Pain education for patients with non-specific low back pain in Nepal: protocol of a feasibility randomised clinical trial (PEN-LBP Trial).
ABSTRACT: INTRODUCTION:Low back pain (LBP) is the leading cause of years lived with disability in Nepal and elsewhere. Management of LBP that is evidence-based, easily accessible, cost-effective and culturally appropriate is desirable. The primary aim of this feasibility study is to determine if it is feasible to conduct a full randomised clinical trial evaluating the effectiveness of pain education as an intervention for individuals with LBP in Nepal, relative to guideline-based physiotherapy treatment. The findings of the study will inform the planning of a full clinical trial and if any modifications are required to the protocol before undertaking a full trial. METHODS/ANALYSIS:This protocol describes an assessor-blinded feasibility clinical trial investigating feasibility of the pain education intervention in patients with non-specific LBP in a physiotherapy hospital in Kathmandu, Nepal. Forty patients with LBP will be randomly allocated to either pain education or guideline-based physiotherapy treatment (control). Outcomes will be assessed at baseline and at a 1?week post-treatment. The primary outcomes are related to feasibility, including: (1) participant willingness to participate in a randomised clinical trial, (2) feasibility of assessor blinding, (3) eligibility and recruitment rates, (4) acceptability of screening procedures and random allocation, (5) possible contamination between the groups, (6) intervention credibility, (7) intervention adherence, (8) treatment satisfaction and (9) difficulty in understanding the interventions being provided. ETHICS/DISSEMINATION:The protocol was approved by Nepal Health Research Council (NHRC; registration number: 422/2017) and University of Otago Human Ethics Committee for Health (registration number: H17/157). The results of the study will be presented at national and international conferences and published in a peer-reviewed journal. TRIAL REGISTRATION NUMBER:NCT03387228; Pre-results.
Project description:OBJECTIVES:The aims of this study were to: (1) develop pain education materials in Nepali and (2) determine the feasibility of conducting a randomised clinical trial (RCT) of a pain education intervention using these materials in Nepal. DESIGN:A two-arm, parallel, assessor-blinded, feasibility RCT. SETTING:A rehabilitation hospital in Kathmandu, Nepal. PARTICIPANTS:Forty Nepalese with non-specific low back pain (mean [SD] age 41  years; 12 [30%] women). INTERVENTIONS:Eligible participants were randomised, by concealed, 1:1 allocation, to one of two groups: (1) a pain education intervention and (2) a guideline-based physiotherapy active control group intervention. Each intervention was delivered by a physiotherapist in a single, 1-hour, individualised treatment session. PRIMARY OUTCOME MEASURES:The primary outcomes were related to feasibility: recruitment, retention and treatment adherence of participants, feasibility and blinding of outcome assessments, fidelity of treatment delivery, credibility of, and satisfaction with, treatment. Assessments were performed at baseline and at 1 week post-treatment. SECONDARY OUTCOME MEASURES:Pain intensity, pain interference, pain catastrophising, sleep disturbance, resilience, global rating of change, depression and quality of life. Statistical analyses were conducted blind to group allocation. RESULTS:Forty participants were recruited. Thirty-eight participants (95%) completed the 1-week post-treatment assessment. Most primary outcomes surpassed the a priori thresholds for feasibility. Several findings have important implications for designing a full trial. Secondary analyses suggest clinical benefit of pain education over the control intervention, with larger decrease in pain intensity (mean difference=3.56 [95% CI 0.21 to 6.91]) and pain catastrophising (mean difference=6.16 [95% CI 0.59 to 11.72]) in the pain education group. Pain intensity would seem an appropriate outcome for a full clinical trial. One minor adverse event was reported. CONCLUSION:We conclude that a full RCT of pain education for back pain in Nepal is feasible and warranted. TRIAL REGISTRATION NUMBER:NCT03387228; Results.
Project description:INTRODUCTION:There is strong evidence that biopsychosocial approaches are efficacious in the management of chronic pain. However, implementation of these approaches in clinical practice is known not to account for the beliefs and values of culturally and linguistically diverse (CALD) patients. This limitation in translation of research contributes to the disparities in outcomes for CALD patients with chronic pain adding to the socioeconomic burden of this prevalent condition. Cultural adaptation of chronic pain assessment and management is urgently required. Thus, the aim of this pilot randomised controlled trial (RCT) is to determine the feasibility, participant acceptance with and clinical effectiveness of a culturally adapted physiotherapy assessment and treatment approach when contrasted with 'usual evidence based physiotherapy care' for three CALD communities. METHODS AND ANALYSIS:Using a participant-blinded and assessor-blinded randomised controlled pilot design, patients with chronic pain who self-identify as Assyrian, Mandaean or Vietnamese will be randomised to either 'culturally adapted physiotherapy assessment and treatment' or 'evidence informed usual physiotherapy care'. We will recruit 16 participants from each ethnocultural community that will give a total of 24 participants in each treatment arm. Both groups will receive physiotherapy treatment for up to 10 sessions over 3 months. Outcomes including feasibility data, acceptance with the culturally adapted intervention, functional and pain-related measures will be collected at baseline and 3 months by a blinded assessor. Analysis will be descriptive for feasibility outcomes, while measures for clinical effectiveness will be explored using independent samples t-tests and repeated measures analysis of variance. This analysis will inform sample size estimates while also allowing for identification of revisions in the protocol or intervention prior to a larger scale RCT. ETHICS AND DISSEMINATION:This trial has full ethical approval (HREC/16/LPOOL/194). The results from this pilot RCT will be presented at scientific meetings and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER:ACTRN12616000857404.
