To assess the effects of the EXOPULSE Mollii Suit on fibromyalgia in terms of health status and functional disability, specifically using the Fibromyalgia Impact Questionnaire (FIQ) as the primary outcome, and evaluating its impact on pain, fatigue, anxiety, depression, and quality of life as secondary outcomes.
Key Findings:
Significant reduction in FIQtotal scores from 66.06 to 50.81 after active intervention (P < .01).
No significant changes observed after sham intervention.
Improvements noted in pain catastrophizing and quality of life domains.
Phase 2 showed sustained benefits in FIQtotal and secondary outcomes.
Interpretation:
The EXOPULSE Mollii Suit demonstrated clinically meaningful improvements in fibromyalgia impact and related symptoms, supporting its potential as a home-based neuromodulation therapy, which could enhance patient quality of life.
Limitations:
Small sample size with only 22 participants completing phase 1, which may introduce bias.
Short duration of follow-up in the study.
Conclusion:
The EXOPULSE Mollii Suit may offer a promising non-pharmacological treatment option for fibromyalgia, warranting further large-scale studies with diverse participant demographics to confirm findings.
