scholarly journals A Pilot Randomised Trial Comparing Individualised Physiotherapy Versus Shockwave Therapy for Proximal Hamstring Tendinopathy: A protocol

2021 ◽  
Author(s):  
Aidan Lindsay Fenner Rich ◽  
Jillianne Leigh Cook ◽  
Andrew John Hahne ◽  
Jon Joseph Ford
Keyword(s):  
Ordinal Data ◽  
Rating Scale ◽  
Pain Catastrophizing ◽  
Randomised Trial ◽  
Pilot Trial ◽  
Activity Level ◽  
Trial Registration ◽  
Global Rating ◽  
Shockwave Therapy ◽  
Proximal Hamstring

Abstract BackgroundProximal hamstring tendinopathy (PHT) presents as localised lower buttock pain with tasks such as squatting and sitting. It is a condition that occurs at all ages and levels of sporting participation and can cause disability with sport, work, and activities of daily living. This paper details a pilot trial protocol for investigating the effectiveness of individualised physiotherapy compared to extracorporeal shockwave therapy (ESWT) on pain and strength in people with PHT.Methods The study is an assessor-blinded, pilot randomised controlled trial (RCT). One hundred participants with PHT will be recruited from the local community and sporting clubs. Participants will be randomised to receive six sessions of either individualised physiotherapy or ESWT, with both groups also receiving standardised education and advice.Primary outcomes will be global rating of change on a 7-point Likert scale, and the Victorian Institute of Sport - Hamstring (VISA-H) scale, measured at 0, 4, 12, 26 and 52 weeks.. Secondary outcomes will include sitting tolerance, the modified Physical Activity Level Scale, eccentric hamstring strength, modified Tampa scale for kinesiophobia, the Orebro Musculoskeletal Screening Questionnaire, Numerical Pain Rating Scale (NPRS) for average and worst pain, participant adherence, the Pain Catastrophizing scale, satisfaction scores, and quality of life. Data will be analysed on an intention to treat basis, with between-group effects estimated using linear mixed models for continuous data and Mann Whitney U tests for ordinal data. DiscussionThis pilot RCT will compare individualised physiotherapy versus ESWT for PHT. The trial will determine feasibility and estimated treatment effects to inform a definitive trial in the future.Trial registrationThe trial has been prospectively registered with the Australia & New Zealand Clinical Trials Registry (ACTRN12621000846820), registered 1 July 2021, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=373085

scholarly journals Pilot trial on the efficacy and safety of pantethine in children with pantothenate kinase-associated neurodegeneration: a single-arm, open-label study

2020 ◽  
Vol 15 (1) ◽  
Author(s):  
Xuting Chang ◽  
Jie Zhang ◽  
Yuwu Jiang ◽  
Bufan Yao ◽  
Jingmin Wang ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Rating Scale ◽  
Pilot Trial ◽  
Trial Registration ◽  
Efficacy And Safety ◽  
Open Label ◽  
Pantothenate Kinase ◽  
Open Label Study ◽  
Label Study

Abstract Objective This study aimed to explore the efficacy and safety of pantethine in children with pantothenate kinase-associated neurodegeneration (PKAN). Methods A single-arm, open-label study was conducted. All subjects received pantethine during the 24-week period of treatment. The primary endpoints were change of the Unified Parkinson’s Disease Rating Scale (UPDRS) I–III and Fahn–Marsden (FM) score from baseline to week 24 after treatment. Results Fifteen children with PKAN were enrolled, and all patients completed the study. After 24 weeks of treatment with pantethine at 60 mg/kg per day, there was no difference in either UPDRS I–III (t = 0.516, P = 0.614) or FM score (t = 0.353, P = 0.729) between the baseline and W24. Whereas the rates of increase in UPDRS I-III (Z = 2.614, p = 0.009) and FM scores (Z = 2.643, p = 0.008) were slowed. Four patients (26.7%) were evaluated as “slightly improved” by doctors through blinded video assessment. Patients with lower baseline UPDRS I–III or FM scores were more likely to be improved. The quality of life of family members improved after pantethine treatment, evaluated by PedsQL TM 2.0 FIM scores, whereas the quality of life of the patients was unchanged at W24, evaluated by PedsQL TM 4.0 and PedsQL TM 3.0 NMM. Serum level of CoA was comparable between baseline and W24. There was no drug related adverse event during the study. Conclusions Pantethine could not significantly improve motor function in children with PKAN after 24 weeks treatment, but it may delay the progression of motor dysfunction in our study. Pantethine was well-tolerated at 60 mg/kg per day. Trial registration Clinical trial registration number at www.chictr.org.cn:ChiCTR1900021076, Registered 27 January2019, the first participant was enrolled 30 September 2018, and other 14 participants were enrolled after the trial was registered.

