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The effectiveness of an electronic pain management programme for the working population with chronic pain: study protocol for a randomized controlled trial.

ABSTRACT: BACKGROUND:Chronic pain is highly prevalent in the working population. People tend to attempt self-initiated treatments to manage their pain. The self-efficacy of behavioural change is a suitable model for guiding the development of an electronic pain management programme (ePain). The aim in this study is to develop ePain and to evaluate its effectiveness at improving pain self-efficacy, reducing pain intensity and negative emotions, and increasing quality of life. METHODS:This study will be a randomized controlled trial. ePain will take the form of a 6-week online pain management programme. Participants will be aged 15 years or above, have chronic pain, and be employed. They must complete the baseline questionnaire and will be randomized into intervention and control groups. They will receive notifications to encourage their participation in ePain and complete the evaluation questionnaires. They will complete the process evaluation at week 3, the post assessment at week 6, and the follow-up assessment at week 12. The study will focus on pain self-efficacy; pain situations; negative emotions including levels of depression, anxiety, and stress; and quality of life. The participants' opinions of ePain will be collected as feedback. Data will be analysed on an intention-to-treat basis and generalized estimating equations will be used to investigate the time-averaged difference and differences at each follow-up time. DISCUSSION:The study will provide information about the pain situations of online users in the working population. The participants will benefit from improvements in pain self-efficacy, pain situations, emotional status, and quality of life. The study will illustrate whether online learning is an effective intervention for improving the pain self-efficacy of the working population. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03718702. Registered on 23 October 2018.

SUBMITTER: Tang SK

PROVIDER: S-EPMC7245757 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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The effectiveness of an electronic pain management programme for the working population with chronic pain: study protocol for a randomized controlled trial.

Tang Shuk Kwan SK Tse Mimi Mun Yee MMY Leung Sau Fong SF Fotis Theofanis T

Trials 20200524 1

<h4>Background</h4>Chronic pain is highly prevalent in the working population. People tend to attempt self-initiated treatments to manage their pain. The self-efficacy of behavioural change is a suitable model for guiding the development of an electronic pain management programme (ePain). The aim in this study is to develop ePain and to evaluate its effectiveness at improving pain self-efficacy, reducing pain intensity and negative emotions, and increasing quality of life.<h4>Methods</h4>This st ...[more]

PMID: 32448387

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Project description:IntroductionPersistent non-cancer pain affects one in five adults and is more common in Māori-the Indigenous population of New Zealand (NZ), adults over 65 years, and people living in areas of high deprivation. Despite the evidence supporting multidisciplinary pain management programmes (PMPs), access to PMPs is poor due to long waiting lists. Although online-delivered PMPs enhance access, none have been codesigned with patients or compared with group-based, in-person PMPs. This non-inferiority trial aims to evaluate the clinical and cost-effectiveness of a cocreated, culturally appropriate, online-delivered PMP (iSelf-help) compared with in-person PMP in reducing pain-related disability.Methods and analysisMixed-methods, using a modified participatory action research (PAR) framework, involving three phases. Phase I involved cocreation and cultural appropriateness of iSelf-help by PAR team members. Phase II: The proposed iSelf-help trial is a pragmatic, multicentred, assessor-blinded, two-arm, parallel group, non-inferiority randomised controlled trial. Adults (n=180, age ≥18 years) with persistent non-cancer pain eligible for a PMP will be recruited and block randomised (with equal probabilities) to intervention (iSelf-help) and control groups (in-person PMP). The iSelf-help participants will participate in two 60-minute video-conferencing sessions weekly for 12 weeks with access to cocreated resources via smartphone application and a password-protected website. The control participants will receive group-based, in-person delivered PMP. Primary outcome is pain-related disability assessed via modified Roland Morris Disability Questionnaire at 6 months post intervention. Secondary outcomes include anxiety, depression, stress, pain severity, quality of life, acceptance, self-efficacy, catastrophising and fear avoidance. Data will be collected at baseline, after the 12-week intervention, and at 3 and 6 months post intervention. We will conduct economic analyses and mixed-method process evaluations (Phase IIA).Ethics and disseminationThe Health and Disability Ethics Committee approved the study protocol (HDEC18/CEN/162). Phase III involves dissemination of findings guided by the PAR team as outcomes become apparent.Trial registration numberACTRN 12619000771156.

