three occasions. Conclusion The intervention appeared acceptable to adults after acute lateral patellar dislocation, and a future randomised pilot trial is feasible. This future pilot trial should estimate attrition with increased precision over a longer duration and assess participants’ willingness to be randomised to different treatments across multiple centres. Trial registration ClinicalTrials.govNCT03798483, registered on January 10, 2019

scholarly journals Is an Individually Tailored Programme of Intense Leg Resistance and Dynamic Exercise Acceptable to Adults with an Acute Lateral Patellar Dislocation? A Feasibility Study

2020 ◽  
Author(s):  
Colin Forde ◽  
Mark Haddad ◽  
Shashivadan P Hirani ◽  
David J Keene
Keyword(s):  
Patellar Dislocation ◽  
Exercise Adherence ◽  
Recurrent Dislocation ◽  
Outcome Data ◽  
Recruitment Rate ◽  
Home Exercise ◽  
Future Research ◽  
Activity Levels ◽  
Lateral Patellar Dislocation ◽  
Intervention Acceptability

Abstract Background: lateral patellar dislocations mainly affect active teenagers and young adults. To help people recover, non-surgical exercise-based treatment is often recommended but the optimal exercise-based treatment is unknown. Currently, treatment outcomes after this injury are variable. Common problems include recurrent dislocation, reduced activity levels, and later surgery. A programme of intense leg resistance exercises, and dynamic exercises related to participants’ activity-related goals, has rationale, but has not been previously reported. In line with Medical Research Council guidance, this study aimed to assess the acceptability of a novel evidence-based exercise programme for adults after acute lateral patellar dislocation and the feasibility of future research evaluating this treatment.Methods: a single-group prospective study was conducted at the John Radcliffe Hospital, Oxford, UK. Participants were 16 years or older with an acute first-time or recurrent lateral patellar dislocation. Participants received up to six face-to-face, one-to-one, physiotherapy sessions, over maximum three months, and performed intensive home exercises independently at least three times per week. Strategies to increase exercise adherence were used. Primary objectives were to determine the number of eligible patients, the recruitment rate (proportion of eligible patients that provided written informed consent), participant adherence to scheduled physiotherapy sessions and self-reported adherence to prescribed exercise, and intervention acceptability to participants measured by attrition and a study-specific questionnaire. Data were analysed using descriptive statistics.Results: 15/22 (68%) patients with a lateral patellar dislocation were eligible. All eligible (100%) were recruited. 2/15 (13%) participants provided no outcome data, 2/15 (13%) provided partial outcome data, and 11/15 (73%) provided all outcome data. Questionnaire responses demonstrated high intervention acceptability to participants. Participants attended 56/66 (85%) physiotherapy sessions and 10/11 (91%) participants reported they ‘always’ or ‘often’ completed prescribed exercise. One participant redislocated their patella; another experienced knee pain or swelling lasting more than one week after home exercise on three occasions.Conclusion: the intervention appeared acceptable to adults after acute lateral patellar dislocation and future larger-scale research appears feasible. Future research should estimate feasibility outcomes with increased precision and assess participants’ willingness to be randomised to different treatments across multiple centres.Trial registration: ClinicalTrials.gov NCT03798483, registered January 10, 2019 https://clinicaltrials.gov/ct2/show/NCT03798483?term=INDEX-KD&draw=2&rank=1

scholarly journals Effectiveness of interactive augmented reality-based telerehabilitation in patients with adhesive capsulitis: protocol for a multi-center randomized controlled trial

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Seung Mi Yeo ◽  
Ji Young Lim ◽  
Jong Geol Do ◽  
Jae-Young Lim ◽  
Jong In Lee ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Physical Therapy ◽  
Augmented Reality ◽  
Controlled Trial ◽  
Adhesive Capsulitis ◽  
Performance Measure ◽  
Home Exercise ◽  
Randomized Controlled ◽  
Link Type ◽  
Home Based