scholarly journals Pilot trial on the efficacy and safety of pantethine in children with pantothenate kinase-associated neurodegeneration: A single-arm, open-label study.

2020 ◽  
Author(s):  
Xuting Chang ◽  
Jie Zhang ◽  
Yuwu Jiang ◽  
Bufan Yao ◽  
Jingmin Wang ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Rating Scale ◽  
Pilot Trial ◽  
Trial Registration ◽  
Efficacy And Safety ◽  
Open Label ◽  
Pantothenate Kinase ◽  
Open Label Study ◽  
Label Study

Abstract Objective This study aimed to explore the efficacy and safety of pantethine in children with pantothenate kinase-associated neurodegeneration (PKAN).Methods A single-arm, open-label study was conducted. All subjects received pantethine during the 24-week period of treatment. The primary endpoints were change of the Unified Parkinson’s Disease Rating Scale (UPDRS) I–III and Fahn–Marsden (FM) score from baseline to week 24 after treatment.Results Fifteen children with PKAN were enrolled, and all patients completed the study. After 24 weeks of treatment with pantethine at 60mg/kg per day, there was no difference in either UPDRS I–III (t=0.516, P=0.614) or FM score (t=0.353, P=0.729) between the baseline and W24. Whereas the rates of increase in UPDRS I-III (Z=2.614, p=0.009) and FM scores (Z=2.643, p=0.008) were slowed. Four patients (26.7%) were evaluated as “slightly improved” by doctors through blinded video assessment. Patients with lower baseline UPDRS I–III or FM scores were more likely to be improved. The quality of life of family members improved after pantethine treatment, evaluated by PedsQL TM 2.0 FIM scores, whereas the quality of life of the patients was unchanged at W24, evaluated by PedsQL TM 4.0 and PedsQL TM 3.0 NMM. Serum level of CoA was comparable between baseline and W24. There was no drug related adverse event during the study.Conclusions Pantethine could not significantly improve motor function in children with PKAN after 24 weeks treatment, but it may delay the progression of motor dysfunction in our study. Pantethine was well-tolerated at 60mg/kg per day.Trial registration:Clinical trial registration number at www.chictr.org.cn：ChiCTR1900021076，Registered 27 January2019，the first participant was enrolled 30 September 2018，and other 14 participants were enrolled after the trial was registered.

Psychological networks in clinical populations: investigating the consequences of Berkson's bias

2019 ◽  
pp. 1-9 ◽  
Author(s):  
Jill de Ron ◽  
Eiko I. Fried ◽  
Sacha Epskamp
Keyword(s):  
Network Structure ◽  
Binary Data ◽  
Ordinal Data ◽  
Graphical Model ◽  
Rating Scale ◽  
Network Models ◽  
Simulation Studies ◽  
Potential Threat ◽  
Sum Score ◽  
Research Populations

Abstract Background In clinical research, populations are often selected on the sum-score of diagnostic criteria such as symptoms. Estimating statistical models where a subset of the data is selected based on a function of the analyzed variables introduces Berkson's bias, which presents a potential threat to the validity of findings in the clinical literature. The aim of the present paper is to investigate the effect of Berkson's bias on the performance of the two most commonly used psychological network models: the Gaussian Graphical Model (GGM) for continuous and ordinal data, and the Ising Model for binary data. Methods In two simulation studies, we test how well the two models recover a true network structure when estimation is based on a subset of the data typically seen in clinical studies. The network is based on a dataset of 2807 patients diagnosed with major depression, and nodes in the network are items from the Hamilton Rating Scale for Depression (HRSD). The simulation studies test different scenarios by varying (1) sample size and (2) the cut-off value of the sum-score which governs the selection of participants. Results The results of both studies indicate that higher cut-off values are associated with worse recovery of the network structure. As expected from the Berkson's bias literature, selection reduced recovery rates by inducing negative connections between the items. Conclusion Our findings provide evidence that Berkson's bias is a considerable and underappreciated problem in the clinical network literature. Furthermore, we discuss potential solutions to circumvent Berkson's bias and their pitfalls.

