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Does early intervention improve outcomes in physiotherapy management of lumbar radicular syndrome? A mixed-methods study protocol.

ABSTRACT: INTRODUCTION:Lumbar radicular syndrome (LRS) can be a painful and debilitating condition. The optimum management strategies and their timing remain elusive despite extensive research. Surgery provides good short-term outcomes but has concomitant risks and costs. Physiotherapy is commonly practised for patients with LRS but its effects remain equivocal and there is a lack of consensus on the type, duration and timing of physiotherapy intervention. There is a lack of high-quality evidence into new and innovative management strategies and the timings of those strategies for LRS. This pilot trial is an essential preliminary to a definitive randomised controlled trial (RCT) assessing the effectiveness and cost-effectiveness of early physiotherapy intervention for patients with LRS. The study will test the protocol, the intervention, the use of outcome measures and the ability to set-up and run the trial to enable refinement of a future definitive RCT. METHODS AND ANALYSIS:This is a mixed-methods study encompassing an external pilot RCT with integrated qualitative interviews with patients, clinicians and other key stakeholders. 80 patients will be recruited from primary care and randomised, after consent into 1 of 2 groups. Both groups will receive individually tailored, goal orientated physiotherapy. The usual care group will begin their physiotherapy 6?weeks after randomisation and the intervention group at 2?weeks after randomisation. Outcome measures will primarily be feasibility parameters including the ability to recruit and retain patients and to deliver the intervention. Data will be collected at baseline, and 6, 12 and 26?weeks following randomisation. ETHICS AND DISSEMINATION:The study has received favourable ethical review from the East of Scotland Research Ethics Service (EoSRES) on the 20 August 2015 (15/ES/0130). Recruitment began on the 1 March 2016 and is expected to close in January 2017. Data collection is anticipated to be complete in July 2017. The study results will be made available to participants, clinicians involved in the study and the wider clinical community through publication in a peer reviewed journal and at conference presentations. TRIAL REGISTRATION NUMBER:ISRCTN: 25018352, Pre-results; Clinical Trials.Gov: NCT02618278 Document version V1.1 23.9.2016.

SUBMITTER: Reddington M

PROVIDER: S-EPMC5353256 | biostudies-literature | 2017 Mar

REPOSITORIES: biostudies-literature

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Does early intervention improve outcomes in physiotherapy management of lumbar radicular syndrome? A mixed-methods study protocol.

Reddington Michael M Walters Stephen J SJ Cohen Judith J Baxter Susan S

BMJ open 20170303 3

<h4>Introduction</h4>Lumbar radicular syndrome (LRS) can be a painful and debilitating condition. The optimum management strategies and their timing remain elusive despite extensive research. Surgery provides good short-term outcomes but has concomitant risks and costs. Physiotherapy is commonly practised for patients with LRS but its effects remain equivocal and there is a lack of consensus on the type, duration and timing of physiotherapy intervention. There is a lack of high-quality evidence ...[more]

PMID: 28259854

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Project description:OBJECTIVE:To investigate the feasibility of undertaking a definitive randomised controlled trial (RCT). SETTING:This was a pilot, pragmatic superiority RCT with a qualitative element, recruiting from 14 general practitioner (GP) practices in England. PARTICIPANTS:Patients over 18 years of age presenting to their GP with unilateral lumbar radicular syndrome (LRS), defined as radicular pain and/or neurological symptoms originating from lumbar nerve roots, were eligible to participate in the study, those who did not have a clear understanding of the English language or had comorbidities preventing rehabilitation were ineligible. INTERVENTIONS:Participants were randomised into early intervention physiotherapy or usual care with the former receiving their treatment within 2 weeks after randomisation and the latter 6 weeks postrandomisation. Both groups received a patient-centred, goal-orientated physiotherapy programme specific to their needs. Participants received up to six treatment sessions over an 8-week period. OUTCOME MEASURES:Process outcomes to determine the feasibility of the study and an exploratory analysis of patient-reported outcomes, including self-rated disability, pain and general health, these were collected at baseline, 6, 12 and 26 weeks postrandomisation. RESULTS:80 participants were recruited in 10 GP practices over 34 weeks and randomised to (early intervention physiotherapy n=42, usual care n=38). Follow-up rates at 26 weeks were 32 (84%) in the usual care and 36 (86%) in the early intervention physiotherapy group. The mean area under the curve (larger values indicating more disability) for the Oswestry Disability Index over the 26 weeks was 16.6 (SD 11.4) in the usual care group and 16.0 (SD 14.0) in the intervention group. A difference of -0.6 (95% CI -0.68 to 5.6) in favour of the intervention group. CONCLUSIONS:The results of the study suggest a full RCT is feasible and will provide evidence as to the optimal timing of physiotherapy for patients with LRS. TRIAL REGISTRATION NUMBER:NCT02618278, ISRCTN25018352.

