JMIR Publications

ABSTRACT

Background:

Chronic musculoskeletal pain (CMSP) affects between 13 and 47% of the population with a global growth rate of 20.3% within the last 15 years, suggesting that there is a high need for effective treatments. Pain diaries have long been a common tool in non-pharmacological pain-treatment in order to monitor and provide feedback on patients’ symptoms in daily life. More recently, positive refocusing techniques have come to use, promoting pain-free episodes and positive outcomes rather than focusing on managing the pain.

Objective:

This study aims to evaluate the feasibility (i.e., acceptability, intervention adherence, and fidelity) and initial signals of efficacy of the PerPAIN app, an ecological momentary intervention (EMI) for patients with CMSP. The app comprises digitalized monitoring using the experience sampling method (ESM) and feedback. Additionally, patients receive three micro-interventions targeted at refocusing of attention on positive events.

Methods:

In a micro-randomized trial, we will recruit 35 patients with CMSP, who will be offered the app for 12 weeks. Participants will be prompted to fill in four ESM monitoring questionnaires a day assessing the proximal outcome variables absence of pain, positive mood, subjective activity, as well as information on their current context. Daily and weekly, participants will be randomized to receive no feedback, verbal feedback or visual feedback on proximal outcomes assessed by ESM. Additionally, the app will encourage participants to complete three micro-interventions that are based on techniques from positive psychology and cognitive-behavioral therapy. These micro-interventions are prompts to report joyful moments, everyday successes, or to plan pleasant activities. After having familiarized themselves with each micro-intervention individually, participants will be randomized daily to receive one of the three exercises, or none. We will assess i) whether the two feedback types and, ii) the three micro-interventions increase proximal outcomes at the following time point. The micro-randomized trial forms part of the PerPAIN study investigating a personalized treatment approach to enhance treatment outcomes in CMSP (German Clinical Trials Register: DRKS00022792).

Results:

Approval was granted by the Ethics Committee II of the University of Heidelberg on August 4, 2020. Recruitment for the micro-randomized trial began in May 2021 and is ongoing at the time of submission. By October 10, 2022 n=24 participants have been enrolled in the micro-randomized trial.

Conclusions:

This trial will provide evidence on the feasibility of the PerPAIN app and initial signals of efficacy of the different intervention components. In a next step, the intervention would need to be further refined and then investigated in a definitive trial. This EMI may offer a way to provide low-level accessible treatment to a broad target population promising significant public health implications by lowering disease burden of chronic pain.