scholarly journals Efficacy and safety of Shi-style cervical manipulation therapy for treating acute and subacute neck pain: study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Mingcai Zhang ◽  
Guoqing Du ◽  
Congying Liu ◽  
Wei Li ◽  
Jiayu Yang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Neck Pain ◽  
Clinical Observation ◽  
Rating Scale ◽  
Neck Disability Index ◽  
Trial Registration ◽  
Activity Measurement ◽  
Manipulation Therapy ◽  
Self Evaluation ◽  
Cervical Manipulation

Abstract Background Neck pain is a common clinical disease, which seriously affects people’s mental health and quality of life and results in loss of social productivity. Improving neck pain’s curative effect and reducing its recurrence rate are major medical problems. Shi’s manipulation therapy has unique advantages and technical features that aid in the diagnosis and treatment of neck pain. Compared with first-line non-steroidal anti-inflammatory drug (NSAID) treatment of neck pain, Shi’s cervical manipulation lacks the relevant research basis of therapeutic advantage, safety, and satisfaction for treating acute and subacute neck pain. Herein, we aim to confirm our hypothesis in a clinical trial that the safety and efficacy of Shi’s cervical manipulation will be more effective, safer, and more satisfactory than NSAIDs to treat acute and subacute neck pain. Methods In this multicenter, positive-controlled, randomized clinical trial, traditional analgesic drug (NSAID) is used to evaluate and show that Shi’s manipulation is more effective, safe, and satisfactory for treating acute and subacute neck pain. Overall, 240 subjects are randomly divided into the trial and control groups, with both groups treated by the corresponding main intervention method for up to 12 weeks. Clinical data will be collected before the intervention and immediately after the first treatment; at 3 days and 1, 2, 4, 8, and 12 weeks after the intervention; and at 26 and 52 weeks after treatment follow-up of clinical observation index data collection. The clinical observation indices are as follows: (1) cervical pain is the primary observation index, measured by Numerical Rating Scale. The secondary indices include the following: (2) cervical dysfunction index, measured by patient self-evaluation using cervical Neck Disability Index; (3) cervical activity measurement, measured by the cervical vertebra mobility measurement program of Android mobile phone system; (4) overall improvement, measured by patient self-evaluation with SF-36; and (5) satisfactory treatment, determined by patient self-evaluation. Discussion We will discuss whether Shi’s cervical manipulation has greater advantages in efficacy, safety, and satisfaction of acute and subacute neck pain than traditional NSAIDs, to provide a scientific basis for the dissemination and application of Shi’s cervical manipulation. Trial registration China Registered Clinical Trial Registration Center ChiCTR1900021371. Registered on 17 February 2019

scholarly journals Otoskills training during covid-19 pandemic: a before-after study

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Maxime Fieux ◽  
Antoine Gavoille ◽  
Fabien Subtil ◽  
Sophie Bartier ◽  
Stéphane Tringali
Keyword(s):  
Surgical Training ◽  
Rating Scale ◽  
Surgical Simulation ◽  
Global Rating Scale ◽  
Middle Ear Surgery ◽  
Global Rating ◽  
Training Requirements ◽  
Significant Difference ◽  
Before And After ◽  
Total Performance

