Study protocol: a mixed methods feasibility study for a loaded self-managed exercise programme for patellofemoral pain

Background: Patellofemoral pain (PFP) is one of the most common forms of knee pain in adults under the age of 40, with a prevalence of 23% in the general population. The long-term prognosis is poor, with only one third of people pain-free 1 year after diagnosis. The biomedical model of pain in relation to persistent PFP has recently been called into question. It has been suggested that interventions for chronic musculoskeletal conditions should consider alternative mechanisms of action, beyond muscles and joints. Modern treatment therapies should consider desensitising strategies, with exercises that target movements and activities patients find fearful and painful. High-quality research on exercise prescription in relation to pain mechanisms, not directed at specific tissue pathology, and dose response clearly warrants further investigation. Our primary aim is to establish the feasibility and acceptability of conducting a definitive RCT which will evaluate the clinical and cost-effectiveness of a loaded self-managed exercise programme for people with patellofemoral pain. Method: This is a single-centred, multiphase, sequential, mixed-methods trial that will evaluate the feasibility of running a definitive large-scale randomised controlled trial of a loaded self-managed exercise programme versus usual physiotherapy. Initially, 8–10 participants with a minimum 3-month history of PFP will be recruited from an NHS physiotherapy waiting list and interviewed. Participants will be invited to discuss perceived barriers and facilitators to exercise engagement, and the meaning and impact of PFP. Then, 60 participants will be recruited in the same manner for the main phase of the feasibility trial. A web-based service will randomise patients to a loaded self-managed exercise programme or usual physiotherapy. The loaded self-managed exercise programme is aimed at addressing lower limb knee and hip weakness and is positioned within a framework of reducing fear/avoidance with an emphasis on self-management. Baseline assessment will include demographic data, average pain within the last week (VAS), fear avoidance behaviours, catastrophising, self-efficacy, sport and leisure activity participation, and general quality of life. Follow-up will be 3 and 6 months. The analysis will focus on descriptive statistics and confidence intervals. The qualitative components will follow a thematic analysis approach. Discussion: This study will evaluate the feasibility of running a definitive large-scale trial on patients with patellofemoral pain, within the NHS in the UK. We will identify strengths and weaknesses of the proposed protocol and the utility and characteristics of the outcome measures. The results from this study will inform the design of a multicentre trial

A loaded self-managed exercise programme for patellofemoral pain: A mixed methods feasibility study

© 2019 The Author(s). Background: A novel loaded self-managed exercise programme that includes pain education and self-management strategies may result in better outcomes for people with patellofemoral pain (PFP). However, establishing program feasibility is an essential first step before testing efficacy. The purpose of this study was to evaluate the feasibility and acceptability of conducting a definitive RCT which will evaluate the clinical and cost-effectiveness of a loaded self-managed exercise programme for people with PFP compared with usual physiotherapy. Methods: In a mixed methods, pragmatic, randomised controlled feasibility study, 60 participants with PFP (57% female; mean age 29 years) were recruited from a physiotherapy clinic within a large UK teaching hospital. They were randomly allocated to receive either a loaded self-managed exercise programme (n = 30) or usual physiotherapy (n = 30). Feasibility indicators of process, resources, and management were collected through follow-up of standardised questionnaires six months after recruitment and semi-structured interviews with 20 participants and physiotherapists. Results: Recruitment rate was 5 participants per month; consent rate was 99%; adherence to intervention appointments was 87%; completeness of questionnaire data was 100%; and adherence to intervention delivery was 95%. Three exercise diaries were returned at six months (5%). At six months, 25 questionnaire booklets were returned (9 in the loaded self-managed group, 16 in the usual physiotherapy group), with a total retention rate of 42%. At six months, 56% (5/9) of respondents in the loaded self-managed group and 56% (9/16) in the usual physiotherapy group were classified as 'recovered'. Both groups demonstrated improvements in average pain (VAS), kinesiophobia, pain catastrophizing, general self-efficacy and EQ-5D-5 L from baseline to six months. Conclusion: The results of this feasibility study confirm that it is feasible and acceptable to deliver a loaded self-managed exercise programme to adults with PFP in an NHS physiotherapy outpatient setting. However, between group differences in lost to follow up and poor exercise diary completion mean we are uncertain on some feasibility aspects. These methodological issues need addressing prior to conducting a definitive RCT. Trial registration: ISRCTN 35272486. Registered 19th December 2016

In vivo determination of the diclofenac skin reservoir: comparison between passive, occlusive, and iontophoretic application

Ron Clijsen,1,2 Jean Pierre Baeyens,2 André Odilon Barel,2 Peter Clarys2 1Department of Health Sciences, University of Applied Sciences and Arts of Southern Switzerland, Landquart, Switzerland; 2Faculty of Physical Education and Physiotherapy, Vrije Universiteit Brussel, Brussels, Belgium Aim: There is scarce information concerning the pharmacodynamic behavior of topical substances used in the physiotherapy setting. The aim of the present study was to estimate the formation and emptying of the diclofenac (DF) skin reservoir after passive, semiocclusive, and electrically assisted applications of DF.Subjects and methods: Five different groups of healthy volunteers (ntotal=60, 23 male and 37 female), participated in this study. A 1% DF (Voltaren Emulgel) formulation (12 mg) was applied on the volar forearms on randomized defined circular skin areas of 7 cm2. DF was applied for 20 minutes under three different conditions at the same time. The presence of DF in the skin results in a reduction of the methyl nicotinate (MN) response. To estimate the bioavailability of DF in the skin, MN responses at different times following initial DF application (1.5, 6, 24, 32, 48, 72, 96, and 120 hours) were analyzed.Results: At 1.5 hours after the initial DF application, a significant decrease in MN response was detected for the occluded and iontophoretic delivery. Passive application resulted in a decrease of the MN response from 6 hours post-DF application. The inhibition remained up to 32 hours post-DF application for the iontophoretic delivery, 48 hours for the occluded application, and 72 hours for the passive delivery. At 96 and 120 hours post-DF application none of the MN responses was inhibited.Conclusion: The formation and emptying of a DF skin reservoir was found to be dependent on the DF-application mode. Penetration-enhanced delivery resulted in a faster emptying of the reservoir. Keywords: transdermal drug delivery, passive diffusion, occlusion, iontophoresis, diclofena