Project description:To develop an optimised 1:1 physiotherapy intervention that reflects best practice, with flexibility to tailor management to individual patients, thereby ensuring patient-centred practice.Mixed-methods combining evidence synthesis, expert review and focus groups.Secondary care involving 5 UK specialist spinal centres.A purposive panel of clinical experts from the 5 spinal centres, comprising spinal surgeons, inpatient and outpatient physiotherapists, provided expert review of the draft intervention. Purposive samples of patients (n=10) and physiotherapists (n=10) (inpatient/outpatient physiotherapists managing patients with lumbar discectomy) were invited to participate in the focus groups at 1 spinal centre.A draft intervention developed from 2 systematic reviews; a survey of current practice and research related to stratified care was circulated to the panel of clinical experts. Lead physiotherapists collaborated with physiotherapy and surgeon colleagues to provide feedback that informed the intervention presented at 2 focus groups investigating acceptability to patients and physiotherapists. The focus groups were facilitated by an experienced facilitator, recorded in written and tape-recorded forms by an observer. Tape recordings were transcribed verbatim. Data analysis, conducted by 2 independent researchers, employed an iterative and constant comparative process of (1) initial descriptive coding to identify categories and subsequent themes, and (2) deeper, interpretive coding and thematic analysis enabling concepts to emerge and overarching pattern codes to be identified.The intervention reflected best available evidence and provided flexibility to ensure patient-centred care. The intervention comprised up to 8 sessions of 1:1 physiotherapy over 8 weeks, starting 4 weeks postsurgery. The intervention was acceptable to patients and physiotherapists.A rigorous process informed an optimised 1:1 physiotherapy intervention post-lumbar discectomy that reflects best practice. The developed intervention was agreed on by the 5 spinal centres for implementation in a randomised controlled trial to evaluate its effectiveness.

Project description:IntroductionObesity and physical inactivity are major societal challenges and significant contributors to the global burden of disease and healthcare costs. Information and communication technologies are increasingly being used in interventions to promote behaviour change in diet and physical activity. In particular, social networking platforms seem promising for the delivery of weight control interventions.We intend to pilot test an intervention involving the use of a social networking mobile application and tracking devices (Fitbit Flex 2 and Fitbit Aria scale) to promote the social comparison of weight and physical activity, in order to evaluate whether mechanisms of social influence lead to changes in those outcomes over the course of the study.Methods and analysisMixed-methods study involving semi-structured interviews and a pre-post quasi-experimental pilot with one arm, where healthy participants in different body mass index (BMI) categories, aged between 19 and 35 years old, will be subjected to a social networking intervention over a 6-month period. The primary outcome is the average difference in weight before and after the intervention. Secondary outcomes include BMI, number of steps per day, engagement with the intervention, social support and system usability. Semi-structured interviews will assess participants' expectations and perceptions regarding the intervention.Ethics and disseminationEthics approval was granted by Macquarie University's Human Research Ethics Committee for Medical Sciences on 3 November 2016 (ethics reference number 5201600716).The social network will be moderated by a researcher with clinical expertise, who will monitor and respond to concerns raised by participants. Monitoring will involve daily observation of measures collected by the fitness tracker and the wireless scale, as well as continuous supervision of forum interactions and posts. Additionally, a protocol is in place to monitor for participant misbehaviour and direct participants-in-need to appropriate sources of help.