Project description:BACKGROUND:The self-management of osteoarthritis (OA) and low back pain (LBP) through activity and skills (SOLAS) theory-driven group-based complex intervention was developed primarily for the evaluation of its acceptability to patients and physiotherapists and the feasibility of trial procedures, to inform the potential for a definitive trial. METHODS:This assessor-blinded multicentre two-arm parallel cluster randomised controlled feasibility trial compared the SOLAS intervention to usual individual physiotherapy (UP; pragmatic control group). Patients with OA of the hip, knee, lumbar spine and/or chronic LBP were recruited in primary care physiotherapy clinics (i.e. clusters) in Dublin, Ireland, between September 2014 and November 2015. The primary feasibility objectives were evaluated using quantitative methods and individual telephone interviews with purposive samples of participants and physiotherapists. A range of secondary outcomes were collected at baseline, 6?weeks (behaviour change only), 2?months and 6?months to explore the preliminary effects of the intervention. Analysis was by intention-to-treat according to participants' cluster allocation and involved descriptive analysis of the quantitative data and inductive thematic analysis of the qualitative interviews. A linear mixed model was used to contrast change over time in participant secondary outcomes between treatment arms, while adjusting for study waves and clusters. RESULTS:Fourteen clusters were recruited (7 per trial arm), each cluster participated in two waves of recruitment, with the average cluster size below the target of six participants (intervention: mean (SD)?=?4.92 (1.31), range 2-7; UP: mean (SD)?=?5.08 (2.43), range 1-9). One hundred twenty participants (83.3% of n?=?144 expected) were recruited (intervention n?=?59; UP n?=?61), with follow-up data obtained from 80.8% (n?=?97) at 6?weeks, 84.2% (n?=?101) at 2?months and 71.7% (n?=?86) at 6?months. Most participants received treatment as allocated (intervention n?=?49; UP n?=?54). The qualitative interviews (12 participants; 10 physiotherapists (PTs) found the intervention and trial procedures acceptable and appropriate, with minimal feasible adaptations required. Linear mixed methods showed improvements in most secondary outcomes at 2 and 6?months with small between-group effects. CONCLUSIONS:While the SOLAS intervention and trial procedures were acceptable to participants and PTs, the recruitment of enough participants is the biggest obstacle to a definitive trial. TRIAL REGISTRATION:ISRCTN ISRCTN49875385 . Registered on 26 March 2014.
Project description:INTRODUCTION:Chronic low back pain (LBP) is a common and costly health problem yet current treatments demonstrate at best, small effects. The concurrent application of treatments with synergistic clinical and mechanistic effects may improve outcomes in chronic LBP. This pilot trial aims to (1) determine the feasibility, safety and perceived patient response to a combined transcranial direct current stimulation (tDCS) and sensorimotor retraining intervention in chronic LBP and (2) provide data to support a sample size calculation for a fully powered trial should trends of effectiveness be present. METHODS AND ANALYSIS:A pilot randomised, assessor and participant-blind, sham-controlled trial will be conducted. Eighty participants with chronic LBP will be randomly allocated to receive either (1) active tDCS + sensorimotor retraining or (2) sham tDCS + sensorimotor retraining. tDCS (active or sham) will be applied to the primary motor cortex for 20?min immediately prior to 60?min of supervised sensorimotor retraining twice per week for 10 weeks. Participants in both groups will complete home exercises three times per week. Feasibility, safety, pain, disability and pain system function will be assessed immediately before and after the 10-week intervention. Analysis of feasibility and safety will be performed using descriptive statistics. Statistical analyses will be conducted based on intention-to-treat and per protocol and will be used to determine trends for effectiveness. ETHICS AND DISSEMINATION:Ethical approval has been gained from the institutional human research ethics committee (H10184). Written informed consent will be provided by all participants. Results from this pilot study will be submitted for publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER:ACTRN12616000624482.