Abstract Background As the primary treatment for adhesive capsulitis, intensive and accurate home exercise is as important as physical therapy in hospitals. Augmented reality (AR)-based telerehabilitation has been implemented recently in various musculoskeletal conditions to increase patient compliance and enable patients to exercise with the correct posture. The objective of this study is to present a protocol for investigating the additive effect of interactive AR-based telerehabilitation in comparison with the usual care for patients with adhesive capsulitis. Methods This study presents the protocol of a prospective, multi-center, single-blinded, two-armed randomized controlled trial (RCT). One hundred patients with stage I or II adhesive capsulitis will be recruited at the physical medicine and rehabilitation clinic. Patients will be randomly divided into two groups with 1:1 allocation. The intervention group will receive 3 months of hospital-based physical therapy in conjunction with home-based telerehabilitation. The control group will receive 3 months of hospital-based physical therapy in conjunction with a home-based exercise described in a brochure provided by the hospital. The primary outcome will be the change in passive range of motion (ROM) of the affected shoulder joint from baseline to 12 weeks after baseline assessment. The secondary outcomes will be active ROM, pain measured with the numeric rating scale, shoulder pain and disability index, 36-Item Short Form Survey, EuroQoL-5D-5L, and Canadian Occupational Performance Measure. Discussion This will be the first RCT study protocol to investigate the effect of telerehabilitation in patients with adhesive capsulitis. The result of this RCT will determine whether AR-based telerehabilitation is more effective than a brochure-based home exercise program and will provide evidence of the usefulness of “telerehabilitation” using hardware (IoT) and software (monitoring platform) technologies to develop “digital therapeutics” for the future. Trial registration This trial was retrospectively registered at the Clinicaltrials.gov website on 20 March 2020, with the identifier NCT04316130.

scholarly journals Efficacy of acupuncture for sciatica: study protocol for a randomized controlled pilot trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Fang-Ting Yu ◽  
Guang-Xia Ni ◽  
Guo-Wei Cai ◽  
Wen-Jun Wan ◽  
Xiao-Qing Zhou ◽  
...  
Keyword(s):  
Pain Intensity ◽  
Lumbar Disc ◽  
Pilot Trial ◽  
Sham Acupuncture ◽  
Leg Pain ◽  
Power Calculation ◽  
Clinical Trial Registry ◽  
Randomized Controlled ◽  
Link Type

Abstract Background Acupuncture is widely used for pain diseases while evidence of its efficacy for sciatica is insufficient. We aim to explore the feasibility and efficacy of acupuncture with different acupoint selecting strategies for sciatica induced by lumbar disc herniation. Methods This is a multicenter, three-arm, patient-assessor-blinded randomized controlled pilot trial. Ninety patients will be assigned randomly into 3 groups including disease-affected meridians (DAM) group, non-affected meridians (NAM) group, and sham acupuncture (SA) group in a 1:1:1 ratio. The trial involves a 4-week treatment along with follow-up for 22 weeks. The primary outcome is the change of leg pain intensity measured by the visual analogue scale (VAS) from baseline to week 4 after randomization. Secondary outcomes include functional status, back pain intensity, and quality of life. Adverse events will also be recorded. Discussion The results will inspire the optimal acupuncture strategy for sciatica and help establish a better design as well as power calculation for a full-scale study. Trial registration ChiCTR2000030680 (Chinese Clinical Trial Registry, http://www.chictr.org.cn, registered on 9 March 2020).

scholarly journals Applications of Medical Tattooing: A Systematic Review of Patient Satisfaction Outcomes and Emerging Trends

2021 ◽  
Author(s):  
Stacie J Becker ◽  
Jeffrey E Cassisi
Keyword(s):  
Patient Satisfaction ◽  
Medical Condition ◽  
Case Series ◽  
Outcome Data ◽  
Future Research ◽  
Health Service Provider ◽  
Level Of Evidence ◽  
Case Examples ◽  
Areola Complex ◽  
Clinical Series