Project description:Aims and objectivesTo investigate uptake of a Chest Injury Protocol (ChIP), examine factors influencing its implementation and identify interventions for promoting its use.BackgroundFailure to treat blunt chest injuries in a timely manner with sufficient analgesia, physiotherapy and respiratory support, can lead to complications such as pneumonia and respiratory failure and/or death.DesignThis is a mixed-methods implementation evaluation study.MethodsTwo methods were used: (i) identification and review of the characteristics of all patients eligible for the ChIP protocol, and (ii) survey of hospital staff opinions mapped to the Theoretical Domains Framework (TDF) to identify barriers and facilitators to implementation. The characteristics and treatment received between the groups were compared using the chi-square test or Fischer's exact test for proportions, and the Mann-Whitney U-test for continuous data. Quantitative survey data were analysed using descriptive statistics. Qualitative data were coded in NVivo 10 using a coding guide based on the TDF and Behaviour Change Wheel (BCW). Identification of interventions to change target behaviours was sourced from the Behaviour Change Technique Taxonomy Version 1 in consultation with stakeholders.ResultsOnly 68.4% of eligible patients received ChIP. Fifteen facilitators and 10 barriers were identified to influence the implementation of ChIP in the clinical setting. These themes were mapped to 10 of the 14 TDF domains and corresponded with all nine intervention functions in the BCW. Seven of these intervention functions were selected to address the target behaviours and a multi-faceted relaunch of the revised protocol developed. Following re-launch, uptake increased to 91%.ConclusionsThis study demonstrated how the BCW may be used to revise and improve a clinical protocol in the ED context.Relevance to clinical practiceNewly implemented clinical protocols should incorporate clinician behaviour change assessment, strategy and interventions. Enhancing the self-efficacy of emergency nurses when performing assessments has the potential to improve patient outcomes and should be included in implementation strategy.

Project description:Background:One in four Canadian families struggle with infant sleep disturbances. The aim of this study is to evaluate Play2Sleep in families of infants with sleep disturbances. In addition to parental education on infant sleep, Play2Sleep uses examples from a video-recorded, structured play session with mothers and fathers separately to provide feedback on parent-infant interactions and their infant's sleep-related social cues. The quantitative phase will answer the research question: Does one dose of Play2Sleep delivered during a home visit with mothers and fathers of infants aged 5?months reduce night wakings at age 7?months? The qualitative phase will answer the research question: What are parental perceptions of family experiences, processes, and contexts related to Play2Sleep and infant sleep? The overarching mixed methods research question is as follows: How do parental perceptions of family experiences, processes, and contexts related to infant sleep explain the effectiveness of Play2Sleep? Method and analysis:An explanatory sequential mixed methods design will be used. In the quantitative phase, a randomized controlled trial and RM-ANOVA will compare night wakings in infants whose parents receive Play2Sleep versus standard public health nursing information. Sixty English-speaking families (mothers and fathers) of full-term, healthy, singleton, 5-month-old infants who perceive that their infant has sleep disturbances will be recruited. The primary outcome measure will be change in the number of night wakings reported by parents. The qualitative component will use thematic analysis of family interviews to describe parental perceptions and experiences of infant sleep. Mixed methods integration will use qualitative findings to explain quantitative results. Discussion:Play2Sleep is a novel approach that combines information about infant sleep with personalized feedback on parent-infant interactions and infant cues. Including fathers and mixed methods should capture complex family experiences of infant sleep disturbances and Play2Sleep. If effective, Play2Sleep has possible application for preventing infant sleep disturbance and tailoring for other populations. Clinical Trial Registration:www.ClinicalTrials.gov, identifier: NCT02742155. Registered on 2016 April 23.