Project description:BACKGROUND:Patient education, advice on returning to normal activities and (home-based) exercise therapy are established treatment options for patients with non-specific low back pain (LBP). However, the effectiveness of physiotherapy interventions on physical functioning and prevention of recurrent events largely depends on patient self-management, adherence to prescribed (home-based) exercises and recommended physical activity behaviour. Therefore we have developed e-Exercise LBP, a blended intervention in which a smartphone application is integrated within face-to-face care. E-Exercise LBP aims to improve patient self-management skills and adherence to exercise and physical activity recommendations and consequently improve the effectiveness of physiotherapy on patients' physical functioning. The aim of this study is to investigate the short- (3?months) and long-term (12 and 24?months) effectiveness on physical functioning and cost-effectiveness of e-Exercise LBP in comparison to usual primary care physiotherapy in patients with LBP. METHODS:This paper presents the protocol of a prospective, multicentre cluster randomized controlled trial. In total 208 patients with LBP pain were treated with either e-Exercise LBP or usual care physiotherapy. E-Exercise LBP is stratified based on the risk for developing persistent LBP. Physiotherapists are able to monitor and evaluate treatment progress between face-to-face sessions using patient input from the smartphone application in order to optimize physiotherapy care. The smartphone application contains video-supported self-management information, video-supported exercises and a goal-oriented physical activity module. The primary outcome is physical functioning at 12-months follow-up. Secondary outcomes include pain intensity, physical activity, adherence to prescribed (home-based) exercises and recommended physical activity behaviour, self-efficacy, patient activation and health-related quality of life. All measurements will be performed at baseline, 3, 12 and 24?months after inclusion. An economic evaluation will be performed from the societal and the healthcare perspective and will assess cost-effectiveness of e-Exercise LBP compared to usual physiotherapy at 12 and 24?months. DISCUSSION:A multi-phase development and implementation process using the Center for eHealth Research Roadmap for the participatory development of eHealth was used for development and evaluation. The findings will provide evidence on the effectiveness of blended care for patients with LBP and help to enhance future implementation of blended physiotherapy. TRIAL REGISTRATION:ISRCTN, ISRCTN94074203. Registered 20 July 2018 - Retrospectively registered.
Project description:Non-specific low back pain (LBP) is one of the leading causes of global disability. Multidisciplinary pain treatment (MPT) programs comprising educational, physical, and psychological interventions have shown positive treatment effects on LBP. Nonetheless, such programs are costly and treatment opportunities are often limited to specialized medical centers. mHealth and other digital interventions may be a promising method to successfully support patient self-management in LBP. To address these issues, we investigated the clinical effects of a multidisciplinary mHealth back pain App (Kaia App) in a randomized controlled trial (registered at German Clinical Trials Register under DRKS00016329). One-hundred one adult patients with non-specific LBP from 6 weeks to 1 year were randomly assigned to an intervention group or a control group. In the intervention group, the Kaia App was provided for 3 months. Control treatment consisted of six individual physiotherapy sessions over 6 weeks and high-quality online education. The primary outcome, pain intensity, was assessed at 12-week follow-up on an 11-point numeric rating scale (NRS). Our per-protocol analysis showed no significant differences between the groups at baseline (Kaia App group: <i>M</i>?=?5.10 (SD?=?1.07) vs. control group: <i>M</i>?=?5.41 (SD?=?1.15). At 12-week follow-up the Kaia App group reported significantly lower pain intensity (<i>M</i>?=?2.70 (SD?=?1.51)) compared to the control group (<i>M</i>?=?3.40 (SD?=?1.63)). Our results indicate that the Kaia App as a multidisciplinary back pain app is an effective treatment in LBP patients and is superior to physiotherapy in combination with online education.
Project description:OBJECTIVE:To evaluate patient engagement with, and the feasibility of, a novel, culturally adapted physiotherapy pain management approach. DESIGN:A participant-blinded and assessor-blinded pilot randomised controlled trial. SETTING:Outpatient physiotherapy departments at two public hospitals and one district pain clinic. PARTICIPANTS:Adults (n=48) with chronic musculoskeletal pain (daily pain >3?months), who self-identified as Mandaean, Assyrian or Vietnamese, were randomised to one of two physiotherapy treatment conditions. INTERVENTIONS:24 participants underwent combined group and individualised treatment described as 'culturally adapted physiotherapy', while 24 underwent evidence-informed 'usual physiotherapy care'. Both treatment arms consisted of up to 10 sessions over a 3-month period. OUTCOME MEASURES:Patient engagement was measured via participant attendance, adherence and satisfaction data. Secondary outcomes included clinical measures of pain severity, interference and suffering, physical function and negative emotional state. RESULTS:96% of participants undergoing culturally adapted physiotherapy completed treatment, compared with 58% of the usual physiotherapy group. For the culturally adapted group attendance (87%±18%) and adherence (68%±32%) were higher relative to usual care (68%±32%?and 55%±43%). Satisfaction was similar for the culturally adapted (82.7%±13.4%) and usual care (79.3±17.3) groups. For secondary outcomes, a significant between-group effect for pain-related suffering in favour of the culturally adapted group was observed with a medium effect size (partial ?2 0.086, mean 3.56, 95%?CI 0.11 to 7), while results for pain severity, interference, physical function and negative emotional state were similar. CONCLUSIONS:Aligning treatment with the beliefs and values of culturally and linguistically diverse communities enhances patient engagement with physiotherapy. These results support the feasibility of a larger, multisite trial to determine if improved engagement with culturally adapted physiotherapy translates to improved clinical outcomes. TRIAL REGISTRATION NUMBER:ACTRN12616000857404; Pre-results.
