Effectiveness of the eVISualisation of physical activity and pain intervention (eVIS) in Swedish Interdisciplinary Pain Rehabilitation Programmes: study protocol for a registry-based randomised controlled clinical trial

Abstract

IntroductionLiving with chronic pain often involves negative consequences. Interdisciplinary Pain Rehabilitation Programmes (IPRP) is considered superior to single-treatment measures in patients with chronic pain. Despite this, effects emerge suboptimal and more than 20% of patients deteriorate in patient-reported physical health outcomes after IPRP. A novel e-Health intervention, eVISualisation (eVIS) of physical activity and pain, was systematically developed to facilitate individualisation of physical activity levels. By adding elements of data collection, visualisation and communication of objectively measured physical activity and patient-reported outcomes (pain intensity, interference of pain, pharmaceutical consumption) to existing treatment modalities in IPRP, the IPRP team acquires prerequisites to adapt advice and physical activity prescriptions and to evaluate set activity goals. The overall aim is twofold. First, the aim is to evaluate the feasibility of the subsequent registry-based randomised controlled clinical trial (R-RCT). Second, the aim is to prospectively evaluate the effectiveness of the eVIS-intervention as a supplement to IPRP on our defined primary (physical health) and secondary outcomes.Methods and analysisIn the R-RCT, recruitment of 400 patients with chronic pain will be performed at 15 IPRP units. A random allocation to either IPRP + eVIS or to control group that will receive IPRP only will be performed. Data from the initial 30 participants completing the study period (6 months) will be included in a pilot study, where key feasibility outcomes (recruitment, randomisation, implementation, treatment integrity, data collection procedure, preliminary outcome measures) will be evaluated. Outcome variables will be extracted from the web application Pain And TRaining ON-line (PATRON) and from six national registries. Multivariate statistics and repeated measure analyses will be performed. Quality-adjusted life years and incremental cost-effectiveness ratio will be calculated for cost-effectiveness evaluation.Ethics/disseminationThe Swedish Ethics Review Board granted approval (Dnr 2021/02109). Results will be disseminated through peer-reviewed journals.Trial registration numberNCT05009459. Protocol V.1.

Evaluation of content validity and feasibility of the eVISualisation of physical activity and pain (eVIS) intervention for patients with chronic pain participating in interdisciplinary pain rehabilitation programs

“…randomized pilot study before proceeding on to an effectiveness trial [20]. The pilot study will enable a further and more robust evaluation of key feasibility outcomes to be made, and on a larger sample.…”

“…Objective monitoring of physical activity combined with self-reported data enables the unique adaptation of physical activity prescriptions based on individual barriers and resources. The effectiveness of eVIS is to be evaluated through a registry-based randomised controlled clinical trial (R-RCT), described in the study protocol by Sjo ¨berg et al [20].…”