Abstract Background The ongoing COVID-19 pandemic has disrupted the surgical training of residents. There is a real concern that trainees will not be able to meet their training requirements. Low-fidelity surgical simulation appears to be an alternative for surgical training. The educational benefits of repeating ossiculoplasty simulations under a microscope have never been evaluated. With this study we aimed to evaluate the differences in performance scores and on a global rating scale before and after training on an ossiculoplasty simulator. Methods In this quasi-experimental, prospective, single-centre, before-after study with blinded rater evaluation, residents performed five microscopic ossiculoplasty tasks with a difficulty gradient (sliding beads onto rods, the insertion of a partial prosthesis, the insertion of a total prosthesis, and the insertion of a stapedotomy piston under microscopic or endoscopic surgery) before and after training on the same simulator. Performance scores were defined for each task, and total performance scores (score/min) were calculated. All data were collected prospectively. Results Six out of seven intermediate residents and 8/9 novices strongly agreed that the simulator was an effective training device and should be included in the ENT residency program. The mean effect of training was a significant increase in the total performance score (+ 0.52 points/min, [95 % CI, 0.40–0.64], p < 0.001), without a significant difference between novice and intermediate residents. Conclusions This preliminary study shows that techniques for middle-ear surgery can be acquired using a simulator, avoiding any risk for patients, even under lockdown measures.

scholarly journals Individual Differences and Similarities in the Judgement of Facial Pain: A Mixed Method Study

2020 ◽  
Vol 10 (4) ◽  
pp. 1186-1194
Author(s):  
Sheila Glenn ◽  
Helen Poole ◽  
Paula Oulton
Keyword(s):  
Individual Differences ◽  
Undergraduate Students ◽  
Pain Assessment ◽  
Health Care Professionals ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Pain Catastrophizing ◽  
Sensory Sensitivity ◽  
Facial Cues ◽  
Numerical Rating

Accurate assessment of pain by health-care professionals is essential to ensure optimal management of pain. An under-researched area is whether personality characteristics affect perception of pain in others. The aims were (a) to determine whether individual differences are associated with participants’ ability to assess pain, and (b) to determine facial cues used in the assessment of pain. One hundred and twenty-eight undergraduate students participated. They completed questionnaire assessments of empathy, pain catastrophizing, sensory sensitivity and emotional intelligence. They then viewed and rated four adult facial images (no, medium, and high pain—12 images total) using a 0–10 numerical rating scale, and noted the reasons for their ratings. (a) Empathy was the only characteristic associated with accuracy of pain assessment. (b) Descriptions of eyes and mouth, and eyes alone were most commonly associated with assessment accuracy. This was the case despite variations in the expression of pain in the four faces. Future studies could evaluate the effect on accuracy of pain assessment of (a) training empathic skills for pain assessment, and (b) emphasizing attention to the eyes, and eyes and mouth.

scholarly journals LOAD-intensity and time-under-tension of exercises for men who have Achilles tendinopathy (the LOADIT trial): a randomised feasibility trial

2021 ◽  
Vol 13 (1) ◽  
Author(s):  
Fatmah Hasani ◽  
Terry Haines ◽  
Shannon E. Munteanu ◽  
Peter Schoch ◽  
Bill Vicenzino ◽  
...  
Keyword(s):  
Adverse Events ◽  
Randomised Trial ◽  
Exercise Adherence ◽  
Achilles Tendinopathy ◽  
Trial Registration ◽  
Feasibility Trial ◽  
Productivity Cost ◽  
Repetition Maximum ◽  
Recruitment And Retention ◽  
Load Intensity

Abstract Background One potential reason for disparate outcomes of exercise for Achilles tendinopathy is poor knowledge about whether exercise parameters (i.e. different exercise doses) influence outcome. Whether parameters that are important for tendon adaptation influence clinical outcomes in Achilles tendinopathy has not been investigated. Therefore, this research aimed to assess the feasibility of conducting a fully powered randomised trial to investigate the efficacy of different load-intensity and time-under-tension exercise parameters for Achilles tendinopathy. Methods A factorial four-arm, randomised trial. Forty-eight male participants (18–70 years old) with mid-portion Achilles tendinopathy (≥ 3 months) were recruited. Participants were randomly allocated to high (6 repetition maximum) or low intensity (18 repetition maximum) exercise, performed with either high (6 s per cycle) or low (2 s per cycle) time-under-tension. Participants performed 12-weeks of standing and seated calf raise exercises three times per week in a gym setting using a Smith machine. One session per week was supervised (via videoconference). Primary feasibility outcomes (recruitment and retention rate, exercise adherence and fidelity [i.e. time-under-tension, volume, load intensity], incidence of adverse events, health care use and productivity cost) were collected weekly. Means and standard deviations were determined for parametric data, medians and interquartile range for non-parametric continuous data, and frequency counts for discrete data. Results Total recruitment (76%) and retention (90%) rates were high. Exercise adherence ranged from 45 to 63% and fidelity ranged from 8 to 83% across the groups. Thirty-one participants reported 64 adverse events over the 3 months. Twenty-one participants (70%) reported mild events. Participants reported reduced presenteeism more than absenteeism. Conclusions A fully powered trial is feasible. The proposed trial design and interventions demonstrated acceptable recruitment and retention rates and safety profile. However, exercise fidelity and adherence to the gym-based intervention was not acceptable. Strategies to improve intervention adherence and fidelity should be considered in future trials. Trial registration Australian New Zealand Clinical Trials Registry, ACTRN12618001315202. Registered retrospectively on August 6th, 2018.