Abstract Background Medical tattooing is often applied in the context of plastic, aesthetic, and reconstructive surgery to help achieve the best cosmetic outcome. Objectives This article reviews various conditions that medical tattooing have been empirically studied in terms of patient satisfaction outcomes; makes practice recommendations; and suggests future directions for research. Methods This review was performed following the PRISMA guidelines. Studies were included if the tattooing application was associated with a medical condition and if outcome data was provided using at least a case series methodology. Where no cohort or clinical series exist, case examples are used from the literature and the author’s practice to illustrate emerging medical tattooing applications that need further evaluation. Results Eighteen studies met the inclusion criteria and were applied to the following conditions: baldness, vitiligo, scars from incisions, lacerations or burns, and nipple areola complex reconstruction following breast surgery. Conclusions The application of medical tattooing has shown high levels of patient satisfaction across various conditions. The practice recommendation grade is “B” or recommend since the level of evidence for these interventions ranged from III to IV according to the ASPS guidelines. This means clinicians can consider this treatment alternative, but they should be alert to new information and be sensitive to patient preferences. Recommendations are made for reporting future research including clearly describing procedural details, identifying the professional performing the procedure, increased use of standardized outcome measures, and that satisfaction ratings be assessed by someone independent of the health service provider. Further research using RCT methodology with waitlist controls is needed.

scholarly journals Gestation-Based Viability–Difficult Decisions with Far-Reaching Consequences

Children ◽  
2021 ◽  
Vol 8 (7) ◽  
pp. 593
Author(s):  
Sumesh Thomas ◽  
Elizabeth Asztalos
Keyword(s):  
Decision Making ◽  
Preterm Birth ◽  
Current Knowledge ◽  
First Trimester ◽  
Perinatal Period ◽  
Outcome Data ◽  
Future Research ◽  
Extremely Preterm ◽  
Fetal Maturity

Most clinicians rely on outcome data based on completed weeks of gestational of fetal maturity for antenatal and postnatal counseling, especially for preterm infants born at the margins of viability. Contemporary estimation of gestational maturity, based on ultrasounds, relies on the use of first-trimester scans, which offer an accuracy of ±3–7 days, and depend on the timing of the scans and the measurements used in the calculations. Most published literature on the outcomes of babies born prematurely have reported on short- and long-term outcomes based on completed gestational weeks of fetal maturity at birth. These outcome data change significantly from one week to the next, especially around the margin of gestational viability. With a change in approach solely from decisions based on survival, to disability-free survival and long-term functional outcomes, the complexity of the parental and care provider’s decision-making in the perinatal and postnatal period for babies born at less than 25 weeks gestation remains challenging. While sustaining life following birth at the margins of viability remains our priority—identifying and mitigating risks associated with extremely preterm birth begins in the perinatal period. The challenge of supporting the normal maturation of these babies postnatally has far-reaching consequences and depends on our ability to sustain life while optimizing growth, nutrition, and the repair of organs compromised by the consequences of preterm birth. This article aims to explore the ethical and medical complexities of contemporary decision-making in the perinatal and postnatal periods. We identify gaps in our current knowledge of this topic and suggest areas for future research, while offering a perspective for future collaborative decision-making and care for babies born at the margins of viability.

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.

The management of lateral patellar dislocation: state of the art

2017 ◽  
Vol 2 (4) ◽  
pp. 205-212 ◽  
Author(s):  
Elizabeth A Arendt ◽  
Simon T Donell ◽  
Petri J Sillanpää ◽  
Julian A Feller
Keyword(s):  
Patellar Dislocation ◽  
State Of The Art ◽  
Lateral Patellar Dislocation

Patellofemoral Arthritis After Lateral Patellar Dislocation: A Matched Population-Based Analysis

2016 ◽  
Vol 45 (5) ◽  
pp. 1012-1017 ◽  
Author(s):  
Thomas L. Sanders ◽  
Ayoosh Pareek ◽  
Nicholas R. Johnson ◽  
Michael J. Stuart ◽  
Diane L. Dahm ◽  
...  
Keyword(s):  
Knee Arthroplasty ◽  
Cumulative Incidence ◽  
Patellar Dislocation ◽  
Trochlear Dysplasia ◽  
Significant Risk ◽  
Significant Risk Factor ◽  
Patellofemoral Arthritis ◽  
Level Of Evidence ◽  
Lateral Patellar Dislocation ◽  
Osteochondral Injury