Project description:INTRODUCTION:Chronic pain has become a matter of public health concern due to its high prevalence and because public costs associated with treatment and disability increase each year. Research suggests that limitations in the traditional assessment of chronic pain patients limit the effectiveness of current medical treatments. The use of technology might serve change patient traditional monitoring into ecological momentary assessments, which might be visualised by physicians live. This study describes a randomised control trial designed to test the utility of a technology-based solution for pain telemonitoring consisting of a smartphone app for patients and a web application for physicians. The goal of this study will be to explore whether this combination of eHealth and mHealth improves the effectiveness of existing pain treatments. METHODS AND ANALYSIS:Participants will be 250 patients randomly assigned to one of these two conditions: treatment-as-usual (TAU) and TAU +app+?web. All participants will receive the usual treatment for their pain. Only the TAU +app+?web group use Pain Monitor app, which generates alarms that are sent to the physicians in the face of previously established undesired events. Physicians will be able to monitor app reports using a web application, which might result in an adjustment of treatment. We anticipate that the use of Pain Monitor plus the therapist web will result in a reduction of pain intensity and side effects of the medication. Improvements on secondary outcomes, namely fatigue, mood, pain interference, rescue medication use and quality of life, are also expected. Mixed repeated-measure multivariate analyses of variances will be conducted to investigate whether there are differences between preassessment and postassessment scores as a function of the experimental condition. ETHICS AND DISSEMINATION:Ethical approval from the Hospital General Universitari de Castellon was obtained. The findings will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER:NCT03606265.

Project description:Previous research suggests that self-management programs for people with chronic pain improve knowledge and self-efficacy but result in negligible effects on function. This study will investigate the effectiveness self-management support with pain science education and exercise on improving function for people with chronic pain in comparison to a wait-list control. A secondary objective is to determine which variables help to predict response to the intervention.This study will be an unblinded, randomized controlled trial with 110 participants comparing a 6-week program that includes self-management support, pain science education and exercise to a wait-list control. The primary outcome will be function measured by the Short Musculoskeletal Function Assessment - Dysfunction Index. Secondary outcomes will include pain intensity measured by a numeric pain rating scale, pain interference measured by the eight-item PROMIS pain interference item-bank, how much patients are bothered by functional problems measured by the Short Musculoskeletal Function Assessment - Bother Index, catastrophic thinking measured by the Pain Catastrophizing Scale, fear of movement/re-injury measured by the 11-item Tampa Scale of Kinesiophobia, sense of perceived injustice measured by the Injustice Experience Questionnaire, self-efficacy measured by the Pain Self-Efficacy Questionnaire, pain sensitivity measured by pressure pain threshold and cold sensitivity testing, fatigue measured by a numeric fatigue rating scale, pain neurophysiology knowledge measured by the Neurophysiology of Pain Questionnaire, healthcare utilization measured by number of visits to a healthcare provider, and work status. Assessments will be completed at baseline, 7 and 18 weeks. After the 18-week assessment, the groups will crossover; however, we anticipate carry-over effects with the treatment. Therefore, data from after the crossover will be used to estimate within-group changes and to determine predictors of response that are not for direct between-group comparisons. Mixed effects modelling will be used to determine between-group differences for all primary and secondary outcomes. A series of multiple regression models will be used to determine predictors of treatment response.This study has the potential to inform future self-management programming through evaluation of a self-management program that aims to improve function as the primary outcome.ClinicalTrials.gov NCT02422459 , registered on 13 April 2015.

Project description:IntroductionGout is increasing despite effective therapies to lower serum urate concentrations to 0.36?mmol/L or less, which, if sustained, significantly reduces acute attacks of gout. Adherence to urate-lowering therapy (ULT) is poor, with rates of less than 50% 1?year after initiation of ULT. Attempts to increase adherence in gout patients have been disappointing. We aim to evaluate the effectiveness of use of a personal, self-management, 'smartphone' application (app) to achieve target serum urate concentrations in people with gout. We hypothesise that personalised feedback of serum urate concentrations will improve adherence to ULT.Methods and analysisSetting and designPrimary care. A prospective, cluster randomised (by general practitioner (GP) practices), controlled trial.ParticipantsGP practices will be randomised to either intervention or control clusters with their patients allocated to the same cluster.InterventionThe intervention group will have access to the Healthy.me app tailored for the self-management of gout. The control group patients will have access to the same app modified to remove all functions except the Gout Attack Diary.Primary and secondary outcomesThe proportion of patients whose serum urate concentrations are less than or equal to 0.36?mmol/L after 6 months. Secondary outcomes will be proportions of patients achieving target urate concentrations at 12 months, ULT adherence rates, serum urate concentrations at 6 and 12 months, rates of attacks of gout, quality of life estimations and process and economic evaluations. The study is designed to detect a ?30%?improvement in the intervention group above the expected 50% achievement of target serum urate at 6 months in the control group: power 0.80, significance level 0.05, assumed 'dropout' rate 20%.Ethics and disseminationThis study has been approved by the University of New South Wales Human Research Ethics Committee. Study findings will be disseminated in international conferences and peer-reviewed journal.Trial registration numberACTRN12616000455460.

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The effectiveness of an electronic pain management programme for the working population with chronic pain: study protocol for a randomized controlled trial.

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The effectiveness of an electronic pain management programme for the working population with chronic pain: study protocol for a randomized controlled trial.

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