Project description:IntroductionMental health services are stretched in the UK and are in need of support. One approach that could improve mental health symptoms is osteopathy. Research suggests that osteopathy influences psychophysiological factors, which could lead to improvements in mental health. The first objective of this protocol is to investigate the feasibility and acceptability of four osteopathic interventions. A secondary aim is to evaluate the interventions' effectiveness for improving psychophysiological and mental health outcomes.Methods and analysisThis study will be an explanatory mixed-methods design. Participants will be 30 adults who have mild to moderate mental health symptoms and not experiencing any issues with pain. The feasibility and acceptability of the interventions will be the primary outcomes. Secondary outcomes will be physiological measures including heart rate variability, interoceptive accuracy and blood pressure. Psychological outcomes, collected preintervention and postintervention, will also be measured by five standardised questionnaires, which include: (1) the Depression, Anxiety and Stress Scale (DASS); (2) the International Positive and Negative Affect Schedule-Short-Form; (3) Acceptance and Action Questionnaire-II; (4) the Self as Context Scale and (5) and the Multidimensional Assessment of Interoceptive Awareness Version 2. Participants will be randomised to one of four intervention groups and receive a single intervention treatment session. These intervention groups are: (1) high-velocity and articulation techniques, (2) soft-tissue massage, (3) craniosacral techniques, and (4) a combination of these three approaches. Mixed design two (preintervention and postintervention) by the four interventions analysis of covariance models will be used to analyse the quantitative data for each quantitative measure. Participants will also be interviewed about their experiences of the study and interventions and a thematic analysis will be used to analyse this qualitative data. This will aid the assessment of the feasibility and acceptability of the study design.Ethics and disseminationThe protocol for this feasibility study has received ethical approval from the Department of Psychology Ethics Committee at Swansea University, ethical review reference number: 2022-5603-4810. Feasibility results from this protocol will be published in a peer review journal and presented at both national and international conferences.DiscussionThis study will assess the feasibility and acceptability of conducting osteopathic interventions for improving mental health outcomes. The results from this will help to inform the development of a future randomised controlled trial. The study will also produce original data which could provide preliminary evidence of whether osteopathic approaches are of benefit to individual's mental health in the form of effect sizes, even if they are pain-free.Trial registration numberNCT05674071.

Project description:BACKGROUND:Optimal self-management in kidney transplant recipients is essential for patient and graft survival, reducing comorbidity and health care costs while improving the quality of life. However, there are few effective interventions aimed at providing self-management support after kidney transplantation. OBJECTIVE:This study aims to systematically develop a nurse-led, self-management (support) intervention for kidney transplant recipients. METHODS:The Intervention Mapping protocol was used to develop an intervention that incorporates kidney transplant recipients' and nurses' needs, and theories as well as evidence-based methods. The needs of recipients and nurses were assessed by reviewing the literature, conducting focus groups, individual interviews, and observations (step 1). Based on the needs assessment, Self-Regulation Theory, and the "5A's" model, change objectives were formulated (step 2). Evidence-based methods to achieve these objectives were selected and subsequently translated into practical implementation strategies (step 3). Then, program materials and protocols were developed accordingly (step 4). The implementation to test the feasibility and acceptability was scheduled for 2015-2017 (step 5). The last step of Intervention Mapping, evaluation of the intervention, falls outside the scope of this paper (step 6). RESULTS:The intervention was developed to optimize self-management (support) after kidney transplantation and targeted both kidney transplant recipients and nurse practitioners who delivered the intervention. The intervention was clustered into four 15-minute sessions that were combined with regular appointments at the outpatient clinic. Nurses received a training syllabus and were trained in communication techniques based on the principles of Solution-Focused Brief Therapy and Motivational Interviewing; this entailed guiding the patients to generate their own goals and solutions and focus on strengths and successes. Kidney transplant recipients were encouraged to assess self-management challenges using the Self-Management Web and subsequently develop specific goals, action plans, and pursuit skills to solve these challenges. CONCLUSIONS:The Intervention Mapping protocol provided a rigorous framework to systematically develop a self-management intervention in which nurses and kidney transplant recipients' needs, evidence-based methods, and theories were integrated. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/11856.