Project description:Whiplash-associated disorder (WAD) causes substantial social and economic burden, with ?70% patients classified as WADII (neck complaint and musculoskeletal sign(s)). Effective management in the acute stage is required to prevent development of chronicity; an issue for 60% of patients. An Active Behavioural Physiotherapy Intervention (ABPI) was developed to address both physical and psychological components of WAD. The ABPI is a novel complex intervention designed through a rigorous sequential multiphase project to prevent transition of acute WAD to chronicity. An external pilot and feasibility cluster randomised double-blind (assessor, participants) parallel two-arm clinical trial was conducted in the UK private sector. The trial compared ABPI versus standard physiotherapy to evaluate trial procedures and feasibility of the ABPI for managing acute WADII in preparation for a future definitive trial. Six private physiotherapy clinics were recruited and cluster randomised using a computer-generated randomisation sequence. Twenty-eight (20 ABPI, 8 standard physiotherapy) participants [median age 38.00 (IQR = 21.50) years] were recruited. Data were analysed descriptively with a priori establishment of success criteria. Ninety-five percent of participants in the ABPI arm fully recovered (Neck Disability Index ?4, compared to 17% in the standard physiotherapy arm); required fewer treatment sessions; and demonstrated greater improvement in all outcome measures (pain intensity, Cervical Range of Motion, Pressure Pain Threshold, EuroQol-5 Dimensions) except for the Impact of Events Scale and Fear Avoidance Beliefs Questionnaire. The findings support the potential value of the ABPI, and that an adequately powered definitive trial to evaluate effectiveness (clinical, cost) is feasible with minor modifications to procedures.
Project description:BACKGROUND:Low back pain (LBP) is the most prevalent musculoskeletal condition. Guidelines advocate a multimodal approach, including prescription of medications. Advanced Physiotherapy Practitioners (APPs) are well placed to manage LBP. To date no trial has evaluated the efficacy of physiotherapist-prescribing for LBP. OBJECTIVES:To evaluate the feasibility, suitability and acceptability of assessing the effectiveness of physiotherapist-prescribing for LBP in primary care; informing the design of a future definitive stepped-wedged cluster trial (SWcRCT). METHODS:Mixed-methods, single-arm feasibility design with two components. 1) Trial component: participants with medium-risk LBP +/-leg pain were recruited across 3 sites. Outcome measures (primary outcome measures-Pain/RMDQ) were completed at baseline, 6 and 12 weeks Physical activity/sedentary behaviour were assessed over 7 days using accelerometery. A CONSORT diagram analysed recruitment/follow-up rates. Descriptive analysis evaluated procedure/floor-effects. 2) Embedded qualitative component: focus groups (n = 6) and semi-structured interviews (n = 3) evaluated the views/experiences of patients and APPs about feasibility/suitability/acceptability of the proposed trial. Thematic analysis synthesised the qualitative data. Findings were evaluated against a priori success criteria. RESULTS:n = 29 participants were recruited. 90% of success criteria were met. Loss to follow-up at 12 weeks (65.5%) did not satisfy success criteria. Primary and secondary outcome measures were suitable and acceptable with no floor effects. The addition of a sleep assessment tool was advised. Accelerometer use was acceptable with 100% adherence. APPs felt all patients presenting with non-specific LBP +/- leg pain and capture data representative of the full scope of physiotherapist independent prescribing should be included. Data collection methods were acceptable to APPs and patients. APPs advocated necessity for using research assistants owing to time limitations. CONCLUSIONS:Methods evaluated are feasible, suitable and acceptable for a definitive SWcRCT, with modification of eligibility criteria, and use of research assistants to overcome limited clinician capacity. A definitive SWcRCT is feasible with minor modifications. REGISTRATION:ISRCTN15516596.
Project description:<h4>Introduction</h4>Non-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.<h4>Methods and analysis</h4>Two 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.<h4>Ethics and dissemination</h4>This trial is approved by the Naresuan University Institutional Review Board (NUIRB_0380/61).<h4>Trial registration number and status</h4>TCTR20180607001; Recruiting commenced 1 February 2019.