The effect of local cryotherapy on subjective and objective recovery characteristics following an exhaustive jump protocol

Erich Hohenauer,1-3 Peter Clarys,3 Jean-Pierre Baeyens,2-4 Ron Clijsen,1-31Department of Business Economics, Health and Social Care, University of Applied Sciences and Arts of Southern Switzerland, Landquart, Switzerland; 2University College Physiotherapy, Thim van der Laan, Landquart, Switzerland; 3Faculty of Physical Education and Physiotherapy, Vrije Universiteit Brussel, Brussels, Belgium; 4Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, BelgiumAbstract: The purpose of this controlled trial was to investigate the effects of a single local cryotherapy session on the recovery characteristics over a period of 72 hours. Twentytwo young and healthy female (n=17; mean age: 21.9±1.1 years) and male (n=5;mean age:25.4±2.8 years) adults participated in this study. Following an exhaustive jump protocol (3×30 countermovement jumps), half of the participants received either a single local cryotherapy application (+8°C) or a single local thermoneutral application (+32°C) of 20-minute duration using two thigh cuffs. Subjective measures of recovery (delayed-onset muscle soreness and ratings of perceived exertion) and objective measures of recovery (vertical jump performanceand peak power output) were assessed immediately following the postexercise applications (0 hours) and at 24 hours, 48 hours, and 72 hours after the jump protocol. Local cryotherapy failed to significantly affect any subjective recovery variable during the 72-hour recovery period (P>0.05). After 72 hours, the ratings of perceived exertion were significantly lower in the thermoneutral group compared to that in the cryotherapy group (P=0.002). No significant differences were observed between the cryotherapy and the thermoneutral groups with respect to any of the objective recovery variables. In this experimental study, a 20-minute cryotherapy cuff application failed to demonstrate a positive effect on any objective measures of recovery. The effects of local thermoneutral application on subjective recovery characteristics were superior when compared to the effects of local cryotherapy application at 72 hours postapplication. Keywords: cryotherapy, cold cuff, muscle damage, recover

Segmentale Hautdurchblutungsreaktion während und nach Stimulation im Bereich der BWS

Hintergrund: Physiotherapeutische Interventionen werden häufig auf Höhe der thorakalen Wirbelsäule angewendet. Die segmentale Wirkung auf das sympathische Nervensystem nach einer Reizung der Haut und Muskulatur ist bislang unklar. Ziel: Das Ziel war die Evaluation (1) der Machbarkeit und (2) der Effekte der segmentalen Perfusion und Erythembildung nach Massage, Mobilisation, Manipulation und Placebotherapie auf Höhe der thorakalen Wirbelsäule, um daraus Studiendesigns zu kreieren und erste mögliche Hypothesen über Veränderungen der segmentalen Perfusion und Erythembildung aufzustellen. Methode: In dieser Einzelfallstudie erhielt ein beschwerdefreier Proband an 4 Tagen jeweils 4 unterschiedliche physiotherapeutische Behandlungsmaßnahmen. Im Gebiet zwischen Th3 und Th6 wurden Massage, Mobilisation, Manipulation und zusätzlich eine Placebointervention appliziert und vor, während und sowie nach der Intervention die Perfusion sowie die Erythembildung im zugehörigen Dermatom während 55 Minuten im Intervall von 5 Minuten gemessen. Ergebnisse: Manipulation und Mobilisation führten akut zu einer Steigerung der Sympathikotonus, während Massage und Placebointervention aufgrund einer Veränderung der Perfusionsmikrozirkulation eine Senkung hervorriefen. Schlussfolgerung: Das Studiendesign muss für zukünftige Studien hinsichtlich Verblindung der Therapeuten und Messzeitpunkte angepasst werden. Von einer Hypothesenbildung soll abgesehen werden, da das Messinstrument für die Erythembildung keine aussagekräftigen Werte lieferte

Test-retest reliability of muscle fiber conduction velocity and fractal dimension of surface EMG during isometric contractions

Objective. The aim of this study was to determine the test-retest reliability of muscle fiber conduction velocity (CV) and fractal dimension (FD) obtained from multichannel surface electromyographic (sEMG) recordings. Approach. Forty healthy recreationally active subjects (20 men and 20 women) performed two elbow flexions on two trials with a 1 week interval. The first was a 20% maximal voluntary contraction (MVC) of 120 s, and the second at 60% MVC held until exhaustion. sEMG signals were detected from the biceps brachii, using bi-dimensional arrays. Main results. Initial values and slope of CV and FD were used for the reliability analysis. The intraclass correlation coefficient (ICC) values for the isometric contraction at 20% MVC were (-0.09) and 0.67 for CV and FD respectively; whereas the ICC values at 60% MVC were 0.78 and 0.82 for CV and FD respectively. The Bland Altman plots for the two isometric contractions showed a mean difference close to zero, with no evident outliers between the repeated measurements: at 20% MVC 0.001 53 for FD and -0.0277 for CV, and at 60% MVC 0.006 66 for FD and 0.009 07 for CV. Significance. Overall, our findings suggest that during isometric fatiguing contractions, CV and FD slopes are reliable variables, with potential application in clinical populations