Objective structured assessment of technical skill in temporal bone dissection: validation of a novel tool

2021 ◽  
pp. 1-11
Author(s):  
M Stavrakas ◽  
G Menexes ◽  
S Triaridis ◽  
P Bamidis ◽  
J Constantinidis ◽  
...  
Keyword(s):  
Temporal Bone ◽  
Rating Scale ◽  
Assessment Tool ◽  
Three Dimensional ◽  
Technical Skills ◽  
Technical Skill ◽  
Global Rating Scale ◽  
Global Rating ◽  
Validity And Reliability ◽  
Cortical Mastoidectomy

Abstract Objective This study developed an assessment tool that was based on the objective structured assessment for technical skills principles, to be used for evaluation of surgical skills in cortical mastoidectomy. The objective structured assessment of technical skill is a well-established tool for evaluation of surgical ability. This study also aimed to identify the best material and printing method to make a three-dimensional printed temporal bone model. Methods Twenty-four otolaryngologists in training were asked to perform a cortical mastoidectomy on a three-dimensional printed temporal bone (selective laser sintering resin). They were scored according to the objective structured assessment of technical skill in temporal bone dissection tool developed in this study and an already validated global rating scale. Results Two external assessors scored the candidates, and it was concluded that the objective structured assessment of technical skill in temporal bone dissection tool demonstrated some main aspects of validity and reliability that can be used in training and performance evaluation of technical skills in mastoid surgery. Conclusion Apart from validating the new tool for temporal bone dissection training, the study showed that evolving three-dimensional printing technologies is of high value in simulation training with several advantages over traditional teaching methods.

scholarly journals ‘Tracking Together’—Simultaneous Use of Human and Dog Activity Trackers: Protocol for a Factorial, Randomized Controlled Pilot Trial

2021 ◽  
Vol 18 (4) ◽  
pp. 1561
Author(s):  
Wasantha Jayawardene ◽  
Lesa Huber ◽  
Jimmy McDonnell ◽  
Laurel Curran ◽  
Sarah Larson ◽  
...  
Keyword(s):  
Physical Activity ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Activity Level ◽  
Analysis Of Covariance ◽  
Moderate Intensity ◽  
Randomized Controlled ◽  
Activity Trackers ◽  
Dog Owners ◽  
Simultaneous Use

Dog-walkers are more likely to achieve moderate-intensity physical activity. Linking the use of activity trackers with dog-walking may be beneficial both in terms of improving the targeted behavior and increasing the likelihood of sustained use. This manuscript aims to describe the protocol of a pilot study which intends to examine the effects of simultaneous use of activity trackers by humans and their dogs on the physical activity level of humans and dogs. This study uses nonprobability sampling of dog owners of age 25–65 (N = 80) and involves four parallel groups in an observational randomized controlled trial with a 2 × 2 factorial design, based on use of dog or human activity trackers for eight weeks. Each group consists of dog-human duos, in which both, either or none are wearing an activity tracker for eight weeks. At baseline and end, all human subjects wear ActiGraph accelerometers that quantify physical activity for one week. Commercial activity trackers are used for tracking human and dog activity remotely. Additional measures for humans are body composition and self-reported physical activity. Dog owners also report dog’s weight and physical activity using a questionnaire. A factorial analysis of covariance (ANCOVA) is used to compare physical activity across the four groups from baseline to week-10.

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