Introduction
Chronic musculoskeletal pain is a highly prevalent, complex and distressing condition that may negatively affect all domains of life. In view of an active inference framework, and resting on the concept of allostasis, human movement per se becomes a prerequisite for health and well-being while chronic pain becomes a sign of a system unable to attenuate an allostatic load. Previous studies on different subgroups of chronic pain conditions have demonstrated alterations in gait kinematics and muscle activity, indicating shared disturbances in the motor system from long-term allostatic load. We hypothesise that such alterations exist in heterogenous populations with chronic musculoskeletal pain, and that exposure to acute and controlled exercise may attenuate these alterations. Therefore, the main aim of this study is to investigate the acute effects of exercise on gait kinematics and activity of the back and neck muscles during diverse walking conditions in patients with chronic musculoskeletal pain compared with a reference sample consisting of healthy participants.
Methods and analysis
This two-sample two-armed parallel randomised controlled laboratory trial will include 40 participants with chronic musculoskeletal pain (>3 months) and 40 healthy participants. Participants will be randomly allocated to either 30 min of aerobic exercise or rest. Primary outcomes are gait kinematics (walking speed, step frequency, stride length, lumbar rotation, gait stability) and muscular activity (spatial and temporal) of the back and neck during diverse walking conditions. Secondary outcomes are variability of gait kinematics and muscle activity and subjective pain ratings assessed regularly during the trial.
Ethics and dissemination
The study has been approved by the Regional Ethics Review Board in Uppsala, Sweden (#2018/307). Findings will be disseminated via conference presentations, publications in peer-reviewed journals and engagement with patient support groups and clinicians.
Trial registration number
NCT03882333.
Background and aims: * Interdisciplinary Pain Rehabilitation Programs (IPRPs) are considered to be superior to single-treatment measures in chronic pain treatment. However, the effects of IPRPs are moderate and as many as 30% of patients deteriorate in some outcomes. Although physical activity and exercise are central components in IPRPs, many patients struggle to achieve and maintain the recommended levels. An intervention, entitled eVISualisation of physical activity and pain (eVIS), has now been systematically developed and designed to facilitate patients with chronic pain in achieving and maintaining recommended physical activity levels. The aim of the present study protocol is to transparently report on the methodology, outcomes, and processes for an initiated registry-based randomized controlled trial (R-RCT), which will evaluate the effectiveness of eVIS on the primary outcome physical health and defined secondary outcomes. Methods: * Participants (approximately 400) will be recruited from IPRP units and randomly allocated to either IPRP with an addition of eVIS or to treatment as usual by IPRP. eVIS entails objectively measured physical activity and patient-reported outcomes of pain intensity, effect on daily activities and pharmaceutical consumption. Data is collected and visualized in a web application, PATRON. Pilot analyses evaluating the feasibility of the R-RCT will be performed on data from initial 30 participants. Outcomes will be extracted from PATRON and from six national registries. Multivariate statistics and repeated measures analyses will be performed. Results: * Recruitment will be initiated in late 2021. ClinicalTrials.gov identifier: NCT05009459. Conclusions: * This study protocol describes a R-RCT that is designed to provide robust data on the feasibility and effectiveness of eVIS as an addition to IPRPs.
Introduction Living 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 patientreported 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 two fold. 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 eVISintervention as a supplement to IPRP on our defined primary (physical health) and secondary outcomes.
Methods and analysis In 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/dissemination The Swedish Ethics Review Board granted approval (Dnr 2021/02109). Results will be disseminated through peer-reviewed journals.
Trial registration number NCT05009459. Protocol V.1