Limitations
pain
EVENT
The main limitation of this study is the drop of 18 patients after the randomization procedure for various reasons mentioned above. This event could have altered the comparability of the two groups, and it is the reason for which we compared the characteristics of patients included in the analysis. To check whether or not the comparability was altered, we also compared the 102 patients included in the analysis to the 18 patients who were not, and we observed their characteristics to be strictly comparable.Moreover, from treatment initiation, while the patient cohort was quite stable on the first 2 days of participation, the participant number decreased continuously until day 5. In addition to the smaller group size, which affects the power of the statistical analysis, patients dropping out can affect patients’ randomization (from day 3 onward). The findings therefore describe the best available data. Reasons for stopping treatments were not collected and such a decrease did not allow a sufficient sample size to conclude on the main objective of the study from days 3 to 5.Further, patients were exposed to only one 20-minute scenario: the same environment repeated up to twice a day may have induced some boredom in exposed patients and may have led some to discontinue the study treatments. This emphasizes the importance of patients’ engagement in this type of new home treatment and the need to develop strategies to ensure treatment adherence over time. Gamification and diversification may play a positive role in this aspect.Finally, considering the objectives, this study was not conducted in a standardized hospital setting but rather at patients’ homes without strict medical supervision and based on declarative data. However, as a reminder, the device is intended to be used at home (over the counter) where and when patients need it the most. Chronic pain is constant and cannot only be treated during hospital consultations. Patients were also given the possibility to use the study treatments at any time of the day without a strict schedule, which may have had an impact on the treatment efficacy depending on their stress level and pain intensity that may vary during the day. The impact of the weekend versus weekdays has not been investigated and may have an influence on multiple parameters, including treatment adherence.