Background: The rate of patellofemoral arthritis after lateral patellar dislocation is unknown. Purpose/Hypothesis: The purpose of this study was to compare the risk of patellofemoral arthritis and knee arthroplasty between patients who experienced a lateral patellar dislocation and matched individuals without a patellar dislocation. Additionally, factors predictive of arthritis after patellar dislocation were examined. The hypothesis was that the rate of arthritis is likely higher among patients who experience a patellar dislocation compared with those who do not. Study Design: Cohort study; Level of evidence, 3. Methods: In this study, 609 patients who had a first-time lateral patellar dislocation between 1990 and 2010 were compared with an age- and sex-matched cohort of patients who did not have a patellar dislocation. Medical records were reviewed to collect information related to the initial injury, recurrent dislocation, treatment, and progression to clinically significant patellofemoral arthritis (defined as symptoms with degenerative changes on patellar sunrise radiographs). Factors associated with arthritis (age, sex, recurrence, osteochondral injury, trochlear dysplasia) were examined. Results: At a mean follow-up of 12.3 ± 6.5 years from initial dislocation, 58 patients (9.5%) in the dislocation cohort were diagnosed with patellofemoral arthritis, corresponding to a cumulative incidence of arthritis of 1.2% at 5 years, 2.7% at 10 years, 8.1% at 15 years, 14.8% at 20 years, and 48.9% at 25 years. In the control cohort, 8 patients (1.3%) were diagnosed with arthritis, corresponding to a cumulative incidence of arthritis of 0% at 5 years, 0% at 10 years, 1.3% at 15 years, 2.9% at 20 years, and 8.3% at 25 years. Therefore, patients who experienced a lateral patellar dislocation had a significantly higher risk of developing arthritis (hazard ratio [HR], 7.8; 95% CI, 3.9-17.6; P < .001) than individuals without a patellar dislocation. However, the risk of knee arthroplasty was similar between groups (HR, 2.8; 95% CI, 0.6-19.7; P = .2). Recurrent patellar dislocations (HR, 4.5; 95% CI, 1.6-12.6), osteochondral injury (HR, 11.3; 95% CI, 5.0-26.6), and trochlear dysplasia (HR, 3.6; 95% CI, 1.3-10.0) were associated with arthritis after patellar dislocation. Conclusion: Patellar dislocation is a significant risk factor for patellofemoral arthritis, as nearly half of patients have symptoms and radiographic changes consistent with arthritis at 25 years after lateral patellar dislocation. Osteochondral injury, recurrent patellar instability, and trochlear dysplasia are associated with the development of arthritis.

scholarly journals Protocol for a factorial randomised controlled trial, embedded within WHiTE 8 COPAL, of an Enhanced Trainee Principal Investigator Package and Additional Digital Nudge to increase recruitment rates

F1000Research ◽  
2019 ◽  
Vol 8 ◽  
pp. 1153 ◽  
Author(s):  
Nickil Agni ◽  
Caroline Fairhurst ◽  
Catriona McDaid ◽  
Mike Reed ◽  
David Torgerson
Keyword(s):  
Randomised Controlled Trial ◽  
Positive Reinforcement ◽  
Controlled Trial ◽  
Significant Proportion ◽  
Educational Programme ◽  
Primary Objective ◽  
Recruitment Rate ◽  
Principal Investigators ◽  
Link Type ◽  
Randomised Controlled

Recruitment remains an issue when conducting randomised controlled trials (RCTs) with a significant proportion of studies failing to reach their target sample size. Studies evaluating interventions to improve recruitment aimed specifically at recruiters to the trial are limited in number. This factorial RCT will evaluate the effectiveness of an educational intervention to trainee principal investigators and a positive reinforcement intervention via an email nudge on increasing recruitment. The targeted recruiters will be in 20 centres nationally recruiting to one large orthopaedic randomised controlled trial, WHiTE 8 COPAL. Centres will be randomised via minimisation to one of four groups. The primary outcome is recruitment rate in the first six months that a centre is actively recruiting, with data being analysed via a Poisson regression model. Results will be presented as adjusted incidence rate ratios with 95% confidence intervals. Secondary outcomes relate to the feasibility and logistics of running the interventions.  We will also collect feedback regarding the educational programme set out for the trainee principal investigators. The study started in August 2018 with the anticipation of the primary objective endpoint by October 2019. The results of this study will be used to inform the design of future RCTs, particularly in orthopaedics in the UK, where the role of Trainee Principal Investigators is now a consistent one across different trials. Trial registration: 11600053, ISRCTN, 20/08/2018; SWAT 67, Northern Ireland Hub for Trials Methodology Research SWAT repository, 01/10/2017.

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