Project description:IntroductionNon-specific neck pain causes pain and disability and contributes substantial socioeconomic burden internationally. Up to 50% of adults experience neck pain annually, leading to reduced the quality of life. An active behavioural physiotherapy intervention (ABPI) may be feasible to manage patients with acute non-specific neck pain to prevent transition to chronicity. A recent pilot and feasibility trial investigating an acute whiplash-associated disorder population found potential value of the ABPI with 95% of participants fully recovered (Neck Disability Index: NDI ?4, compared with 17% in the standard physiotherapy arm); supporting a definitive trial. Qualitative findings from the physiotherapists supported the potential of the ABPI in a non-specific neck pain population.Methods and analysisTwo phases: (1) Pragmatic cluster randomised double-blind, parallel 2-arm (ABPI vs standard physiotherapy intervention) pilot and feasibility trial to evaluate the procedures and feasibility of the ABPI for the management of acute non-specific neck pain. Six physiotherapy departments from six public hospitals in Thailand will be recruited and cluster randomised by a computer-generated randomisation sequence with block sampling. Sixty participants (30 each arm, 10 per hospital) will be assessed at baseline and 3 months following baseline for NDI, Numerical Rating Scale for pain intensity, cervical range of motion, fear-avoidance beliefs questionnaire and EuroQol-5 dimensions 5 levels outcomes, and (2) Embedded qualitative study using semistructured interviews to explore acceptability of the ABPI to participants (n=12) and physiotherapists (n=3). Descriptive analysis of the quantitative data and interpretative phenomenological analysis to code and analyse qualitative data (deductive and inductive) will inform feasibility for a future definitive trial.Ethics and disseminationThis trial is approved by the Naresuan University Institutional Review Board (NUIRB_0380/61).Trial registration number and statusTCTR20180607001; Recruiting commenced 1 February 2019.

Project description:BackgroundUniversity students are at risk for acquiring sexually transmitted infections and suffering other negative health outcomes. Sexual health services offer preventive and treatment interventions that aim to reduce these infections and associated health consequences. However, university students often delay or avoid seeking sexual health services. An in-depth understanding of the factors that influence student use of sexual health services is needed to underpin effective sexual health interventions.ObjectiveIn this study, we aim to design a behavior change intervention to address university undergraduate students' use of sexual health services at two universities in Nova Scotia, Canada.MethodsThis mixed methods study consists of three phases that follow a systematic approach to intervention design outlined in the Behaviour Change Wheel. In Phase 1, we examine patterns of sexual health service use among university students in Nova Scotia, Canada, using an existing dataset. In Phase 2, we identify the perceived barriers and enablers to students' use of sexual health services. This will include focus groups with university undergraduate students, health care providers, and university administrators using a semistructured guide, informed by the Capability, Opportunity, Motivation-Behaviour Model and Theoretical Domains Framework. In Phase 3, we identify behavior change techniques and intervention components to develop a theory-based intervention to improve students' use of sexual health services.ResultsThis study will be completed in March 2018. Results from each phase and the finalized intervention design will be reported in 2018.ConclusionsPrevious intervention research to improve university students' use of sexual health services lacks a theoretical assessment of barriers. This study will employ a mixed methods research design to examine university students' use of sexual health service and apply behavior change theory to design a theory- and evidence-based sexual health service intervention. Our approach will provide a comprehensive foundation to co-design a theory-based intervention with service users, health care providers, and administrators to improve sexual health service use among university students and ultimately improve their overall health and well-being.

Dataset Information

Does early intervention improve outcomes in physiotherapy management of lumbar radicular syndrome? A mixed-methods study protocol.

Publications

Does early intervention improve outcomes in physiotherapy management of lumbar radicular syndrome? A mixed-methods study protocol.

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